Robert Kramer, CEO of Emergent BioSolutions
Scott Mlyn | CNBC
The FDA holds over 100 million Johnson & Johnson Covid-19 vaccine doses for further testing after agency found multiple security breaches at the facility – operated by Emergent BioSolutions – That helped make the decision, Emergent CEO Robert Kramer told lawmakers on Wednesday.
The USA appointed J&J to manage the Baltimore facility last month after learning that Emergent, a federal contractor, had made key ingredients for J&J and J&J AstraZenecawho have cross-contaminated the two shots. Kramer testifies before the legislature of the house on Wednesday about bad conditions At the Baltimore plant, the company is believed to be 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 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 regulators had 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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