By Sara G. Miller -
NBC News
The pharmaceutical company Pfizer and its partner BioNTech on Tuesday applied to the Food and Drug Administration (FDA) for emergency authorization to administer the booster dose of their COVID-19 vaccine to all older adults. of 18 years.
Pfizer's application will be studied by the FDA, which will make a final decision in the coming weeks.
It's unclear whether the agency will ask its independent advisory group, called the Vaccines and Related Biologics Advisory Committee, to offer guidance on authorizing the booster.
The Pfizer booster dose is now licensed for people 65 and older;
those who live in long-term care facilities;
and people ages 18 to 64 at high risk of contracting the disease due to underlying medical conditions or the nature of their jobs.
It is given six months after completing the initial vaccination series of just two doses.
[Thousands of people entered hospitals to cure themselves of other diseases and there they contracted COVID-19. Many did not come out]
But these criteria are not what the company intended to pass.
Pfizer initially asked the FDA to authorize the booster dose for everyone 16 years of age and older.
But the FDA advisory panel rejected that request, limiting vaccines to certain groups, believing it unnecessary to extend it to the entire population.
Pfizer will ask for its booster vaccine to be authorized for all people over 18 years of age
Nov. 9, 202100: 27
Now, in its application, Pfizer claims that the results of a phase 3 clinical trial with more than 10,000 participants have shown that the third dose is safe and effective.
If the FDA authorizes the booster, the Centers for Disease Control and Prevention (CDC) will also need to give its okay before it can be administered.
[The United States reopens its borders for vaccinated foreigners and families meet again]
The question of when to lower the age requirements for booster vaccines came up during an FDA advisory committee meeting last month, though no vote was taken on the issue.
At the time, some committee members were open to raising it again.
"This is a complex issue," said Dr. Ofer Levy, a member of the committee and director of the Precision Vaccine Program at Children's Hospital Boston.
"And I think we have to follow the data and keep an open mind and in general I am in favor of lowering the age of reinforcements and I look forward to those conversations," he added.
Dr. Peter Chin-Hong, an infectious disease physician at the University of California, San Francisco, said his opinion on the boosters has changed in recent months.
["I can't put into words how happy I am": hugs and emotional tears after the US borders reopened]
"I think a lot of people are changing their minds a bit from the initial idea that no reinforcements are needed," Chin-Hong said.
This change is due to the personal experience of patients with COVID-19 cases, as well as improved data demonstrating decreased efficacy over time.
The fact that early vaccines are still valid against hospitalization and death in younger age groups is reassuring, but protection against infection is also important, Chin-Hong said.
"Right now, it's a bummer to even get an infection, which means you have to tell everyone you come in contact with, that you stay home and that you don't go to work or school," he added.
[The reopening of the border is a "revival" for merchants and something "nice" for tourists]
Since the Pfizer booster was first authorized in late September, more than 14 million Americans have rolled up their sleeves for the vaccine, according to the CDC.
The Moderna and Johnson & Johnson booster vaccines were licensed in October.
Anyone over 18 years of age who was initially vaccinated with Johnson & Johnson is entitled to a booster dose.
Eligibility for a booster after being initially vaccinated with Moderna reflects Pfizer's criteria.
