HONOLULU (KHON2) — An FDA panel of vaccine advisers voted against a plan to approve Pfizer’s booster COVID shots for most Americans.
Experts said Pfizer did not provide enough data on the safety of the extra doses in those 16 and older, and that data showing the success of booster shots in Israel does not mean an extra shot will be successful in the U.S.
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“So, I think we need to target where we are going to do boosters and continue to examine the potential efficacy of boosters in a broader population,” said Dr. Michael Kurilla, FDA Advisory Committee Member.
The panel discussed the booster shot for about eight hours.
“They felt that they wanted to see a little bit more data on microconditis in particular with the Pfizer vaccine for that age group,” explained Dr. Douglas Kwock, Hawaii Pacific Health Pediatric Infectious Disease specialist.
The Moderna and Johnson & Johnson vaccines were not up for review.
The FDA panel only approved boosters for those 65 and older, healthcare workers and those at high-risk for severe illness. Studies discussed during the FDA panel meeting showed immunity waned within six to eight months.
“People’s immunity does wane faster when they’re older because they just don’t have the same immune response,” explained Lt. Gov. Josh Green. “Their lymphatic tissues, their bone marrow, the blood cells are not quite as capable of constantly producing blood cells to fight infection and antibodies to fight infection.”
The CDC also needs to approve the Pfizer booster shot for people 65 and older, and their panel is expected to meet Wednesday, Sept. 22. CDC data released on Friday, Sept. 17, showed Moderna was 93% effective in preventing hospitalizations, Pfizer was 88% effective and Johnson & Johnson was 71%.
In Hawaii, all patients with the coronavirus on ventilators and in the ICU at Queen’s Health Systems are unvaccinated.
“It’s clear, these vaccines will keep you out of the hospital,” said Hawaii Department of Health spokesperson Brooks Baehr.
For now, the Hawaii Department of Health (DOH) said they are still focusing on getting initial shots in arms.
About 12,000 immunocompromised residents have gotten their third shot.
“The booster shot is going to be for people who have who got their initial series of vaccines so long ago that the potency, the effectiveness of that vaccine, may have waned,” explained Baehr.
“Our focus is not so much on booster shots, but it’s still on administering initial shots, we’ve got about 153,000 people in Hawaii who are eligible to receive their first vaccine dose, and we’d really like those people to come forward and be part of the solution,” he continued.
The DOH said it is waiting on final federal guidance from the FDA and CDC before announcing any kind of booster rollout.
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“Hold off on running out to get your third, your third shot booster, because there’s still more guidance that needs to be coming out,” explained Dr. Kwock.