Citing an urgent global need for COVID-19 vaccine, government regulators said Friday that some bulk AstraZeneca vaccine made at the Emergent BioSolutions’ troubled East Baltimore plant was okay to use and could be exported.
AstraZeneca is not yet authorized for use in the United States, but once it is put in vials at another facility, it could be used in other countries.
“The agency conducted a thorough review of facility records and the results of quality testing performed by the manufacturer and reached its decision based on this review, taking into consideration the current worldwide COVID-19 public health emergency,” according to a statement from the U.S. Food and Drug Administration.
Officials did not say how many doses were being released, but this is the first lot of AstraZeneca vaccine given the stamp of approval since the plant was shut down for widespread quality control problems. The plant had to dump millions of doses of vaccine, primarily one made by Johnson & Johnson.
The FDA had said the plant mixed up the ingredients in some batches of the two vaccines, among other quality control issues. Since then, the FDA ordered AstraZeneca to be made elsewhere and asked Johnson & Johnson to oversee a plan to correct issues and again produce vaccine in Baltimore.
Several batches of Johnson & Johnson made at the plant have gotten the FDA’s approval to be used.
Emergent spokesman Matt Hartwig did not specify how many batches of vaccine received FDA authorization. But previous reports by the Wall Street Journal and others indicated that tens of millions of doses of AstraZeneca and Johnson & Johnson were being inspected for clearance.
”The availability of these doses is good news for people around the world in desperate need of Covid-19 vaccines, and we are pleased to see the drug substance manufactured by Emergent being cleared for use,” Hartwig said in a statement. ”We will continue working closely with the FDA to facilitate the review and release of additional batches of drug substance, and with the agency and Johnson & Johnson to resume full scale production as soon as possible.”
The Gaithersburg-based vaccine producer that runs the Baltimore plant was built and operated with millions in federal dollars. The U.S. government further contracted with the company to produce COVID-19 vaccines.
Emergent still faces a shareholder lawsuit over the drop in share price and information allegedly withheld from the public, as well as an inquiry from Congress. Shares closed Friday at $60.81, down 74 cents.
AstraZeneca didn’t immediately respond to a request for comment.