The Food and Drug Administration (FDA) said it will not require expert advice from its advisory committee that evaluates and reviews vaccine efficacy and safety to amend Pfizer-BioNTech’s emergency use authorization of its COVID-19 vaccine to include adolescents aged 12 to 15, according to an FDA spokesperson. That decision will be made by the agency after reviewing the relevant data.
“As Pfizer has announced, the FDA has received the company’s request to amend its emergency use authorization (EUA) in order to expand the age range for its COVID-19 vaccine to include individuals 12-15 years of age,” a spokesperson told The Epoch Times via email.
“Based on an initial evaluation of the information submitted, at this time, the agency does not plan to hold a meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on this request to amend the EUA for the Pfizer-BioNTech COVID-19 Vaccine, which was discussed and recommended for authorization at a VRBPAC meeting in December 2020,” she added.
The VRBPAC, established in 1979, is composed of independent experts from the medical and scientific community, who provide the FDA with recommendations and advice on scientific and regulatory issues, including the evaluation of “data concerning the safety, effectiveness, and appropriate use of vaccines” that are “intended for use in the prevention, treatment, or diagnosis of human diseases,” according to the Federal Advisory Committee Act database.
However, the role of the “advisory committee is purely advisory in nature” and although the FDA will “most often accept” the recommendations, it “has the option of not implementing the advice.”
Pfizer submitted a request (pdf) to the FDA on April 9 to expand its vaccine emergency authorization to the adolescent group, after the drug manufacturer said its vaccine “demonstrated 100 percent efficacy and robust antibody response after vaccination with the COVID-19 Vaccine.”
The results were from a Phase 3 trial involving over 2,200 volunteers ages 12 to 15, where 1,131 received a vaccine and the rest were given a placebo.
Preliminary data showed that no COVID-19 cases were observed in the vaccinated group versus the 18 cases in the placebo group. Side effects such as pain, fatigue, and fever were consistent with those observed in participants 25 and younger. The study has not been published yet.
Pfizer-BioNTech’s vaccine is currently authorized for emergency use in people ages 16 and older. The company says it plans to make similar requests to other regulatory authorities worldwide.
“There is no reason to mandate healthy children ages 12 to 15 years old with any of the investigational COVID-19 vaccines,” Dr. Teryn Clarke, MD, communications director of America’s Frontline Doctors told The Epoch Times in an email. “The facts are clear: children do not get serious illness from this virus.”
“Until larger-scale studies are completed, including on people who have recovered from COVID-19, parents should carefully weigh the facts when deciding on vaccination,” Clarke added.
According to the FDA (pdf), any vaccine issued an emergency use authorization and not FDA-licensed is considered an investigational vaccine. All three COVID-19 vaccines authorized for use in the United States continue to collect safety and efficacy data for their Phase 3 clinical trials that will complete either in 2022 or 2023.
It is expected that the FDA will extend the emergency authorization of Pfizer-BioNTech’s vaccine to kids ages 12 to 15 years old, but the agency said it doesn’t know when that decision will be made.
“While the FDA cannot predict how long its evaluation of the data and information will take, the agency will review the request as expeditiously as possible using its thorough and science-based approach,” the spokesperson said. “As with all FDA-authorized COVID-19 vaccines, we are committed to transparency with this EUA review process.”
The Pfizer-BioNTech COVID-19 vaccine may be available for adolescents before they head back to school this coming fall.
Johnson & Johnson announced on April 2 that it had begun testing its vaccine on adolescents aged 12 to 17 in a Phase 2a trial, while Moderna began testing children aged six months to 11 years with its vaccine in March.
As of April 13, more than 192 million doses of a COVID-19 vaccine had been administered, with at least 75 million Americans vaccinated or 22.7 percent of the total population.