Tens of Millions of J&J Doses Sit on Shelves, Await FDA Nod

Emergent BioSolutions Inc. has produced more than 115 million doses of drug substance used in the Johnson & Johnson Covid-19 vaccine, according to a person familiar with the matter, 60 million doses of which are in vials and ready to deploy at U.S. regulators’ discretion.

The Gaithersburg, Maryland-based contract manufacturer has been producing the J&J single-shot vaccine since the fourth quarter of 2020, said the person. The size of the stockpile, which isn’t yet cleared by the Food and Drug Administration for release, hasn’t been previously reported.

A Biden administration official, speaking on condition of anonymity, said the figures were roughly correct but declined to specify further. It’s not clear if or when regulators would authorize the facility to release the doses in the U.S. J&J, White House officials and the FDA declined to comment on how much supply has been produced at the site.

Emergent-made supply had been expected to be cleared for use last month. But 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 plant, a setback in J&J’s ability to deliver significant supply. The error led Emergent to discard 15 million doses of an ingredient used in the J&J vaccine.

The 115 million doses worth of ready-made drug substance do not include the 15 million discarded doses, said the person.

Production Pause

The production flub led the FDA to launch an inspection of the site on April 12. Four days later, the agency said Emergent should stop making new materials and quarantine existing materials and product until further notice.

Emergent’s facility in the Bayview neighborhood of Baltimore is crucial to J&J meeting its U.S. production target of delivering 100 million does by the end of June. It’s also an essential part of the global supply chain, one of few facilities responsible for making the bulk drug substance, or the active ingredient, used in the vaccine.

Once produced, Emergent sends the substance to other facilities contracted by J&J. It is combined with other materials and put in sterile vials, known as the final-stage fill-finish process, before being shipped to administration sites. As a result, the 60 million vialed doses that contain the Emergent-made drug substance are not actually stored at the Bayview facility.

To date, a J&J-run facility based in the Netherlands is the only one in the global manufacturing network cleared to make the drug substance used in the vaccine. That suggests delays to Emergent’s authorization could impact delivery timelines around the world.

Vaccine Contamination

The FDA inspection, which concluded last week, determined that Emergent failed to thoroughly investigate unexplained discrepancies, including the cross-contamination of a vaccine substance batch with ingredients from another shot. It also found that the facility lacked sufficient oversight and that conditions were unsanitary. The production halt remains in place.

The U.S. regulator said on April 21 that manufactured vaccines from the Bayview facility will undergo additional testing and evaluation to ensure their quality before they are distributed. No vaccine manufactured at the plant has been distributed for use in the U.S.

Emergent Chief Executive Officer Robert Kramer said Thursday that the company will submit a response to the FDA’s inspection findings within days, outlining how it will meet or exceed the agency’s standards.

“We had implemented multiple layers of disinfection and other protocols to lessen the inherent risk of cross-contamination,” Kramer told investors on a call after the company reported first-quarter earnings. “The batch was likely contaminated when one or more of these precautions did not function as anticipated resulting in the transmission of the AstraZeneca virus to the J&J production suite.”

Moving forward, Emergent is focused on resuming production of tens of millions per month, he said.

Kramer added that Sean Kirk, the executive vice president of manufacturing and technical operations, is taking a leave of absence to address personal matters.

The contract manufacturer said after the close of trading that revenue for the full year would be in the range of $1.7 billion to $1.9 billion, lower than its previous range of $1.95 billion to $2.05 billion. Its shares declined 5% after-hours in New York.

Immunizations Slowing

Though J&J’s vaccine has resumed use after U.S. health agencies conducted an unrelated safety review over rare yet severe cases of blood clotting, the nation has limited supply on hand. There are just under 10 million J&J doses that have been delivered but are still unused, according to data for the Centers for Disease Control and Prevention.

A majority of American adults have been vaccinated, and the rate of new immunizations is slowing in the U.S. Close to 30 million doses a week of two-shot vaccines from Moderna Inc. and the partnership of Pfizer Inc. and BioNTech SE are being shipped in the U.S., more than enough to meet current demands, according to data compiled by the Bloomberg Vaccine Tracker.

That means the White House may soon take on a new strategy, shifting away from a mass immunization campaign and focusing instead on hard-to-reach populations and those hesitant about vaccination.

The refrigerator-stored, single-shot format remains an attractive option for some populations, said Shereef Elnahal, the chief executive officer of University Hospital in Newark, New Jersey.

“We’re going to make good use of our stock and essentially use all of it,” said Elnahal, noting that the population his hospital serves often lack transportation or can’t afford to take off time from work for two vaccine appointments. For them, J&J’s Covid shot is the most convenient option, he said.

Global Ramifications

In the European Union, meanwhile, deliveries of the J&J vaccine have been sparse. Only a few million shots have been delivered to date, according to a EU official familiar with the rollout. A total of 55 million J&J vaccines are expected to be delivered in the second quarter of 2021, the EU’s executive arm has said.

Ambassadors of EU member states were told Wednesday that the European Medicines Agency is talking to the FDA about a contaminated batch of J&J vaccine, according to a diplomatic memo seen by Bloomberg. The memo said J&J will imminently be confirming to the EU a new delivery target, given those discussions.

The contaminated vaccine mentioned in the memo refers to doses made at the Emergent plant, according to a person familiar with the matter. The Bayview facility has been approved by the EU to manufacture the J&J drug substance, the person said, and has already made three batches of vaccine intended for Europe.

One of these batches is already being used in the EU, said the person, noting that thorough testing and review of controls in place at the Emergent site determined there wasn’t a need for regulatory action.

The EU has taken precautions to put the two other batches on hold until the investigations conclude, according to the person. European authorities and the EMA are working with the FDA to ensure adequate preventive and corrective measures are put in place, the person said.

J&J declined to comment on discussions with the European health regulator, or if the setbacks at the Emergent facility had affected deliveries of its vaccine outside of the U.S.

©2021 Bloomberg L.P.

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