FDA Approves Johnson & Johnson Single-Dose Vaccine For COVID-19

By Sarah Ruiz-Grossman

The government regulator approved a third vaccine to battle the coronavirus pandemic in the U.S. — and it’s the only one so far to require just one dose.

The Food and Drug Administration approved Johnson & Johnson’s coronavirus vaccine for emergency use on Saturday, the third such vaccine available for use in the U.S. and the first to require only a single dose.

After a panel of experts met Friday and voted to recommend the Johnson & Johnson vaccine for COVID-19, the FDA approved the drug for use by Americans ages 18 and older the following day.

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.”

Johnson & Johnson’s vaccine can be stored in a normal freezer or refrigerator, making 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 now awaits an update to its FDA guidelines.

So far, 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. The CDC has recommended that states make people over age 65 eligible for the vaccine, as well as front-line workers such as educators, food industry workers and public transportation employees.

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

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