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FDA experts recommend another dose of vaccine for the elderly and vulnerable but not for the rest

2021-09-17T20:43:01.723Z

They consider that the scientific data on safety and efficacy do not support the Biden government's plan to administer another Pfizer injection in six months to the entire population but only to the sectors with the highest risk.



A panel of experts from the Food and Drug Administration (FDA, for its acronym in English) decided this Friday after a meeting open to the public to recommend the additional dose of the COVID-19 vaccine for

people over 65 and those in situation of vulnerability

and not for the general population. 

The experts considered that the scientific data on safety and efficacy does not support the Biden government's plan to administer another Pfizer injection within six months to the entire population over 16 years of age. 

The panel voted 16-2 against the question of whether safety and efficacy data from clinical trials support approval of a booster dose given at least 6 months after completing the first series for use in people 16 and older. years or more.

The vote was held to decide whether to apply the vaccine to the entire population, but it remains to be seen if the FDA decides whether it can be applied to the elderly or vulnerable people.

The federal agency on Wednesday released much of the evidence its advisory group examined.

He had taken a neutral tone on the rationale for booster shots,

an unusual and prudent approach made even more surprising

after the President, Joe Biden, and his top health advisers announced a booster campaign they hoped for. start next week.

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What is Pfizer's argument?

While it continues to protect people from becoming seriously ill in the United States, immunity against the mildest infection decreases six to eight months after the second dose.

The company administered an additional dose to 306 people and

recorded levels of antibodies that fight the virus three times higher

than after the first injections.

Most importantly, according to Pfizer, those antibodies appear to be strong enough to

deal with the

extra-contagious

delta variant

that is dominant across the country.

The case of Israel

To bolster its case, Pfizer pointed to the data from Israel to the FDA, which began offering reinforcements over the summer.

That study followed about a million people aged 60 and over and found that

those who got vaccinated were much less likely to become infected soon after.

Pfizer said that translates to "about 95% efficacy" when the delta variant was spreading, comparable to the protection seen shortly after the vaccine was launched earlier in the year.

The Israeli data, also published Wednesday in the New England Journal of Medicine, does not say how long the booster protection lasts.

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However, members of the FDA panel suggested that they will focus primarily on research on how vaccines work among Americans, saying it "may more accurately represent the efficacy of the vaccine in the American population."

The data shows that Pfizer and other US-licensed COVID-19 vaccines "continue to offer protection against severe COVID-19 disease and death in the United States," the agency said.

Pfizer-BioNTech COVID-19 vaccine at a Reading Area Community College clinic in Reading, Pennsylvania, Tuesday, Sept. 14, 2021.AP Photo / Matt Rourke

The FDA is not required to follow the advice of its independent advisory panel.

But if the agency ignores its own experts, that could add to public opinion confusion.

Earlier this week, two of the FDA's top vaccine regulators joined a group of international scientists in rejecting booster vaccines now for otherwise healthy people, citing continued strong protection against serious disease.

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Dr. Anna Durbin of the Johns Hopkins School of Public Health said it's important to understand that the FDA's decision is simply whether an extra dose is safe and does what it promises: boost immunity levels.

If the FDA decides that the extra shot does both of those things, then the Centers for Disease Control and Prevention (CDC)

will have to decide who should get another dose.

CDC has scheduled a meeting with its own advisers for next week and said they are considering boosting certain individuals - such as older adults, those living in nursing homes, and frontline healthcare workers - rather than to the general population.

The question is broader: "What is really going to control the delta variant is the vaccination in the unvaccinated people, not the boosters," Durbin said.

According to CDC data,

more than a third of Americans who qualify for vaccines are not yet fully vaccinated.

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The United States already offers an extra dose of Pfizer or Moderna vaccines to people with severely weakened immune systems.

For the average citizen, what is the evidence that immunity is waning?

The CDC says the data reveals that protection against serious illness, hospitalizations and deaths remains strong.

However, in a recent study, protection against infection

was lowered as the delta variant became present: it was 91% in spring, but 78% in June and July.

The CDC has also seen an indication that, for people 75 and older, protection against hospitalizations decreased slightly in the summer.

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Moderna has also asked the FDA to allow a booster dose of its vaccine, and on Wednesday published its own study on lowering immunity.

The researchers compared about 14,000 people in Moderna's 2020 vaccine study who had received a first dose about a year ago with another 11,000 vaccinated last winter, about eight months ago.

When the delta variant soared in July and August, Moderna concluded that the more recently vaccinated group had a 36% lower rate of infections compared to those vaccinated longer ago.

It is unclear when the FDA will consider a booster dose of Moderna or for people who received the single dose of Johnson & Johnson.

Source: telemundo

All news articles on 2021-09-17

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