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FDA strikes cautious tone ahead of coronavirus vaccine booster meeting – Fresno, California

Fresno, California 2021-09-17 05:41:19 –

Influential government advisers today discuss whether there is sufficient evidence that Pfizer’s COVID-19 booster vaccine is safe and effective-which Americans need it and when. This is the first step in deciding.

The Food and Drug Administration on Wednesday posted much of the evidence that its advisory board would consider. The agency made a clear neutral tone about the booster’s rationale-abnormally after defeating the booster campaign that President Joe Biden and his best health adviser wanted to start next week. The careful approach is even more impressive.

Pfizer’s claim: While strong protection against serious illness is maintained in the United States, immunity to mild infections weakens approximately 6-8 months after the second dose. The company then gave 306 additional doses and recorded levels of antibodies that fight the virus three times higher than after previous shots.

More importantly, Pfizer said these antibodies appear to be powerful enough to treat the proliferation of highly contagious delta variants across the country.

To reinforce that case, Pfizer pointed out to the FDA data from Israel, which began offering boosters in the summer.

The study tracked about 1 million people over the age of 60 and found that those who took additional shots were much less likely to get infected immediately. Pfizer said it was “about 95% effective” when the delta was widespread, comparable to the protection seen shortly after the vaccine was launched earlier this year.

Israeli data, also published Wednesday in the New England Journal of Medicine, cannot say how long the enhanced protection will last.

However, FDA reviewers said that “it may be the most accurate representation of vaccine efficacy in the U.S. population,” mainly in studies of how vaccines work among Americans. He suggested that he should look.

Overall, the data show that Pfizer and other US-approved COVID-19 vaccines “still provide protection against severe COVID-19 disease and death in the United States,” summarizing the evidence.

FDA is not obliged to follow the advice of an independent advisory board. But if a government agency dismisses its own expert, it can cause public turmoil. Earlier this week, two top FDA vaccine regulators joined a group of international scientists who rejected boosters for otherwise healthy individuals because of their strong ongoing protection against severe illness.

Dr. Anna Durbin of the Johns Hopkins School of Public Health said it was important to understand that the FDA’s decision was simply whether additional doses were safe and performed as promised to raise immune levels. ..

If the FDA decides that an additional shot will do these two things, the Centers for Disease Control and Prevention will need to decide who should take different doses. The CDC is planning its own advisory meeting next week, showing that it is considering boosters for specific people (elderly people, nursing home residents, front-line healthcare professionals, etc.) rather than the general public. I am.

Broader issue: “It’s not the boosters that are actually trying to control the delta variant, but the unvaccinated vaccination,” Durbin said. According to CDC data, more than one-third of the Americans shot are not yet fully vaccinated.

The United States has already provided additional doses of Pfizer or Remodeler vaccines to people with significantly weakened immune systems.

What is the evidence of weakened immunity for the average person? According to the CDC, actual data show strong protection against severe illness, hospitalization, and death. However, in one recent study, the hit of the delta variant reduced protection against infection. It was 91% in spring, but 78% in June and July. The CDC has also seen hints that protection against hospitalization has declined slightly in the summer for people over the age of 75.

Moderna also requested the FDA to allow booster vaccinations and posted its own study on weakened immunity on Wednesday.

Researchers said that in Moderna’s 2020 vaccine study, which was first vaccinated about a year ago, about 14,000 people were vaccinated about eight months ago last winter with another 11,000 people. I compared. Due to the surge in deltas in July and August, Moderna concluded that recently vaccinated groups had a 36% lower incidence of “breakthrough” infections than previously vaccinated groups. rice field.

It’s not clear how soon the FDA will consider a Moderna booster, or a booster for people who have received a single-shot Johnson & Johnson vaccine.

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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 By AP communication. all rights reserved.



FDA strikes cautious tone ahead of coronavirus vaccine booster meeting Source link FDA strikes cautious tone ahead of coronavirus vaccine booster meeting

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