Robert Frenck, MD, director of the Gamble Vaccine Research Center at Cincinnati Children’s, was lead author of a study published May 27, 2021, in the New England Journal of Medicine, that reports on a clinical trial to assess the safety, immunogenicity, and efficacy of the Pfizer/BioNTech vaccine in adolescents ages 12 to 15 in the United States.

The clinical trial was funded by BioNTech and Pfizer. Dr. Frenck is the site principal investigator for the part of the study conducted at Cincinnati Children’s.

The manuscript, “Safety, Immunogenicity, and Efficacy of the BNT162b2 COVID-19 vaccine in Adolescents,” includes the input of 25 co-authors from institutions across the United Stated and Europe.

On the basis of data presented in the report, the U.S. Food and Drug Administration on May 10, 2021, extended the emergency use authorization for the Pfizer/BioNTech vaccine to include children 12 to 15 years old. The FDA had authorized emergency use for those 16 or older on Dec. 11, 2020.

Safe and effective vaccines are needed to protect children 15 or younger from COVID-19, facilitate in-person learning and socialization, and contribute to herd immunity, the authors noted.

100% Efficacy Reported in 12- to 15-year-olds

The scientists concluded that the BNT162b2 vaccine in 12- to 15-year-old recipients had a favorable safety profile, produced a greater immune response than in young adults, and was highly effective against COVID-19.

The study included volunteers ages 12 to 15 who received two injections, 21 days apart, of either 30 micrograms of Pfizer vaccine or a placebo. The vaccine dosage was the same as given to adults in an earlier trial.

“As has been found in other age groups, BNT162b2 had a favorable safety and side-effect profile, with mainly transient mild-to-moderate reactogenicity (predominantly injection-site pain [in 79 to 86% of participants], fatigue [in 60 to 66%], and headache [in 55 to 65%]),” the authors stated. “There were no vaccine-related serious adverse events and few overall severe adverse events.”

The observed vaccine efficacy in the 12 to 15 age group was 100%, the authors reported. Among adolescents without evidence of previous SARS-CoV-2 infection, no COVID-19 cases with an onset of seven or more days after Dose 2 were noted among the BNT162b2 recipients. However, 16 cases of COVID occurred among placebo recipients.

Overall, 2,260 adolescents in the study received injections across 29 U.S. sites. Of those, 1,131 received BNT162b2 and 1,129 received placebo. Cincinnati Children’s enrolled 244 adolescents in the Pfizer/BioNTech trial at its site, beginning in October 2020.

Gamble Center a Leader in Vaccine Studies

Cincinnati Children’s Gamble Vaccine Research Center is one of the top sites in the nation for the testing, evaluation, and development of vaccines. Including adults, over 1,300 individuals are participating in one of the COVID-19 vaccine clinical trials at Cincinnati Children’s. That includes Pfizer/BioNTech vaccine as well as vaccines manufactured by AstraZeneca and Moderna.

Other vaccines against COVID-19 are authorized for emergency use, but BNT162b2 is the only one currently authorized for use in those younger than age 16.

“Although children and adolescents generally have milder COVID-19 than adults, severe illness can occur in this population, especially in those with underlying medical conditions,” Frenck and the other authors noted. “Adolescents may play an important role in SARS-CoV-2 transmission. Thus, their vaccination may prevent disease and contribute to herd immunity.

“Furthermore, with immunization of older persons, younger persons account for an increased proportion of COVID-19 infections,” the authors stated. “The pandemic has interrupted the education and social development of students and has simultaneously burdened caregivers. Safe, efficacious vaccines for younger populations are therefore paramount.”

Study Notes

Pfizer was responsible for the trial design and conduct, data collection, data analysis, data interpretation, and writing of the manuscript that was submitted, the authors noted.

Both Pfizer and BioNTech manufactured the vaccine and placebo. BioNTech was the regulatory sponsor of the trial and contributed to data interpretation and writing of the manuscript. All data were available to the authors, who vouched for their accuracy and completeness and for the adherence of the trial to the protocol.