A manufacturing accident affected 15 million doses of an ingredient for Johnson & Johnson’s Covid-19 vaccine
According to two people familiar with the situation, a manufacturing accident at a plant involved in Covid-19 vaccine development affected 15 million doses of an ingredient for Johnson & Johnson’s vaccine, but the company downplayed the situation and said it reached its most recent vaccine delivery deadline.
According to the people, the incident, which occurred recently at an Emergent BioSolutions Inc. facility in Baltimore, is unlikely to change President Joe Biden’s expectation that the United States will have enough vaccine for all adults by May.
According to two administration officials who spoke on the condition of anonymity, none of the doses produced and shipped in the United States have come from that factory, which isn’t yet approved. J&J said in a statement that a batch of drug substances failed a quality control test.
The New York Times was the first to announce manufacturing issues at the plant on Wednesday. According to the paper, workers there mistakenly mixed ingredients from the J&J vaccine with those from another vaccine made on the premises for AstraZeneca Plc. Astra did not respond to a request for comment right away.
It’s unclear if this would impact the vaccine’s introduction in the United States. J&J actually has the smallest stock of the Covid-19 vaccines that have been approved in the United States. Pfizer Inc. and Moderna Inc., the other two vaccine manufacturers, all reached their first-quarter expectations of 120 million and 100 million doses, respectively. Two doses are needed for those vaccines.
In an emailed statement, J&J spokesman Jake Sargent said, “This quality control process found one batch of drug substance that did not meet quality requirements at Emergent BioSolutions, a site not yet approved to produce drug substance for our Covid-19 vaccine.” “Our manufacturing process never advanced this batch to the filling and finishing stages.”
The drugmaker discussed the problem with Emergent and reported it to the Food and Drug Administration, according to the release.
J&J’s one-dose, refrigerator-stored Covid shot has been hailed by the Biden administration as a cost-effective way to provide security to Americans, especially those in hard-to-reach areas. Emergent representatives declined to comment, citing J&J’s assertion. The White House did not respond to a request for comment.
J&J, based in New Brunswick, New Jersey, said it exceeded its March distribution deadline, delivering more than 20 million doses to the US government, and that it plans to deliver another 24 million by the end of April. Another contract maker, Catalent Inc., has been approved to produce the shot at a facility in Bloomington, Indiana, and is supplying a large portion of it.
Biden has set a target of approximately 100 million J&J doses by the end of May, based on his assumption that the United States will have enough vaccine to reach all adults by then.
J&J said on Wednesday that it is still on track to deliver 100 million doses by the end of June and that it is “aiming” to do so by the end of May. The issues at J&J’s manufacturing partner indicate that the US government’s vaccination targets are vulnerable to incidents beyond its control. With just over 260 million adults in the world, Biden will have enough doses for 300 million people by then if J&J and other companies meet their goals, giving him plenty of space to reach his target if any one company fell short.
According to the announcement, Johnson & Johnson is now expanding its presence in the Emergent facility. It will send more manufacturing, technological processes, and quality experts to Emergent to oversee, guide, and support the production of its vaccine.