U.S. regulators are allowing the release of 10 million doses of Johnson & Johnson’s COVID-19 vaccine from a troubled Baltimore factory, but many other doses can’t be used and must be thrown out.
The Food and Drug Administration (FDA) determined that two batches of the concentrated vaccine at the Baltimore plant, owned by Emergent BioSolutions which has been shuttered for weeks, could be released, according to ABC News.
The FDA said that several other batches are “unsuitable for use,” and additional batches are still under review. The batches being thrown out amount to about 50 million doses.
The 10 million doses of the J&J COVID-19 vaccine being released from the Emergent BioSolutions plant marks the first time that doses of the vaccine will come from the facility.
Emergent’s factory has a history of FDA citations for a number of problems including mold, dirty walls, and floors, poorly trained employees, and an inadequate strategy for preventing contamination.
Despite its poor record, Emergent was handed a very lucrative contract to make millions of COVID-19 vaccines for both J&J and AstraZeneca at the Bayview factory.
The J&J vaccines already in many American’s arms came from J&J’s other plants. Emergent is just one of several contractors for J&J that produces its one-shot vaccine in bulk.
The concentrated vaccine is then shipped to other plants for final steps, including diluting them to the correct strength, putting them in vials and packaging them up.
Adding to the problems being encountered with the J&J vaccine, the federal government is stopping orders of Johnson & Johnson COVID-19 vaccines so states can try to use up stockpiled doses as vaccination rates drop, the Wall Street Journal reported on Thursday.
State and federal health officials told the WSJ that the CDC is banning states from ordering the J&J shot. However, some of the officials said it was only a temporary measure.
Regardless, all this has come about after the FDA on Thursday, extended the shelf life of the J&J vaccine from three months to four-and-a-half months, as long as it is refrigerated.
J&J told Insider it would “continue to work with the US government and health authorities to support the use of our vaccine, which continues to play an important role, including among those who wish to be fully vaccinated with one shot.”