J&J Seeks Emergency Use Approval of Single Dose COVID-19 Vaccine

Johnson & Johnson (J&J) filed yesterday for FDA Emergency Use Authorization (EUA) of its single-dose COVID-19 vaccine — which if granted will help ease vaccine supply shortages and significantly ramp up the pace of inoculations in the U.S.

The FDA is expected to grant an EUA following a meeting of the agency’s vaccine advisory committee on Feb. 26.

The EUA submission is supported by data showing the vaccine demonstrated an overall efficacy of 66 percent in a global phase 3 study (DID, Feb. 1) — which is above the FDA’s required threshold of 50 percent although significantly lower than 95 percent efficacy of the previously authorized Pfizer/BioNTech and Moderna vaccines.

However, the J&J vaccine showed a higher efficacy of 72 percent in the U.S. arm of the global trial and demonstrated 85 percent efficacy in preventing severe disease, an impressive result that was highlighted by Anthony Fauci, director of the NIH’s National Institute of Allergy and Infectious Diseases.

J&J’s vaccine also provided full protection against coronavirus-related hospitalizations and deaths, including against the deadly variant first identified in South Africa.

Beyond its single-shot advantage, the J&J vaccine can also be shipped using normal refrigeration temperatures of 36 to 46 degrees Fahrenheit and can be stored at those temperatures for at least three months, giving it a clear edge over Pfizer/BioNTech’s ultra-cold storage requirements.

J&J said it is ready to distribute its vaccine immediately after receiving an EUA and that it expects to produce 12 million doses by month’s end. The company has a $1 billion contract with the U.S. government to supply 100 million doses, with an option for 200 million more (DID, Jan. 28).

Within the coming weeks, J&J will also seek conditional marketing authorization from European regulators and has committed to supply the EU with up to 400 million doses. ― Jason Scott