FDA advisers recommend EUA for Janssen’s single-shot COVID-19 vaccine

Brittany A. Roston - Feb 26, 2021, 5:20pm CST
FDA advisers recommend EUA for Janssen’s single-shot COVID-19 vaccine

The Food and Drug Administration’s vaccine advisers have officially recommended that Johnson & Johnson’s Janssen single-shot COVID-19 vaccine receive an Emergency Use Authorization, which will make it the first single-shot vaccination against SARS-CoV-2 in the US. With this recommendation in place, the EUA is expected to drop any time now.

Unlike the Moderna and Pfizer COVID-19 vaccines currently distributed in the US, Johnson & Johnson’s Janssen vaccine only requires a single shot, which may be more ideal for people who are less likely to return for the second dose. The company announced earlier this month that it had submitted its Emergency Use Authorization request to the FDA.

At the time, the FDA had said that it would likely only take a couple of weeks to review the materials and make the decision. In an update today, the agency published a long document on the Janssen vaccine, ultimately noting that its advisors have recommended that Johnson & Johnson receive the EUA.

Support for the EUA was unanimous among the FDA’s Vaccines and Related Biological Products Adivosry Committee. Assuming the FDA acts on this recommendation, the EUA will result in a third vaccine for use in the US, one that can be kept in ordinary refrigerators and that speeds up the rate at which people can be vaccinated.

The FDA is expected to quickly grant the EUA, possibly as soon as Friday night. Johnson & Johnson previously stated that it is ready to ship its single-dose Janssen COVID-19 vaccine when the EUA arrives. Getting a third vaccine on the market will help the Biden administration reach its goal of ‘open season’ vaccinations by this summer.


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