Around 10M AstraZeneca COVID Vaccine Doses Awaiting FDA Approval Will Be Donated to Other Countries

The United States has decided to share its entire supply of the AstraZeneca vaccine with the rest of the world once it clears federal safety reviews.

White House COVID-19 coordinator Jeff Zients said around 10 million doses of the vaccine have already been produced, but have yet to pass the FDA review to "meet its expectations for product quality."

The AstraZeneca vaccine is in widespread use around the world, and could be approved in the U.S. in the next several weeks. Some 50 million additional doses are in various stages of production, and could be ready to ship in May and June if the FDA gives its approval.

"Given the strong portfolio of vaccines that the U.S. already has and that have been authorized by the FDA, and given that the AstraZeneca vaccine is not authorized for use in the U.S., we do not need to use the AstraZeneca vaccine here during the next several months," Zients said. "Therefore the U.S. is looking at options to share the AstraZeneca doses with other countries as they become available."

The move follows increased confidence in the White House about U.S. vaccine supply, especially after use of the Johnson & Johnson vaccine resumed over the weekend.

For more reporting from the Associated Press, see below:

AstraZeneca Vaccine Sign France
Around 10 million AstraZeneca COVID vaccine doses awaiting FDA approval in the U.S. will be donated to other countries. Above, a sign indicates a vaccination area near Paris on April 24. Raphael Lafargue / POOL / AFP/Getty Images

The move greatly expands on the Biden administration's action last month to share about 4 million doses of the vaccine with Mexico and Canada.

More than 3 million people worldwide have died of COVID-19.

The U.S. has yet to finalize where the AstraZeneca doses will go, Zients said. Neighbors Mexico and Canada have asked the Biden administration to share more doses, while dozens of other countries are looking to access supplies of the vaccine. The doses will be donated by the U.S. government, which has contracted with the company for a total of 300 million doses — though the company has faced production issues.

AstraZeneca's doses in the U.S. were produced at an Emergent BioSolutions plant in Baltimore that has come under increased regulatory and public scrutiny after botching batches of the J&J vaccine. The U.S. pressed J&J to take over the plant and, as part of the effort to ensure the quality of newly produced vaccines, directed the facility to stop making the AstraZeneca shot. AstraZeneca is still looking to identify a new U.S. production facility for its future doses.

AstraZeneca's vaccine was initially expected to be the first to receive federal emergency authorization, and the U.S. government ordered enough for 150 million Americans before issues with the vaccine's clinical trial held up clearance. The company's 30,000-person U.S. trial didn't complete enrollment until January, and it has still not filed for an emergency use authorization with the FDA.