The move comes as India in particular faces an increasingly dire situation, with its health system showing signs of collapse - adding to the sense of urgent global need. The AstraZeneca vaccine, which is not authorized for use in the United States by the Food and Drug Administration, will be shipped out once it clears federal safety reviews, officials said.
The White House took pains to stress that the move will not affect the United States' internal vaccination drive. "We do not need to use AstraZeneca in our fight against covid," press secretary Jen Psaki told reporters, noting that the domestic U.S. push relies on vaccines made by other companies.
It is not clear how many of the AstraZeneca doses would go to India, but in the interim the United States announced other actions to help the struggling country, including sending raw materials to help India make its own vaccine.
The question of when and how to send vaccine overseas has been a vexing one for the White House. President Joe Biden's promise to rid the United States of the coronavirus was a top campaign pledge, and he does not want to be seen as prioritizing other countries. Yet he also speaks often of restoring the United States to moral leadership in the world and showing compassion for other nations.
Monday's decision came after weeks of pressure. Foreign policy staffers have been advocating for sharing more of the surplus, but senior White House officials did not want to send doses abroad as the United States scrambles to vaccinate its citizens, according to two people with knowledge of the matter who spoke on the condition of anonymity to discuss internal deliberations.
As it has become increasingly clear that AstraZeneca's vaccine will not be a big part of the plan for vaccinating Americans, the people said, it became harder to justify not sending it to other countries.
But while many countries are desperate for vaccine, AstraZeneca's version may not be their first choice. The vaccine has faced concerns about rare blood clots, its effectiveness against variants and its overall efficacy.
The European Union is suing the company for missed delivery targets, and South Africa stopped using the vaccine after a small trial found that it was not effective against the dominant variant in the country. The European Union also temporarily paused distribution of the vaccine while it investigated the blood clots associated with it, before ultimately resuming injections.
With all Americans 16 and older eligible for vaccination as of last week and countries such as India experiencing dramatic case increases, the White House's calculations have appeared to shift. Last month, the United States said it would share a much smaller amount, about 4 million doses of vaccine, with Mexico and Canada.
"The India crisis has put the spotlight back on the United States in a dramatic and difficult way that's very, very uncomfortable," said Stephen Morrison, director of the Global Health Policy Center at the Center for Strategic and International Studies.
He said India's spike in cases exposed a slowness by the United States to respond to the gap between the abundance of vaccine at home and the gaping need in the rest of the world. "We're not being very fast. We're not being very nimble and pivoting to a new position," Morrison said. "We look a little sluggish."
China and Russia have shared vaccines with neighboring countries and the developing world, raising concerns about U.S. geopolitical rivals making inroads while the United States holds back.
Even as the Biden administration now prepares to share vaccine, it could be weeks or months before those doses reach other countries, because the FDA must complete its safety review. AstraZeneca vaccine in the United States has been produced at an Emergent BioSolutions manufacturing plant in Baltimore that has since shut down production because of safety issues.
One major problem there occurred when 15 million doses of the Johnson & Johnson vaccine were contaminated by having the AstraZeneca vaccine mixed in. However, the AstraZeneca doses are not believed to have been affected, according to an administration official with knowledge of the situation who spoke on the condition of anonymity to discuss the sensitive matter.
Officials said the United States would ensure that vaccine doses were safe before sending them abroad.
"Over the next few months, before any AstraZeneca doses are shipped from the United States, the FDA will confirm any such doses meet its expectations for product quality," Psaki said. "This is being done in the context of the ongoing review of all doses made at the plant where these AstraZeneca doses were produced."
Administration officials also said discussions were underway to determine how exactly to allocate and distribute the doses once they are cleared by the FDA.
Given the gravity of the situation in India, U.S. officials have engaged in high-level calls with Indian officials about how the Biden administration can assist the country in the meantime. Biden spoke Monday with Indian Prime Minister Narendra Modi, pledging support as the country battles what is now arguably the world's biggest coronavirus outbreak.
A senior administration official who spoke with reporters Monday afternoon but declined to be named, in accordance with White House policy, described the call as "warm and positive" and said Modi did not request any of the ready-to-use vaccine doses the United States has in its stockpile.
Instead, the United States will supply India with raw materials to manufacture the AstraZeneca vaccine on its own. It is also sending ventilators, personal protective equipment, oxygen-related supplies and therapeutic medicines. An American team of health experts will go to India to help fight the outbreak.
The rapidly deteriorating situation in India reflects the disproportionate share of vaccine supply between a small number of relatively rich nations and most of the world. Countries that the World Bank classifies as "high-income," accounting for 16% of the world's population, have locked up more than 50% of near-term supply, according to research from Duke University. By July, the Duke team estimates, the United States could be sitting on hundreds of millions of surplus doses.
Those purchases by wealthier countries have undercut an effort known as Covax, backed by the World Health Organization, that aims to get vaccine to low- and middle-income countries that would otherwise be cut out of the vaccine race. Biden has pledged $4 billion for Covax, an initiative that President Donald Trump spurned.
Covax's goal for 2021 was to deliver about 2 billion doses to participating countries, but it has been stymied by funding shortages and a supply crunch. Covax has delivered about 43 million doses, and the crisis in India - where much of the vaccine for Covax will be made - could make things worse.
While the United States has fully vaccinated 28.5% of its population, India has vaccinated 1.55%, according to data from the U.S. Centers for Disease Control and Prevention and Our World in Data.
The abundance of vaccine in some rich countries has stoked envy and anger around the world. Several countries, including Namibia and Kenya, have called the gap "vaccine apartheid" and urged countries such as the United States to do more.
Some U.S. officials and business leaders say privately that the issue of vaccine distribution is more complicated than sometimes portrayed. The United States may need some of its surplus if it turns out that people must get regular booster shots to remain healthy, they say.
In addition, U.S. health officials may decide to begin vaccinating younger children, which also would require more vaccine. And setbacks to the vaccination drive are always possible, they add, such as the recent pause in the Johnson & Johnson vaccine because of rare blood clots.
Some activists suggest that one solution would be to suspend patent protections for the coronavirus vaccines so other countries and companies could manufacture them on their own.
The United States, Britain and members of the European Union have blocked a World Trade Organization proposal backed by roughly 80 nations to do so, but the organization will revisit the issue next month.
A Biden administration official, in the call with reporters on Monday, declined to elaborate on the administration's thinking on the issue.
"We are looking at it but have nothing to say," the official said.
A group of senators led by Bernie Sanders, I-Vt., Elizabeth Warren, D-Mass., and Tammy Baldwin, D-Wis., along with former heads of state and Nobel laureates, have urged Biden to support a temporary patent waiver, citing what they describe as an urgent moral need.
"We can't in good conscience sit there and say, 'Well, tough - we're not going to require these pharmaceutical companies to license to you, and we're not going to give the technology to you,' " said Rep. Ro Khanna, D-Calif. "That would be a total disaster not just on a humanitarian level but from a national security perspective of America's standing in the world."
Opponents of such a waiver say it would interfere with the global supply chain and slow down, not speed up, manufacturing and distribution of vaccine.
As Brazil, India and other countries see their cases multiply, more leaders inside and outside the administration are concluding that slowing the pandemic's global spread is necessary to the health of Americans, not just those in other countries.
Biden administration officials said the United States must play a significant role in doing that. "This pandemic will not end unless we help the world end it," an official said.
Published : April 27, 2021
By : The Washington Post · Tyler Pager, Annie Linskey, Emily Rauhala