Production problems at an Emergent BioSolutions manufacturing plant put tens of millions of AstraZeneca doses under scrutiny, forcing the Biden administration to revise its plan for needy countries.
With less than two weeks remaining to fulfill President Biden’s pledge to share 80 million doses of coronavirus vaccine with countries in need, production problems at an Emergent BioSolutions manufacturing plant are forcing the administration 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 it had initially planned to include in the donation with others made by Pfizer and BioNTech, Moderna and Johnson & Johnson, according to people familiar with the discussions. Those three vaccines are authorized for emergency use in the United States; AstraZeneca’s is not. A pattern of serious lapses at the plant, in Baltimore, has thrown into question the fate of more than 100 million doses of both the AstraZeneca and Johnson & Johnson vaccines made there. The Food and Drug Administration is poring over records of virtually every batch that Emergent produced to determine if the doses are safe. The F.D.A. has so far ruled that about 25 million Johnson & Johnson doses made at the factory can be released but has made no decision on the AstraZeneca doses.
