The Food and Drug Administration granted Pfizer-BioNTech emergency use authorization for its Covid-19 booster shot for everybody ages 18 and up on Tuesday, a decision the company had pursued for several months.
Pfizer’s request will be evaluated by the FDA, which will make a final judgment in the coming weeks.
It’s unclear whether the FDA will consult the Vaccines and Related Biological Products Advisory Committee, an independent advisory body.
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Pfizer’s booster shot is available to persons aged 65 and up, those living in long-term care facilities, as well as people aged 18 to 64 who are at high risk of Covid because of pre-existing medical conditions or their jobs.
It is given six months after the first two doses of the vaccine series have been finished.
On the other hand, those sophisticated criteria were not intended to be used by the corporation.
Pfizer’s initial effort at a booster injection was to ask the FDA to allow the additional doses for anyone aged 16 and up.
On the other hand, the FDA advisory committee rejected the plan, limiting the doses to specified groups, citing safety concerns among minors as one of the reasons.
According to Pfizer’s latest request, the third dose was found safe and effective in Phase 3 clinical trial with over 10,000 participants.
The FDA must approve the booster shot for the younger age group, and the Centers for Disease Control and Prevention must explicitly recommend it before it can be given.
Last month, the FDA advisory group discussed when to drop booster age requirements, but no decisions were reached.
At the time, some committee members showed an interest in reviewing it.
At the time, Dr. Ofer Levy, the director of Boston Children’s Hospital’s Precision Vaccines Program, remarked, “This is a hard subject.”
“And I think we need to keep an eye on the statistics and keep an open mind, and I’m generally in favor of lowering the booster age, and I’m looking forward to those discussions.”
In the last several months, Doctor Peter Chin-Hong of California, an infectious disease expert, has changed his mind about boosters.
“I believe a lot of people are changing their opinions from the initial belief that no boosters are required,” Chin-Hong remarked.
He said that the change stemmed from his personal experience seeing patients with Covid breakthrough instances and better evidence indicating the vaccines’ diminishing effectiveness over time.
The fact that the initial immunizations still protect against hospitalization and death in younger age groups is encouraging, but infection prevention is also important, according to Chin-Hong.
“It’s a pain to develop an infection right now,” he continued, “since you have to notify everyone you come into contact with and remain home from work and school.”
According to the CDC, more than 14 million people in the United States have rolled up their sleeves for Pfizer’s booster since it was originally allowed in late September.
Moderna and Johnson & Johnson vaccination booster dosages were approved in October. Anyone over 18 who had the Johnson & Johnson vaccine as a child is eligible for a booster.
After receiving the Moderna vaccination, the eligibility standards are identical to the Pfizer criteria.