What comes next after FDA panel’s rejection of Pfizer’s third booster shot?

Washington-DC

WASHINGTON (Nexstar) — A U.S. Food and Drug Administration panel on Friday rejected Pfizer’s request to administer a third COVID-19 booster shot to the general public.

The independent advisory committee heard from doctors and health officials on whether a third booster shot is necessary, but it ultimately decided there wasn’t enough data to give full approval.

They did, however, approve boosters for people 65 years of age or older and those at higher risk of severe illness from COVID-19.

The committee convened virtually and heard directly from the makers of the COVID-19 vaccine shot.

“The full duration of the Pfizer vaccine is currently unknown,” said Senior Vice President of Pfizer’s Clinical Research and Development Dr. Bill Gruber. He argued a third booster is needed.

Other health officials, including the Centers for Disease Control and Prevention’s Dr. Sara Oliver said its true vaccine efficacy has dropped in the last few months, and it isn’t clear why.

“The reasons for this lower effectiveness likely include both waning overtime and the delta variant,” she said.

Dr. David Wiseman, who led the research and clinical trials for the Johnson & Johnson vaccine, questioned the science behind Pfizer’s data.

“They are short term, there is no randomized control, there are no clinical outcome data,” he said.

The advisory panel declined to endorse the booster shot, so a vote will now go before the FDA for a final decision. If boosters are approved, the Biden administration says it will be ready to jump into action.

“Yesterday, the CDC sent a message to state health officers, laying out the process ahead and offering to help implement it in their jurisdiction,” said U.S. Surgeon General Vivek Murthy.

The CDC must also give its recommendation on the Pfizer booster. Its advisory committee meets on Wednesday.

Vaccine ground effort continues locally

Amanda De Los Santos says despite Friday’s recommendation, she plans to get a booster shot.

“I want to get it just because, the more protection the better,” she said.

We met De Los Santos at a Walgreens vaccination clinic at the San Marcos High School football game Friday. This is the second time the pharmacy has held a mobile vaccine clinic at the high school; it has also brought clinics to homeless shelters and food drives.

De Los Santos said she convinced her son and husband to get their first vaccine dose. Jesse De Los Santos tells us he held out initially, but now says there is too much at stake.

“It’s time to get it,” he said. “I was fighting it for a long time, but knowing quite a few people who have gotten sick, I don’t want to be like that, I’m just trying to get it and be here for my kids.”

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