Robert Kramer, CEO of Emergent BioSolutions
Scott Mlyn | CNBC
The FDA is holding more than 100 million vaccine doses of Johnson & Johnson Covid-19 for further testing after the agency identified multiple security breaches at the Emergent BioSolutions facility that helped make the decision, said Robert Kramer, CEO by Emergent, on Wednesday opposite the legislature.
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.
In a statement, an FDA spokesman said, “We are working closely with the companies for whom products were made to find a solution to dispose the products.”
At the hearing, Kramer expressed his disappointment that the conditions at the plant resulted in the cans being ruined and production being discontinued.
Representative James Clyburn (D-SC) speaks during a House Select subcommittee on the coronavirus crisis hearing at the Rayburn House office building on Capitol Hill in Washington, DC on May 19, 2021.
Stefani Reynolds | AFP | Getty Images
An inspection by the FDA revealed that the facility was unsanitary and unsuitable for making the recordings. In a 13-page report, the inspectors wrote that the facility used to manufacture the vaccine “was not kept in a clean and sanitary condition” and “was not of the appropriate size, design and location for cleaning, maintenance and to facilitate proper operation. “”
FDA inspectors said they observed paint peeling in multiple areas and damaging walls, which could affect “Emergent’s ability to adequately clean and disinfect”. They also found that when handling waste or materials used to make vaccines, employees did not follow standard operating procedures to ensure they were not contaminated.
Some workers at the Baltimore plant were unable to shower or change, which is required when working at the plant.