Third COVID-19 Vaccine Earns Emergency Use Authorization Following Favorable Advisory Committee Meeting

February 28, 2021
Audrey Sternberg

The first single shot COVID-19 vaccine, and the third overall, to receive Emergency Use Authorization will start shipping to all parts of the United States immediately following a meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.

The first single-dose COVID-19 vaccine was granted Emergency Use Authorization (EUA) by the FDA, according to its developer Janssen Pharmaceutical Companies of Johnson & Johnson, and is the third to become available for use in patients within the United States.1

Shipping of vaccines is set to start immediately, with estimates reporting around 20 million doses being delivered in March and 100 million to become available in the first half of 2021.

“This milestone follows a year of incredible work by our dedicated teams and unprecedented collaboration with health leaders around the world–all of whom shared a goal of bringing a single-shot vaccine to the public,” Alex Gorsky, Chairman and Chief Executive Officer at Johnson & Johnson, said in a press release. “We will do everything we can to help bring this pandemic to an end, in the United States and throughout the world.”

Data from the phase 3 ENSEMBLE trial (NCT04505722) served to support the FDA’s decision showing that the vaccine had 85% efficacy in preventing severe disease across all regions studied. In addition, protection against COVID-19–related hospitalization and death beginning 28 days after vaccination was demonstrated.

This decision by the agency occurred 1 day after a meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee, where there was a unanimous vote in favor of the EUA.2

“We believe the Johnson & Johnson single-shot COVID-19 vaccine is a critical tool for fighting this global pandemic, particularly as it shows protection across countries with different variants. A vaccine that protects against COVID-19, especially against the most dire outcomes of hospitalization and death, will help ease the burden on people and the strain on health systems worldwide,” Paul Stoffels, MD, Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson, said in a press release. “We look forward to our continued efforts around the world as we collectively aim to change the trajectory of this global pandemic.”

Although the EUA will make the vaccine available while more research is done, the company plans to submit a biologics license application later in the year. They have also submitted a European Conditional Marketing Authorisation Application to the European Medicines Agency, an Emergency Use Listing (EUL) with the World Health Organization, and rolling submissions to various agencies worldwide.

References:

1. Johnson & Johnson COVID-19 Vaccine Authorized by U.S. FDA For Emergency Use. News release. Johnson & Johnson. February 27, 2021. Accessed February 27, 2021. https://prnmedia.prnewswire.com/news-releases/johnson--johnson-covid-19-vaccine-authorized-by-us-fda-for-emergency-use-301236878.html

2. Johnson & Johnson Single-Shot COVID-19 Vaccine Candidate Unanimously Recommended for Emergency Use Authorization by U.S. FDA Advisory Committee. News release. Johnson & Johnson. February 26, 2021. Accessed February 27, 2021. https://prnmedia.prnewswire.com/news-releases/johnson--johnson-single-shot-covid-19-vaccine-candidate-unanimously-recommended-for-emergency-use-authorization-by-us-fda-advisory-committee-301236740.html