The Biden administration is preparing to send up to 60 million AstraZeneca doses to countries in need over the next several months, once a federal safety review is conducted, according to two senior Biden administration officials.
The company has produced about 10 million doses of the vaccine for the U.S. but the FDA has not yet authorized their use. The agency is still examining the doses to ensure they meet the necessary quality control standards. An additional 50 million doses are in production, one of the senior officials said.
It is unclear where the U.S. will send the AstraZeneca doses and whether it will send them through COVAX or directly to individual countries. The administration’s decision to commit the doses was first reported by the Associated Press.
It comes on the heels of the Biden administration’s announcement that it will send India raw materials and components to manufacture Covishield, a version of the AstraZeneca vaccine produced by the country’s Serum Institute.
Those materials were already wrapped up in contracts held by the U.S. But the administration decided over the weekend to divert pending orders of vaccine supplies such as filters to India, and to ship additional drugs, test kits and personal protective equipment. The administration has not yet decided whether to send India AstraZeneca doses directly.
U.S. production of the AstraZeneca vaccine is on hold after the FDA ordered contract manufacturer Emergent Biosolutions to stop making the drug substance for the AstraZeneca and Johnson & Johnson vaccines. In March, Emergent’s Bayview plant in Baltimore accidentally contaminated 15 million doses of the J&J vaccine by mixing them with drug substance for the AstraZeneca vaccine.
AstraZeneca is looking for an alternative to Emergent to help with production of future U.S. doses.
The Biden team’s decision to send up to 60 million doses of the vaccine across the world comes as the administration tries to ramp up vaccination in the U.S. Officials say they have begun to see the number of people signing up for Covid-19 shots go down in recent days, indicating that the U.S. might finally be hitting a point where it has more supply than demand.
One senior health official said the administration had initially pushed back on the idea of sending any doses overseas — even if they were not approved for use in the U.S. — because officials feared there could be additional production hiccups over the next several months that would limit the country’s supply.