With less than two weeks left to fulfill President Biden’s promise to share 80 million doses of the coronavirus vaccine with countries in need, production problems at an Emergent BioSolutions manufacturing facility are forcing the government to revise its plan to send AstraZeneca doses overseas .
Officials are now working to replace tens of millions of doses of the AstraZeneca vaccine that were originally intended to be included in the donation with others from Pfizer and BioNTech, Moderna and Johnson & Johnson, according to people familiar with the discussions. These three vaccines are approved in the US for emergency use.
A pattern of serious neglect at the Baltimore facility has challenged the fate of more than 100 million doses of AstraZeneca and Johnson & Johnson vaccines manufactured there. The Food and Drug Administration is going through the records of virtually every batch that Emergent has produced to determine if the cans are safe. The F.D.A. has so far decided that approximately 25 million Johnson & Johnson cans made at the factory can be released but has not made a decision on the AstraZeneca cans.
AstraZeneca’s vaccine is significantly cheaper than the other three vaccines: the federal government paid less than $ 4 per dose, compared to up to $ 19.50 for Pfizer. A administration official said that if the AstraZeneca cans made by Emergent are declared safe, the supply will ultimately be shared with other nations.
The cans the government plans to ship overseas this month will be part of existing orders from other manufacturers that have not yet been shipped to states, said a person familiar with the planning. Ten million doses of the three US-approved vaccines that have already been shipped are unused. Over 175 million people in the US have received at least one dose according to the Centers for Disease Control and Prevention.
Until the White House announced last week it would share 500 million doses of the Pfizer vaccine with the rest of the world, the AstraZeneca doses made up the bulk of the government’s vaccine diplomacy.
Mr Biden pledged to share up to 60 million doses of AstraZeneca’s vaccine with other nations in late April pending the ongoing review of Emergent by the F.D.A. In May the White House said it would send at least another 20 million doses of other vaccines overseas, bringing the total to 80 million by the end of June.
Earlier this month, the White House stated how it would initially distribute 25 million of the 80 million cans across “a wide range of countries.” Millions of them have already been shipped and more will be shipped shortly, a White House spokesman said.
Jeffrey D. Zients, the White House’s Covid-19 response coordinator, said Thursday that 80 million doses would be allocated by the end of the month but did not specify the type. He said the government was working with other countries on complicated logistical issues, including securing needles, syringes and alcohol swabs that would fit the cans.
“We will allocate all of the initial 80 million cans in the coming days, with deliveries as soon as countries are ready to receive the cans,” Mr. Zients said at a press conference. “There will be an increasing number of broadcasts each week as we step up these efforts.”
To share vaccines other than AstraZeneca’s, said a person familiar with the plan, the administration will likely need permission from the manufacturers. These discussions are still going on, said the person.