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FDA Authorizes Use of Johnson & Johnson COVID Vaccine

photo of janssen vaccine

Feb. 27 2021 -- And then there were three. The FDA today granted emergency use authorization to the coronavirus vaccine from Janssen/Johnson & Johnson after reviewing its safety and efficacy data.

More vaccine availability at a time of high demand and limited supply could help officials vaccinate more Americans, more quickly. In addition, the Johnson & Johnson vaccine only requires one dose and can be stored at conventional refrigeration temperatures.

Initial reactions to the EUA for the Johnson & Johnson vaccine have been positive.

"The advantages of having a third vaccine, especially one that is a single shot and can be stored without special refrigeration requirements will be a major contribution in getting the general public vaccinated sooner, both in the U.S. and around the world," Phyllis Tien, MD, professor of medicine in the Division of infectious Diseases at the University of California San Francisco, told Medscape.

"It's great news. We have yet a third vaccine that is highly effective at preventing COVID, and even more effective at preventing severe COVID," said Paul Goepfert, MD. It's a "tremendous boon for our country and other countries as well."

"This vaccine has also been shown to be effective against the B.1.351 strain that was first described in South Africa," added Goepfert, director of the Alabama Vaccine Research Clinic and infectious disease specialist at the University of Alabama-Birmingham.

One recent concern centers around people 60 years and older. Documents the FDA released earlier this week suggest a lower efficacy, 42%, for the Janssen/Johnson and Johnson immunization among people in this age group with certain relevant comorbidities. In contrast, without underlying conditions like heart disease or diabetes, efficacy in this cohort was 72%.

The More the Merrier

The scope and urgency of the COVID-19 pandemic necessitates as many protective measures as possible, said Raj Sha, MD, associate professor of family medicine and co-director of the Center for Community Health Equity at Rush University in Chicago.

"Trying to vaccinate as many individuals living in the United States to prevent the spread of COVID is such a big project that no one company or one vaccine was going to be able to ramp up fast enough on its own," Sha said.

"This has been the hope for us," he added, "to get to multiple vaccines with slightly different properties that will provide more options."

Experience with the Johnson & Johnson vaccine so far suggest reactions are less severe.

On the other hand, low grade fever, chills or fatigue following vaccination can be considered a positive because they can reflect how well the immune system is responding, she added.

One and Done?

Single dose administration could be more than a convenience – it could help doctors and nurses vaccinate members of underserved communities and rural locations as well, where returning for a second dose could be more difficult for some people.

"In a controlled setting, in a clinical trial, we do a lot to make sure people get all the treatment they need," Sha said. "We're not seeing it right now, but we're always worried when we have more than one dose that has to be administered, that some people will drop off and not come back for the second vaccine."

This group could include the needle-phobic, he added. "For them, having it done once alleviates a lot of the anxiety."

Looking Beyond the Numbers

The phase III study of the Johnson & Johnson revealed a 72% efficacy for preventing moderate-to-severe COVID-19 among U.S. participants. In contrast, researchers reported 94% to 95% efficacy reported for the Pfizer/BioNTech and Moderna vaccines.

However, experts agreed that focusing solely on these numbers can miss more important points. For example, no participants who received the Johnson & Johnson vaccine in the phase III  trial died from COVID-19 related illness. There were five such deaths in the placebo cohort

"One of the things that these vaccines do very well is they minimize severe disease," Colleen Kraft, MD, associate chief medical officer at Emory University Hospital and associate professor at Emory University School of Medicine in Atlanta, said. "As somebody that has spent an inordinate time in the hospital taking care of patients with severe disease from COVID, this is very much a welcome addition to our [tool box] to fight this virus."

"If you can give something that prevents people from dying, that is a true path to normalcy," Goepfert added.

More Work to Do

"The demand is strong from all groups right now. We just have to work on getting more vaccines out there," Sha said.

"We are at a point in this country where we are getting better with the distribution of the vaccine," he added, "but we are nowhere close to achieving that distribution of vaccines to get to everybody."

Dr Goepfert, Dr Sha and Dr Kraft had no relevant financial relationships to disclose. Dr Tien received support from Johnson & Johnson to conduct the J&J COVID-19 vaccine trial in the San Francisco VA HealthCare System.


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