FDA arranges Feb. 26 AdComm to discuss J&J COVID-19 vaccine EUA

Johnson & Johnson expects to have doses of its one-dose COVID-19 vaccine ready to ship as soon as the FDA makes a decision. (Raysonho/CC0)

Johnson & Johnson has filed for emergency FDA authorization of its one-dose COVID-19 vaccine. The FDA has scheduled an advisory committee meeting to discuss the application for Feb. 26.

One week ago, J&J presented data showing its viral vector vaccine was 66% effective at preventing moderate to severe COVID-19 in a phase 3 clinical trial. The efficacy, while below that achieved by vaccines from BioNTech-Pfizer, Moderna and Novavax, marked a step toward the sale of a vaccine that could deliver a big boost to the global vaccination effort given its stability at fridge temperature, one-dose regimen and J&J’s manufacturing muscle. 

J&J has moved quickly to get the vaccine to market, filing for emergency use authorization less than one week after sharing the top-line data. The Big Pharma plans to keep up the pace after securing an EUA. J&J expects to have doses ready to ship as soon as the FDA makes a decision and to go on to sell 100 million doses in the U.S. by the midpoint of the year.

Sponsored By Metabolon

Five Translational Insights Key to a Successful First-in-Human (FIH) Study – Metabolite-Based Biomarker Discovery and Validation

Translational success rates from pre-clinical animal studies to human clinical trials remain frustratingly low. Learn how metabolomics helps you bridge between the theoretical & practical, between the function & actual activity of your drug molecule to get you closer to the phenotype, sooner.

With the FDA scheduling a meeting of outside experts to review the data for Feb. 26, J&J may be able to start shipping doses by the end of the month. In December, the FDA granted an EUA to Moderna’s vaccine one day after it received the support of the advisory committee. 

Authorization of the vaccine would boost the U.S. vaccination program, which has been blighted by shortages. With J&J’s vaccine only needing one dose, it alone will equip the U.S. to vaccinate more than one-third of all adults by around the middle of the year if it hits its target of 100 million vials. With Pfizer aiming to supply 200 million doses, enough to vaccinate 100 million people, by the end of May and Moderna also making shipments, the U.S. could soon have the vials to vaccinate all adults. 

The success of the mass-vaccination campaign will depend on the evolution of the virus and the efficacy of the prophylactics against whatever variants are circulating in the U.S. J&J saw efficacy fall away somewhat in South Africa, where a troublesome variant is predominant, but not to the extent that the protection provided by Novavax’s vaccine declined in the country.