US FDA: "Pfizer COVID-19 Vaccine Also Offers Significant Benefits for Adolescents Aged 16-17"

CBER Director: "It is Wise for 16-17 Year Olds to Interact with the Community and Get Vaccinated"

[Image source=Reuters Yonhap News]

[Asia Economy Reporter Jeong Hyunjin] On the 12th (local time), the U.S. Food and Drug Administration (FDA) evaluated that the benefits of vaccination outweigh the risks for 16- to 17-year-old adolescents, whose safety was questioned due to the small sample size in clinical trials, regarding the novel coronavirus disease (COVID-19) vaccine developed by U.S. Pfizer and German BioNTech.

According to CNN, Peter Marks, director of the FDA's Center for Biologics Evaluation and Research (CBER), said at a briefing that the potential benefits of the Pfizer vaccine for 16- to 17-year-old adolescents outweigh the risks. He stated that after reviewing safety-related records for 16- to 17-year-olds based on data, he judged them to be acceptable.

The Pfizer vaccine faced questions about data reliability because the number of 16- to 17-year-old participants in the clinical trial phase was smaller than other population groups. In response, Marks emphasized that although the study group was small and teenagers are relatively less severely affected by COVID-19, they can still become very ill, have a risk of death, and can easily spread the virus as asymptomatic carriers.

He said, "Some 16- and 17-year-olds work as store or supermarket clerks and interact with the community, so vaccinating them could be wise," adding, "Therefore, we believe the known potential benefits outweigh the known potential risks."

Marks also said that for pregnant women, whether to receive the Pfizer vaccine should be a personal decision. He stated, "It is not good for pregnant women to contract COVID-19. Therefore, some may decide to get vaccinated. However, this is not something we currently recommend," adding, "This is left to the individual."

According to Marks, although pregnant women were not recruited as participants during the clinical trial phase of the Pfizer vaccine, some women became pregnant during the trial. However, Marks explained that the data is not sufficient to prove safety. He added, "For pregnant women and immunocompromised individuals, at this point, medical professionals should make decisions on a case-by-case basis."

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