Federal regulators have instructed Johnson & Johnson to discard roughly 60 million single-shot COVID-19 vaccines due to possible contamination following a manufacturing mishap at the Baltimore-based Emergent BioSolutions, an error that shut down the plant two months ago.
The Food and Drug Administration told the company to throw out the shots, and it has not yet decided whether the plant can reopen, according to the New York Times.
Federal regulators closed the plant two months ago amid reports that factory workers mistakenly contaminated 15 million J&J shots with the key ingredient for the AstraZeneca vaccine, which was also in production at that plant, even though it has not yet passed regulatory muster in the United States.
The mix-up caused federal officials to strip the plant of its responsibility to produce the AstraZeneca vaccine and handed over production authority to J&J.
The J&J vaccine was authorized for public use by the FDA in February. It is the first single-dose COVID-19 vaccine to enter the market and is much easier to store and transport than other vaccines because it doesn't require ultracold temperatures to keep it viable for up to three months. The introduction of the single-shot vaccine has sped up vaccinations and proven a more sensible option for hard-to-reach parts of the country where access to ultracold storage is limited.
The plant ran into more problems with the FDA in April when inspectors produced a 13-page report describing significant sanitation issues there, such as poor decontamination procedures and unsafe disposal of manufacturing waste that the agency said had the potential to infect other parts of the manufacturing warehouse.
"There is no assurance that other batches have not been subject to cross-contamination," the FDA said at the time.
The April inspection was unrelated to several reports of rare and severe blood clotting in people who had received the shot. Regulators recommended a pause on the Johnson & Johnson vaccine administration on April 13 until the panel of vaccine experts at the CDC charged with making recommendations on vaccines could conclude that the cases of dangerous clotting are not associated with the shots.
The pause was lifted 10 days later after experts deemed that the benefits of the shots outweighed the risks, but confidence in the vaccine appears to have taken a hit. In fact, daily vaccination rates just a couple of days after the pause began a steady decline that continued up to the second week of May, when the rates of shots administered saw a modest upswing for a few days.
The agency is still deliberating whether to reopen the plant, and a decision is not likely to come before the end of the month.