FDA allows export of certain lots of AstraZeneca vaccine made at Baltimore plant

USA – The U.S. Food and Drug Administration has said certain lots of AstraZeneca’s COVID-19 vaccine manufactured at a problem-plagued Baltimore facility are fit to be shipped outside the United States.

The plant, owned by Emergent Biosolutions, was producing vaccines for AstraZeneca and Johnson & Johnson but U.S. health regulators in April halted operations following a discovery that J&J’s vaccine was contaminated with material used in the AstraZeneca shots.

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,” FDA spokesperson Stephanie Caccomo said in a statement.

Late in July, Emergent BioSolutions said it will resume production of Johnson & Johnson’s COVID-19 vaccine at its troubled Baltimore facility.

The Wall Street Journal, which first reported the news, cited a letter from the FDA saying the agency had no objections with the plant resuming manufacturing.

“We will continue working closely with the FDA to facilitate the review and release of additional batches of drug substance,” Emergent said on Friday, adding that it is also working with the agency and Johnson & Johnson to resume full-scale production as soon as possible.

The facility could make as many as 120 million doses a month at full capacity, but the finished doses might not be available until this fall, the Journal reported.

Emergent expects to launch in the near future a late stage study for a COVID-19 therapeutic it is developing in partnership with the U.S. government, executives said on the investor call.

The two-dose AstraZeneca vaccine made in collaboration with the Oxford University is not yet authorized in the United States but has gained regulatory nods in several countries across the globe.

According to the WHO, the AstraZeneca vaccine can now be used interchangeably with an mRNA vaccine from Pfizer/BioNTech or Moderna, offering countries suffering from supply disruptions a new lease on life.

According to the WHO, a single dose of AstraZeneca followed by an injection of Pfizer/BioNTech or Moderna’s mRNA vaccine was more effective than two doses of AstraZeneca.

A minimum of 14 days should elapse between the administration of the ChAdOx1-S vaccine and any other immunization against other conditions.

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