COVID-19 Vaccine for 12-to-15-Year-Olds: Pfizer Seeks FDA Approval

Pfizer recently asked the Food and Drug Administration for an amendment to its emergency use authorization for its COVID-19 vaccine to expand its use in individuals aged 12 to 15 in the United States.

According to an active chairman of an FDA vaccine advisory committee, it is highly possible that the agency will allow such an expansion and could act relatively fast.

It is highly likely, epidemiology professor, Dr. Arnold Monto at the University of Michigan said, if the data submitted to support the authorization. Monto also serves as acting chairman of the advisory committee for its review of COVID-19 vaccines.

CNN reported, the pharmaceutical firm said in a statement it would seek the same rulings by other authorities globally in the coming days.

ALSO READ: Moderna Planning to Start Testing Its COVID-19 Vaccine on Children

(Photo: Matthew Hatcher/Getty Images)
A group of teenagers serving as 'COVID-19 Student Ambassadors' joined Governor Gretchen Whitmer to receive a dose of the Pfizer COVID-19vaccine at Ford Field during an event to promote and encourage Michigan residents to go and get their vaccines on April 6, 2021, in Detroit, Michigan.

Requests Based on Phase 3 Trials of 12-to-15-Year-Olds

In the same statement, Pfizer said the requests are based on data coming from a vital Phase 3 trial in young individuals aged 12 to 15 years old whether or not they have prior evidence of COVID-19 infection, which demonstrated 100-percent efficacy and strong antibody response following a COVID-19 vaccine.

Currently, the FDA is allowing the use of the vaccine in individuals aged 16 years and above. The said news report specified, the FDA possibly won't ask the Vaccines and Related Biological Products Advisory Committee, the committee chaired by Monto, for a meeting to discuss the expansion of the use of the Pfizer COVID-19 vaccine, he said. Monto also said they are not going to have advisories every time they are tweaking things.

The two other vaccines for COVID-19 which Moderna and Johnson & Johnson developed are authorized for use in individuals aged 18 years and above.

100-Percent Vaccine Efficacy in Adolescents

Last month, cΙnet reported, the Pfizer-BioNTech COVID-19 vaccine showed 100-percent efficacy and strong antibody responses in younger teens.

In a Phase 3 trial involving more than 2,200 teenagers aged 12 to 15 years old, Pfizer said it found the efficacy of the vaccine was higher compared to those aged 16 to 25 years old.

According to Pfizer's chairman and CEO, Albert Bourla they share the urgency to expand the authorization of their COVID-19 vaccine to use in younger populations are encouraged by the clinical trial data taken from adolescents whose age ranges from 12 to 15 years.

The two-shot jab, which Pfizer developed with German partner BioNTech, is already being given to adults in the US.

As the March report specified, Bourla explained in the statement, Pfizer is submitting its latest data to the FDA within the coming weeks, as a modification to its EUA.

Vaccine Goal

Based on the Centers for Disease Control and Prevention's vaccination tracker, over 96 million people in the country have already received at least one dose of the COVID-19 vaccine.

US President Joe Biden revised his vaccine goal last week saying he now wants to reach 200 million shots by his first 100 days in administration.

The trial findings came on the heels of an announcement the CDC made that Pfizer and Moderna vaccines have 80-percent efficacy in real-world conditions when it comes to preventing COVID-19 contagions two weeks after some people get their first dose of the vaccine.

A related report on the COVID-19 vaccine for teens is shown on NBC Bay Area's YouTube Video below:

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