J&J preparing for FDA approval but lags behind COVID-19 vaccine manufacturing goal

Johnson & Johnson on Aug. 5 signed a $1 billion contract with Operation Warp Speed in which the company promised to deliver 100 million doses of its COVID-19 vaccine candidate by the end of June — a  schedule that the drugmaker has fallen significantly behind, according to a Jan. 13 New York Times report.

The vaccine candidate is expected to inoculate recipients using a single shot, as opposed to the two-dose regimen Pfizer and Moderna use. It also uses an adenovirus, which creates coronavirus proteins within the body that could prepare the immune system to fend off COVID-19. Adenovirus vaccines do not need to be stored in frozen settings and can remain stable in refrigerated conditions for months, unlike Pfizer and Moderna's vaccines.

Once crucial results from the vaccine candidate's clinical trials are finalized in late January or early February, an advisory board will review the data to determine its safety and efficacy in preventing COVID-19. The FDA is already examining Johnson & Johnson's manufacturing data weeks ahead of when the drugmaker is expected to apply for emergency use authorization, according to NYT.

Under the terms of its August contract with Operation Warp Speed, Johnson & Johnson promised to manufacture 12 million doses of its vaccine candidate by the end of February and complete production of 100 million doses by the end of June.

However, Operation Warp Speed chief Moncef Slaoui, PhD, said the number of doses the drugmaker will produce by the end of February will be in the "single-digit" millions during a Jan. 12 news conference. He said Johnson & Johnson was working to rapidly increase the number of doses it's manufacturing, aiming for "a larger number in March and a much larger number in April."

"We are confident we can meet our contractual obligations to supply our vaccine candidate to the U.S. government,” a Johnson & Johnson spokesperson told NYT.

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