J&J Partner Catalent Gets Key U.S. Clearance to Make Vaccine

Millions more doses of Johnson & Johnson’s Covid-19 vaccine are expected to be released after U.S. regulators cleared the way for contract manufacturer Catalent Inc. to help produce them.

The Food and Drug Administration has granted emergency-use authorization to Catalent’s facility in Bloomington, Indiana, to make the single-dose vaccine’s active ingredient and ship the filled and finished product, according to the contract manufacturer. Bloomberg was first to report the regulatory clearance before the announcement.

With the clearance, Catalent is expected to ship millions of doses in inspected and packaged vials, according to a person familiar with the manufacturing process who asked not to be identified because the details aren’t public.

Catalent confirmed authorization of the newly expanded site in a statement. The contract manufacturer’s shares fell 1.6% at 2:39 p.m. in New York, while J&J rose 0.3%. The FDA declined to comment on the authorization.

J&J has said it would provide enough shots to immunize 20 million Americans by the end of this month. As of March 22, only 4.25 million J&J doses had been delivered, and of those, 2.4 million have been administered, according to the Centers for Disease Control and Prevention.

White House Covid-19 adviser Andy Slavitt said Monday that J&J would increase shipments this week and come close to hitting its target of 20 million doses by the end of March. J&J spokesman Jake Sargent said Tuesday that J&J still expects to hit the target.

Catalent’s Bloomington biologics facility is expected to account for the majority of the March supply, said the person familiar with the manufacturing process.

Supply Promises

J&J has agreed to deliver some 200 million doses. President Joe Biden has said he expects the first 100 million to be available by the end of May, though J&J had promised them by the end of June. The second tranche is expected later in the year.

Biden administration officials have lamented the slow and uneven trickle of J&J supply. The company fell short of its commitment to supply 12 million doses to the U.S. by the end of February, including two million it planned to deliver in January. The officials have said they were helping to accelerate production.

But J&J’s ability to deliver doses has also hinged on the FDA. Richard Nettles, vice president of U.S. medical affairs for J&J’s Janssen infectious diseases and vaccines unit, told lawmakers on Feb. 23 that the company would need to secure “regulatory approvals related to our manufacturing process” to deliver the promised shots. Though J&J’s vaccine was authorized for emergency use in the U.S. four days later, many of its facilities hadn’t been cleared to produce doses.

Coupled with 300 million doses of the two-shot vaccines made by Pfizer Inc. and Moderna Inc., the U.S. has secured enough supply to inoculate 500 million people.

Catalent, which is helping produce 80 different coronavirus-fighting vaccines and therapeutics, announced a collaboration with J&J last April. The global contract manufacturer has spent the past year constructing and preparing an expansion and scale-up of its facilities in Bloomington to produce, fill and package J&J’s vaccine.

“A year might sound like a long time, but in pharmaceutical manufacturing terms, it’s pretty compressed,” said Michael Riley, president of Catalent’s North America-based biologics unit. Over the course of that period, U.S. regulators have inspected the site in person.

Catalent has relied on the federal government for logistical support and expedited access to suppliers and construction firms to build the J&J vaccine site, according to Riley. The Trump and Biden administrations have used the Defense Production Act to secure so-called government-rated orders from Catalent to prioritize its work on Covid-19 vaccines and therapeutics.

“We’re doing whatever we can to limit the impact on our other customers, recognizing there’s an acute public health need,” Riley said.

Global Network

J&J has partnered with other U.S. contract manufacturers, including Emergent BioSolutions Inc. and Grand River Aseptic Manufacturing Inc.. Earlier this month, Merck & Co. agreed to make the vaccine’s active ingredient and fill vials.

Outside the U.S., J&J has built a global manufacturing network to produce vaccine substance and put it into vials. Though many of the facilities haven’t yet come online, the drugmaker has said it is on track to produce more than 1 billion doses this year.

Production, including quality testing and release, takes about three months, during which the vaccine often crosses multiple borders for various steps.

Last week, Catalent said it would expand production of J&J’s vaccine in Europe, bringing on a second line at its plant in Anagni, Italy, in the fourth quarter. Through the new agreement with J&J, Catalent will scale up a high-speed vial filling line to support production through late 2022.

©2021 Bloomberg L.P.

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