The FDA is holding over 100 million Johnson & Johnson Covid-19 vaccine doses for further testing after the agency found multiple safety violations at the plant — run by Emergent BioSolutions — that was helping make the shots, Emergent CEO Robert Kramer told lawmakers Wednesday.
The U.S. put J&J in charge of the Baltimore plant last month after learning that Emergent, a federal contractor that had been making key ingredients for J&J and AstraZeneca, cross-contaminated the two shots. Kramer is testifying before House lawmakers Wednesday about poor conditions at the company’s Baltimore plant said to be responsible for ruining millions of J&J Covid-19 shots.
During the hearing before the House Select Subcommittee on the Coronavirus Crisis, Rep. Steve Scalise, R-La., asked Kramer how many doses of J&J vaccine are being held by the Food and Drug Administration but weren’t contaminated.
“There are a significant number of doses that we’ve manufactured. Again, we manufacture the bulk drug substances,” Kramer told the lawmaker. “It has been reported in a number of news agencies that there are probably over 100 million doses of the J&J vaccine that we’ve manufactured that are now being evaluated by the FDA for potential release and availability.”
Kramer later indicated that the regulator requested additional testing on the doses.
“The FDA is evaluating, to my understanding, the doses that had been manufactured for bulk drug substances, most of which has been provided to J&J,” Kramer said. “As far as I understand, there had been a request for some additional testing on all of those lots and doses that had been provided by J&J to the FDA. And it’s under their evaluation right now.”
J&J declined to comment on the number of doses. The FDA did not immediately respond to a request for comment.
This is a developing story. Please check back for updates.