Washington – 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 impressive and unusual cautious approach after defeating the booster campaign that President Joe Biden and his best health adviser wanted to launch next week.
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. In a document posted by the FDA, Pfizer states that it corresponds to “about 95% effectiveness” when the delta spreads, comparable to the protection seen shortly after the vaccine was launched earlier this 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. Suggested to 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.
It is important for Dr. Anna Durbin of the Johns Hopkins School of Public Health to understand that the FDA’s decision is simply to make the additional dose safe and to do what it promises, that is, to raise immunity levels. Said.
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 shows that it is considering boosters for specific people (elderly people, nursing home residents, front-line healthcare professionals, etc.) rather than the general public.
Broader issue: “It’s not the boosters that actually control the delta variant, it’s the unvaccinated vaccination,” Durbin said. According to CDC data, more than one-third of the Americans targeted for the shot have not yet been 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.
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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