The U.S. Food and Drug Administration asked Emergent BioSolutions last week to stop vaccinating Johnson & Johnson’s COVID-19 vaccine at its troubled facility in Baltimore, according to legislation released by Emergent Monday.
The FDA began an inspection of the contract manufacturer’s plant on April 12, but on April 16 requested that production be stopped “pending the completion of the inspection and repair of the consequences that follow”, the documentation reads. Any vaccine material already made at the plant will be kept in quarantine.
The production strike follows news last month that an accident at the plant led to the downfall of 15 million doses of Johnson & Johnson’s COVID-19 single-shot vaccine. The destroyed doses were reportedly contaminated with ingredients of AstraZeneca’s COVID-19 vaccine, which was also manufactured in the factory at the time.
The accident was a major obstacle to Johnson & Johnson’s vaccine production – but not a matter of consumer safety. All doses of Johnson & Johnson’s vaccine used so far in the USA are manufactured in the Netherlands. The Emergent facility in Baltimore had not yet been approved by the FDA for vaccine production when the doses were destroyed, and none of the spoiled doses completed the production process.
Earlier this month, the administration of Biden Johnson & Johnson put the facility in charge and ordered AstraZeneca’s vaccine production to prevent further cross-contamination problems. The company said at the time that, despite the setback, it still expects to meet its commitment to deliver nearly 100 million doses of the vaccine to the U.S. government by the end of May. But the current production break again raises questions about whether the company will still be able to meet the target.
“At the moment, it is premature to speculate about the possible impact this could have on the timing of our vaccine delivery,” the company told Reuters.
In a statement to Politico, Emergent said:
While awaiting the full feedback from the FDA, we are working with J&J and the FDA to strengthen the supply chain for this vital vaccine … We recognize that there are improvements we need to make to meet the high standards we have set for ourselves and to restore confidence in our quality systems and manufacturing processes.
Break outside break
For now, Biden officials say they have enough vaccine supply from Moderna and Pfizer-BioNTech to continue the current rate of vaccinations, which recently exceeded more than 3 million doses per day.
Regardless of the production break, the use of the Johnson & Johnson vaccine was already interrupted as federal health experts and advisers examined the data linking the vaccine to an extremely rare but dangerous blood clotting condition.
Last week, the FDA and the Centers for Disease Control and Prevention said they had identified six cases of the unusual condition out of more than 6.8 million administered vaccines, leading to dangerous life-threatening blood clots combined with low levels. of platelets. One person dies from the condition, and another person is in a critical condition.
A vaccine advisory committee for the CDC, called ACIP, held an emergency meeting last week, but pointed out that from now on it would make any recommendations for the use of the Johnson & Johnson vaccine. Instead, the committee has again scheduled a public meeting for this Friday, April 23, from 11 a.m. to 5 p.m. EDT, where it will examine further data and analyzes.
In a press release from the White House on Monday, CDC director Rochelle Walensky said the agency had received additional reports of cases of blood clots possibly related to the vaccine.
There were “a handful of cases, not an overwhelming number of cases,” Walensky said in the briefing. “We are assessing it and verifying that it is a real case.” The CDC and the FDA will then present their findings to ACIP on Friday, she said.