USA: Experts reject third dose of Pfizer in people over 16 | Who will it apply to and who has the final say



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El committee asesor de la Administración de Alimentos y Medicamentos (FDA) de Estados Unidos recomendó este viernes administrar una tercera dosis de la vacuna de Pfizer a los mayores de 65 años ya quienes sean factores de riesgo, pero rechazó la aplicación en mayores de 16 años no problem.

The agency voted 16 to 3 against applying the third dose to the general population, a blow to Joe Biden’s government, which is seeking to boost protection amid growing cases of the variant. Delta, of enormous contagiousness.

The FDA is under no obligation to follow the evaluators’ determinations and will make a decision in the coming days.

Biden had announced two weeks ago that starting September 20, an adult empowerment campaign would begin. However, the hurdles started as FDA approval was required.

“It is not clear that everyone needs the booster dose, beyond a population group that is clearly at high risk for serious illness,” said Michael G. Kurilla, committee member and from the National Institute of Health.

In fact, the president had proposed a third dose eight months after receiving the second, but Pfizer presented its own data on how its vaccine decreases effectiveness after six months from the second dose and how a third dose strengthens it. immunity.

Moderna, which uses RNA in its vaccine, like Pfizer, has also considered a third dose. At the same time, joint studies by the FDA, the World Health Organization and the University of Oxford published in The Lancet they argue that it is not necessary to apply a third dose.

Despite this, the most vulnerable groups of people with weakened immune systems or who have developed high immunity are receiving a third dose in several countries.

Two FDA vaccine reviewers signed the article for The Lancet and announced their resignation from the body. “All of my actions and decisions throughout my 32-year career at the FDA have been based on science,” Miriam Gruber, one of the signatories, said Friday.

The dilemma for experts is whether the decrease in vaccine effectiveness can lead to an increase in cases in vaccinees or not.

CDC technicians ensure that the two doses of the vaccine prevent serious illness, even in those over 75 years old. “At the moment, it is clear that the unvaccinated are the source of transmission in the United States,” said Amanda Cohn of the CDC.

Federal advisers, including Anthony Fauci, warn that immunity falls among those vaccinated with the full schedule and that there are already indications of decreased effectiveness in protecting those vaccinated in severe cases, including consequence could lead to an increase in hospitalizations.

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