Johnson & Johnson's COVID-19 vaccine production lags goals as data readout nears: NYT

Amid slower than expected rollouts for the Pfizer and Moderna COVID-19 vaccines in the U.S., Johnson & Johnson’s vaccine could serve as a key boost for the nationwide immunization push. But the pharma giant has fallen behind on its initial manufacturing goals, The New York Times reports, just as its first big data readout looms.

Under J&J’s original $1 billion contract with Operation Warp Speed, the company was set to deliver 12 million vaccine doses by the end of February and 100 million by the end of June. Now, sources told the NYT, federal officials have been informed the company is behind its original manufacturing timeline.

During a press briefing last week, Operation Warp Speed chief adviser Moncef Slaoui told reporters he thought the company would be able to deliver doses in the “single-digit” millions by the end of February, the NYT reports. J&J was “trying to make that number get as close to a double-digit number as possible, and then a larger number in March and a much larger number in April,” Slaoui added, as quoted by the newspaper.

A J&J spokesman said it's "premature to get into the specifics of the supply of our vaccine candidate" as the company has not yet posted phase 3 data or applied for an emergency authorization.

"We remain in active discussions with regulators, including on the approval and validation of our manufacturing processes," he added. "We have begun production of our vaccine candidate and are confident in our ability to meet our 2021 supply commitments signed with governments, and we expect to share more detail after some of these steps are achieved."

The news comes right after J&J CEO Alex Gorsky said at the annual J.P. Morgan healthcare conference the company is in the “final stages” of a phase 3 trial data analysis. Gorsky didn’t mention a production delay Monday; instead, he said the company is “on track” to deliver hundreds of millions of doses worldwide in the first half of 2021 and nearly a billion doses by the end of 2021.

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So far, the U.S. government has nailed down 400 million coronavirus vaccine doses between the Pfizer and Moderna mRNA programs—enough to vaccinate 200 million people. But those rollouts have started more slowly than expected, with only about 9.3 million people getting their first shots in the first month, according to CDC data. Around 28 million doses have been delivered.  

As a one-dose regimen, J&J’s vaccine may be able to help simplify and expand the nationwide immunization push. Plus, the vaccine is stable at refrigerated temperatures, while the mRNA shots must be frozen at very low temps. Previously, Slaoui said the J&J vaccine would be a “game-changer” if it can score an FDA emergency use authorization.

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Meanwhile, CNBC reports that Slaoui has agreed to step down from Operation Warp Speed at the request of the coronavirus team assembled by President-elect Joe Biden. He’ll stay on for a month to assist with the transition.

Aside from J&J, coronavirus vaccines from Novavax and AstraZeneca are in late-stage trials, and a host of other companies are in various stages of research. At a Fierce JPM Week panel, experts said there will be plenty of need for a “second wave” of coronavirus vaccines.