Janssen COVID-19 vaccine becomes third authorized for emergency use by FDA

The United States will now benefit from the rollout of a third COVID-19 vaccine, following last week’s emergency use authorization (EUA) of the Janssen vaccine by the U.S. Food and Drug Administration (FDA).

That decision came in the wake of recommendations from an advisory panel known as the Vaccines and Related Biological Products Advisory Committee (VRBPAC). Janssen Pharmaceutical Companies, a Johnson & Johnson company, will now be able to distribute the vaccine to anyone in the United States ages 18 years or older.

“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 said. “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.”

Manufactured from a specific type of virus known as adenovirus type 26, the Janssen vaccine is notably less effective at fighting SARS-CoV-2 — the virus that causes COVID-19 — than its competitors. However, it makes up for it in other important ways, such as being able to be stored through refrigeration rather than freezing, a reduced number of side effects, and delivery through a single dose. In its determination, the FDA declared that the known and potential benefits outweigh any risks.

Much of the FDA’s decision was based on an analysis of 39,321 participants in an ongoing, randomized, placebo-controlled study in South Africa, various South American countries, Mexico, and the United States. That study enrolled people who showed no signs of SARS-CoV-2 infection prior to injection and were split into two groups: 19,630 received the vaccine, while 19,691 received a placebo.

For at least 14 days after vaccination, the vaccine showed an overall efficacy of 67 percent in preventing moderate to severe COVID-19 cases. That figure dropped a percent when reaching 28 days post-vaccination. In preventing specifically severe/critical cases of COVID-19 after 14 days, however, the vaccine’s efficacy went up to 77 percent and to 85 percent after at least 28 days. Most resulting side effects, such as headaches, were mild to moderate and lasted a couple of days at most.

“Importantly, the vaccine was 100 percent effective in protecting against death from the disease everywhere it was tested,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said. “In addition to meeting the expectations of safety and effectiveness to support emergency use authorization, the Janssen vaccine has the advantage of requiring only a single injection and can be easily transported and stored without special refrigeration requirements. To get control of the COVID-19 pandemic, stay ahead of worrisome viral mutations, and protect the American public, we must vaccinate as many Americans as we can as quickly as possible. The Janssen vaccine provides yet another option to help achieve those goals.”

Dr. Francis Collins, director of the National Institutes of Health, added that the vaccine’s authorization comes on the heels of a particularly sobering milestone in the U.S. struggle against COVID-19: the crossing of 500,000 deaths.

“The loss attributed to the disease is almost unfathomable,” Collins said. “To have a third vaccine that meets the expectations of an EUA for safety and effectiveness at preventing severe disease and death from COVID-19 brings us one step closer to protecting the American public, staying ahead of concerning viral variants, and finding our way out of the pandemic.”

As part of the authorization, Janssen Biotech Inc. and vaccination providers will have to report serious adverse events, cases of Multisystem Inflammatory Syndrome, and cases of COVID-19 leading to hospitalization or death to the FDA. At this time, no one knows how long the vaccine will provide protection.