FDA Panel Recommends Johnson & Johnson Vaccine For COVID-19

If approved as expected by the Food and Drug Administration, this would be the third coronavirus vaccine available in the U.S. and the only one to require just one dose.

A panel of medical experts recommended that the Food and Drug Administration approve Johnson & Johnson’s coronavirus vaccine for use in the U.S.

If approved by the FDA as expected, this would be the third vaccine, after those from Pfizer-BioNTech and Moderna, to be available in the U.S. — and the only one so far to require just one dose.

The advisory panel of over a dozen vaccine and infectious disease experts gathered virtually on Friday and, after discussing the Johnson & Johnson vaccine’s safety and side effects, voted unanimously to endorse it for emergency use for people 18 and older.

An FDA analysis of Johnson & Johnson’s vaccine released Wednesday found that it was safe and effective. A study reported that the vaccine protected against COVID-19 at a rate of about 66% against symptomatic cases and 85% against severe cases. After 28 days following vaccination, there were zero cases of hospitalizations or deaths.

The Pfizer and Moderna vaccines, which are given in two doses, were found to be about 95% effective at preventing symptomatic cases. It’s worth noting that Johnson & Johnson’s vaccine study was conducted after more contagious virus variants were circulating, unlike Pfizer and Moderna’s studies.

“It’s important for people to not think that one vaccine is better than another,” expert panelist Dr. Cody Meissner, director of pediatric infectious disease at Tufts Medical Center, said Friday. “Hopefully [the CDC] will emphasize that there is no preference for one vaccine over another. All vaccines work with what appears to be equal efficacy and equal safety.”

Dr. Arnold Monto, a professor of epidemiology at University of Michigan School of Public Health, echoed the sentiment: “In this environment, whatever you can get, get.”

The two vaccines authorized for use so far in the U.S. require two doses. The Johnson & Johnson vaccine would require just one shot.
The two vaccines authorized for use so far in the U.S. require two doses. The Johnson & Johnson vaccine would require just one shot.
Matt Rourke/Associated Press

More than 47 million people in the U.S. have received at least one dose of a COVID-19 vaccine, according to the Centers for Disease Control and Prevention. So far, the CDC has recommended to states that people over age 65 be eligible for the vaccine, as well as front-line workers such as educators, food industry workers and public transportation employees.

Even as daily cases and deaths have dropped significantly since their peak in December and January, the U.S. hit a horrific COVID-19 milestone this week of more than 500,000 deaths in total.

The panelists engaged in hours of debate on Friday over the technical details of Johnson & Johnson’s vaccine study, including issues like protection against new virus variants.

After an expert panel similarly recommended Pfizer and Moderna’s vaccines for emergency use in December, the FDA approved each of them the next day.

Johnson & Johnson’s vaccine can be stored in a normal freezer or refrigerator, which makes it easier to transport and distribute. Moderna’s vaccine needs to be stored at super-cold temperatures. Pfizer recently reported that its vaccine could be stored in normal freezers and refrigerators and has submitted evidence to the FDA to update its guidelines.

CORRECTION: A previous version of this article overstated the number of deaths due to COVID-19 in the U.S. as “500 million.”

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