FDA review confirms safety and efficacy of single-shot Johnson & Johnson coronavirus vaccine, especially against severe cases

Washington Post, February 24, 2021

A Food and Drug Administration review released Wednesday of the single-shot coronavirus vaccine made by pharmaceutical giant Johnson & Johnson found it was safe and effective and completely prevented hospitalizations and deaths in a large clinical trial.

The review sets the stage for a third coronavirus vaccine to be authorized as soon as this weekend, a point of hope in the middle of a pandemic that has killed more than a half-million people in the United States.

The review, although positive, was more nuanced than regulators’ assessments of the first two coronavirus vaccines, reflecting a pandemic that has entered a more complicated phase as variants capable of slipping by some aspects of immunity have emerged. The Johnson & Johnson vaccine was more than 85 percent effective at preventing severe illness, including in a region dominated by a concerning variant, but only 66 percent protective overall when moderate cases were included.

The FDA scientists found that the “known benefits” of the vaccine included reducing the risk of symptomatic and severe cases of its disease, covid-19, at least two weeks after vaccination. The review found vaccine efficacy against severe covid-19 “was similarly high across the United States, South Africa, and Brazil.”

“We know this vaccine prevents 85 percent of the severe disease. . . . It was 100 percent effective in preventing hospitalization and deaths, and that’s really what’s important,” said Nancy M. Bennett, a professor of medicine and public health sciences at the University of Rochester School of Medicine and Dentistry. “Those facts are the most important thing to recognize.”

The vaccine was less effective in a subgroup of adults older than 60 who also had risk factors for severe illness, but regulators noted there were no deaths or cases requiring medical intervention a month after those older adults received vaccines. Overall, there were seven deaths in the trial, all in the group that received a placebo.

An external committee of scientific experts is scheduled to meet Friday to recommend whether the FDA should authorize the shot. If the regulatory deliberations follow the path of the previous two authorized coronavirus vaccines — a joint vaccine from U.S. pharmaceutical giant Pfizer and German biotech firm BioNTech, and one from U.S. biotech company Moderna — a decision could come this weekend.

Public health officials have eagerly awaited the arrival of the Johnson & Johnson vaccine because it is expected to streamline the logistics of a complicated mass vaccination campaign. The vaccine can be stored in a refrigerator for several months, which should ease the challenges of distributing frozen products, and it doesn’t require a follow-up visit for a booster shot.