BALTIMORE — Federal regulators will allow Emergent Biosolutions to resume production of the Johnson & Johnson COVID-19 vaccine after production woes, officials said Thursday.
The Food and Drug Administration ordered the plant to pause production of the vaccine in April after ingredient mix-ups ruined 75 million doses. The FDA’s review of the plant found problems with cross contamination and mismanagement. About 10 million doses produced at the factory were salvaged.
The greenlight from the FDA is just the first step in the plant’s return. The vaccines produced must also receive authorization from the agency in order to be released to the public.
“The American people should have high expectations of the partners its government chooses to help prepare them for disaster, and we have even higher expectations of ourselves,” said Emergent CEO Robert Kramer. “We have fallen short of those lofty ambitions over the past few months but resumption of manufacturing is a key milestone and we are grateful for the opportunity to help bring this pandemic to an end.”
The FDA did not immediately respond to a request for comment.
A study released earlier this month found that the single-dose Johnson & Johnson vaccine could be less effective against the delta variant of COVID-19 than mRNA vaccines such as those created by Pfizer and Moderna. That study conflicted with earlier, smaller studies released by the company, which indicated a single shot remained effective against the variant about eight months post-vaccination.
Regardless, the vaccine remains a key part of the global vaccination campaign, given that inoculations are scarce in many parts of the world, and variants are presenting a new threat.
Christine Condon, Baltimore Sun