Robert Kramer, CEO of Emergent BioSolutions
Scott Mlyn | CNBC
The FDA is holding over 100 million vaccine doses of Johnson & Johnson Covid-19 for further testing after the agency found multiple security breaches at the Emergent BioSolutions facility that helped make the gunshots, said Robert Kramer, CEO of Emergent, on Wednesday to lawmakers.
The US hired J&J to run the Baltimore facility last month after learning that Emergent, a federal company that made key ingredients for J&J and AstraZeneca, contaminated the two shots. Kramer testified before House lawmakers Wednesday that the conditions at the Baltimore plant allegedly were responsible for the destruction of millions of J&J Covid-19 shots.
During the hearing before the House Select Coronavirus Crisis Subcommittee, Rep. Steve Scalise, R-La., Kramer asked how many doses of J&J vaccine are held by the Food and Drug Administration but are not contaminated.
“There are a significant number of doses that we have made. Again we are making the mass drugs,” Kramer told lawmakers. “It has been reported by a number of news outlets that there are likely over 100 million doses of the J&J vaccine we make that are now under FDA review for possible release and availability.”
Kramer later stated that the regulator requested additional testing of the cans.
“The FDA, to the best of my knowledge, evaluates the doses made for mass drug use, most of which were provided to J&J,” Kramer said. “As far as I know, there was a request for additional testing on all of these lots and doses that J&J had made available to the FDA. And they are currently being evaluated.”
J&J declined to comment on the number of doses. The FDA did not immediately respond to a request for comment.
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