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FDA gives a neutral tone prior to the Vaccine Booster Conference

Prepare a syringe with the Pfizer COVID-19 vaccine at the Reading Area Community College clinic in Reading, Pennsylvania, Tuesday, September 14, 2021. Credit: AP Photo / Matt Rourke

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

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 rationale for boosters. This is an even more striking, unusual and careful approach after President Joe Biden and his best health adviser. trumpet A booster campaign they wanted to start next week.

Pfizer: Strong protection against serious illness is maintained in the United States, but immunity to mild infections weakens about 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 support that claim, Pfizer pointed out data from Israel to the FDA. Israel 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. In a document posted by the FDA, Pfizer states that it corresponds to “about 95% effectiveness” when the delta was widespread, comparable to the protection seen shortly thereafter. vaccinationDevelopment at the beginning of the year.

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 gives a neutral tone prior to the Vaccine Booster Conference

In this August 26, 2021 file photo, Parsia Jahanbani is preparing a syringe for the Pfizer COVID-19 vaccine at a mobile vaccine clinic run by Families Together in Orange County, Santa Ana, California. You don’t need a COVID-19 booster yet — an opinion that highlights the fierce scientific division of this question.Credits: AP Photo / Jae C. Hong, File

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 the FDA’s decision is important to understand that additional doses are safe and that they promise, that is, whether they raise immunity levels. ..

If the FDA decides that an additional shot will do these two things, the Centers for Disease Control and Prevention will discuss who should take different doses. The CDC indicates that we are considering it. amplifier For certain people-like senior citizenNursing home residents and front-line healthcare professionals, not the general public.

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

The United States has already provided additional doses of the Pfizer or Moderna vaccine 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.


Pfizer seeking FDAOK for COVID-19 vaccine booster dose


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Quote: FDA is a Vaccine Booster Conference (September 15, 2021) obtained from https://medicalxpress.com/news/2021-09-fda-neutral-tone-vaccine-booster.html on September 15, 2021. ) Prior to hitting the neutral tone

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FDA gives a neutral tone prior to the Vaccine Booster Conference

Source link FDA gives a neutral tone prior to the Vaccine Booster Conference

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