- The FDA is holding more than 100 million Johnson & Johnson Covid-19 vaccine doses for further testing, Emergent BioSolutions CEO Robert Kramer told lawmakers Wednesday.
- The agency found multiple safety violations at a plant — run by Emergent — that was helping make the shots.
The FDA is holding more than 100 million Johnson & Johnson Covid-19 vaccine doses for further testing after the agency found multiple safety violations at a 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 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 the J&J vaccine are being held by the Food and Drug Administration but weren't contaminated.
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"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.
In a statement, an FDA spokesperson said, "We are working closely with the companies for whom products were manufactured in order to come to resolution on the disposition of the products."
At the hearing, Kramer expressed disappointment that conditions at the plant led to doses being ruined and manufacturing suspended.
An inspection by the FDA found the plant was unsanitary and unsuitable to manufacture the shots. In a 13-page report, inspectors wrote that the facility used to manufacture the vaccine was "not maintained in a clean and sanitary condition" and was "not of suitable size, design, and location to facilitate cleaning, maintenance, and proper operations."
FDA inspectors said paint was observed to be peeling in multiple areas and walls were damaged that could impact Emergent's "ability to adequately clean and disinfect." They also noted that employees did not follow standard operating procedures in handling waste or vaccine manufacturing materials to ensure they weren't contaminated.
Some employees at the plant in Baltimore failed to shower or change clothes, which is required when working in the factory.