June 13, 2021

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Biden admin reveals plans for first 25 million donated vaccine doses – POLITICO

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“We are sharing these doses not to secure favors or extract concessions,” President Joe Biden said in a statement Wednesday. “We are sharing these vaccines to save lives and to lead the world in bringing an end to the pandemic, with the power of our example and with our values.”

The donation will come from the U.S. stockpile of Johnson & Johnson, Pfizer and Moderna vaccines.

Six million of the doses allocated to COVAX will go to countries in South and Central America, including Brazil, Paraguay and El Salvador. Seven million doses will be sent to Asian countries, including India, Nepal, Pakistan and the Phillippines. Another 5 million doses will go to African countries that will be selected in coordination with the African Union. The U.S. will also send a total of 6 million doses directly to allies and “regional priorities,” including Mexico, Canada, West Bank and Gaza, Ukraine, Egypt and Iraq, the White House said.

The world has waited for months to see which countries would share in the United States’ vaccine bounty.

Biden said in late April that the U.S. would send 60 million doses of AstraZeneca’s vaccine abroad by July 4 — a commitment made amid growing global concern about sharp spikes in Covid-19 cases and deaths in India. On May 17, Biden said the U.S. would donate an additional 20 million doses — a mix of Pfizer, Moderna and Johnson & Johnson’s shots — by the end of June.

But problems with the AstraZeneca doses available slowed the White House’s roll out. The shots were manufactured by a contractor, Emergent BioSolutions, at the same plant where 15 million doses of Johnson & Johnson’s vaccine were contaminated in March. Emergent inadvertently mixed the J&J doses with the active ingredient of AstraZeneca’s vaccine.

The Food and Drug Administration has been trying to determine whether the AstraZeneca doses made by Emergent are contaminated. The agency recently asked AstraZeneca and J&J to conduct risk assessment analyses of any effects from possible trace contamination. Once the FDA clears the the AstraZeneca doses, they will be available for distribution domestically and internationally.

The administration said Thursday it is not still ready to announce where the 60 million AstraZeneca doses will go, because the FDA safety review is still pending.

But in the last week, officials at the White House, State Department and the U.S. Agency for International Development decided to publicly announce where the 20 million J&J, Pfizer and Moderna doses would be sent, two senior officials involved in those discussions told POLITICO.

White House Covid-19 response coordinator Jeff Zients said Thursday that the government is also removing Defense Production Act priority ratings for three not-yet-authorized vaccines from AstraZeneca, Novavax and Sanofi because the U.S. is confident in its vaccine supply.

“While the manufacturers will continue to make these three vaccines, This action will allow U.S-based companies that supply these vaccine manufacturers to make their own decisions on which orders to fulfill first,” he said.

The Trump administration ordered 300 million doses from AstraZeneca and 100 million each from Novavax and Sanofi, but the development of those vaccines has lagged behind global frontrunners like Pfizer and its partner BioNTech.

The Biden team has come under increasing pressure by lawmakers on Capitol Hill to accelerate its vaccine-donation plans, especially when countries such as India and Brazil have seen tens of thousands of people die of Covid-19 in the span of just a few weeks. U.S. diplomats overseas have also pushed the State Department to send vaccine abroad as a way to counter Russia and China, which are using their homegrown shots to win political concessions from recipients. And senior health officials have told the White House that the U.S. has more than enough vaccine in its stockpile for America’s needs.

“We will work as expeditiously as possible,” National Security Adviser Jake Sullivan told reporters Thursday. “This is certainly a complex operational challenge but one that we will take on. Our goal is in service of ending the pandemic globally. We want to save lives and thwart variants that place all of us at risk. Most important, this is just the right thing to do.”

Senior administration officials have rejected criticism that the Biden team has moved too slowly to on vaccine donations, citing a Food and Drug Administration safety review of AstraAzeneca doses as the reason for the delay.

Those officials said the administration also needed time to work out a rubric to guide which countries or groups would receive the doses before they made an announcement about the allocations. An interagency team including representatives of the National Security Council, State Department and the U.S. Agency for International Development has worked for weeks to determine how to rank donation requests based on factors such as a country’s rate of virus transmission and its existing supplies of vaccine and drugs for treating Covid-19.

Any country on the receiving end must have a robust distribution infrastructure to ensure the shots are used before they expire. The Biden administration also will need to work with receiving countries on contract language that includes an indemnification clause to protect a vaccine’s maker against legal liability for things like adverse reactions, the officials said.

Two national security officials familiar with deliberations on vaccine requests told POLITICO the administration was originally concerned about the situation in South Asia, including Nepal and the Philippines, but that the focus has shifted in recent days to South America.

The vaccine donations supplement a broader effort in the Biden administration to provide Covid-19 humanitarian assistance to the rest of the world. USAID is leading the effort in trying to identify life saving supplies such as masks, gloves and oxygen components in the supply chain, buy the products and find ways to ship them to countries across the world.

That effort has slowed in recent weeks, even after the administration said it would provide supplies to India, two officials with knowledge of the matter said. Prices for personal protective equipment are rising again and oxygen components are increasingly difficult to come by. Officials said there is an added hurdle of finding enough cargo space to ship the materials overseas.

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