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FDA Advisory Committee Recommended Approval of J&J Vaccine

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Experts urge anyone who has received Johnson & Johnson’s COVID vaccine to get a booster shot after the Food and Drug Administration (FDA) advisory committee voted unanimously to recommend a second dose to anyone 18 years and older.

The advisory committee, made up of a range of public health experts, announced Friday that all adults vaccinated with the single-dose vaccine will receive a second shot at least two months after their first.

A study, released Thursday but not peer-reviewed, followed more than 620,000 military veterans who received the vaccine and found that protection fell from 88% in March to just 3% in August.

“There’s a public health need here because what we’re seeing is this is a group that has generally lower efficacy than we’ve seen with the mRNA vaccines,” Dr. Arnold Monto, acting committee chairman and a professor of epidemiology at the University of Michigan School of Public Health, said.

“So there is some urgency to do something.”

The Food and Drug Administration’s advisory committee has recommended that all adults be advised to receive a booster shot of the Johnson & Johnson COVID vaccine

Nearly 15 million Americans have received the J&J vaccine that was first approved in February

Nearly 15 million Americans have received the J&J vaccine that was first approved in February

After the unanimous vote of the FDA advisory committee, the FDA must now make a decision, but it expected to follow the committee's suggestion

After the unanimous vote of the FDA advisory committee, the FDA must now make a decision, but it expected to follow the committee’s suggestion

In comparison, Moderna’s vaccine effectiveness dropped from 92% to 64% and Pfizer’s vaccine protection dropped from 91% to 50%.

Nearly 15 million Americans received the J&J vaccine, nearly 91% of whom received the injection more than two months ago, according to the Center for Disease Control (CDC).

COVID vaccine booster shots are recommended, although infections have declined following a summer surge caused by the Delta variant. Experts point to CDC data showing that unvaccinated adults are 11 times more likely to die from COVID than vaccinated adults.

‘J&J is a very good vaccine. I also believe it’s probably a dual vaccine,” Dr. Ashish Jha, dean of the Brown University School of Public Health to CNN. ‘It is really urgent that people get that second chance fairly quickly.

On Thursday, the FDA advisory committee recommended booster shots from Moderna to people over 65, but the agency delayed its decision to approve the COVID vaccine for teens and younger adults.

The FDA will now consider the advisory committee’s recommendations on the J&J and Moderna COVID booster shots to make an official decision. If the FDA accepts the recommendation, which is expected to happen, booster shots could be made available next week.

The FDA has previously approved booster shots of the Pfizer COVID vaccine for individuals age 65 and older or for any adult considered “high risk” due to their life, work or health condition.

COVID booster shots are recommended as the Delta variant continues to spread

COVID booster shots are recommended as the Delta variant continues to spread

More than 353,000 deaths from coronavirus have been reported this year, more than the 352,000 recorded in 2020, according to data from Johns Hopkins University

More than 353,000 deaths from coronavirus have been reported this year, more than the 352,000 recorded in 2020, according to data from Johns Hopkins University

Recent CDC data has shown that unvaccinated adults are 11 times more likely to die from COVID than those who have been vaccinated

Recent CDC data has shown that unvaccinated adults are 11 times more likely to die from COVID than those who have been vaccinated

“I think anyone who has received one dose of the Johnson & Johnson vaccine could benefit from a second dose of a Johnson & Johnson vaccine,” Dr. Paul Offit, a member of the FDA’s Vaccines and Related Biological Products Advisory Committee to CNN.

He believes the J&J vaccine would have initially been recommended as a two-dose vaccine had it not been made at a time of such urgency.

The study of military veterans concluded that: “Vaccines remain the primary tool to prevent infection, serious illness and death, but vaccines must be accompanied by additional measures, including masking, hand washing, physical distancing and other public health interventions, in the face of an increased risk of contamination by the Delta variant.’

The FDA advisory committee also discussed the possibility of mixing and matching booster shots at Friday’s meeting, which they believe would provide flexibility and potentially give those on a dose of J&J better immunity.

However, some were skeptical about combining vaccines due to the limited data on this.

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