U.S. aims to share up to 60 million AstraZeneca vaccine doses with other countries after FDA review
The Biden administration is planning to share up to 60 million doses of AstraZeneca's COVID-19 vaccine with other countries, officials confirmed Monday. The decision comes after the White House has faced growing calls to share shots that are likely to otherwise go unused in the United States.
Some 10 million doses manufactured in the U.S. could be shipped out to other countries within the "coming weeks," White House press secretary Jen Psaki said Monday. But Psaki noted that the shots first need to clear safety reviews by federal regulators.
"Given the strong portfolio of vaccines that the United States has already authorized and that is available in large quantities, including two two-dose vaccines and one one-dose vaccine, and given AstraZeneca is not authorized for use in the United States, we do not need to use AstraZeneca in our fight against COVID over the next few months," Psaki told reporters.
Psaki said officials were still "working through what the process will look like" to share the doses. The Biden administration has faced criticism for its previous plans to loan AstraZeneca doses directly to Canada and Mexico in March, instead of sharing them with the international COVAX effort to vaccinate poorer countries that has faced steep challenges scaling up production.
Federal health officials also offered few details on what the current safety review entailed. AstraZeneca's doses have so far been manufactured at the same plant run by Emergent BioSolutions that was forced to trash some 15 million doses worth of Johnson & Johnson's COVID-19 vaccine over concerns they had been contaminated.
An AstraZeneca spokesperson later said their doses passed "stringent requirements" and were subject to "safety tests and quality control measures" before being used in Mexico and Canada.
Emergent BioSolutions has since disclosed it expected to ramp down its manufacturing of AstraZeneca doses and is quarantining all vaccine doses manufactured at its Baltimore factory, as it worked to resolve a number of issues flagged by FDA inspectors.
The move comes as the Biden administration has announced a slew of actions to address a deadly surge of COVID-19 that has ravaged India's healthcare system. Over the weekend, the White House said it would divert "pending orders of vaccine filters" from U.S. factories to India to aid the nation's effort to manufacture doses of AstraZeneca's vaccine.
India set a world record for new coronavirus infections for the fifth day in a row on Monday, reporting 352,991 new cases and 2,812 deaths.
When asked if the White House planned to prioritize India for AstraZeneca vaccine doses, Psaki said the country's current priority is obtaining oxygen and PPE, and noted that there are not yet any AstraZeneca doses ready for the U.S. to provide. When doses are available, Psaki said, the White House will work to "assess a range of requests, a range of needs around the world."
AstraZeneca in March had said it planned to seek emergency use authorization "in the coming weeks" for its shots in the U.S., but has yet to announce their submission to the Food and Drug Administration — a process that can take another month to clear the scrutiny of regulators.
Between the COVID-19 vaccine doses made by Pfizer, Moderna, and Johnson & Johnson, the Biden administration expects to have enough supply to vaccinate all adults by the end of May — and to have millions more doses to potentially vaccinate children over the summer.
However, in part thanks to deals struck by the Trump administration's Operation Warp Speed, the U.S. still has another 500 million doses already on order to be manufactured from drugmakers AstraZeneca, Novavax, and Sanofi as the companies work on developing their vaccines.
All six of the vaccines ordered by the U.S. government have been accelerated by the Defense Production Act, which is able to force companies to prioritize U.S. orders for key vaccine equipment and supplies.
However, a Government Accountability Office report warned earlier this month that wielding the priority orders had begun to crowd out other critical medicines and may have led to unnecessary stockpiling of key supplies. Vaccine makers abroad, including in India, have complained that the Biden administration's use of the Defense Production Act amounted to an export ban — a claim the White House has repeatedly rejected.
Bio, the trade lobbying group spanning U.S. biotech firms including Pfizer, Moderna, and Johnson & Johnson, recently called on the Biden administration to ramp down its use of powers that were "well intentioned but somewhat misguided at this stage."
"We need to get those raw materials out to the limited manufacturing capacity that exists around the globe. And now is the time to act on this," said Bio's President Dr. Michelle McMurry-Heath during a recent press briefing.
