The COVID-19 vaccine from Janssen or Johnson & Johnson. Image – Public Domain of the New York National Guard
U.S. regulators allow the release of 10 million doses of Johnson & Johnson’s COVID-19 vaccine from a troubled Baltimore factory, but many other doses cannot be used and must be discarded.
The Food and Drug Administration (FDA) has determined that two batches of the concentrated vaccine could be released at the Baltimore plant, owned by Emerging BioSolutions that has been closed for weeks, according to ABC News.
The FDA said several other batches are “unfit for use” and that additional batches are still being reviewed. The batches that are thrown out add up to about 50 million doses.
The 10 million doses of J&J COVID-19 vaccine released from the Emergent BioSolutions plant marks the first time that vaccine doses have come from the facility.
The Emergent factory has one history of FDA citations for various problems, including molds, walls and dirty floors, poorly trained employees and an inadequate strategy to prevent contamination.
Despite its poor track record, Emergent was given a very lucrative contract to manufacture millions of COVID-19 vaccines for J&J and AstraZeneca at the Bayview factory.
The J&J vaccines that already existed in many American arms came from other J&J plants. Emergent is just one of J&J’s contractors producing its unique bulk vaccine.
The concentrated vaccine is then sent to other plants to take the final steps, including dilution until they get the right strength, put them in vials, and pack them.
In addition to the problems with the J&J vaccine, the federal government is stopping Johnson & Johnson’s COVID-19 vaccine orders so states can try to use stored doses as vaccination rates go down. Wall Street Journal reported Thursday.
State and federal health officials told the WSJ that the CDC prohibits states from ordering J&J shot. However, some of the officials said it was only a temporary measure.
However, all of this came 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 “We would continue to work with the U.S. government and health authorities to support the use of our vaccine, which continues to play an important role, including among those who want to be completely vaccinated with a single shot.”