J&J Covid Vaccine Manufacturer Gets OK to Resume Production

The U.S. Food and Drug Administration cleared Johnson & Johnson’s Covid-19 vaccine manufacturer Emergent BioSolutions Inc. to resume production of the shot after a series of mishaps that led it to halt manufacturing.

The Gaithersburg, Maryland-based contract manufacturer said in statement on Thursday that U.S. regulators decided to allow it to resume production after completing extensive reviews at its facility in Baltimore’s Bayview neighborhood. A Biden administration official said that the FDA decided to allow Emergent to resume production after visiting the facility earlier this week.

U.S. regulators have inspected the Bayview site at least three times since a cross-contaminated batch of the J&J vaccine was discovered this winter, according to a person familiar, who asked not to be named as the details of the meetings aren’t public.

However, the Bayview facility still hasn’t received an emergency-use authorization to be able to deploy the product it makes to the American public. J&J said in a statement that it will continue working toward securing an authorization for the Bayview facility as quickly as possible.

Emergent shares jumped 1.5% to $66.15 at 11:28 a.m. in New York on Thursday, while J&J was down 0.4% to $171.46.

Three-Month Hold

At the outset of the pandemic, Emergent was tasked by the U.S. government with manufacturing the main ingredient of J&J’s single-shot coronavirus vaccine, known as the underlying drug substance. As the only U.S.-based company making the substance, its role in the nationwide immunization campaign was considered critical.

The plant had been expected to receive such an emergency-use authorization earlier in the year but faced delays after staff conflated materials for the J&J vaccine with those for doses from U.K. drugmaker AstraZeneca Plc that were also being made at the facility. The error led Emergent to discard millions of doses worth of J&J’s vaccine substance and prompted the FDA to start an inspection of the facility.

On April 16, the FDA said Emergent should stop production altogether and quarantine already-made materials. Emergent has remained in limbo for more than three months since, hampering the reach of the vaccine.

Emergent Chief Executive Officer Robert Kramer said he’s proud to see the facility resume production.

“The American people should have high expectations of the partners its government chooses to help prepare them for disaster, and we have even higher expectations of ourselves,” Kramer added. “We have fallen short of those lofty ambitions over the past few months, but resumption of manufacturing is a key milestone and we are grateful for the opportunity to help bring this global pandemic to an end.”

Emergent said it will continue to work closely with the FDA and J&J to address quality concerns, “committing extensive resources” to bring operations up to the agency’s standards.

Releasing Doses

Without granting an emergency-use authorization, the FDA has inspected and released five batches of Emergent-made J&J doses. The process has been tedious, and batches have often been released one at a time.

All together, U.S. regulators have cleared enough vaccine substance for about 50 million doses. Other batches have been deemed unsuitable and discarded. Tens of millions of doses remain under review, according to the person familiar.

As Emergent restarts production, newly made substance will have to undergo the same inspection process.

Emergent is no longer making the AstraZeneca vaccine. At the request of the Biden administration in April, the contract manufacturer ramped down its work with the British drugmaker. The White House said it would seek out a new U.S.-based production partner for AstraZeneca, but to-date a new one hasn’t been identified.

©2021 Bloomberg L.P.

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