Millions of J&J Doses Cleared for Use, But Many Remain in Limbo

(Bloomberg) -- Millions of doses of Johnson & Johnson’s Covid-19 vaccine were cleared for use after a months-long delay due to problems at a manufacturer hired to make the shot. Millions more could end up being thrown away.

The Food and Drug Administration released 10 million doses of the vaccine that were produced by Emergent BioSolutions Inc., according to people familiar with the matter.

The agency said in a statement Friday that after a thorough review of a troubled Emergent manufacturing facility in Baltimore, they had authorized two batches of underlying drug substance for the vaccine made at the site. The statement didn’t detail how many doses are in a batch.

At the same time, the FDA said it had determined several other batches aren’t suitable for use, while others are still under review. Emergent has said it has made more than 100 million doses worth of the vaccine’s bulk drug substance.

The FDA said it wasn’t ready to provide a full clearance to Emergent’s facility, which has been under scrutiny for months after staff accidentally contaminated millions of doses earlier this year. In a statement, J&J said it would continue working to expand its global manufacturing network.

The New Brunswick, New Jersey-based company’s shares declined 1.4% to $164.82 at 2:26 p.m. in New York, while Emergent shares fell 2.9% to $63.61.

Manufacturing Woes

The single-shot, refrigerator-stored J&J vaccine had been expected to boost the U.S. immunization drive, but the output woes and a pause in dosing over safety concerns have limited its reach so far. It has accounted for 11.3 million of the 306 million vaccine doses administered in the U.S. through Wednesday.

The newly released 10 million Emergent-made doses have already gone through the final stages of the fill-finish process. Between 5 and 6 million of the doses are owned by the U.S. government, and 3 to 4 million are owned by J&J, according to one of the people familiar with the matter. But it’s not clear how many of the doses will be needed domestically.

Immunizations have been slowing in the U.S., with more than half of all American adults fully vaccinated, according to the Centers for Disease Control and Prevention. Many pharmacies, hospitals and health systems have more J&J supply on hand than they’ve been able to deploy as demand wanes.

The vaccine could yet play a bigger role in the global immunization drive, however, as the U.S. ramps up efforts to provide doses to countries where doses are scarce and Covid-19 infections are high.

International Campaign

President Joe Biden’s administration has come under pressure to share its excess vaccines with countries in need of supply. It has struck a deal with Pfizer Inc. to send more doses to lower-income countries, and Moderna Inc. has been said to be in talks with the U.S. on a similar pact.

The FDA said Friday that the two authorized batches of J&J doses can be exported to other countries under the condition that the drugmaker and its contract manufacturer Emergent share sensitive production information with their regulatory authorities.

The distribution and administration of exported J&J doses must also comply with the laws of those countries, the agency added.

Emergent has faced a long road in search of a U.S. authorization. In early March, J&J discovered a batch of drug substance made at the Emergent facility had been contaminated. Further testing and investigation found that Emergent staff mixed up ingredients for the J&J vaccine and another manufactured by AstraZeneca Plc.

The error led the site to discard 15 million doses worth of an ingredient for the J&J shot. The AstraZeneca vaccine hasn’t been cleared by U.S. regulators.

J&J said on April 3 that it would assume responsibility for making the drug substance at the plant. The White House said at the time it would help install new leadership at the facility and asked Emergent to stop making AstraZeneca’s shot.

After further discussion, the FDA on April 16 asked Emergent to stop making any new materials and to quarantine the doses it had made. An agency inspection report found the company had failed to maintain a sanitary facility and that it wasn’t sufficiently on guard against mix-ups between the J&J and AstraZeneca vaccines.

The New York Times, citing unidentified people familiar with the situation, reported that about 60 million doses produced at the Emergent facility must be discarded because of possible contamination, and that the 10 million doses being released would carry a warning that regulators can’t guarantee Emergent followed good manufacturing practices.

Unprecedented Steps

At a congressional hearing in late May, Emergent Chief Executive Officer Robert Kramer said the U.S. government directed the company to take unprecedented steps to ramp up production of two vaccines in a single facility, even though the site wasn’t fully staffed or operating at scale.

Emergent began making AstraZeneca’s bulk drug substance in the third quarter of last year, and J&J’s in the fourth quarter. Kramer described the ingredient mix-up as a setback and said Emergent could produce 1 billion vaccines this year.

However, Democrats on the House Committee on Oversight and Reform and the Select Subcommittee on the Coronavirus Crisis said that Emergent had failed to maintain rigorous quality standards.

The lawmakers pointed to two FDA inspections from June 2020, saying in a report that the company was warned that employees needed extensive training and that it had deficient virus contamination control. Emergent said in response to the FDA’s findings that it would improve sanitation and better train its workers. It has since concluded remediation activities.

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