FDA Advisor Discussing the Safety of Recommending Pfizer Booster Shots | US News

The Food and Drug Administration (FDA) Scientific Advisor Booster shots are recommended For fully vaccinated Americans who have been vaccinated with Pfizer.

The panel’s decision will be an important milestone in the Biden administration’s plan to provide booster shots eight months after full vaccination.

The FDA’s Vaccine and Related Biopharmaceutical Advisory Board decisions are not binding, but the FDA usually follows its advice. Centers for Disease Control and Prevention (CDC) scientific advisors will hold a free hearing next week.

Whatever the outcome of the advisory board hearing, recommendations on whether shots are appropriate to prevent mild to moderate illness when most of the world remains unvaccinated disagrees. Is unlikely to be chanted.

“We are committed to focusing on science,” said Dr. Peter Marks, director of the FDA’s Center for Biopharmaceutical Evaluation and Research, at the beginning of the multi-hour conference.

He said the group “needs to drive our decisions, carefully consider these data in the light of clear and explicit public health needs, and continue to delay the spread of Covid-19. There were 2,000 Americans every day. “

Currently, the United States recommends a vaccine against Covid-19 for people over the age of 12. The FDA’s hearing focuses on the Pfizer Messenger RNA vaccine, which has applied for a license to provide a third vaccine to Americans over the age of 16. The FDA is considering whether it is appropriate to boost people “at least” six months after complete vaccination.

Moderna, who also developed the mRNA vaccine, applied it individually to provide booster shots. Government officials do not recommend booster shots for people who have been vaccinated with Johnson & Johnson, but they may still do so. All vaccines currently available in the United States are highly effective against hospitalization and death from Covid-19.

Mid-August, Biden administration Recommended booster shots Mild to moderate cases of all Americans vaccinated with the Pfizer or Moderna vaccine in response to a “breakthrough infection” eight months after the first vaccination, or those who were completely vaccinated.

At the time, officials said mild illnesses could weaken the immune system and potentially weaken the immune system to protect against severe illnesses that could lead to hospitalization and death. The project was supported by Dr. Anthony Fauci, White House Chief Medical Advisor. Not only FDA and CDC leaders.

However, the administration’s plans include a start date of September 20, effectively scheduling the launch of the campaign before FDA and CDC scientific advisors can publicly discuss its benefits. rice field. As a result, government agencies are under high pressure and are expected to have a free panel vote on whether to recommend plans that are scheduled to begin within a week.

One of the recent studies published in New England Journal of Medicine Using data from Israeli health officials seemed to support the government’s claim that booster shots may be needed to prevent weakening of immunity from serious illness, but the findings are long-term. It may not be generalized to the US population without revealing profits.

With many scientists Global Health Leader Since the announcement, he has criticized the plan and Two top FDA scientists..

In the article published in Lancet“Current evidence does not appear to indicate the need for booster in the general population, which remains highly effective against serious illness,” said FDA scientists who departed. Does not outweigh the benefits of providing initial protection. ” For those who have not been vaccinated. “

The strongest criticism is that providing booster shots to wealthy Westerners is not as effective as vaccination of new people around the world, and providing booster shots is inevitably poor. Claims to reduce the supply available for vaccination against.

The US plan for booster shots may also have had an impact Other wealthy countries Deploy a booster program to further reduce global vaccine supply. Notwithstanding the FDA’s recommendations, some healthy Americans I felt unavoidable To find the third shot.

There is little argument that a third shot is appropriate for people with weakened immunity and a slow response to the vaccine. FDA recommended third shot For this group in august.. Scientists also widely agree that efficacy against mild illness appears to have diminished from its peak immediately after vaccination.

Scientists argue that vaccination of more people around the world can more effectively stop the flow of new variants. Mutants pose a risk to the overall efficacy of the vaccine, as coronaviruses can evolve to circumvent vaccine protection. Vaccines are highly effective against the delta variant, the most widely distributed variant in the United States.

FDA Advisor Discussing the Safety of Recommending Pfizer Booster Shots | US News

Source link FDA Advisor Discussing the Safety of Recommending Pfizer Booster Shots | US News

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