The manufacturing debacle at Emergent BioSolutions' Baltimore plant keeps getting worse.
After spending weeks inspecting the site, the FDA has instructed COVID-19 vaccine maker Johnson & Johnson and its production partner Emergent BioSolutions to throw out 60 million vaccine doses, The New York Times reports, citing people familiar with the matter. This comes after a manufacturing error earlier this year ruined a large batch containing about 15 million doses.
Now, federal regulators have decided tens of millions of doses will have to be discarded because of possible contamination. The FDA will allow about 10 million doses to ship out to the U.S. and other countries, but those shots will come with a warning that regulators can’t guarantee Emergent followed good manufacturing practices, NYT reports.
Later on Friday, the FDA said it would issue an emergency authorization for two batches of drug substance manufactured at the Emergent plant. The agency based the decision on a "thorough review of facility records and the results of quality testing performed by the manufacturer." It did not disclose how many doses the two batches would generate.
While the FDA isn't ready to give the plant a full go ahead, it "continues to work through issues" at the plant with J&J and Emergent, the statement said.
Under partnerships inked last year, Emergent took on the responsibility of manufacturing active substance for J&J and AstraZeneca's pandemic shots. Then, a manufacturing error at the company's Baltimore site ruined up to 15 million J&J jabs. AstraZeneca was later forced to scout for a new production site and J&J took charge at Emergent's facility.
In mid-April, Emergent and officials agreed to halt production so the FDA could investigate. Regulators have yet to allow the site to reopen.
In the meantime, the agency has been left to decide what to do about roughly 170 million COVID-19 vaccines made at the site and placed on hold after the production snafu, the Times reports.
Earlier on Friday, the European Union’s medicine regulator said it was aware of the cross-contamination at the site but believed none of the batches delivered to the bloc have been impacted.
But as a precaution, supervising authorities in Belgium and the Netherlands have recommended “not releasing vaccine batches containing the active substance made at around the same time that the contamination occurred,” the European Medicines Agency said in a statement.
Meanwhile, safety concerns over rare blood clots have hurt J&J's shot rollout in the U.S. Just as millions of doses were set to expire in the coming weeks, the FDA approved a longer shelf life for the shot. To allow states to work through their current stockpiles, the feds have temporarily halted new J&J vaccine shipments, WSJ reported Thursday.