J&J seeks FDA EUA for single-shot vax

Feb. 5, 2021

Johnson & Johnson announced that Janssen Biotech has submitted an application to the U.S. FDA requesting Emergency Use Authorization (EUA) for its investigational single-dose Janssen COVID-19 vaccine candidate.

If granted EUA in the U.S., the vaccine will be the first single-dose COVID-19 vaccine available — a more convenient option as countries struggle with vaccine supplies. The vaccine also has the advantage of being considered stable for up to three months kept in regular refrigerated temperatures.

J&J's EUA submission is based on efficacy and safety data from the phase 3 ENSEMBLE clinical trial, announced last week. The data demonstrated that the investigational single-dose COVID-19 vaccine met all primary and key secondary endpoints. Among all participants from different geographies and including those infected with an emerging viral variant, Janssen’s COVID-19 vaccine candidate was 66% effective overall in preventing moderate to severe COVID-19, 28 days after vaccination.

The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet to discuss the country's third vaccine option on Feb. 26. The drugmaker said it will be ready to ship immediately upon authorization of the vaccine for emergency use.

J&J will also submit a Conditional Marketing Authorisation Application (cMAA) with the European Medicines Agency in the coming weeks.

Read the press release