FDA authorizes J&J partner to help with vaccine production

A contract manufacturer helping to produce Johnson & Johnson’s coronavirus vaccine has begun delivering millions of doses after the Food and Drug Administration cleared them for emergency use late Tuesday.

Catalent, a "fill-finish" facility that bottles vaccines, revealed in a tweet that FDA had authorized its Bloomington, Ind., factory to begin shipping out shots. The company started sending out vaccine immediately after receiving permission from FDA, said one person familiar with the situation.

The decision removes one barrier to J&J meeting its goals of supplying 20 million doses to the U.S. by the end of the month, and 100 million by June. But the FDA still has not decided whether a second key partner in J&J’s plan to jump-start its vaccine production can proceed. The agency is mulling an emergency authorization application from Maryland-based Emergent BioSolutions, which is producing the J&J vaccine’s active ingredient, according to two people familiar with J&J’s emergency use authorization process.

That decision could come "very soon," possibly even today, one of the people said.

Emergent is already sending millions of doses to Catalent, the people said. But those shots cannot be used until Emergent receives its own FDA authorization. Catalent has not yet responded to questions about which company made the active ingredient for the doses it has begun shipping out. But a person familiar with the matter said J&J is currently using drug substance flown in from the Netherlands, not substance produced by Emergent, to manufacture its vaccine.

The delayed Emergent authorization comes as U.S. health officials are increasingly worried that J&J will not be able to meet its March delivery goal. Despite logistical challenges and regulatory delays that have hindered getting Emergent and Catalent-supplied doses to the public, J&J has insisted that it will hit its 20-million-dose goal this month.

Adding to the confusion, FDA refused to confirm that it had authorized Catalent to produce J&J vaccine, saying that information about which contract manufacturers a pharmaceutical company enlists is considered "confidential commercial information" that it is legally prohibited from disclosing.

"The manufacture of authorized COVID-19 vaccines is limited to those facilities identified and requested for authorization by the sponsor," FDA said in a statement.

The agency is regularly barred from publicly discussing drugmakers’ manufacturing plants. It has caused confusion before, such as when Hurricane Maria hit Puerto Rico in 2017 and FDA could confirm that pharmaceutical companies would experience production delays, but could not disclose which ones they were.

FDA does publicly post vaccine authorizations, including the clearance for Johnson & Johnson, on its website.

J&J did not include its manufacturing partners in its original emergency use application, so doses made by the partners have been sitting unused while tensions have ratcheted up between the federal government and the drugmaker over manufacturing delays.

“There is a slowness to J&J getting stuff done,” a person familiar with the process said Monday. “They are slow to address some of this stuff. No one thinks they move fast.”

It is not clear exactly how many doses Catalent has shipped, and the company did not comment on the number.

But over time, the FDA authorization will let Catalent "produce and ship millions of doses," said Mike Riley, the company’s regional biologics president for North America. "The site recently completed a major expansion and scale-up activities on a dedicated, high-speed vial-filling line to support the production of this important vaccine … Catalent is now on track to deliver over a billion doses of COVID-19 vaccines and treatments in 2021."

Emergent told POLITICO earlier this week that it aims to provide one billion shots this year between its deals with J&J and AstraZeneca, another manufacturer aiming for emergency use in April. A person familiar with the process said “tens of millions” of doses are stored. An Emergent spokesperson confirmed that the company has already been shipping the vaccine’s active ingredient for fill-finish.

J&J also struck a deal with Merck in early March for the pharmaceutical giant to chip in on producing and fill-finishing the vaccine. But while the fill-finish facility could be up and running by May, the factory producing vaccine substance itself will not be ready until the second half of the year, according to two people familiar with the process.

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