What the FDA revealed about the safety, efficacy of Johnson and Johnson's vaccine

Johnson and Johnson vaccine
Posted at 7:12 PM, Feb 24, 2021

SAN DIEGO (KGTV) -- A review by the Food and Drug Administration found Johnson and Johnson’s single-dose vaccine is safe and provides strong protection against severe COVID-19, suggesting the agency will likely grant an emergency authorization for the shot later this week.

The FDA’s 62-page analysis was published Wednesday ahead of a key meeting by an outside group of scientific advisers to the agency.

Government scientists confirmed what Johnson and Johnson reported last month: the vaccine is 72 percent effective in the U.S. at preventing COVID-19 symptoms and 86 percent effective at preventing severe disease.

But the report contained a surprise revelation. “The surprising thing is that it actually performed pretty decently against the South African variant,” said University of California San Francisco infectious disease specialist Dr. Peter Chin-Hong.

FDA regulators found Johnson and Johnson’s vaccine was 64 percent effective in South Africa, seven points higher than the company’s initial estimate. The vast majority of the sequenced cases in the study, 95 percent, involved the tricky B.1.351 variant.

The vaccine was 82 percent effective against severe disease in that region.

“Above 80% efficacy in preventing severe covid 19 disease is something to celebrate,” Dr. Chin-Hong said. “I think it's cause for hope after we've been feeling kind of down and scared of this variant.”

The vaccine worked well across different racial groups and ages, but it appeared less effective in people over 60 with conditions that put them at greater risk from the virus.

The efficacy for that subgroup dropped to 42.3 percent.

Dr. Abisola Olulade of Sharp-Reas Stealy said the public should not put too much weight on that figure.

“[The FDA] actually mentioned in the study that it may have been a statistical issue, and it may have been a lower number of people in that age range that confounded the data,” she said. “This is an effective vaccine. That's the important thing.”

On the question of safety, the FDA scientists reported “no specific safety concerns” that would stay in the way of emergency authorization.

The vaccine caused short-term side effects like fatigue, headache, muscle pain and fever, but at lower rates than the vaccines from Pfizer and Moderna. The one-dose Johnson and Johnson vaccine may have fewer side effects than the two-dose mRNA shots because side effects are most common after the second dose, said Dr. Chin-Hong.

There were no reports of severe allergic reactions to the Johnson and Johnson vaccine that have popped up in rare occasions to the mRNA vaccines. A compound in the mRNA vaccines called polyethylene glycol (PEG) has been identified as the possible trigger of these reactions. The Johnson and Johnson vaccine relies on different technology and does not contain PEG, according to the listed ingredients in the FDA’s document.

Of the 45,000 volunteers in the trial, the FDA did note that 15 people who got the vaccine developed blood clots compared to 10 in the placebo group. The agency said there was not enough evidence to draw a conclusion.

“There's no direct link at this point that states that the vaccine is definitively what caused it, but they're going to continue to monitor that,” said Dr. Olulade.

The FDA's findings will be presented Friday to a group of outside scientific experts called the Vaccines and Related Biological Products Advisory Committee. The committee will vote on whether to recommend an emergency use authorization of the vaccine in adults.

Although the vote is non-binding, the FDA typically follows the advice of the committee. In case of Pfizer and Moderna, the agency issued an emergency use authorization the day after the VRBPAC meeting.