Confirmed Safety and Efficacy of Pfizer Vaccine for Children Aged 5 to 11 Years

Pfizer Reports Adult-Level Antibody Formation in 5-11 Year-Old Clinical Trials
Pfizer Plans to Request FDA Approval for Vaccination in This Age Group

[Asia Economy International Department Reporter] The Pfizer COVID-19 vaccine has been proven to be safe and highly effective for children aged 5 to 11.

Overseas media outlets such as The New York Times (NYT) reported on the 20th (local time) that Pfizer and BioNTech disclosed the results of such clinical trials.

At a press conference that day, the two companies explained that they conducted clinical trials involving 2,268 kindergarten and elementary school children.

[Image source=Reuters Yonhap News]

The clinical trial was conducted by administering a dose of 10 μg (micrograms), which is one-third of the dose given to teenagers and adults, to children aged 5 to 11 at three-week intervals. According to the companies, the trial results showed that after the second dose, children aged 5 to 11 developed virus antibodies at levels as strong as those in teenagers and adults.

Pfizer added, "The 10 μg dosage was carefully determined considering the safety for children aged 5 to 11, their tolerance, and the effective formation of immunity."

They also emphasized that side effects such as pain at the injection site or fever were similar to or less than those typically observed in teenagers, confirming the vaccine's safety.

Pfizer further noted that there were no cases of myocarditis, a side effect observed with messenger RNA (mRNA) vaccines.

Pfizer plans to submit the related data to the U.S. Food and Drug Administration (FDA) by the end of this month to request approval for vaccination in this age group.

The NYT forecasted, "If the regulatory review process proceeds smoothly, millions of elementary school students will be vaccinated before the Halloween festival (October 31)."

The Pfizer vaccine is currently fully approved for those aged 16 and older in the United States and has emergency use authorization for those aged 12 to 15.

Pfizer also stated that clinical trial results for children aged 6 months to under 5 years are expected as early as the fourth quarter of this year.

According to the American Academy of Pediatrics (AAP), more than 5 million children have been diagnosed with COVID-19 so far, with at least 460 deaths among them.