FDA review supports Johnson & Johnson vaccine for emergency use
The FDA reviewed data on Johnson & Johnson’s one-shot COVID-19 vaccine and found no issues that would prevent its emergency use authorization, according to a briefing document meant for the expert panel that will review the vaccine this week.
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet Friday to make a recommendation on whether the shot should become the third COVID-19 vaccine to receive emergency use authorization (EUA) in the United States.
In the new briefing document, the FDA said the submitted clinical trial data “supported a favorable safety profile with no specific safety concerns identified that would preclude issuance of an EUA,” and that the safety and efficacy data are “consistent with the recommendations set forth in FDA’s guidance [on] emergency use authorization for vaccines to prevent COVID-19.”
“As such, FDA has determined that the sponsor has provided adequate information to ensure the vaccine’s quality and consistency for authorization of the product under an EUA,” the agency wrote.
An EUA requires that the known and potential benefits of a product outweigh the known and potential risks. In December, the VRBPAC recommended authorizing vaccines manufactured by Pfizer-BioNTech and Moderna for emergency use, which was followed in both instances by the FDA issuing the EUAs.
Both of those vaccines are given in two shots, either 21 or 28 days apart. The Johnson & Johnson vaccine has been heralded as a potential “game changer” for the U.S. response because it is given in just one shot and can be kept for months at normal refrigerated temperatures rather than in extremely cold storage.
Johnson & Johnson previously announced phase 3 data showing that the vaccine was around 85% efficacious at preventing severe disease at least 28 days after vaccination and 66% efficacious overall at preventing moderate to severe or critical disease. Efficacy was reported to be 72% in the U.S., 66% in Latin America and 57% in South Africa, where 95% of the COVID-19 cases that occurred during the trial were from the B.1.351 variant of SARS-CoV-2.
However, the vaccine was 100% effective at preventing hospitalization from COVID-19 at least 28 days after vaccination in all regions, according to the phase 3 data. Two COVID-19 hospitalizations occurred in vaccine recipients with onset at least 14 days after vaccination, but both occurred in participants with comorbid conditions who were aged 60 years or older, the FDA noted.
“The data are very strong, the J&J vaccine provides robust efficacy across all demographics and variants; and shows rising protection over time, consistent with [the] belief it's eliciting strong T-cell response,” former FDA Commissioner Scott Gottlieb, MD, tweeted.
A Johnson & Johnson executive said this week that the company remained on track to deliver 100 million doses to the U.S. by the end of June, and there were indications that the doses could be ready earlier than that.