FDA Approved Booster Dose of Pfizer Vaccine for People Over 65 and Those at Risk

The FDA cleared a booster dose of the Pfizer coronavirus vaccine on Wednesday evening, following the recommendations of a panel of experts who voted last week in favor of the administration of the third dose for people over 65, people at high risk of severe cases or in workplaces at high risk of exposure.

In a statement, the FDA explained that “Modification of the Pfizer-BioNTech emergency use authorization for the COVID-19 vaccine to allow the use of a single booster dose, which must be administered at least six months after the end of the primary series . “

The people authorized to receive this third inoculation are: “People aged 65 or aged 18 to 64 at high risk of severe COVID-19; and people aged 18 to 64 whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications from COVID-19, including severe COVID-19. “

“Today’s action demonstrates that currently available science and data continue to guide FDA decision making for COVID-19 vaccines during this pandemic. After reviewing all of the available scientific evidence and the deliberations of our advisory panel of external and independent experts, the FDA has modified the EUA of the Pfizer-BioNTech COVID-19 vaccine to allow a booster dose in certain populations, such as healthcare workers, teachers and daycare staff, grocery store workers and those in homeless shelters or prisons, among others“said Acting FDA Commissioner Janet Woodcock.

Woodcook further stated that “this pandemic is dynamic and evolving, with new data on the safety and efficacy of the vaccine becoming available every day. As we learn more about the safety and effectiveness of COVID-19 vaccines, including the use of a booster dose, we will continue to assess rapid scientific changes and keep the public informed. . “

Last Friday, an influential federal advisory group overwhelmingly rejected a Pfizer’s plan to give COVID-19 booster shots to most Americans, but approved additional injections for those who have 65 years of age or older, or those at risk of developing serious illness.

The two voices represented one blow to the initiative of the government of President Joe Biden strengthen the protection of almost all Americans against the contagious Delta variant.

The decision was made by a committee of external experts who advise the Food and Drug Administration (FDA).

During several hours of discussion last week, panel members expressed frustration Pfizer had provided little data on the safety of additional doses. AND they complained that the data Israeli researchers provided about their recall campaign might not be sufficient to predict the US experience.

President’s administration Joe Biden had announced in August that he would launch a recall campaign starting September 20. for all Americans who received their second dose eight months earlier.

The FDA’s decision surprised many experts, cautious about the possible side effects that this additional dose would cause, also key at a time when many countries have only had access to a very limited number of injections.

“Overall, the data indicates that anticovid vaccines licensed in the United States still provide protection against severe forms of COVID-19 and death.”the FDA said in the report.

The experts of this committee (researchers, epidemiologists, infectiologists) they need to decide if they think there is enough evidence for the effectiveness and safety of a booster dose.

The recommendations of this committee They are not binding, but are generally followed.

Last Sunday, however, White House top epidemiologist Anthony Fauci claimed that The FDA could potentially approve a booster dose of the COVID-19 vaccine for most of the population in the future.

This was highlighted in an interview with the television network CNN, where he was asked about Friday’s decision by FDA experts to Recommend the third dose of Pfizer vaccine only to people 65 years of age and older.

“The optimal regimen may be three doses for everyone, but now, based on the data reviewed by the (FDA) advisory committee for their decision, which I respect, we are going that route.”remarked Fauci.

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