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The pharmaceutical company Pfizer and its partner BioNTech requested this Tuesday the Food and Drug Administration (FDA) for emergency authorization to administer the booster dose of their vaccine against COVID – 19 to all adults over 18 years.
Pfizer’s application will be studied by the FDA, which will take a final decision in the next few weeks. It is unclear whether the agency will ask its independent advisory group, called the Vaccines and Related Biologics Advisory Committee, to provide guidance on booster authorization.
The Pfizer booster dose is now licensed for people 65 years and older; those who live in long-term care facilities; and people from 18 to 64 years at high risk of contracting the disease due to underlying medical conditions or the nature of their jobs.
Given six months after completing the initial vaccination series of only two doses.
But these criteria are not what the company intended to be approved. Pfizer initially asked the FDA to authorize the booster dose for all people 16 years 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.
Now, in your application, Pfizer states 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) must also give its approval before it can be administered. .
The question of when to lower the age requirements for booster vaccines came up during an FDA advisory committee meeting last month, although there was no vote on the issue. At that time, some committee members were open to raising it again.
“This is a complex issue,” Dr. Ofer said then Levy, a committee member and director of the Precision Vaccine Program at Children’s Hospital Boston. “And I think that we have to follow the data and keep an open mind ; in general I am in favor of lowering the age of reinforcements ”, he added.
Dr. Peter Chin-Hong, an infectious disease physician at the University of California, San Francisco, said his views on boosters have changed in recent months.
“ I think a lot of people are changing their minds a bit about the initial idea that no reinforcements are needed ”, assured Chin-Hong.
This change is due to the personal experience of patients with COVID cases – 19, as well as the improvement in data showing decreased vaccine efficacy over time.
The fact that the first vaccines remain valid against hospitalization and death in younger age groups is reassuring , said Chin-Hon g, but protection against infection is also important.
“Right now it’s a bummer to even get an infection, which means you have You have to tell everyone you come in contact with, stay home and not go to work or school, ”he added.
Since the Pfizer booster was first authorized in late September, more than 14 million of Americans have come close to receiving the vaccine, according to the CDC.
Moderna and Johnson & Johnson booster vaccines were licensed in October. Anyone older than 18 years who have been initially vaccinated with Johnson & Johnson are entitled to a booster dose .
Eligibility for a booster after being initially vaccinated with Moderna reflects criteria for Pfizer.
By Sara G. Miller – NBC News