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The recommendation was made after the scientific advisory panel rejected Pfizer’s proposal to provide enhanced injections to most people.
An advisory panel from the U.S. Food and Drug Administration (FDA) has approved Pfizer’s COVID-19 vaccine for people over 65 and other high-risk groups.
But Friday’s influential panel of FDA scientists rejected the broad delivery Booster For most Americans, this is an unexpected blow to the Biden administration’s plan to launch a third vaccination next week to combat the highly contagious Delta variant.
After rejecting Pfizer’s proposal to provide a booster for the vaccine to the public, members of the FDA’s external expert panel unanimously voted to provide boosters for the elderly and high-risk populations in the United States.
Just as President Joe Biden plans to host the COVID-19 summit during the United Nations General Assembly in New York next week, the US Food and Drug Administration took action to clear the way for intensive injections for the elderly and high-risk groups.
The United States has been pushing partner countries to increase the global supply of vaccines.The World Health Organization has urged the United States Suspend the provision of boosters Its citizens, until more of the world’s population has received the initial vaccination.
White Press Secretary Jen Psaki said in a statement, “We will ask participants to commit to a higher level of ambition in the “shared vision of defeating COVID-19.”
During several hours of discussion, the FDA scientific advisory panel expressed disappointment that Pfizer had hardly provided additional dose safety data. They complain that the information provided by Israeli researchers about their booster activities is not useful for predicting the American experience.
Pfizer, its German partner BioNTech, and rival vaccine manufacturer Moderna Inc have submitted analyses of clinical trials that show that the effectiveness of vaccines will diminish over time.
As a result, people who were vaccinated earlier in the pandemic are now more susceptible to infection, especially in the face of the rapidly spreading coronavirus Delta variant.
The drug maker said that the booster dose can help restore the decline in antibody levels produced by the initial vaccination.
Top FDA members disagree on the need for boosters. Interim head Janet Woodcock supports them, but some of the agency’s top scientists believe they don’t need it yet.
The members of the advisory panel stated that Pfizer and the FDA had too broad approval requirements for people as young as 16 years old. Most of them said that they would provide boosters for the elderly in the United States, but believe that young people do not need them yet.
Many vaccine experts say that the data so far only show that the elderly and people with compromised immune systems need to be vaccinated. Critics included two FDA scientists who resigned when the Biden administration announced its booster plan.
A separate group that advises the Centers for Disease Control and Prevention (CDC) will meet next week to advise which groups should receive these drugs.
The White House said that if health officials approve the plan, it is ready to launch the booster next week. Given the advice of the advisory group and the partial approval of the FDA for the use of boosters, the plan may now be reduced in scope.
A sort of Report published In the September 13th issue of The Lancet, the medical journal concluded that even with the threat of the more contagious Delta variant, “at this stage of the pandemic, it is not appropriate to give booster doses to the general population. of.”
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