J&J Vaccine Batch Is Cleared by FDA After Safety Review

(Bloomberg) -- The U.S. Food and Drug Administration authorized another batch of the main ingredient for Johnson & Johnson's coronavirus vaccine for use after a safety review, the drug regulator said on Friday.

The drug substance was produced at an Emergent BioSolutions Inc. plant in Baltimore. A past mix-up at the Bayview facility, which had been producing two vaccines, triggered a sprawling safety review.

The substance is enough for up to 15 million doses of J&J's single-shot vaccine, but it must still go through the “fill-finish” process where it is placed into vials, according to a person familiar with the matter.

Once finished, the shots could further fuel President Joseph Biden's effort to donate vaccines abroad. He has promised to ship 80 million doses by the end of July, and hinted at expanding that pledge.

“As Covid-19 continues to impact countries and cause untold suffering worldwide, we remain committed to producing safe, high-quality vaccines,” J&J spokesman Jake Sargent said in a statement.

“We will continue to work cooperatively with the FDA and J&J to release additional doses under review and resume production to help bring the pandemic under control,” said Emergent spokesman Matt Hartwig in a statement.

New Brunswick, New Jersey-based J&J's shares gained 1.8% in New York on Friday, while Emergent declined 0.4%.

The FDA said it has authorized four batches of J&J vaccine substance produced at the Emergent facility to date. That is enough for about 40 million doses. Other batches have been deemed unsuitable and discarded.

Tens of millions of doses worth of drug substance made at the Emergent plant are still under FDA review, according to a person familiar with the process, as are 60 million doses of AstraZeneca Plc vaccine substance produced by Emergent.

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Emergent has promised to carry out a series of fixes in response to an FDA inspection earlier this year that led to a halt in production at the Bayview facility, which had been making drug substance for both the J&J and AstraZeneca shots. Emergent staff conflated materials from the two vaccines early in 2021.

The FDA hasn't provided a full clearance to the facility itself to release all its doses, nor has it allowed it to resume production.

J&J's vaccine, which can be stored in a refrigerator for long periods, had been expected to crucial to the U.S. immunization effort. But Emergent's manufacturing problems have curtailed the number of doses available and the speed at which they've been delivered.

Only 12.5 million Americans have been given J&J's vaccine, compared with more than 140 million people in the U.S. who have received shots made by Pfizer Inc. or Moderna Inc.

Emergent has halted all production of the AstraZeneca shot at the facility at the request of the Biden administration. AstraZeneca's vaccine hasn't been authorized for use in the U.S.