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What comes next after FDA panel’s rejection of Pfizer’s third booster shot? – Nashville-Davidson, Tennessee

Nashville-Davidson, Tennessee 2021-09-18 15:48:28 –

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

The Independent Advisory Board asked doctors and health officials if a third booster shot was needed, but ultimately decided that there was not enough data to give approval.

The committee was effectively convened and heard directly from the manufacturer of the COVID-19 vaccination.

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

Other health authorities, including Dr. Sara Oliver of the Centers for Disease Control and Prevention, have stated that their true vaccine efficacy has declined in the past few months, for unknown reasons.

“The reason for this low efficacy can include both reduced overtime and delta variants,” she said.

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

“They are short-term, there are no randomized controlled trials, and there are no clinical outcome data,” he said.

The advisory board refused to approve the booster shot, so a vote will be held in front of the FDA for the final decision. If the booster is approved, the Biden administration says it is ready to take action.

“Yesterday, the CDC sent a message to state health officials, explaining the process ahead and offering to help implement it in their jurisdiction,” said US surgeon General Vivek Murthy. I did.

The CDC should also recommend Pfizer boosters. The advisory board will meet on Wednesday.

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

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