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FDA Authorizes Johnson & Johnson’s Single-Dose COVID-19 Vaccine
The emergency use authorization is based on Phase 3 data, which showed that the COVID-19 vaccine was 67% effective in preventing moderate-to-severe coronavirus 14 days after vaccination.
FDA has issued an emergency use authorization for a third COVID-19 vaccine to Johnson & Johnson, which will be distributed in the US for use in individuals 18 years of age and older.
The agency determined that the COVID-19 vaccine, Ad26.COV2.S, met the criteria to issue an emergency use authorization based on data that showed that the vaccine’s known and potential benefits outweighed its known and potential risks.
“The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” Acting FDA Commissioner Janet Woodcock, MD, said in the announcement.
“The FDA, through our open and transparent scientific review process, has now authorized three COVID-19 vaccines with the urgency called for during this pandemic, using the agency’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization,” Woodcock continued.
At the beginning of February, a single-dose of Ad26.COV2.S was found to be 67 percent effective in preventing moderate-to-severe and critical COVID-19 14 days after vaccination and 66 percent effective 28 days after vaccination.
The Phase 3 ENSEMBLE trial enrolled 43,783 participants, of which 468 had symptomatic cases of COVID-19. Researchers measured the co-primary endpoints 14 and 28 days after vaccination.
Johnson & Johnson explained that efficacy against COVID-19 increased over time, with no cases in vaccinated participants reported after Day 49.
Additionally, Ad26.COV2.S significantly helped infected individuals requiring medical intervention, including hospitalization, ICU admission, mechanical ventilation, and extracorporeal membrane oxygenation. There were no reported cases among participants who received the vaccine.
The most common adverse events were pain at the injection site, headache, fatigue, muscle aches, and nausea. And most of these side effects were mild to moderate in severity and lasted one to two days.
FDA noted that under the authorization, it is mandatory for Janssen Biotech and vaccination providers to report to the Vaccine Adverse Event Reporting System (VAERS) any serious adverse events, cases of Multisystem Inflammatory Syndrome, and cases of the coronavirus that result in hospitalization or death.
Vaccination providers must also report all vaccine administration errors to VAERS, including a summary and analysis of all identified vaccine administration errors in monthly safety reports submitted to FDA.
Johnson & Johnson has already begun shipping Ad26.COV.2 and expects to deliver enough single-shot vaccines to enable the full vaccination of more than 20 million people in the US by the end of March.
Additionally, the company plans to deliver 100 million doses to the US during 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 following the authorization.
“We will do everything we can to help bring this pandemic to an end, in the United States and throughout the world,” Gorsky continued.
