F.D.A. approved Pfizer Booster Shots for Older and At-Risk Americans. After weeks of internal wrangling at the Food and Drug Administration, the government decided to allow anyone over 65 who had received the Pfizer vaccination to get a booster dose at least six months after their second injection.
Adult Pfizer-BioNTech recipients who are at high risk of becoming extremely ill with Covid-19 or of significant sequelae from the disease due to repeated contact to the coronavirus at their jobs are also eligible for booster doses, according to the FDA.
The authorization establishes a staggered campaign to administer the doses, with the most vulnerable Americans receiving the shots first. It allows tens of millions of people who have already been vaccinated to get booster shots at pharmacies, health centers, doctors’ offices, and other locations.
The license would allow for booster dosages “among select populations, such as health care workers, teachers, and daycare employees, grocery workers, and people in homeless shelters or jails, among others,” according to Dr. Janet Woodcock, the interim FDA commissioner. Her comments showed that the agency’s management had a lenient attitude toward the categories that were deemed eligible for an additional injection.
According to the Centers for Disease Control and Prevention, approximately 22 million Americans have received their second dose of the Pfizer-BioNTech vaccine. About half of them are beyond the age of 65.
Millions of Americans who received the Moderna and Johnson & Johnson vaccines are still waiting to find out if they are eligible for boosters. The Food and Drug Administration is anticipated to take up the issue of boosters for them in the near future.
A two-day meeting of the C.D.C.’s advisory group on the subject is underway. Even if the C.D.C. takes a different view, health care practitioners are now allowed to give Pfizer-BioNTech recipients who meet the F.D.A.’s eligibility criteria third shots.
The decision came after weeks of internal F.D.A. debate, in which some vaccine officials openly opposed the concept of issuing booster shots to the general public. Public health professionals and state officials have blasted the Biden administration for sending out conflicting public messages about who should get a booster injection and when.
The booster rollout that top federal health officials devised and President Biden announced in mid-August has been considerably hampered by regulators. Mr. Biden said at the time that, assuming regulatory permission, he planned to begin offering third shots this week to every American adult who had been completely vaccinated with the Pfizer-BioNTech or Moderna vaccine at least eight months before.
The United States is the most recent wealthy nation to offer booster doses, joining Germany, France, Israel, and the United Kingdom. According to some public health experts, such doses should instead be distributed to countries with significantly fewer citizens who have been vaccinated.
Mr. Biden committed an additional 500 million doses of Pfizer-vaccine BioNTech’s to countries in need at a virtual Covid-19 summit on Wednesday.
Pfizer’s chairman and chief executive, Albert Bourla, stated, “We believe boosters have a key role to play in addressing the persistent threat of this illness, complementing efforts to enhance worldwide access and uptake among the unvaccinated.”
Dr. Peter Marks, the FDA’s chief vaccine regulator, called the necessity to provide boosters to Pfizer-BioNTech patients aged 65 and older a “no-brainer” in an interview.
However, the agency’s decision to make additional population categories eligible for the programme could spark a more heated dispute.
It’s unclear if the C.D.C. will prescribe booster injections for those who are regarded as at high risk because they work in health care, education, or retail, or because they live in homeless shelters or prisons, as the F.D.A. obviously recommends.