Pfizer-BioNTech requested the Food and Drug Administration on Tuesday to authorize the emergency use of its powerful Covid-19 pistol to anyone 18 years of age and older, a decision the company has been making for several months.
Pfizer's application will be considered by the FDA, which will make the final decision in the coming weeks. It is unclear whether the agency will ask its independent advisory team, called the Vaccines and Related Biological Products Advisory Committee, to provide guidance.
The full spread of the Covid-19 epidemic
Pfizer's booster shooting is approved for certain sections of the US: people aged 65 and over, people living in long-term care facilities and people aged 18 to 64 who are at high risk of Covid due to poor health conditions or jobs their. It is given six months after the completion of the first two-dose vaccination series.
But those sophisticated methods are not what the company originally intended.
In its first booster push, Pfizer has asked the FDA to authorize more shooting for anyone 16 years of age and older. The FDA advisory panel, however, rejected the application, limiting the shooting to certain groups, in part due to safety concerns among young people.
Pfizer's latest application states that the results of a Phase 3 clinical trial with more than 10,000 participants found that the third dose was safe and effective.
If the FDA approves a booster shot for a minor group, the Centers for Disease Control and Prevention should officially recommend it before it can be given.
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The question of when to reduce the age requirements for boosters arose at a FDA advisory committee meeting last month; No votes were taken on this issue. At that point, some committee members indicated the openness of the re-visit.
"This is a complex topic," said committee member Dr. Ofer Levy, director of the Precision Vaccines Program at Boston Children's Hospital, at the time. "And I think we need to follow the details and keep an open mind, and I support the downsizing on booster, and I look forward to those conversations."
Drs. Peter Chin-Hong, an infectious disease specialist at the University of California, San Francisco, said his thinking about boosterers had changed in recent months.
"I think a lot of people actually change their minds a little bit at the first thought '' no boosters are needed, '" Chin-Hong said. He said the change stemmed from the personal experience of seeing patients with successful Covid cases and better data showing a decrease in vaccine efficacy over time.
The fact that the first vaccines are still stuck in hospitals and the deaths of young people reassures us, but infection prevention is important, too, says Chin-Hong.
"It is very difficult to get the disease right now, which means you have to tell everyone you come in, to stay home from work and school," he said.
Since the Pfizer booster was first approved in late September, more than 14 million people have tied their arms to be shot in the US, according to the CDC.
Encouraging shot of Moderna and Johnson & Johnson vaccines were approved in October. Anyone over the age of 18 who was vaccinated with the Johnson & Johnson vaccine is eligible to receive a booster. Qualification rules for booster after vaccination with modern vaccine Moderna Pfizer process mirror.