USA TODAY US Edition
FDA panel OKs boosters for 65 and older or at risk
hours of discussion, a federal advisory committee on Friday recommended a third dose of the Pfizer-BioNTech vaccine six months after full vaccination for people age 65 and older and those at high risk of severe COVID-19.
Pfizer had asked to make the booster available to everyone age 16 and up.
There isn’t sufficient evidence to show boosters for people under 65 are necessary, said members of the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee.
Those at high risk would include health care workers, first responders and people likely to be exposed to the virus at work, committee members said.
Members said getting it right, and waiting to follow the science, were important factors.
“We may need it, but we don’t have the data yet,” said Dr. Ofer Levy, direcAfter tor of the precision vaccines program at Boston Children’s Hospital.
Pfizer thanked the committee for its "thoughtful" review of the data.
“We will work with the FDA following today’s meeting to address the committee’s questions, as we continue to believe in the benefits of a booster dose for a broader population," said Kathrin Jansen, the company's head of vaccine research and development.
The committee doesn't make the decision for the FDA, but the FDA almost always takes its recommendations to heart. A final decision by the agency is expected over the next few days. If FDA agrees with the recommendation, the booster shot will come under an emergency use authorization.
The committee’s decision doesn’t mean booster shots for those who got Pfizer doses more than six months ago will immediately become available.
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is scheduled to discuss the matter on Wednesday and Thursday.