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Jake O'Keeffe — Thu, 17 Mar 2022 17:58:49 +0000

Press articles and a release from the World Trade Organization indicate that the small group negotiations between the European Union, United States, India and South Africa have reached a compromise on the India-South Africa proposal for a broad waiver of TRIPS requirements during the COVID-19 pandemic and the European Union’s proposal for a different solution that wouldn’t constitute a waiver.

The agreement, which still requires final agreement on text by the small group and then consideration and acceptance by the full WTO Membership, is a staged one, applying first to vaccines and six months later (if subsequently agreed) to diagnostics and therapeutics. The agreement would apply to developing countries other than those who exported 10% or more of vaccines in 2021. Based on the WTO-IMF COVID-19 Vaccine Trade Tracker, the only developing country with 10% or more of global exports in 2021 was China.

By picking exports in 2021 as the test for eligibility for developing countries, India remains eligible for the proposed compromise simply because the country, one of the world’s largest vaccine producers and a country that had contracts to export huge quantities to many of the world’s poorest countries in 2021, closed off exports for much of 2021 because of internal needs.

Press reports have indicated that some other countries, like Brazil, are not eligible. If true, this would flow from something other than export volume (e.g., indication that it would not seek special and differential treatment going forward) as Brazil had a negligible share of global exports of COVID vaccines in 2021.

The WTO’s Director-General released a press statement on March 16 which is copied below.

“World Trade Organization Director-General Ngozi Okonjo-Iweala today warmly welcomed the breakthrough among four WTO Members on a waiver of the Trade Related Intellectual Property agreement for the production of vaccines against the COVID-19 pandemic.

“’This is a major step forward and this compromise is the result of many long and difficult hours of negotiations. But we are not there yet. We have more work to do to ensure that we have the support of the entire WTO Membership,’ the Director-General said.

“While the agreement between the European Union, India, South Africa and the United States is an essential element to any final deal, she cautioned that not all the details of the compromise have been ironed out and that internal domestic consultations within the four members are still ongoing.Bodog Poker Moreover, she stressed that work must commence immediately to broaden the discussions to include all 164 members of the WTO.

“’In the WTO we decide by consensus, and this has not yet been achieved. My team and I have been working hard for the past three months and we are ready to roll up our sleeves again to work together with the TRIPS Council Chair Ambassador Lansana Gberie (Sierra Leone) to bring about a full agreement as quickly as possible. We are grateful to the four Members for the difficult work they have undertaken so far,’ said Dr. Okonjo-Iweala.”

Neither the EU nor the U.S. have released statements which is consistent with the apparent state of play of the negotiations in the small group. One of the parties or one of those private parties being consulted by WTO Members presumably has leaked the text which is available on Stats News.

Proponents and opponents of a TRIPS waiver responded quickly as reflected in press releases and other articles.

The proponents of a waiver are basically unhappy with the compromise which is not a waiver but rather a modification to requirements under TRIPS Art. 31. They are also unhappy with the fact that only vaccines are covered initially and the fact that the draft agreement deals with patents only versus the broader array of intellectual property rights. The statement from Doctors Without Borders reflects the types of concerns from those wanting a broader agreement and is copied below.

“MSF responds to potential compromise on the ‘TRIPS Waiver’

“Compromise neglects COVID-19 treatments and diagnostics and fails to address intellectual property barriers beyond patents, but there’s still time to get it right

“Geneva, 16 March 2022

“– The European Union, India, South Africa and the United States are working on a possible compromise to address intellectual property (IP)barriers on COVID-19 medical products. Médecins Sans Frontières/Doctors Without Borders (MSF) acknowledges the efforts towards a final resolution, but notes that the text that was leaked today is far from being an IP ‘waiver’ for pandemic medical tools.

“MSF urges all World Trade Organization (WTO) members to be aware of the limitations of the leaked text. WTO members should work together to ensure that any agreement tackles the current barriers to accessing all COVID-19 medical tools, including treatments and diagnostics, and also addresses patents and non-patent barriers in an effective way.

“According to MSF’s initial analysis, key limitations of the leaked text include that it covers only vaccines, is geographically limited, and covers only patents and does not address other intellectual property barriers, such as trade secrets, which may cover critical information needed to facilitate manufacturing. Regarding compulsory licensing for patents on COVID-19 vaccines, the leaked text introduces unnecessary reporting requirements for WTO members that could undermine the effectiveness of the mechanism.

“The leaked text appears to leave the door open for possible inclusion of treatments and diagnostics at a later stage. But delaying the decision on treatments is unacceptable, as many people will have no access to generic antivirals and countries are paying high prices for access to lifesaving treatments like baricitinib due topatent monopolies that block more affordable generic versions.

“The leaked text also fails to cover all countries. It limits ‘eligible members’ to developing countries and only those who exported less than 10 percent of the world’sCOVID-19 vaccine exports in 2021, effectively excluding Brazil and China from being able to use the ‘waiver’.

“The proposed compromise would require authorisation by governments on a product-by-product basis, which was one of the shortcomings of the existing mechanism in a pandemic context and makes its use very cumbersome. There is also a new obligation to identify all patents covered by the authorisation, something not required today under WTO trade rules.

“MSF points again to our position underlining the necessary scope and duration of an effective TRIPS Waiver for COVID-19.

“Dimitri Eynikel, EU Policy Advisor for MSF’s Access Campaign:

“‘While it is good to see the groundwork for a potential compromise on addressing COVID-19 intellectual property barriers, all WTO members should remain vigilant to the fact that this leaked text contains considerable limitations, and needs to be urgently improved.

“It is incredibly concerning that the leaked text currently only covers vaccines, but neither treatments nor diagnostics. Excluding treatments and diagnostics is acritical weakness, especially as access to COVID-19 treatments remains a significant problem in many low- and middle-income countries, particularly in Latin America, in part because of patent barriers and restrictive licensing deals controlled by pharmaceutical corporations. Excluding countries with significant manufacturing and supply capacity like Brazil is highly problematic as it arbitrarily blocks potential critical avenues to increase access to COVID-19 medical tools for low- and middle-income countries.

“‘The world needs effective solutions to the inequities in access for all COVID-19 medical tools witnessed in this pandemic. The good news is there is still room for governments to improve and make sure that any final agreement adequately addresses the remaining barriers now missing in the leaked text. We urge all WTO members to do so.’”

The pharmaceutical industry’s concerns basically follow their longstanding position that with the rapid increase in vaccine production in 2021 and ongoing in 2022, there is no need for the agreement and it sends the wrong message to innovators. The statement from the IPFMA is copied below.

“Following reports on the status of informal discussions led by the WTO Secretariat with the European Union (EU), India, South Africa, and the USA, on 16 March 2022, biopharmaceutical companies reaffirm their position that weakening patents now when it is widely acknowledged that there are no longer supply constraints of COVID-19 vaccines, sends the wrong signal.

“2022 kicked off with COVID-19 vaccine production from both developing and developed country manufacturers reaching 12 billion within a year of the first vaccine being authorized. Today industry is able to produce over a billion vaccine each month. COVAX is now fully meeting its commitments. Since the beginning of 2022, there has been broad consensus that the challenge now is how to get the vaccines into the arms of people who need them, rather than vaccine supply. When the IP TRIPS Waiver was first proposed in 2020, it was to the wrong solution to the problem of scaling up manufacturing of potential COVID-19 vaccines which at the time had not yet even been authorized. Now the problem of supply has been addressed thanks to unprecedented collaboration involving companies from industrialized and developing countries, the TRIPS Waiver is not only the wrong solution, it is also an outdated proposal, that has been overtaken by events.

“Weakening intellectual property (IP) will do nothing to help the scaling up of vaccine manufacturing. There is a broad consensus among experts that waiving patents would not add a single additional vaccine dose, because technology transfer goes far beyond the patent, is built on trust, know-how sharing and voluntary licensing. This is exactly what manufacturers have done on an unprecedented scale. As of now, there are 371 collaborations on vaccines manufacturing and 155 for therapeutics and, in addition, the multiple announcements of partnerships to improve geographical diversity of vaccine production, are proof in themselves that the proposed IP TRIPS waiver is unnecessary and irrelevant, at worst sends the wrong signal at the wrong time.

“The IP TRIPS Waiver proposals should be recognized for what they are – political posturing that are at best a distraction, at worse creating uncertainty that can undermine innovation’s ability to respond to the current and future response to pandemics. The current proposals should be shelved; and the focus should be directed, to admittedly more difficult actions that will change lives for the better: supporting country readiness, contributing to equitable distribution, and driving innovation”

Comments

Over the last eighteen months, I have posted regularly on the COVID-19 pandemic and the Indian and South African proposal for a broad TRIPS waiver. Following the recent European Union – African Union meeting in Brussels, it was clear that the EU was committed to finding a mutually agreeable solution with the countries of Africa in the coming months. Thus, the announcement of a breakthrough in the small group negotiations is not surprising.

Data gathered and published by various multilateral organizations confirm the enormous ramp up in both vaccine capacity and production. And there has been significant movement in increasing production of vaccines in more developing countries, including a number in Africa.

Articles also confirm that the challenge in low-income countries is now not access to vaccines but rather all of the other requirements to achieve much higher vaccination rates (including better access to testing).

Thus, it is hard for me to find merit in the ongoing claims for a need for a broad TRIPS waiver or even the draft agreement at least as it pertains to the COVID-19 pandemic and equitable access to vaccines. WTO relevance requires addressing either current pressing issues or those that will continue to be present in the future. The draft agreement may meet the need for some compromise between Members like the EU and India, South Africa and other supporters of the waiver. However, the agreement doesn’t appear to serve a useful purpose by addressing current challenges (e.g., testing) or addressing a road forward for future pandemics.

Terence Stewart, former Managing Partner, Law Offices of Stewart and Stewart, and author of the blog, Current Thoughts on Trade.

To read the full commentary from Current Thoughts on Trade, please click here.

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Bodog Poker|Welcome Bonus_Vaccine Archives - WITA

Samantha Kromkowski — Wed, 16 Feb 2022 21:05:37 +0000

BioNTech which has partnered with Pfizer in producing an mRNA vaccine to address COVID-19, issued a press release today (February 16, 2022) from Mainz, Germany outlining its development of modular mRNA manufacturing facilities and their intended deployment in Africa. See BioNTech, Press Release, BioNTech introduces first modular mRNA manufacturing facility to promote scalable vaccine production in Africa, 16 February 2022, https://investors.biontech.de/news-releases/news-releasedetails/biontech introduces-first-modular-mrna-manufacturing-facility (https://investors.biontech.de/news-releases/news-release-details/biontech introduces-first-modularmrna-manufacturing-facility). Part of the press release is copied below.

” BioNTech SE (Nasdaq: BNTX, “BioNTech”) has taken a next step to improve vaccine supply in Africa. The company has introduced its approach to establishing scalable vaccine production by developing and delivering turnkey mRNA manufacturing facilities based on a container solution. At a high-level meeting 2/16/22, 3:54 PM Building Vaccine Capacity in Africa – Exciting News from BioNTech | Current Thoughts on Trade https://currentthoughtsontrade.com/2022/02/16/building-vaccine-capacity-in africa-exciting-news-from-biontech/ 2/8 at BioNTech’s new manufacturing facility in Marburg and at the invitation of kENUP Foundation, the company presented the container solution named ‘BioNTainer’ to key partners.

“Attendees included President Macky Sall of Senegal, President Nana Akufo-Addo of Ghana, President Paul Kagame of Rwanda, Tedros Adhanom Ghebreyesus, Director General of the World Health Organization, John Nkengasong, Director of the Africa Centers for Disease Control and Prevention (Africa CDC), and Svenja Schulze, the Federal Minister of Economic Cooperation and Development of Germany. Together with BioNTech’s Co-Founders Prof. Ugur Sahin, CEO, and Prof. Özlem Türeci, CMO, and COO Dr. Sierk Poetting, they jointly discussed the infrastructure, regulatory and technological requirements to establish an end-to end manufacturing network for mRNA-based vaccines in Africa.

“The manufacturing solution consists of one drug substance and one formulation module, each called a BioNTainer. Each module is built of six ISO sized containers (2.6m x 2.4m x 12m). This allows for mRNA vaccine production in bulk (mRNA manufacturing and formulation), while fill-and-finish will be taken over by local partners. Each BioNTainer is a clean room which BioNTech equips with state-of-the-art manufacturing solutions. Together, two modules require 800 sqm of space and offer an estimated initial capacity of for example up to 50 million doses of the Pfizer-BioNTech COVID-19 vaccine each year. The BioNTainer will be equipped to manufacture a range of mRNA-based vaccines targeted to the needs of the African Union member states, for example the Pfizer-BioNTech COVID-19 vaccine and BioNTech’s investigational malaria and tuberculosis vaccines, if they are successfully developed, approved or authorized by regulatory authorities.

“The capacity can be scaled up by adding further modules and sites to the manufacturing network on the African continent. One of the most critical parts of the manufacturing process is quality control, which includes all necessary tests for each finished vaccine batch. In partnership with local quality control testing labs, BioNTech will help to ensure the identity, composition, strength, purity, absence of product- and process-related impurities, as well as the absence of microbiological contamination of each produced batch.

“The establishment of the first mRNA manufacturing facility by BioNTech in the African Union is expected to start in mid-2022. The first BioNTainer is expected to arrive in Africa in the second half of 2022. Manufacturing in the first BioNTainer is planned to commence approximately 12 months after the delivery of the modules to its final location in Africa. BioNTech expects to ship BioNTainers to Rwanda, Senegal and potentially South Africa in close coordination with the respective country and the African Union. BioNTech will be responsible for the delivery and installation of the modules, while local organizations, authorities and governments will ensure the needed infrastructure. Partners in Ghana and South Africa could support the manufacturing with fill and-finish capacities. BioNTech will work closely 2/16/22, 3:54 PM Building Vaccine Capacity in Africa – Exciting News from BioNTech | Current Thoughts on Trade
https://currentthoughtsontrade.com/2022/02/16/building-vaccine-capacity-in africa-exciting-news-from-biontech/ 3/8 with local authorities to ensure compliance to relevant regulatory procedures of the national regulatory agencies in each partner country, and also coordinate where appropriate with relevant continental and international agencies, including WHO, Africa CDC, the African Medicines Agency (AMA), and the African Union Development Agency (AUDA-NEPAD).

“BioNTech will initially staff and operate the facilities to support the safe and rapid initiation of the production of mRNA-based vaccine doses under stringent good manufacturing processes (“GMP”) to prepare for the transfer of know-how to local partners to enable independent operation. Vaccines manufactured in these facilities are expected to be dedicated to domestic use and export to other member states of the African Union at a not-for-profit price.”

While the announcement by BioNTech will not address the short-term 2022 production and distribution needs of COVID-19 vaccines to low and lower-middle income countries (WHO is urging the world to obtain 70% vaccination rates in all countries by summer 2022), the announcement adds to the momentum of creating manufacturing of vaccines (for COVID-19 and other needs) in Africa. See Carnegie Endowment for International Peace, Is there Any COVID-19 Vaccine Production in Africa?, September 13, 2021, https://carnegieendowment.org/2021/09/13/is-there-any-covid-19-vaccine production-in africapub85320#:~:text=Africa%20manufactures%20less%20than%20one, ave%20faced%20severe%20supply%2 0shortages (https://carnegieendowment.org/2021/09/13/is-there-any-covid-19-vaccine production-inafrica pub85320#:~:text=Africa%20manufactures%20less%20than%20one,have%2 faced%20severe%20supply%2 0shortages) (“Efforts are being made to ramp up production of COVID-19 vaccines on the African continent. As of September 2021, there are at least twelve COVID-19production facilities set up or in the
pipeline across six African countries (see figure). African COVID-19 vaccine manufacturing in the coming year could range from Pfizer-BioNTech and Johnson & Johnson vaccines to Russia’s Sputnik V and China’s Sinovac vaccines. In South Africa, the U.S. International Development Finance Corporation, along
with European partners, announced a 600 million euro ($710 million)financing package for Aspen Pharmacare. Aspen’s facility has already produced millions of doses and will ‘fill-and-finish’ (i.e. package imported vaccine substance) around 500 million Johnson & Johnson doses by the end of 2022. South Africa’s Biovac Institute has also agreed to accelerate fill-and-finish Pfizer vaccine manufacturing in Cape Town from 2022. In Senegal, the government—with Pfizer support from the United States and Europe—is building a $200million COVID-19 vaccine manufacturing facility with the Fondation Institut Pasteur de Dakar. This facility would represent the first on the continent to actually manufacture the substance of vaccines in parallel with fill-and-finish. Starting in November 2021, the Egyptian government will produce Chinese Sinovac at a new Vacsera facility outside Cairo, with a planned capacity of 2/16/22, 3:54 PM Building Vaccine Capacity in Africa – Exciting News from BioNTech | Current Thoughts on Trade https://currentthoughtsontrade.com/2022/02/16/building-vaccine-capacity-in africa-exciting-news-from-biontech/ 4/8 1 billion vaccines annually. And with two agreements for drug substance manufacturing and fill-andfinish of Russia’s Sputnik V vaccine, Egypt may soon join Senegal in reducing Africa’s dependency on vaccine imports.”) The BioNTech press release contains eleven quotes from government and business officials, including EC President Ursula von der Leyen, the Presidents of Senegal, Rwanda, Ghana and the African Union, the WHO Director-General, the Chancellor of the Republic of Germany and others.

2/16/22, 3:54 PM Building Vaccine Capacity in Africa – Exciting News from BioNTech | Current Thoughts on Trade https://currentthoughtsontrade.com/2022/02/16/building-vaccine-capacity-in africa-exciting-news-from-biontech/ 5/8 The announcement by BioNTech is both exciting and important longer term for greater vaccine equity for various purposes. As noted in one of the many news articles on the announcement, Pfizer and BioNTech have also pledged to supply up to two billion COVID-19 vaccine doses to low-income countries during 2022. See Wall Street Journal, BioNTech Unveils Mobile Covid-29 Vaccine Factories for Developing World, February 16, 2022, https://www.wsj.com/articles/biontech-unveils-mobile-covid-19-vaccine factoriesfor-developing-world-11645007401 (https://www.wsj.com/articles/biontech-unveils-mobile-covid-19- vaccine-factories-for-developing-world-11645007401); see also Reuters, BioNTech to ship mRNA vaccine factory kits to Africa, February 16, 2022, https://www.reuters.com/business/healthcarepharmaceuticals/biontech-ship-mrna-vaccine-factory-kits-africa-2022-02-16/ (https://www.reuters.com/business/healthcare-pharmaceuticals/biontech-ship mrna-vaccine-factorykits-africa-2022-02-16/); Fortune, Pfizer partner BioNTech unveils container-based COVID vaccine factories that could start manufacturing doses in Africa this year, February 16, 2022,
https://fortune.com/2022/02/16/pfizer-biontech-covid-vaccine-biontainers inequality-africa-afrigenwho/ (https://fortune.com/2022/02/16/pfizer biontech-covid-vaccine-biontainers-inequality-africaafrigen-who/). It is those efforts at getting doses produced in the front half of 2022 to low income and lower-middle income countries that will be most important in meeting the immediate goal of dramatically increasing vaccine rates in Africa and in other countries with current low vaccination rates.

As reviewed in a number of earlier posts, the progress being made in vaccine equity to address COVID-19 in 2022 will not be dependent on the outcome of the ongoing WTO consideration of whether TRIPS obligations should be waived for COVID-19 vaccines. Rather progress is dependent on expanded production, moving product to needed countries, work in countries to ensure the ability to distribute vaccines received and expanded funding of COVAX. See, e.g., January 30, 2022: Recent National Public Radio story, “Africa may have reached the pandemic’s holy grail,” raises interesting questions on a country’s age distribution and ability to get past the pandemic stage with lower vaccination rates, 2/16/22, 3:54 PM Building Vaccine Capacity in Africa – Exciting News from BioNTech | Current Thoughts on Trade https://currentthoughtsontrade.com/2022/02/16/building-vaccine-capacity-in-africa-exciting-news-from-biontech/ 6/8
https://currentthoughtsontrade.com/2022/01/30/recent-national-public-radio-story-africa-may-havereached-the-pandemics-holy-grail-raises-interesting-questions-on-a-countrys-age-distribution-andability-to-get-past-the-pandemic-stage-wit/ (https://currentthoughtsontrade.com/2022/01/30/recentnational-public-radio-story-africa-may-have-reached-the-pandemics-holy-grail-raises-interestingquestions-on-a-countrys-age-distribution-and-ability-to-get-past-the-pandemic-stage-wit/); January 23,
2022: COVID-19 Omicron variant – hopeful signs of peaking in the U.S. and Europe; supply disruptions continue from zero tolerance policy in China, https://currentthoughtsontrade.com/2022/01/23/covid-19- omicron-variant-hopeful-signs-of-peaking-in-the-u-s-and-europe-supply-disruptions-continue fromzero-tolerance-policy-in-china/ (https://currentthoughtsontrade.com/2022/01/23/covid-19-omicronvariant hopeful-signs-of-peaking-in-the-u-s-and-europe-supply-disruptions-continue from-zerotolerance-policy-in-china/); January 11, 2022: WTO efforts to address the COVID-19 pandemic — the January 10, 2022 General Council meeting and some current developments of interest, https://currentthoughtsontrade.com/2022/01/11/wto-efforts-to-address-the covid-19-pandemic-thejanuary-10-2022-general-council-meeting-and-some current-developments-of-interest/ (https://currentthoughtsontrade.com/2022/01/11/wto-efforts-to-address-the covid-19-pandemic-thejanuary-10-2022-general-council-meeting-and-some current-developments-of-interest/).

Terence Stewart, former Managing Partner, Law Offices of Stewart and Stewart, and author of the blog, Current Thoughts on Trade.

To read the full commentary from Current Thoughts on Trade, please click here.

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Bodog Poker|Welcome Bonus_Vaccine Archives - WITA

Jude Althagafi — Wed, 13 Oct 2021 15:39:52 +0000

The world’s trade ministers are struggling to deliver a concrete response to the urgent appeal by the new director-general of the World Trade Organization (WTO), Ngozi Okonjo-Iweala, that vaccinating the world against COVID-19 “is a moral, practical, and economic imperative.” The WTO’s twelfth ministerial conference (MC12) at the end of November can make progress by getting trade officials to reengage in the pandemic challenge. To vaccinate the world, they should support a new COVID-19 Vaccine Investment and Trade Agreement that focuses on accelerating immediate-term production.

In the story of COVID-19 vaccines, trade is both hero and villain. The unglamorous, day-to-day import and export of raw materials, equipment, and vaccines taking place under the rules of the multilateral trading system have already helped save millions of lives and livelihoods. The WTO should be celebrated for creating an environment to facilitate this progress, however limited.

But WTO members also deserve criticism for not doing more to scale up vaccine production. Despite some progress on international cooperation, their efforts have been piecemeal, often bilateral and inefficient, failing to leverage the collective action framework the WTO provides. In addition, the activities of some of the WTO members actively engaged in Geneva are not necessarily aligned with Okonjo-Iweala’s implicit call for measures that would immediately increase vaccine production.

Accordingly, the United States, European Union, and India must convene a small and select group of critical WTO members to facilitate a plurilateral COVID-19 Vaccine Investment and Trade Agreement. The deal should be agreed by MC12 and focus on accelerating the manufacturing needed to get more than 16 billion additional vaccine doses produced and traded as soon as possible.

COVID-19 VACCINE DOSES CONSTITUTE PROGRESS, BUT BILLIONS MORE ARE NEEDED

As of October 6, 2021, roughly 6.5 billion COVID-19 vaccine doses have been administered globally. Together the United States and European Union account for nearly one billion of those doses, increasingly the highly effective mRNA-based vaccines from Pfizer-BioNTech and Moderna (figure 1). India has dispensed more than 900 million doses; much of that is the AstraZeneca vaccine manufactured locally by the Serum Institute of India. China has administered more than 2.2 billion doses of its home-grown vaccines, including Sinovac and Sinopharm.

At the other extreme is Africa, which has administered only 160 million doses. Roughly 4 percent of the continent’s adult population has been fully vaccinated. Globally, low-income countries are estimated to have vaccinated less than 3 percent of their populations. The World Health Organization target of vaccinating 40 percent of their populations by the end of 2021 is increasingly out of reach.

It is remarkable that the world acted with unprecedented speed to invent multiple life-saving vaccines, get them through clinical trials and rigorous regulatory processes, and manufacture as well as distribute 6.5 billion doses globally so far. Few would have predicted this achievement at the outset of the pandemic. But the crisis is far from over, and obvious shortfalls need to be addressed. COVAX, the consortium organized by Gavi (the Vaccine Alliance), the Coalition for Epidemic Preparedness Innovations (CEPI), and the World Health Organization, was established early for distributing COVID-19 vaccines to poor countries. But it has failed to do so because it could not secure a sufficient number of doses from companies and the countries where the manufacturing is located. Instead, India, the United States, European Union, United Kingdom, and China all prioritized allocating locally produced doses to their entire eligible domestic populations, including those at low risk.

In the continued absence of vaccine-producing countries agreeing and adhering to a more equitable vaccine sharing scheme based on global public health needs, the only solution is that manufacturers in those countries greatly expand their production targets.

The mathematics are simple but stunning. With the exception of Johnson & Johnson, each of the other vaccines is a two-dose regimen. For a global population of more than 7 billion, the starting point is thus roughly 14 billion doses. With waning immunity, some governments are already granting third doses; universal adoption could push demand to 21 billion doses. Finally, because governments are stockpiling excess doses and because there is some inevitable waste in the system (e.g., expired, or opened but unused vaccines), estimated demand must be increased by 10 percent. To be safe, about 23 billion doses of COVID-19 vaccines may thus be needed in the immediate term.

Going from 6.5 billion administered doses to the capacity to manufacture roughly 16 billion more doses is still a long way off.

TRADE AND COVID-19 VACCINE MANUFACTURING SUPPLY CHAINS TODAY

Trade will ultimately be the unsung hero if and when COVID-19 vaccines are eventually credited with helping to control the pandemic. For billions globally, shots will not be available through local production, and imports are the only answer. But even Americans and Europeans living in countries where vaccines are manufactured depend on international supply chains in ways that are still poorly understood.

Start with the cross-border movement of people and ideas. In the United States, two of the three authorized vaccines were invented at least partially overseas. The Pfizer jab was created by Turkish immigrants at BioNTech in Germany; Johnson & Johnson was codeveloped at the Janssen R&D lab in the Netherlands. A similar story has emerged for vaccines being administered across the European Union. US-based scientists came up with the Moderna shot, and British researchers at Oxford invented the AstraZeneca vaccine.

Trade has also enabled the cross-border transfer of technology and development of brand new supply chains for COVID-19 vaccine manufacturing. While each vaccine maker created a unique supply chain capable of producing billions of doses annually, one common feature was trade.[1] Take two examples of the basic two-step process of first manufacturing the drug substance and formulating it into drug product in one set of plants before shipping it to a second “fill and finish” assembly-line style plant where the liquid vaccine is put into millions of vials for distribution.

Pfizer and BioNTech mostly relied on their own manufacturing facilities to perform the first step, even by mid-2021 (figure 2). The flow of technology and ingredients between the Pfizer and BioNTech plants in different countries was one form of trade. A second arose within its European supply chain, where the mRNA vaccine might be manufactured at facilities in Germany or Ireland but then shipped over a border to that second type of plant for bottling in Switzerland, France, or Italy.

AstraZeneca set up a different type of production network, but one that also featured trade (figure 3). The jab was invented in Oxford, but instead of using its own plants, AstraZeneca transferred the technology to contractors to manufacture its vaccine, including companies in many developing countries. The largest manufacturer of the AstraZeneca vaccine is the Serum Institute of India. It is also being produced through networks of facilities in the European Union, South America, Japan, Thailand, and Australia, as well as in the United Kingdom and elsewhere.

Highly specialized inputs are a third way in which trade has been essential. Each COVID-19 manufacturer relies on a host of critical equipment and raw materials—such as bioreactors, bioreactor bags, filtration pumps, filters, cellular materials, vials, stoppers, syringes, and other ancillary supplies—that are often produced only in other countries.

Shortages of those imported inputs often grabbed headlines during the pandemic. The heads of the Serum Institute of India, Novavax, Biological E., and CureVac all complained publicly that such import shortfalls impeded their abilities to reach production targets. (Pfizer and Moderna also complained of input shortages but did not necessarily tie them to imports.) On the other hand, such interdependence and the fear of a trading partner retaliating by shutting down a vaccine input pipeline likely also helped keep trade for finished vaccines flowing in the other direction. Take the lipid nanoparticles critical to the mRNA vaccine of Pfizer-BioNTech (see again figure 2). The United Kingdom was a critical source of lipid nanoparticles early in 2021 for the plants in the European supply chain. Keeping those UK exports flowing during the pandemic was essential to getting those vaccines manufactured and ultimately shipped back to the United Kingdom despite rising UK-EU political tensions.[2]

But trade disruptions are also the problem in the COVID-19 vaccine story. Though less an indictment of the WTO, governments of vaccine-manufacturing economies engaged in “vaccine nationalism” by refusing to share enough doses with COVAX to distribute to health care workers and vulnerable populations globally. The failure to prioritize the global public health crisis has led to additional deaths and to the emergence of lethal virus variants that have spread to vaccine-hoarding countries themselves.

These problems demonstrate the critical need for further geographic diversification of manufacturing facilities. For Africa, COVID-19 vaccine makers have taken baby steps to address this during the pandemic. Johnson & Johnson was the first—its vaccine is already being bottled by Aspen Pharmacare in South Africa, but only starting in July 2021. Pfizer-BioNTech signed an agreement with Cape Town-based pharmaceutical company Biovac, also to begin doing fill and finish for their vaccine, but the South African facility is expected to come online only in 2022. In October 2021, Moderna announced plans to build a 500-million-dose mRNA vaccine production facility in Africa, but the site had not yet been selected. Neither has the timeline for when it would become operational. Finally, in another long-run initiative, the European Commission announced in May it would provide €1 billion to help “develop a number of regional manufacturing hubs across the continent.”

Getting COVID-19 shots quickly into the arms of people across Africa, as well as low-income countries elsewhere, cannot wait until more African production comes online sometime late in 2022 or 2023. That goal must therefore rely on trade and expanding production in manufacturing countries today.

INTERNATIONAL COOPERATION SO FAR

Policymakers at the highest levels in major vaccine-manufacturing economies have now recognized the need for enhanced cooperation and engagement. Significant steps began in March 2021 and have accelerated since, albeit in a disorganized fashion and not in concert with the WTO. The United States has been heavily involved, in part because the inputs in short supply in other countries were primarily sourced from US manufacturers.

In March, Presidents Joseph R. Biden and Ursula von der Leyen appointed Jeffrey Zients and Thierry Breton to facilitate US-EU cooperation over COVID-19 vaccine supply chains. Their relationship helped resolve input bottlenecks—CureVac is one public example—and was formalized into a joint COVID-19 Manufacturing and Supply Chain Taskforce in September.

There are other examples. A US-India dialogue began in earnest in April 2021, triggered by the CEO of the Serum Institute of India accusing the Biden administration of imposing an “embargo” on US exports of vaccine-making inputs. The United States responded by immediately sending emergency supplies of that equipment, later cementing US-India vaccine collaboration through the “Quad” (with Japan and Australia) in September. Furthermore, the United States, France, Germany, and the World Bank announced funding in June to South Africa’s Aspen Pharmacare to expand its vaccine manufacturing.

Manufacturing more vaccine doses more quickly, cheaply, and in more locations also requires expanding the capacity to supply critical inputs and facilitating additional investment. The United States provided some subsidies to companies manufacturing those inputs in 2020 and early 2021 under Operation Warp Speed. In the face of continued input shortages, the Biden administration announced an additional $2.7 billion from the American Rescue Plan in September 2021. Aside from CEPI, few others globally have announced subsidies to expand capacity to vaccine input suppliers.[3]

HOW TO MAKE CVITA A REALITY

The United States, European Union, India, and their partners in vaccine manufacturing supply chains must now consolidate their fragmented initiatives into a COVID-19 Vaccine Investment and Trade Agreement (CVITA). To start, CVITA would be a plurilateral agreement, demanding participation by those WTO members, as well as the United Kingdom, Switzerland, Japan, Australia, and potentially South Africa. (It could include China, but uncertainty over Chinese vaccines, its mostly local supply chain, and onerous transparency demands described below mean China may be unwilling to participate.)

CVITA must have four components to work:[4]

First, CVITA should be aligned to leverage COVAX, the umbrella for the public and private international organizations that have joined together for the purchase and distribution of vaccines. The committed vaccine output of the producing-economy members of CVITA would be allocated between themselves and COVAX. Other countries would subscribe to COVAX for their vaccine disbursements, with the subscriptions having zero cost (or being highly subsidized) for low-income countries.

Second, the investment component of the agreement must create a framework to subsidize the full vaccine manufacturing supply chains for the committed vaccine manufacturers. “Push” contracts must be written to coordinate expansion of input production capacity to supply COVAX; they must not simply be deals to buy supplies that allow firms to use existing capacity to eventually deliver on their own timetables.[5] Furthermore, since the benefits of such investments spill over outside of national borders, local governments (including the United States) lack the incentive to subsidize input capacity enough to meet global manufacturing demand. Those public investments in supply chains should thus also be funded by the subscriptions paid into COVAX. Finally, CVITA should also support COVAX Marketplace, a secondary market established by CEPI to help short-term reallocation of scarce inputs when inevitable bottlenecks materialize. (This exchange would include for plants set up by manufacturers prior to obtaining regulatory approval where the vaccine candidate subsequently failed to pass clinical trials.)

Third, CVITA should include an enforceable commitment not to place export restrictions on supplies of vaccines and related materials destined for other signatory countries. In effect, subsidized imported inputs would be exchanged for future doses of an exported vaccine. Countries should agree that vaccine export restrictions may enable other treaty participants to retaliate by jointly curbing their supply of inputs to the export-restricting country. This potential mechanism for reciprocity, if made explicit, can be used to convince skeptical domestic audiences that hoarding—while politically tempting—is self-defeating. Since CVITA would not apply to non-participants, it would not alter the current status quo under WTO agreements which permit export restrictions on public health grounds to vaccine-consuming countries refusing to participate. Receiving protection against export restrictions would thus provide an incentive for nations to join the CVITA.

Fourth, this type of international policy cooperation demands high levels of transparency. Trust can be maintained—decreasing the likelihood of hoarding—only if access to information on COVID-19 vaccines and inputs reduces uncertainty. When supply disruptions occur, transparency will also help differentiate between genuine input shortages versus those resulting from export bans.[6]

In response to dozens of countries imposing export restrictions on staples during a perceived food crisis in 2008-2011, the Group of Twenty (G20) developed the Agricultural Market Information System (AMIS) to improve transparency and coordinate policy in the event of sudden scarcity. That system generated information and trust that arguably reduced the use and duration of agricultural export bans in the early days of the COVID-19 pandemic.[7]

These four components must all be part of the deal. If not, CVITA will fail. Firms will refuse investments to achieve economies of scale without guarantees that they can “export” from those facilities. Governments will refuse to subsidize the full supply chain needed to create that expansion if they fear insufficient access to finished vaccines that get manufactured.[8]

NOW IS THE TIME FOR CVITA

Establishment of a CVITA faces many obstacles. The unprecedented nature of the pandemic demands new types of international collaboration over different policy instruments because of the cross-border nature of vaccine manufacturing supply chains. To its credit, the WTO Secretariat has played an important role in convening industry, civil society, and policymakers to educate the community about the underlying supply chain challenges and to generate potential policy solutions.

Until now, small groups of well-intentioned negotiators have proposed a few initiatives without making progress on turning those ideas into reality. The Trade and Health initiative received a lukewarm reception, in part because it focused on trade facilitation and stopping export bans. Those are important issues, but negotiators must achieve a joint commitment that members subsidize and provide transparency over the full vaccine manufacturing supply chains as well as ensure that poorer countries are not priced out of the market for the vaccines they are someday able to produce domestically.[9] A second proposal, initially made by India and South Africa, was to waive patents for vaccines. Such a waiver by itself is likely to have only a limited immediate impact on increasing production, given that the main technological impediment to vaccine manufacturing is how to affirmatively transfer production knowhow, not the patent. (There are other impediments to scaling up manufacturing, such as insufficient supply of specialized inputs, inadequate regulatory oversight, and an inexperienced workforce, that a patent waiver would also not resolve.)

A final challenge is that many governments have not adequately included trade ministers in the domestic pandemic policy response. For COVID-19 vaccine supply chain policy, US efforts have been shepherded by the White House (Jeffrey Zients) as opposed to the US Trade Representative (Katherine Tai). In the European Union, policy has been driven by the Commissioner for the Internal Market (Thierry Breton) as opposed to the Trade Commissioner (Valdis Dombrovskis).

The time is now for the US Trade Representative, EU Trade Commissioner, and other trade ministers to become more engaged. Over 16 billion additional doses are still needed to save lives globally. The world economy is suffering trillions of dollars of losses due to the ongoing pandemic. Inequality is rising. Supply chains for other products are under attack.

At MC12 in November, the United States, European Union, India, and a select group of other key countries should commit to a small, plurilateral CVITA to enshrine and expand upon the cooperative steps they are already taking outside of the WTO. The threat that new and more devastating virus variants could emerge, against which existing COVID-19 vaccines would be ineffective, means that no one is safe until the pandemic is under control globally. Trade ministers should do their part to ensure that everyone everywhere has access to COVID-19 vaccines.

Chad P. Bown, Reginald Jones Senior Fellow since March 2018, joined the Peterson Institute for International Economics as a senior fellow in April 2016. His research examines international trade laws and institutions, trade negotiations, and trade disputes. With Soumaya Keynes, he cohosts Trade Talks, a weekly podcast on the economics of international trade policy.

Thomas J. Bollyky is director of the global health program and senior fellow for global health, economics, and development at the Council on Foreign Relations (CFR). He is also an adjunct professor of law at Georgetown University. Bollyky is the author of the book Plagues and the Paradox of Progress: Why the World is Getting Healthier in Worrisome Ways and the founder and managing editor of Think Global Health, an online magazine that examines the ways health shapes economies, societies, and everyday lives around the world.

To read the full commentary from the Peterson Institute for International Economics, please click here.

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Bodog Poker|Welcome Bonus_Vaccine Archives - WITA

Ryan Murphy — Tue, 10 Aug 2021 18:30:41 +0000

For many of us, Chad Bown of the Peterson Institute for International Economics — a boutique think tank specializing in, duh, international economics — has become the go-to guy for current developments in trade policy. His work tracking the evolution of Donald Trump’s trade war was invaluable.Now he has a highly informative new paper with Thomas Bollyky on the vaccine supply chain. I won’t lie: There’s a lot of detail, and the paper is fairly heavy going. But it’s full of useful details, and it also, I’d argue, tells us some interesting things about the nature of world trade in the 21st century.One thing that caught my eye — probably not the most important thing, but one close to my heart — is that the story of global vaccine production demonstrates the continuing relevance of the so-called New Trade Theory, or as some now call it, the “old New Trade Theory.”

Producing these vaccines is evidently a complicated process, involving facilities in many locations, presumably implying a lot of cross-border shipments of vaccine ingredients. Notably, in Pfizer’s case all these facilities are in the United States and Western Europe, which is typical across pharma firms, although other companies have a few facilities in Brazil and India.So where do vaccine supply chains fit into the theory of international trade?If you’ve ever taken an economics course, you probably learned about the theory of comparative advantage, which says that countries trade to take advantage of their differences. The classic original example, from the early-19th-century economist David Ricardo, involved the exchange of English cloth for Portuguese wine.Comparative advantage is a powerful, illuminating theory — especially because it shows why countries export goods they’re relatively good at producing even if they’re less productive in those industries than potential competitors. Bangladesh is a low-productivity nation across the board (although it has been improving), but its productivity disadvantage is less pronounced in apparel than in other industries, so it has become a major clothing exporter.In the 1960s and 1970s, however, a number of economists began suggesting that comparative advantage was an incomplete story. World trade had been growing over time, but much of that growth involved trade between countries that didn’t seem very different — the United States and Canada, for example, or the nations of Western Europe. Furthermore, what these countries were selling to each other looked pretty similar: There was a lot of “intra-industry” trade like the large-scale, two-way trade in autos and related goods across the U.S.-Canada border.

What was going on? A few economists had long noted that comparative advantage wasn’t the only possible reason for international trade. Countries might also trade because production of some goods involves increasing returns — there are advantages to large-scale production, which creates an incentive to concentrate production in a few countries and export those goods to other countries. Automotive trade between the United States and Canada was a classic example: After the countries established a free-trade agreement for autos in 1965, North American car companies achieved economies of scale by limiting the range of items produced in Canada, exporting these goods and importing other items from the United States.But if trade reflected increasing returns rather than country characteristics, which countries would end up producing which goods? It might be largely random, the result of accidents of history.There was, however, remarkably little economic literature on increasing-returns trade until the late 1970s. Economists don’t like to talk about stuff they find hard to model, and trade models with increasing returns tended to be messy and confusing. Eventually, however, some economists came up with clever ways to cut through the confusion, in papers like this 1980 piece in the American Economic Review:

God, I was young! Anyway, history has a sense of humor. No sooner had economists come up with nifty models of trade between similar countries, driven by economies of scale, than the world economy took a hard turn away from that kind of trade toward trade between dissimilar countries driven by things like large differences in wages.World trade exploded from the mid-1980s until around 2008, a process sometimes called hyperglobalization:

And where trade growth in the ’60s and ’70s had largely involved advanced economies selling stuff to each other, hyperglobalization involved a surge in exports of manufactured goods from relatively low-wage developing countries:

So we had a New Trade Theory, but the new trade we were actually getting was much better explained by, well, old trade theory.

So what does all this have to do with vaccine supply chains? Well, as I already noted, vaccine ingredients are mainly produced in advanced countries — countries that are very similar in their education levels, overall level of technological competence and more. So why wasn’t each advanced country producing the whole ensemble of vaccine-related inputs? Here’s what Bown and Bollyky say:

“The business model that much of the pharmaceutical industry had shifted toward over the previous 25 years involved fragmentation. As tariffs and other trade barriers had fallen globally, information and communications technology (ICT) developed, shipping and logistics efficiency increased, and protection of intellectual property rights steadily improved. The fact that trade could play a greater role in distributing pharmaceutical products globally meant that companies could operate fewer plants but at a larger scale.”

Hey, it’s New Trade Theory in action! And it sure looks as if there was a lot of random historical contingency determining national roles in the pattern of specialization. Europe was initially very dependent on Britain’s exports of lipids — but I doubt that there’s something about British culture that makes the country especially good at lipids. It’s just one of those accidents that play a big role in economic geography.Is there a moral to this story? There’s been a lot of backlash against globalization over the past decade, to some extent justified: Advocates of free-trade agreements oversold their benefits and understated the disruptions they might cause. But the case of vaccine production illustrates a positive side of globalization we tend to forget. These miracle vaccines are incredibly complex products that would have been hard to develop and produce in any one country, even one as large as the United States. A global market made it possible to deliver all the specialized inputs that are saving thousands of lives as you read this.

Paul Krugman joined The New York Times in 2000 as an Op-Ed columnist. He is distinguished professor in the Graduate Center Economics Ph.D. program and distinguished scholar at the Luxembourg Income Study Center at the City University of New York. In addition, he is professor emeritus at the Princeton School of Public and International Affairs

To read the full commentary from The New York Times, please click here.

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Bodog Poker|Welcome Bonus_Vaccine Archives - WITA

Ryan Murphy — Tue, 20 Jul 2021 16:03:11 +0000

Perhaps surprisingly, little is known about the capacities of different countries to produce vaccines. Official data on global production volumes is not available and trade data only gives an incomplete picture of production capacity. The United States and China, for instance, import and export low levels of vaccines relative to their population sizes, suggesting that major parts of vaccine production are not reflected in trade data.

To understand how COVID-19 has affected global trade in, and production of, vaccines, and to get a sense of where the main capacities to produce COVID-19 vaccines at scale might be found, we looked at global vaccine trade prior to the pandemic and estimated production worldwide, with two main results. First, pre-pandemic, the EU was the world’s largest producer of vaccines. Second, the pre-pandemic market for vaccine was divided into two spheres: rich countries are supplied by EU and US production capacity (with the latter mostly producing for itself), while India was the main producer for developing countries. China produced almost exclusively for its own market.

Evidence since the start of the pandemic indicates that, while broadly COVID-19 has not changed these production patterns, there have been modifications. China has become a major supplier of COVID-19 vaccines to developing countries, using its vaccines as political leverage and benefitting from the fact that the US has yet to export its production, while India has stated explicitly that it will prioritise its own population. In this context, with its substantial production capacity, the EU will play a major role as a global COVID-19 vaccine supplier as the world continues to tackle the pandemic.

The global vaccine trade pre-pandemic

Figure 1 shows the biggest vaccine exporters pre-pandemic (2017-2019). The EU27 as a bloc (ignoring intra-EU trade) was by far the largest exporter of vaccines to the world, both in terms of volumes (44% of total global exports) and value (60.3%). The larger share of value compared to volume indicates that the EU exported relatively more to markets where it could supply at higher prices, ie high-income countries (HICs). Figure 2 shows this: while the EU supplied 60% of the vaccines imported by HICs, it only supplied 12% of the vaccines imported by low-income countries (LICs). The US and the United Kingdom were the major revenue markets for the EU’s vaccines exports, representing 43.4% and 16.7% respectively of total EU revenues from export of vaccines. Taken together, LICs provided only 1.2% of EU revenues from vaccine exports (7.4% from lower-middle income countries, so 8.6% for LICs and lower-middle income countries), but absorbed 3.9% of volumes exported from the EU (33.2% for lower-middle income countries).

With a share of 22%, the US was the second largest exporter in value terms (though only one third of the EU size). But like the EU, the US pre-pandemic mostly exported to other HICs: it represented only 2% of volumes imported by LICs (Figure 2). For India, the opposite was the case. While India was the second-largest vaccine exporter in terms of volumes (24.7% of total global exports) it represented barely more than 2% of vaccines exports in terms of value. This huge discrepancy is linked to the fact that India exported virtually only to LICs, representing 80% of their vaccine imports by volume (Figure 2).

These trade patterns reflect a highly segmented market for vaccines, with HICs representing the bulk of revenues, while LICs represent the bulk of volumes. High-income producers (EU, US) sell vaccines to high-income countries, while India provides vaccines to low-income countries. This notable market segmentation is associated with the licensing practices of the pharmaceutical industry.

The largest life sciences companies by vaccine revenues are: GSK, Merck, Sanofi and Pfizer, which represent about 90% of global vaccine revenues. They license their patents to producers in LICs to produce and sell to LICs, reserving HIC markets for their own production or dedicated HIC licensees. In particular, the Serum Institute of India plays an outsized role as a licensee, supplying vaccines to low-income countries.

Estimating vaccine production capacities

To get a full picture of global vaccines supply patterns before the pandemic, we looked not only at the trade flows, but also at production capacities. In the absence of official data on global vaccine production, we estimated countries’ production volumes from the available trade data. For this, we first estimated internal demand. We looked at countries that are not producers (ie countries that export virtually no vaccines). For these countries, we assumed that their total demand for vaccines is equal to their imports. This gives a sense of what the ‘consumption’-based demand for vaccines is. Based on this approach, we provide a range of estimates. We computed the average imports per capita of non-producing countries and used this to compute demand for all countries. We also looked at the relationship between imports per capita and a ‘vaccine index’ based on the demographics and immunisation rates in the same non-producing countries. We computed estimates both with and without income-level segmentation by country. We then derived production estimates per country as the sum of our estimates of their demand and their net exports.

All estimates produce similar results and give a good sense of the scale of production volumes across the world. Table 1 sets out our estimated production volumes per country. Taken as a whole, the EU is the world’s largest producer of vaccines, closely followed by India, with estimates of around 15.5 million and 14.5 million kilogrammes of vaccines produced yearly, respectively. China with production in the realm of 8 million to 12 million kilogrammes comes in third place. The United States is in fourth place, but with considerably smaller production volumes of 4.5-5.2 million kilogrammes. Other countries with considerable vaccine production capacity are Indonesia, Japan, South Korea and Russia. No African or Latin American country has an estimated production capacity of more than 1 million kilogrammes.

Among vaccine producers, the EU pre-pandemic exported the greatest (estimated) volumes of the vaccines it produced, apart from South Korea, which also has a high export-intensity, but from only a small (estimated) production capacity. China, meanwhile, exported almost no vaccines before COVID-19.

Table 1: Range of estimates of yearly vaccine production (millions of kg, 2017-2019 data)

COVID-19 and the future of vaccine production

While it is tempting to draw conclusions from these numbers about the capacity to produce COVID-19 vaccines, there are couple of caveats. First, our data reflects production capacity in ‘normal’ times (2017 to 2019 averages) and for a broad spectrum of vaccines. It is unclear to what extent new capacity has been installed or how much this capacity has been adapted to produce COVID-19 vaccines at the required scale and speed. More importantly, vaccines pre-pandemic were produced with different technologies.

The leading western producers mostly produce vaccines using viral vector and/or protein technology. Older inactivated virus technology is mostly used in LIC production, most notably in China. For COVID-19, the two Chinese vaccines approved by the World Health Organisation use inactivated virus technology, while vaccines from Astra Zeneca and Johnson & Johnson use viral vector technology (this includes the Serum Institute, which licenses Astra Zeneca vaccines for supply to LICs). However, the vaccines from BioNTech and Moderna use a novel mRNA technology. At the start of the COVID-19 pandemic, it was unclear how much of the established vaccine production capacity could be quickly activated for COVID-19 vaccine production, particularly for the novel mRNA vaccines.

Data on COVID-19 vaccine production from Airfinity, a small private firm that specialises in COVID-19 data, shows the similarities and differences compared to the pre-pandemic situation (Figure 3). The biggest producers of COVID-19 vaccines are the same as the biggest vaccine producers before the pandemic (China, the US, the EU and India), but the ranking has changed.

A significant change can be observed in China’s vaccine policy. While China exported hardly any vaccines before the pandemic, it is now the largest exporter of COVID-19 vaccines. Chinese vaccines are mainly exported to a handful of LICs in central and South-East Asia, South America and North Africa. The US, meanwhile, is yet to export any COVID-19 vaccine, as it has prioritised vaccinating its own population first. India, which pre-pandemic was the main exporter of vaccines to LICs and could be a pivotal country for meeting LIC demand, is exporting but redirecting its capacity in order to meet local demand. Russia’s Sputnik V viral vector vaccine has received a lot of media attention, but Russia, although it is exporting more than usual, only plays a minor role in volume terms.

Figure 3: Production and exports of COVID-19 vaccines

Overall, the evidence shows that high-income vaccine producers (US, EU) have, in the pandemic, continued to produce for high-income countries (though the US currently produces only for itself). In the light of our data, it is unsurprising that keeping global vaccine markets open was less of a priority for the US than the EU, given the much greater pre-pandemic export intensity of EU vaccine production.

However, for LICs, India’s apparent big step back during the pandemic from its role of exporter could be bad news. Until now, India has been the major supplier to LICs. Interestingly, China (and Russia, to a smaller degree) has seized the opportunity to increase production and exports to LICs.

Outlook

The pressing question currently is how to increase the volume of COVID-19 vaccines available to the world and, more specifically, to low-income countries. The developing world until now has relied on India for vaccines. Can other suppliers and countries scale up in the face of India’s retrenchment in the face of the devastating COVID-19 wave in India in spring 2021? China has significantly increased its capacity and now exports massively to low-income countries, but will be constrained by the willingness of countries to take up China’s vaccines, which use the older inactivated virus technology. Even if the US changes policy and exports more of its unused capacity, this capacity is not so sizeable.

While much hope has been invested in patent waivers to increase production in LICs, it is unclear if such a policy will work in the short term, given how little experience producers have with mRNA vaccines (making even voluntary licensing deals difficult). Even for vaccines based on the old inactivated vaccine or viral vector technologies, further transfers of production know-how are needed.

This leaves the EU as the main supplier to the world, given its capacity to produce at scale the most sought-after COVID-19 vaccines. In addition, EU producers have a legacy of exporting, though mainly intra-EU or to other HICs. In the medium-term, partnerships with emerging markets will remain absolutely essential. Notable is the EU’s initiative to support the creation of vaccine production in Africa, including through mRNA manufacturing. In addition, since developing markets are not served by European manufacturers in the first place, there is little risk of harming EU industry.

Lionel Guetta-Jeanrenaud is working at Bruegel as a Research Assistant. He studied economics at the Ecole normale supérieure de Lyon, in France. Before joining Bruegel, Lionel worked as a research assistant at the Department of Economics of Harvard University.

Niclas Poitiers, a German citizen, joined Bruegel as a research fellow in September 2019. Niclas’ research interests include international trade, international macroeconomics and the digital economy. He is working on topics on e-commerce in trade as well as European trade policy in global trade wars. Furthermore he is interested in topics on income inequality and welfare state policies.

Prof Dr. Reinhilde Veugelers is a full professor at KULeuven (BE) at the Department of Management, Strategy and Innovation. She is a Senior Fellow at Bruegel since 2009. She is also a CEPR Research Fellow, a member of the Royal Flemish Academy of Belgium for Sciences and of the Academia Europeana. From 2004-2008, she was on academic leave, as advisor at the European Commission (BEPA Bureau of European Policy Analysis). She served on the ERC Scientific Council from 2012-2018 and on the RISE Expert Group advising the commissioner for Research. She is a member of VARIO, the expert group advising the Flemish minister for Innovation. She is currently a member of the Board of Reviewing Editors of the journal Science and a co-PI on the Science of Science Funding Initiative at NBER.

To read the full commentary from Bruegel, please click here.

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Bodog Poker|Welcome Bonus_Vaccine Archives - WITA

Ryan Murphy — Wed, 30 Jun 2021 20:10:41 +0000

Relations between the major powers are at their worst for decades with cooperation thin on the ground, and COVID-19 having deepened suspicions further.

In April, the US Senate passed the Strategic Competition Act with bipartisan support, promising to ‘counter the malign influence of the Chinese Communist Party globally’. In front of his American counterpart, China’s top foreign policy official denounced the effrontery of those who ‘smear’ Chinese democracy. Joe Biden calls Vladimir Putin ‘a killer’, while the Kremlin has put the US at the top of its list of unfriendly countries. Tension between China and India is high, the EU and UK are involved in repeated spats. Competition and mistrust are everywhere.

Far from producing greater collaboration in adversity, COVID-19 has exacerbated global rivalries. Given that the tensions long pre-dated the pandemic and are unlikely to improve any time soon, it is hard to see how the major powers can be persuaded to cooperate better to tackle this crisis. Coronavirus is just the first test. Other crises will follow.

President Biden calls the relationship with China ‘naturally competitive, sometimes adversarial and, on key issues, necessarily collaborative’. Managing these competing impulses is proving difficult to navigate. One route is the established one, focusing on international institutions and multilateral groups to tackle the big global challenges. In times of tension they have a restraining role; in times of cooperation, they can do so much more.

Yet, if the disappointing results of the G7 are anything to go by, expectations should be managed even lower than they are already. But there is another way. The present atmosphere of intense competition can actually be exploited to the advantage of developing economies.

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A few weeks into the crisis, Ricardo Lagos, former president of Chile and a member of the Elders group of international leaders wrote: ‘Hopefully the international institutions will rise to the challenge of responding to this pandemic with the force that it demands, because this crisis will not be overcome by defeating the disease in any one country alone, but by guaranteeing an end to the affliction throughout the world.’

The first reaction of nation states was to protect their own, hoard, close borders – and indulge in nationalist points-scoring.

The more the US and its allies blamed China, both for the outbreak in Wuhan and for what many considered to be a cover-up, and the more China refused to provide the necessary access or information, the more distrustful and disjointed the global response became.

The final year of Donald Trump’s ‘America First’ presidency was characterized by a COVID-19 policy of denial, denigration of science and, at that point, the world’s highest infection rate. The president launched repeated broadsides against the World Health Organization (WHO), denouncing its Director General Tedros Ghebreyesus as a ‘puppet’ of China; he announced the termination of the US’s WHO membership and $400m annual payment, putting its finances in peril just at a time when the organization was most needed. Trump’s approach was borne partly of ideology, partly of a need to create a distraction from his administration’s incompetence.

The medical and health community rallied early, creating an initiative designed to distribute vaccines, even as they were still in the early stage of development. The aim of COVAX was to produce and make available two billion vaccines by the end of 2021. ‘No-one is safe until everyone is safe’ became the mantra of collaboration.

Solidarity was not the problem among the organizations – Gavi, the global vaccine alliance, and the Coalition for Epidemic Preparedness Innovations (CEPI) worked with the WHO to get access to the COVID -19 Tools Accelerator, ACT-A, up and running.

COVAX was heralded as the ‘only truly global solution’, but it was a mix of ambition and acknowledgement of the limited commitment of the big powers to collaborate to vaccinate the world. Still, vaccinating ‘the priority fifth’ of the world’s population is better than nothing.

Vaccines and flags

From the start of the pandemic, in the provision of masks or personal protective equipment (PPE), nation states indulged their competitive instincts. Vaccine diplomacy and its alter ego vaccine nationalism followed this trend.

Public relations battles were fought out not just between rivals, but also among supposed allies. The British government juxtaposed its mass purchase of vaccines with the early failures of the European Union (EU) as vindication of Brexit. For its part, the EU’s definition of solidarity was largely confined to the bloc.

Chinese vaccines were present in, or pledged to, 90 countries. Each shipment carried national flags and were accompanied by photo-opportunities with grateful local dignitaries at the airport of arrival.

By the end of May, China had sold or donated 700 million doses worldwide. Chinese vaccines were present in, or pledged to, 90 countries. Each shipment carried national flags and were accompanied by photo-opportunities with grateful local dignitaries at the airport of arrival. The biggest deals were geographically and politically disparate – from Chile to Egypt, Mexico to the Philippines. Russia was in 80 countries. As Champa Patel, director of Chatham House’s Asia-Pacific programme, notes: ‘Russia and China are not new actors on these continents and are sometimes capitalising on long-established political or economic relationships.’

The key question is why China and Russia were faster. China’s heavily enforced early lockdowns kept numbers at home far lower than elsewhere in the world. In Russia, COVID-19 spread rapidly but much of the public was wary of accepting the home-produced vaccine, leading to one of the lowest take-up rates among industrialized nations. At least that freed up stocks to enable the Kremlin to go on a global charm offensive.

Two regions

By late May, Latin America had exceeded one million deaths, the highest for any region in the world. The region was long considered to be the United States’ backyard. Frustrated at the lack of vaccines, several leaders took to social media diplomacy to ‘vaccine shame’ their traditional ally.

In March, president of the Dominican Republic Luis Abinader tweeted: ‘President @JoeBiden, less-developed countries and traditional allies of the USA, like Dominican Republic, have approved the AstraZeneca vaccine and we need it urgently’ while Paraguay was struggling to get Chinese vaccines because of its recognition of Taiwan.

Latin America didn’t help itself. ‘The region has failed to coordinate through existing mechanisms or to act as a bloc,’ says Chris Sabatini, senior fellow for Latin America at Chatham House. ‘Combined with the absence of the US, this has enabled others to fill the vacuum and split the region even more deeply.’

Shortly after delivering 400,000 doses to Bolivia, the Kremlin trumpeted access to its resources. ‘We are sure that Russian-Bolivian ties will expand, especially in sectors such as energy, mining and the peaceful use of nuclear technologies,’ Vladimir Putin said after meeting President Luis Arce. Bolivia has the world’s largest supply of lithium – an indispensable component in batteries for mobile phones – but has struggled to attract foreign investment to extract it.

Goodwill was thin on the ground in contract negotiations. The Bureau of Investigative Journalism alleged in February that Pfizer had insisted to several Latin American governments that they put up sovereign assets such as embassy buildings and military bases as collateral against the cost of potential future legal cases.

Africa has received two per cent of vaccines administered globally. The crisis was worsened by India’s decision to divert vaccines from the Serum Institute, the world’s largest vaccine manufacturing facility, which had been earmarked for export to deal with the country’s own COVID-19 emergency.

By May 2021, of 36 countries where death rates were rising, all but four were low- or middle-income countries. The cumulative effect has been to eradicate years of development, leading to a further division of wealth between nations and regions.

The African Union has set a goal of 40 per cent of vaccines to be produced on the continent within 20 years. Reforms such as these, vital though they are in the medium-term, will not alleviate the present crisis.

At first glance, the situation suggests a reversion back to the old paradigm of dependency. Yet there is another way of way of looking at Africa’s present predicament.

‘We are playing out the same thing again – but this time the politics are different,’ says Yates. This, he says, is reflected in the leadership of international agencies as three major UN institutions are now run by Africans. World Trade Organization (WTO) Director General Ngozi Okonjo-Iweala is a former Nigerian government minister; UNAIDS’ Executive Director Winnie Byanyima was a Ugandan MP who then ran Oxfam International. The head of the WHO, Tedros, was an Ethiopian minister.

Alex Vines, director of the Africa Programme, notes a series of regional summits with Africa planned for 2022 (several of which had been postponed because of the pandemic), including the EU, China and Turkey. Everyone is piling into Africa – and Africa knows it. ‘The trend is towards multi-polarity,’ he says.

Discussion of big-power winners and losers may actually be missing the point. This narrative assumes that recipient countries have little or no agency and are unable to disaggregate the various motivations and decide for themselves. Therefore, it may not feel like that now, as populations reel, but developing economies have more agency, more influence, than before.

Do motives matter?

A recent Chinese White Paper on international development states: ‘China considers it a mission to contribute more to humanity. Its wish is to offer more public goods to the international community and join forces with other countries to build a better common future’. Humanitarian assistance merges with geo-strategic motives. Is that noticeably different to other countries’ international development policies?

COVID-19 has also given China an opportunity to portray itself as a responsible, science-based global leader, a ‘pharma power’, helping to shift the narrative from its role in the cause of the crisis. Yu Jie, senior research fellow on China, points to another motivation. ‘Ultimately so much of this comes down to economic self-interest. China is pursuing its vaccine diplomacy to help secure its many Belt and Road-related projects. The quicker those developing countries recover from the pandemic, the better it is for China’s own economic growth,’ she says.

Patel points to a failure of analysis among Western powers. ‘What will not work is trying to instrumentalize emerging powers for Western capital’s strategic interests. This is as true for China attempting to do as much as for Western capitals.’

In any case, do motives matter that much in a time of crisis, particularly when the other side is absent from the pitch?

Ideas aplenty

At the start of 2021, the immediate tasks for the world were: share more vaccines now, provide more money for that international endeavour, and get serious about tech transfer to allow production to take place in more facilities around the world.

Just how committed is the Biden administration? A number of its initiatives seemed designed more to project systemic rivalry, particularly against China, than to embrace multilateralism. In early May, US Trade Representative Katherine Tai announced that Washington would support a waiver on intellectual property for vaccines. A number of countries, led by India and South Africa, had long been calling for the removal of restrictions on the transfer of patents in pharmaceuticals, something that had been agreed at the WTO in 1995. It had become an emotive issue.

Tedros hailed it move as ‘a monumental moment’. The move delighted civil society groups, but startled allies. A number of biotech-strong countries, including Germany, Switzerland, Canada and Britain opposed the idea. The White House is likely to have assumed that it would not prevail, but the initiative secured two goals: it put pressure on big pharma to do more to free up licensing and transferring technology, and it made America look good.

In the same week, Biden declared: ‘Our nation is going to be the arsenal of vaccines for the rest of the world. I literally have, virtually 40 per cent of the world leaders calling and asking, can we help them. We’re going to try’. He promised that the US would deliver 80 million vaccines, including from AstraZeneca, which had not been approved by his own country’s regulator, the FDA.

By this point, the US had not exported a single vial. A whole year after the establishment of COVAX, a mere 70 million vaccines had been sent through the multilateral facility – a tiny proportion of the not so ambitious two billion target.

To compensate at least in part for the political failures, a number of non-governmental organizations (NGOs) worked hard to find practical solutions to help alleviate the suffering. For its part, Chatham House brought together big pharma, leaders of international organisations and health experts in a global vaccine supply chain and manufacturing summit to look for an agreed set of measures to tackle shortages. The March 2021 summit led directly to the establishment of a COVAX Manufacturing Task Force to address bottlenecks.

Yates, who helped to bring the parties together for that summit, also points to the work of the International Panel for Pandemic Preparedness and Response (IPPPR). In a report commissioned by the WHO and published in mid-May, the group of 13 global statesmen and women, led by former New Zealand prime minister Helen Clark and former president of Liberia Ellen Johnson Sirleaf, sketched out a credible road map across all areas of COVID-19 policy, providing a midway point between radicalism – what should be achieved – and realism – what, given the disappointing circumstances, could be achieved.

The IPPPR called for a UN Pandemic Treaty and an International Pandemic Financing Facility that could mobilise funding of up to $10 billion per year. It also proposed a new global surveillance system, in which the WHO would have explicit authority to publish information about outbreaks without the prior approval of national governments and to dispatch experts to investigate pathogens with guaranteed right of access.

In spite of the exhortations and the clear proposals, the chances of countries coming to any form of meaningful consensus on the pandemic remained elusive. Meeting in Rome, the Global Health Summit of the G20 proposed a watered-down push for waivers and stopped short of committing wealthier states to provide more funds for the WHO. A few weeks later, the World Health Assembly, the WHO’s policy-making body, stepped back even further, delaying even consideration of a convention, agreement ‘or other international instruments on pandemic preparedness and response’ until a special conference in November.

On the eve of each of these forums, elder statesmen and women, health experts and activists urged governments to do more. They cited compelling economic arguments. Fully financing ACT-A for 2021 would cost less than one per cent of what governments have spent on stimulus packages for their own citizens.

The task is enormous and urgent. The number of doses needed to vaccinate 70 per cent of the world’s population is a staggering 11 billion. So far only about 1.7 billion have been produced; far, far fewer have been equitably distributed.

Has the West failed – again?

On the eve of the G7, the director of the Africa Centres for Disease Control and Prevention, Dr John Nkengasong, declared: ‘Our worst nightmare has come to reality’. He added: ‘When this pandemic started, we cautioned that if we do not work in a cooperative way and express global solidarity we may run into a moral catastrophe’.

The messaging NGOs have used to persuade governments has become ever more desperate and ever more instrumentalist. ‘Self-interest’ became too tame. ‘Return on investment’ – a curious term for saving lives – started to be used.

In spite of all the entreaties, COVAX remains low on nations’ priorities. Two reasons point to self-interest of the most unappealing variety. ‘For COVAX to work as its originators intended, it needed essentially all governments to buy into it, rather than making their own deals with potential producers,’ Chatham House experts note in a forthcoming July 2021 research paper. The primary objective of the US, UK, and EU was to secure vaccines for their own populations. ‘There was therefore always an inevitable tension, even contradiction, between the expressions of support for equitable global access by governments and their simultaneous pursuit of bilateral deals for domestic populations’, the paper notes.

One example spoke volumes. French president Emmanuel Macron and European Commission president Ursula von der Leyen toyed with the idea of circumventing COVAX by donating directly – with supplies labelled ‘Team Europe’ alongside colour-coded maps to track the destinations of vaccines from rival producers. In the UK, Boris Johnson was reported to have wanted the AstraZeneca vaccine, developed in conjunction with Oxford University, to be labelled with Union Jacks. Compassion wrapped up in a logo. Why bother with a centralized distribution network when you can earn plaudits for ostentatious generosity?

Considerations such as these formed the backdrop for the G7 summit in mid-June. For the first time since the pandemic started, leaders of the richest nations gathered by a Cornish beach to discuss COVID-19, climate change – and the rise of China. Their deliberations were not helped by a renewed bout of in-fighting between the UK and the EU. Biden used the meeting to frame geopolitics as a contest between democracies and autocrats and called for a Western infrastructure alternative to China’s Belt and Road.

The final decision – to provide fewer than the one billion vaccines that had been trailed beforehand, with no mechanism for delivery and with a vague deadline – was denounced by experts and activists. Gordon Brown, the former British prime minister who had been one of the most active lobbyists for radical action, called it an ‘unforgivable moral failure’.

China and Russia lost no time in denouncing both the tough tone of the G7 communique towards both countries and the weakness of its vaccine response. A few days after the summit, the US said it was sending 80 vials of vaccine to Trinidad and Tobago, a decision that was mocked in the Chinese media. ‘Would this be selected for the Worst Public Relations Award of the Year?’ the official Xinhua news agency asked in a carefully coordinated set of social media posts.

Because of the length and breadth of the G7 closing statement, some useful decisions received less prominence than they otherwise might have done, such as the agreement to establish a Global Health Board that could improve the early-warning system for future pandemics. Few would disagree however with an assessment that the G7 had fallen woefully short, suggesting that this gathering of nations which now constitutes less than half the world’s GDP is losing ever more influence.

The economist and long-time adviser to the UN, Jeffrey Sachs, was scathing in his assessment. Describing gatherings such as the one in Cornwall as an anachronism, Sachs argued: ‘The G7 is particularly irrelevant because its leaders don’t deliver on their promises. They like making symbolic statements, not solving problems. Worse, they give the appearance of solving global problems, while really leaving them to fester. This year’s summit was no different.’

Will the G20 meeting in Rome at the end of October, with its wider representation, do any better? More nations and more political systems will be represented. That is an opportunity to do business face-to-face. It is also opportunity for more grandstanding between systemic rivals.

Poorer nations and power

Even at the height of Cold War tensions, the US and Russia were part of a global coalition to eradicate smallpox. Yet with COVID-19, big-power collaboration has been virtually non-existent, with little prospect for improvement.

Biden’s instruction to his intelligence to ‘redouble’ their efforts and identify a ‘definitive conclusion’ within 90 days on how the virus was first transmitted in humans has enraged the Chinese government.

In February, when urging rich nations to agree a target of sending five per cent of vaccines to poorer ones – something they are as far away as ever from achieving – Macron said: ‘It is an unprecedented acceleration of global inequality and it is politically unsustainable too because it’s paving the way for a war of influence over vaccines. You can see the Chinese strategy, and the Russian strategy too’. In other words, competition should be the key driver.

The question now is: have the US and its allies left it too late? The poorest countries hit hardest in the last few months may well remember the fact that America was planning to inoculate its children while the elderly and frail and key workers in Africa and Latin America were dying.

Those countries who were helped out at their time of most need may retain a residual sense of affinity, perhaps obligation, towards China and Russia. Chatham House’s Yu Jie quotes a Chinese proverb: ‘You always offer the burning coals at times of heaviest snow’.

Perhaps with this in mind, American officials insist that they are not trying to pressurise countries to make a zero-sum choice, on health or broader partnerships. As Blinken told a NATO meeting in March: ‘The United States won’t force allies into an ‘us-or-them’ choice with China’.

Several Chatham House experts argue that if the US and its allies act quickly and deftly, they may be able to repair some of the damage. ‘Helping developing countries to vaccinate their populations represents a tremendous opportunity for the West to make up lost ground,’ Yates argues. ‘Not only will this potentially win over wavering non-aligned nations; it will accelerate the end of the pandemic and bring disproportionate benefits to their own economies as the world economy recovers.’

Vines says of Africa: ‘There is plenty of room left for the Americans to re-engage and be involved. This is also where the EU has a role.’ He adds: ‘African countries like choice.’

Perhaps developing countries can make a virtue of this unrelenting soft-power rivalry. Imagine a situation in which production increases and the competing powers vie to entice recipient countries. They would compete against each on the efficacy and reliability of vaccines, on cost and terms – and on geo-strategic allegiances.

‘Is it the end of the world if America, China and the others compete to ensure vaccinations?’ asks Chatham House chair Jim O’Neill, who has been on a number of inter-governmental preparatory groups for the G7 and G20.

This is not as it should be. In a perfect world, multilateral and cooperation would be the guiding principles. And where such collaboration exists, it should be promoted and pursued. But this crisis has shown the world at its most imperfect. If rivalry has to prevail, it can be turned around to the advantage of those who most need assistance.

John Kampfner has recently become a Consulting Fellow at Chatham House and has written the first in a three-part series on competitive rivalries in an era of global crisis. The first report, on the Covid pandemic, was published on 30 June. He is also a Senior Associate Fellow at the Royal United Services Institute.

John established the Creative Industries Federation to much acclaim in 2014, providing a single voice for the UK’s creative sector. For eight years he was founder Chair of Turner Contemporary, one of the country’s most successful art galleries. He is now Chair of the House of Illustration. He was awarded an Honorary Doctorate for his services to the arts by Bath Spa University in 2019.

For four years running he was named one of the most influential Londoners in the Evening Standard Progress 1000 survey. Fluent in German and Russian, he regularly speaks at political conferences and cultural festivals around the world.

To read the full commentary from Chatham House, please click here.

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Bodog Poker|Welcome Bonus_Vaccine Archives - WITA

Ryan Murphy — Tue, 15 Jun 2021 18:24:19 +0000

The COVID-19 pandemic has revealed many problems in American society ranging from public health and racial disparities to economic challenges and supply chain limitations. As was true with many nations around the world, the United States was caught without a detailed plan for dealing with a pandemic. Hospitals were unprepared for the deluge of patients and health care providers did not have access to the supplies they needed to protect themselves. State and national leaders provided mixed cues on how to shut down and when to reopen, and there continue to be sharp partisan differences in how people feel about wearing masks and getting vaccinations.

The result has been nearly 600,000 American fatalities, the loss of millions of jobs, and a widening in the inequities that exist based on race, gender, age, income, and geography. While more than half of Americans now have received at least one dose of the COVID-19 vaccine, a significant number indicate they don’t want to be vaccinated. That reticence runs the risk that the virus will not be eradicated and could return at some point in the future.

Among the most fundamental challenges that remain as we move forward is the fact that most pharmaceuticals and protective personal equipment are manufactured outside the United States. It was a shock for many people to learn during the pandemic that many of their essential medicines and products came from outside the country. In keeping with trends that have emerged in recent decades with manufacturing in general, China and India are big suppliers of medicinal drugs, as are places such as Germany, Switzerland, the United Kingdom, France, Israel, South Africa, and Brazil. Most American drug companies have outsourced manufacturing to foreign locations. In that situation, supply chains are long and there often are logistical problems that limit availability of needed treatments.

Now, a new report from the Washington University Olin School of Business outlines several reasons why this is the case and what we need to do about it. In terms of the causes of drug shortages, authors Tony Sardella and Paolo De Bona cite a 2019 U.S. Food and Drug Administration analysis that emphasized three factors: “1) the lack of incentives to produce less profitable drugs; 2) the market not recognizing or rewarding manufacturer for mature quality management systems, 3) logistical and regulatory challenges that make it difficult to recover after a disruption.” Taken together, these problems help people understand how we reached the current point and what leaders can do to address these matters.

According to the authors, there are a number of ways to improve the situation. These steps include decreasing dependence on foreign drug-makers, developing U.S. drug manufacturing, providing financial support for domestic capabilities, and offering faster drug approval processes.

Decrease single-country dependence

Part of the current challenge is the heavy reliance on foreign manufacturers. Few medications are made in the United States and that creates domestic risks. In a world with a considerable number of geopolitical uncertainties, it is challenging to rely on nations with which America has an adversarial relationship. Right now, there are many complicating issues in the relationship with China including trade, national security, and foreign policy. As the two countries move from a relationship that emphasized cooperation to one that is either competitive or conflictual, the risk of medical drugs being made in China increases. Depending on how relations ebb and flow, there could be times where China needs to redirect drug and PPE manufacturing to domestic needs as opposed to foreign ones. Or they could use its control of drug production to reward allies and punish adversaries. Either way, it is risky for the United States to rely heavily upon China during a time of considerable tension.

Develop U.S. drug manufacturing capabilities

At the same time, it makes sense to reduce reliance upon foreign manufacturers and develop U.S. drug manufacturing capabilities. For medicines that are essential to the health and well-being of Americans, it is vital to have some drug manufacturing options. That type of capability would insulate the U.S. from international disruptions and supply chain logistical problems. The same is true for necessary PPE and medical devices. There is legislation pending in the U.S. Congress that is designed to encourage American drug manufacturing.

Strengthen “made in America” requirements

The U.S. government long has had a “buy American” policy but it was vaguely worded and weakly enforced, so that stance has lost much of its relevance. President Biden has signed an executive order that clarifies the definition and puts stronger regulatory protections in place to make sure the policy is implemented. The order includes a mandate that American-made products must include materials with at least 55% domestic content. Companies can assemble products in the United States but the component parts must come from within the country. Having stronger “country-of-origin” requirements would boost the meaningfulness of “buy American” provisions.

Define the market to include friendly nations

In thinking about domestic drug manufacturing capabilities, it is important to consider the overall drug marketplace and how American firms fit into the global landscape. It would obviously be costly to cease all foreign operations and rely only on U.S.-based facilities. But it is important to think about the geographical combination that would bring needed security to American health products and medicines. It may take a novel combination of domestic and friendly foreign sites to ensure products are available when the U.S. needs them.

Avoid guaranteed contracts

Protecting the production of essential medicines requires a manufacturing competition policy that actually is pro-competition. Guaranteeing contracts for one or two firms in a sector gives them enormous power and sometimes squeezes out competitors. It is important to spread federal resources around so that more companies benefit and more have incentives to manufacture drugs for the United States.

Provide financial support

There are a variety of ways the federal government can provide assistance to domestic drug producers such as tax credits, loans, infrastructure investment, and direct support for production facilities. Any of those methods would improve the U.S. manufacturing climate and make it possible for firms to re-shore drug production and strengthen domestic supply chains.

Offer faster drug approval processes

The last recommendation is to expedite federal drug approval processes. Right now, the U.S. Food and Drug Administration protocols require lengthy times and considerable resources to navigate. Anything that speeds up the process, while still protecting patients, would be helpful. Expediting these processes would make it possible for companies to get drugs to market quicker and offer assistance during vital times. This would ultimately help companies financially and provide drug access to patients who would benefit from its use.

Darrell M. West is vice president and director of Governance Studies and holds the Douglas Dillon Chair. He is Co-Editor-in-Chief of TechTank. His current research focuses on artificial intelligence, robotics, and the future of work. West is also director of the John Hazen White Manufacturing Initiative. Prior to coming to Brookings, he was the John Hazen White Professor of Political Science and Public Policy and Director of the Taubman Center for Public Policy at Brown University.

To read the full commentary from the Brookings Institute, please click here.

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Bodog Poker|Welcome Bonus_Vaccine Archives - WITA

Johnny Morris — Thu, 06 May 2021 18:53:38 +0000

Angela Merkel’s Kriegserklärung against America in its effort to to build consensus for a WTO vaccine waiver will come as no shock to those familiar with Germany’s punitive moralism and gratuitous cruelty in the Greek debt crisis a few years back. But the chancellor’s salvo raises an obvious question: What if the US loses the battle for agreement in Geneva?

One possibility: the US can step back, its global reputation enhanced by having fought the good fight, and focus on other issues. The WTO will have failed the test of “relevance” or “doing good” in today’s world (expressions of USTR Katherine Tai). While keeping an open mind about efforts of others, the Administration never was that invested in making big changes to revitalize the WTO, at least of the kind that the EU, for instance, has been proposing-such as the ill-timed demand for tighter disciplines on subsidies at a moment when governments are spending flat out to prevent economic collapse from the pandemic. (On subsidies reform, the US is supposedly in agreement with the EU in principle but is much more focused now on doing industrial policy as opposed to curbing it).

On the vaccine front, the Biden Administration would have a range of options, some more unilateral while others would focus on cooperation mechanisms such COVAX. Senator Elizabeth Warren, former professor at Harvard Law School, has long argued that the federal US government has sufficient legal authority to break patents where overriding public health concerns are at issue. She is probably referring to “march in” rights in the Bayh Dole Act, which allow the government to engage in compulsory licensing where federal funding has been involved in a patented innovation; one of the criteria is that “action is necessary to alleviate health or safety needs which are not reasonably satisfied by the contractor, assignee, or their licensees.” The pandemic seems to be the test case for these provisions, which have so far not been applied, as I far as I can learn. I’m not an IP lawyer but I’m sure that any effort of the Administration to move in this direction for purposes of alleviating global needs would be heavily debated and litigated. As a non-expert on US IP law, I offer no view of who would win the court case, but I’m pretty sure that pharma won’t prevail in the moral debate. Mobility of people is a major part of the spread of the virus, and soAmerican “health and safety needs” are compromised if the rest of the world can’t get reasonable access to vaccines. Once it has the intellectual property, the Administration can ensure it is freely available to any country or manufacturer that wants to move into production, and can do so safely and reliably. This solution isn’t as comprehensive as a waiver, as it could only apply to those vaccines invented with US federal funding in the picture. Still, combined with US technical assistance, and help on ingredients, it could go fairly far.

But there is another choice-disruptive in its own way. The US could decide to push the WTO beyond its current consensus-based approach. Ambassador Tai has made it crystal clear that the US will try first for consensus in Geneva. But this pronouncement also sets the scene for the US if need be declaring at some point that a consensus “cannot” be reached and therefore that, in accordance with the terms of the WTO Agreement (Article IX:1), the matter at issue “shall” be decided by voting. Yes, “shall”, not might or should. In this case (a waiver) a supermajority of 3/4 would be required. If there were any situation that could push the WTO beyond consensus decision making, it would be the exceptional challenge of the pandemic, one shared by the peoples of all WTO Members. Since the consensus practice gives a veto that de facto will be most easily exercised by the major powers, breaking the practice almost certainly needs to be supported by a major power like the US (here India might be on board too). The nice thing about moving in this direction in the specific circumstances of the pandemic is that it could be presented as a truly unique recourse to unused but totally valid treaty provisions, thus as a limited & fully legal departure from custom, but also serving as a first tentative step in an institutional shift that might lead to faster, more successful negotiations at the WTO and increasing global relevance.

Robert Howse is Professor of International Law at New York University Law School. Professor Howse has been a member of the faculty of the World Trade Institute, Berne, Master’s in International Law and Economics Programme.

To read the original commentary from the World Trade Law Blog, please visit here.

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Bodog Poker|Welcome Bonus_Vaccine Archives - WITA

Caroline Hillier — Sun, 18 Apr 2021 14:32:15 +0000

WTO’s Director-General Ngozi Okonjo-Iweala had indicated when she took office that she would be gathering industry, multilateral groups, and some governments to look at how vaccine production could be expanded and the role the WTO could play in that effort. At the same time, with the proposal from India and South Africa for waiver from most TRIPS obligations on medical products relevant to addressing the COVID-19 pandemic still under consideration in the TRIPS Council, with opposition from a number of important Members, DG Okonjo-Iweala has been seeking an approach that in fact expands production in developing and least developed countries and greater distribution to low- and middle-income countries. without needing an all or nothing resolution to the proposed waiver.

“COVID-19 and Vaccine Equity: What Can the WTO Contribute?”

While the virtual meeting convened by DG Okonjo-Iweala was conducted under Chatham House rules, a number of participants made their prepared comments public and there was some press coverage.

DG Okonjo-Iweala provided a wrap-up at the end of the session which was posted on the WTO website. See WTO news, DG Okonjo-Iweala calls for follow-up action after WTO vaccine equity event, April 14, 2021, https://www.wto.org/english/news_e/news21_e/dgno_14apr21_e.htm (“Director-General Ngozi Okonjo-Iweala today (14 April) called on WTO members, vaccine manufacturers and international organizations to act to address trade-related obstacles to the scale-up of COVID-19 vaccine production to save lives, hasten the end of the pandemic and accelerate the global economic recovery.”). DG Okonjo-Iweala’s summary comments are copied below. See WTO speeches, Chair Summary following “COVID-19 and Vaccine Equity: What Can the WTO Contribute?”, April 14, 2021, https://www.wto.org/english/news_e/spno_e/spno7_e.htm.

“One thing that came out of today’s discussions is that it was only through working together across borders that scientists developed safe and effective vaccines in record time. And it is only by working together, across borders, that we’ll be able to solve the problems [of vaccine scarcity and equitable access] discussed today. This is a problem of the global commons, and we have to solve it together.

“Our purpose today was to contribute to efforts to increase vaccine production and broaden access, starting with the immediate term.

“Specifically we had three goals:

“The first was to pinpoint the obstacles, particularly the trade-related obstacles, to ramping up production, and to equitably distributing and administering vaccines — and we looked at how the WTO could contribute to these solutions.

“The second was to bring together people who are able to increase and to scale up manufacturing, people in a position to share technology and knowhow, and people willing to finance additional manufacturing capacity.

“And third, to think about the road ahead, including on the TRIPS waiver and incentives for research and development, so that we get the medical technologies we need, and no country is left at the back of the line waiting. If there is one refrain we heard continuously from everyone today it is that no one is safe until everyone is safe.

“We heard first-hand from governments and vaccine manufacturers from developed, developing, and least developed countries, as well as a wide range of other stakeholders from international organizations, civil society and development finance institutions.

“And we heard good news: that supplies are ramping up and companies are learning by doing, that there have been major gains in productivity, and that there is still capacity. We also heard that there is a willingness to finance investment in vaccine manufacturing both in the short- and long-term, and there are ideas and energy to do things differently.

“However, we heard from many that we need to do more. It hasn’t really been business as usual, so we may need to move on to ‘business unusual’ to solve the problems before us.

“In the discussions today we heard a great deal of agreement. We agree that it’s not acceptable for people and countries to have to wait indefinitely for vaccines. We do not want to repeat experiences of the past.

“We heard a consensus on the urgent need to scale up production and vaccinate everyone, because every day the shortage continues, scope for dangerous new variants will increase, and the number of prevent preventable deaths will grow. The economic impact of these delays can and has been quantified by many institutions, including the IMF, the World Bank, and the WTO.

“It was agreed that production capacity needs to be expanded, particularly in developing and least developed countries and emerging markets. And that vaccine distribution needs to be more effective and more equitable.

“We heard that open cross-border trade in raw materials, and other inputs, was essential for maintaining and scaling up production, and that supply chains in these inputs must be maintained.

“Also widely shared was the view that innovation, research and development will be vital for dealing with COVID-19 variants and in other health crises.

“We had useful exchanges on issues where some perspectives were different, such as on the future shape of vaccine supply chains, on the appropriate role for intellectual property protections, on issues of vaccine contract transparency — which was pointed to by many as an important factor in appropriate pricing and distribution and a critical part of access and equity.

“Concerns expressed by some about cross-border supply chain operations, including export restrictions and shortages of skilled personnel reinforced my view, and hopefully that of members, that the WTO must and can play a central part in the response to this crisis.

“Various perspectives about the TRIPS Agreement, and whether the existing flexibilities are enough to address developing country needs were put on the table. These echoed the discussions on the waiver proposal going on in the TRIPS Council, and I want to reiterate that today is a way of contributing to that discussion.

“I agree with the view that the WTO is a logical forum for finding a way forward on these issues, and I hope that the ideas raised here will contribute to convergence in the TRIPS Council on meaningful results that can contribute to the goals that we have.

“I hope that the discussion today, listening to each other, seeing that we all share a common goal, and that we may not be so far apart, will lead to the willingness to come to the middle, and work out something that will be acceptable to all.

“Participants were generally of the view that ramping up vaccine manufacturing capacity is a complex process. It requires large, long-term investment and sustainable business models. It relies on open international supply lines for ingredients and equipment. We heard how shortages of even a single piece of equipment, filters, can halt operations at a production facility. Vaccine manufacturing necessitates collaboration, and the movement of skilled labour, to facilitate transfer of technology and knowhow.

“Safety is a paramount consideration, and quality is the other part of safety. This demands effective regulatory capacity and stringent compliance, down to the factory floor. Indeed we heard this is a big risk companies factor in when making decisions as to where to produce, and how to produce. I hope that they’ve heard sufficient encouragement today, to enable us to move towards leveraging the existing capacities in emerging markets and developing countries mentioned repeatedly today, which could actually help to take care of the shortages talked about.

“Turning capacity around to produce COVID-19 vaccines is not only about the physical space alone. We heard repeatedly that it requires transfer of technology and knowhow, together with investment and support for quality assurance.

“We also learned about how existing licensing arrangements have operated — including an example of how skills transfer was carried out in a few as six months. We also heard calls for support to build human capital, and to help build regulatory cooperation.

“Some participants suggested more active matchmaking to connect companies that have the investment capacity with those that have potential for expanding production capacity, even in the short term.

“We also heard about ongoing efforts to build new manufacturing capacity, and the lessons that can be learned from that.

“We also began to see the aspects of the collaboration we need to make things happen. We had many international organizations show they are willing to work together to bring to fruition things like putting in place technical expertise, helping with capacity building and quality control, and investing directly in production.

“I believe that today’s exchanges have advanced our understanding of the challenges we face for scaling up vaccine production, and that working together is the only way ahead.

“In the coming weeks and months, we expect concrete follow-up action. These issues are not easy, but the political will and engagement from the private sector displayed today, suggests it is possible.

“As we move forward, I expect:

“- From WTO members:

“- Action to further reduce export restrictions and supply chain barriers, and to work with other organizations to facilitate logistics and customs procedures. We are monitoring this as part of our regular work, and we’ll continue doing so to increase supplies and maintain robust supply chains. Trade has been underlined as a critical factor in production; it is incumbent upon WTO members to act.

‘- Advance negotiations in the TRIPS Council on the waiver proposal and incentives for research and innovation. I hope that the ideas and the open dialogue heard will move us closer to agreement.

‘- For vaccine manufacturers:

‘- Concrete moves to scale up vaccine manufacturing, both short-term turnaround of existing capacities, milking whatever productivity gains we can from current facilities, and taking steps to invest.

“- Increased technology and knowhow transfer, which many participants stressed would be necessary to make additional production work.

“- We need transparency in contract agreements and product pricing. We hope to continue this dialogue and to help monitoring steps in that direction.

“- For international organisations and financial institutions:

“- We noted your willingness to finance, both existing and new capacity, your willingness to work on capacity building for regulatory issues, not just for vaccines, but also for therapeutics and diagnostics, which are equally important.

“I trust that we have found a good basis to deliver concrete action, and to continue this discussion that we’ve had today.

“This should not be a one-off, we should continue to talk to each other, and make sure that we can deliver.

“I hope that besides concrete action to increase capacity, this discussion has given us elements of a framework on trade and health that we can put together at the WTO, and that can be put before ministers at the 12th Ministerial Conference in mid-December. Such a framework should provide for trade-related preparedness to handle this pandemic, and the next one.”

Press accounts indicate that the United States, European Union, India and South Africa participated. Statements from USTR Katherine Tai and Executive Vice President Dombrovskis are available from government websites. See USTR press release, Ambassador Katherine Tai’s remarks at a WTO virtual conference on Covid-19 vaccine equity, April 14, 2021, https://ustr.gov/about-us/policy-offices/press-office/press-releases/2021/april/ambassador-katherine-tais-remarks-wto-virtual-conference-covid-19-vaccine-equity; European Commission press release, Speech by Executive Vice-President Valdis Dombrovskis at the WTO Webinar “Covid and Vaccine Equity,” 14 April 2021, https://ec.europa.eu/commission/commissioners/2019-2024/dombrovskis/announcements/speech-executive-vice-president-valdis-dombrovskis-wto-webinar-covid-and-vaccine-equity_en.

The Biden Administration has been meeting with various interest groups on the TRIPS wavier proposal (both pro and con) and is receiving pressure from some Members of Congress and prior government officials to agree to a waiver. Ambassador Tai’s statement stresses the need for equity in vaccine availability. “These losses have been disproportionately borne by vulnerable and economically disadvantaged communities within our countries. And the significant inequities we are seeing in access to vaccines between developed and developing countries are completely unacceptable. Extraordinary times require extraordinary leadership, communication, and creativity. Extraordinary crises challenge all of us to break out of our comfortable molds, our in-the-box thinking, our instinctive habits. This is not just a challenge for governments. This challenge applies equally to the industry responsible for developing and manufacturing the vaccines. The desperate needs that our people face in the current pandemic provide these companies with an opportunity to be the heroes they claim to be – and can be. As governments and leaders of international institutions, the highest standards of courage and sacrifice are demanded of us in times of crisis. The same needs to be demanded of industry.”

The EU statement is consistent with their views that equity is necessary and that the EU has been working to contribute to that result through production ramp up and large exports in fact, including to the COVAX facility. The EU summed up what the WTO should be doing. “To sum up, the WTO can support vaccine equity through five sets of actions:
Promoting best practices in terms of trade facilitation and regulatory cooperation to maintain open supply chains; Facilitating cooperation with the private sector, both to ramp up production in the short term, and to enhance manufacturing in global regions with under-capacity, focusing in particular on Africa; Supporting Members’ use of the available TRIPs flexibilities; Continuing to seek joint approaches with the World Health Organisation and the World
Intellectual Property Organisation; and Ensuring transparency and effective monitoring of any temporary export restriction, as proposed by the Ottawa Group.”

I have not found statements from either India or South Africa but at least one publication indicated they stressed the need for a TRIPS waiver for all Members. See Washington Trade Daily, WTO’s Role in Vaccine Equity, April 15, 2021, https://files.constantcontact.com/ef5f8ffe501/63ac7508-8034-44b3-8c3c-045c1bedec43.pdf.

The World Health Organization also participated and the Director-General’s statement is available from the WHO website. See WHO press release, COVID-19 and vaccine equity panel: what can the World Trade Organization contribute?, 14 April 2021, https://www.who.int/director-general/speeches/detail/covid-19-and-vaccine-equity-panel-what-can-the-world-trade-organization-contribute(“COVAX was created, as you know, almost a year ago to avoid the same thing happening again. And although COVAX has distributed almost 40 million doses of vaccine to 110 countries and economies, vaccine nationalism, vaccine diplomacy and severe supply constraints have so far prevented COVAX from realizing its full potential. Global manufacturing capacity and supply chains have not been sufficient to deliver vaccines quickly and equitably where they are needed most. More funding is needed, but that’s only part of the solution. Money doesn’t help if there are no vaccines to buy. We need to dramatically scale up the number of vaccines being produced. To address this challenge, WHO and our partners have established a COVAX manufacturing task force, to increase supply in the short term, but also to build a platform for sustainable vaccine manufacturing to support regional health security. We need to go beyond the traditional modus operandi to provide sustainable and effective solutions to address this extraordinary crisis. Some manufacturers have begun sharing the know-how and technologies to produce more vaccines, but only under restrictive conditions, on a very limited basis. The current company-controlled production sharing agreements are not coming close to meeting the overwhelming public health and socio-economic needs for effective, affordable and equitable access to vaccines, as well as therapeutics and other critical health technologies. This is an unprecedented emergency that demands unprecedented measures.”).

One of the private sector participants, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) included its statement on the IFPMA website. See IFPMA, IFPMA statement at WTO event “COVID-19 and Vaccine Equity: What can the WTO Contribute”, 14 April 2021, https://www.ifpma.org/resource-centre/ifpma-statement-at-wto-event-covid-19-and-vaccine-equity-what-can-the-wto-contribute/. The IFPMA statement is embedded below but highlights the extraordinary effort of the private sector in ramping up production which is expected to be 10 billion doses by the end of 2021 with some 272 partnerships entered into and 200 technology transfer agreements.

IFPMA_WTO_Event_COVID-19_and_Vaccine_Equity_Statement_15April2021

Rising Infections; dramatically ramped up production

Last Thursday’s summary from the European Centre for Disease Prevention and Control (ECDC) shows the world going through a massive ramp up of new infections such that week 14 of 2021 is the second highest week during the pandemic of new infections with the vast majority of the cases and increase in Asia, the Americas and Europe. See ECDC, COVID-19 situation update worldwide, as of week 14, updated 15April 2021, https://www.ecdc.europa.eu/en/geographical-distribution-2019-ncov-cases.

“Distribution of COVID-19 cases worldwide, as of week 14 2021

“Distribution of cases of COVID-19 by continent (according to the applied case definition and testing strategies in the affected countries)

“Cases reported in accordance with the applied case definition and testing strategies in the affected countries.”

The ECDC data show Africa as accounting for 3.18% of total infections during the pandemic, Asia accounting for 19.50% (India is 9.91%; China is 0.07%), the Americas for 43.18% (United States 22.91% and Brazil 9.90%), Europe 34.08% (the Eu is 20.79%, the UK is 3.20%, Russia is 3.4%), and Oceania 0.05%.

At the same time as new infections are ramping up, vaccinations are also increasing sharply. Bloomberg data through April 17, 2021 shows a global total of 884 million vaccinations having been given globally. See Bloomberg, More Than 884 Million Shots Given: Covid-19 Tracker, updated April 17, 2021, https://www.bloomberg.com/graphics/covid-vaccine-tracker-global-distribution/.

While there are countries who have fewer or more vaccinations as a percent of the global total than their share of infections, considering distribution equity from that vantage point has some surprising results.

Country Percent of infections Percent of vaccinations

United States 22.91% 23.16%

European Union 20.79% 12.36%

United Kingdom 3.20% 4.76%

Japan 0.37% 0.21%

Republic of Korea 0.08% 0.17%

India 9.91% 13.85%

China 0.07% 21.18%

South Africa 1.14% 0.33%

Brazil 9.90% 3.92%

The pharmaceutical industry is projecting that 10 billion doses of COVID-19 vaccine will ship in 2021. That means that in the next eight and a half months, some nine billion doses will ship. If 10 billion doses are shipped in 2021, that is sufficient to fully vaccinate 5-6 billion people in 2021 (depending on number of doses that are for single shot vaccines). That is sufficient doses to vaccinate 63.3-75.9% of the current estimate of the global population (7.9 billion). SeeWorldometer, Current World Population, https://www.worldometers.info/world-population/#:~:text=The%20current%20world%20population%20is,currently%20living)%20of%20the%20world./ With the continued efforts to expand production and approve additional vaccines, 10 billion doses may be exceeded in fact by the end of the year.

This suggests, just as the COVAX and UNICEF distribution plans indicate, that low- and middle-income countries will see a large increase in supplies in the second half of 2021, just as will be true for the rest of the world.

The U.S.-Gavi event on April 15 talked about increasing funding for COVAX to go from 20% to 30% of populations the COVAX facility is serving. See U.S. Department of State, Video Remarks of Secretary of State Antony Blinken, Launch of GAVI’s COVAX Commitment, April 15, 2021, https://www.state.gov/launch-of-gavis-covax-commitment/. Moreover, the World Bank is committing billions to increases purchases of vaccines for low- and middle-income countries. And many countries are executing their own contracts with vaccine producers.

If there are issues besides assistance in resolving bottlenecks that would appear to be important to speeding up distribution and ensuring access by all, it would be to ensure that all countries with vaccine supplies greater than their internal needs, work to get those vaccines distributed to other countries later this year as their internal needs clarify.

Moreover, there are very exciting developments on the vaccine front with the start up of trials in a number of developing countries of a new vaccine where the potential exists for low costs with a vaccine that can be produced locally by many countries based on technology similar to what is already used for other vaccines. See New York Times, Researchers Are Hatching a Low-Cost Coronavirus Vaccine, A new formulation entering clinical trials in Brazil, Mexico, Thailand and Vietnam could change how the world fights the pandemic, April 5, 2021, updated April 17, 2021, https://www.nytimes.com/2021/04/05/health/hexapro-mclellan-vaccine.html.

All to say, there is considerable reason for optimism with the current efforts and progress. Efforts by governments, multilateral institutions, industry and others are helping identify challenges both to production and distribution but also to the needs for a speedy recovery once the pandemic is brought under control. While everyone needs to continue to focus on resolving bottlenecks, securing cooperation to ensure all are reached, and addressing developments as they arise, 2021 is not a repeat of the HIV situation.

The WTO has an important role in monitoring trade restrictions and looking forward to what actions Members are willing to take to advance trade and health needs and help ensure a next pandemic is handled more quickly than the COVID-19 has been. The effort to obtain a waiver from TRIPS obligations is, in this writer’s view, missing where the challenges are and seeking an outcome that will not advance improved vaccinations in 2021. While it is common for countries to continue to fight yesterday’s problems instead of addressing the current challenges, such an approach will not secure equitable and affordable access to vaccines in 2021-2022.

Terence Stewart, former Managing Partner, Law Offices of Stewart and Stewart, and author of the blog, bodog poker review|Most Popular_Congressional

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Bodog Poker|Welcome Bonus_Vaccine Archives - WITA

Caroline Hillier — Thu, 08 Apr 2021 15:28:38 +0000

Apress release from the WHO, Gavi, CEPI and UNICEF on the COVAX facility’s success in getting vaccines to 100 countries by April 8 is impressive news for the efforts of the WHO, GAVI, CEPI, UNICEF and their supporters to get vaccines to low- and middle-income countries as part of the effort to have vaccine distribution done equitably and affordably. See Press Relase from WHO, Gavi, CEPI, UNICEF, COVAX reaches over 100 economies, 42 days after first international delivery, April 8, 2021, https://www.gavi.org/news/media-room/covax-reaches-over-100-economies-42-days-after-first-international-delivery#:~:text=The%20milestone%20comes%2042%20days,Ghana%20on%20February%2024th.&text=Of%20the%20over%20100%20economies,Advance%20Market%20Commitment%20(AMC). The press release is embedded below.

COVAX reaches over 100 economies, 42 days after first international delivery | Gavi, the Vaccine Alliance

While the release indicates that there will be delays in deliveries of vaccines in March and April because of increased COVID-19 cases in India, developments in India could mean an even greater delay in supplies than announced in March. For example, the major supplier of vaccines to COVAX in the first half of 2021 is the Serum Institute of India (“SII”) which is licensed by AstraZeneca to produce that vaccine in India for distribution in large part to COVAX. Yesterday, the president of SII indicated that export shipments could resume in June depending on cases levels in India. See Financial Times, India to restart Covid vaccine exports in June if local cases fall, April 7, 2021, https://www.ft.com/content/fcdffb8f-f86e-4bd9-adec-20256aeb0a07. It doesn’t appear that SII has notified COVAX of a further delay past April, but a June resumption, if it occurs, suggests that delays will continue through May at a minimum.

The situation for SII is complicated by a need for expanded capacity. It has sought $400 million from the Indian government to ramp up production from 71 million to 100 million doses per month by May. See Fierce Pharma, ‘Very stressed’ Serum Institute asks government for $400M vaccine production boost, April 8, 2021, https://www.fiercepharma.com/manufacturing/very-stressed-serum-institute-india-asks-government-for-vaccine-production-boost.

Moreover, the refusal of SII to export doses to the United Kingdom, to COFAX and others has become the basis for a legal notice from AstraZeneca. See Times of India, Covid-19: AstraZeneca sends legal notice to SII over delays in vaccine supply, April 8, 2021, https://timesofindia.indiatimes.com/india/astrazeneca-sends-legal-notice-to-sii-over-delays-in-vaccine-supply/articleshow/81960902.cms. SII is also finding itself refunding moneys paid by countries who are not getting supplies. See Reuters, Serum Institute refunds S. Africa for undelivered AstraZeneca doses, April 8, 2021, https://www.reuters.com/article/us-health-coronavirus-safrica/serum-institute-refunds-south-africa-for-undelivered-astrazeneca-doses-idUSKBN2BV1TI.

While COVAX is looking to expand sources of vaccines, SII is the major source through June. Professor Simon Evenett has put out a one page analysis of the implications for supply to COVAX from SII if the resumption of exports is premised on India fully vaccinating all those willing to be vaccinated for whom the government of India has opened up vaccinations. While SII has not stated that resumption of exports is tied to full vaccination of Indians who are 45 years or older, Prof. Evenett’s paper is an interesting analysis of how long a delay could occur in terms of SII becoming a major exporter again. His paper entitled “Vaccine Maths 2: Will India start exporting COVID-19 vaccines again in June 2021?” is embedded below.

PDF file

Conclusion

With the spread of the new variants of COVID-19 that have higher rates of transmission and higher rates of serious infection, many countries find themselves facing increased numbers of cases and increased hospitalizations and deaths even as vaccine supplies are increasing and vaccination roll outs starting in many countries. There is a lot of attention within multilateral organizations such as the World Bank, IMF and WTO and by a number of countries on the needs for increased production and distribution to all countries. See, e.g., April 6, 2021, IMF April World Economic Outlook, IMF and World Bank Spring Meetings and U.S. efforts on global access to vaccines, https://currentthoughtsontrade.com/2021/04/06/imf-april-world-economic-outlook-imf-and-world-bank-spring-meetings-and-u-s-efforts-on-global-access-to-vaccines/. COVAX is an important part of the solution but it will need more funding and greater diversity of suppliers to meets its role in the equitable and affordable access to vaccines in 2021 and 2022.

Terence Stewart, former Managing Partner, Law Offices of Stewart and Stewart, and author of the blog, bodog poker review|Most Popular_Congressional

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