Washington — The Biden administration was the first to make a surprise plan to distribute COVID-19 booster shots to most Americans on Friday, when a government advisory board met to decide whether to approve additional doses of the Pfizer vaccine. I faced a big hurdle.
Scientists inside and outside the government have recently disagreed over the need for boosters and who should get them, and the World Health Organization says that when poor countries don’t have enough vaccines, rich countries can get a third vaccine. Strongly oppose giving.
A panel of outside experts advising the Food and Drug Administration was less important than the clear case: Studies show that the immunity levels of vaccinated people decrease over time, and boosters reverse this. While there are suggestions that it can be done, the Pfizer vaccine is still very protective against serious illness and death, even with the spread of the highly infectious delta variant.
FDA experts were planning to vote on a fundamental question. What evidence suggests that Pfizer Boosters are safe and effective for people over the age of 16? If voted in favor, the FDA is expected to immediately approve Pfizer’s shot booster.
But this is just one step in the process. The more vexing question of when should be shot next week by an advisory from the Centers for Disease Control and Prevention. CDC generally adopts the recommendations of the group that sets policy for US vaccination campaigns.
Some members of the group have shown that they prefer a third dose for older people, nursing home residents and front-line health professionals rather than all adults.
Individual FDA and CDC decisions are required to allow those receiving Moderna or J&J shots to receive the booster.
The meeting on Friday was held as the Delta variant continues to bring US cases and deaths back to levels not seen since last winter. It urged efforts by the highest health officials to strengthen US defenses against the virus.
The FDA’s top vaccine regulator, Dr. Peter Marks, acknowledged a fierce disagreement in opening remarks to the FDA’s advisory board.
“We know that there can be differing opinions on the interpretation of the data,” he said. “We strongly encourage you to express and discuss all the different perspectives on complex and evolving data.”
President Joe Biden’s top health advisers, including FDA and CDC chiefs, first announced plans for a wide range of booster shots a month ago, with the week of September 20 as a nearly fixed start date. The booster will be given eight months after the second dose of Pfizer and Moderna Vaccines.
But that was not before FDA staff scientists completed their evaluation of the data. Some experts questioned whether Biden had broken his pledge to “follow the science” in COVID-19 by staying ahead of government scientists.
Earlier this week, two top FDA vaccine reviewers joined a group of international scientists and published an editorial denying the need for boosters for healthy people. Scientists say ongoing research shows that shots work well regardless of the delta version.
Pfizer was expected to provide data on Friday suggesting that immunity to the vaccine will begin to decline about 6-8 months after the second dose.
The panel was also set up to hear from Israeli health officials, who began offering boosters in the summer. Officials there tracked nearly a million people over the age of 60 and found that those who took additional shots were much less likely to be infected immediately.
The Associated Press’s Department of Health Sciences is supported by the Department of Science Education at the Howard Hughes Medical Institute. AP is solely responsible for all content.
Copyright 2021 AP Communications. All rights reserved. This material may not be published, broadcast, rewritten or redistributed without permission.
source link FDA panel conducts first critical test of Biden COVID-19 booster project