FDA approval of the first COVID-19 vaccine—the Pfizer-BioNTech COVID-19 vaccine—might have muddied the waters even more for parents confused about vaccinating their children.
The vaccine, which is marketed as Comirnaty, is approved for the prevention of COVID-19 disease in people aged 16 years and older. The vaccine also continues to be available, however, under Emergency Use Authorization (EUA), including for adolescents aged 12 through 15 years.
Furthermore, the FDA emphasizes that the Pfizer/BioNTech Covid-19 vaccine is not currently approved nor authorized for children younger than age 12 years. One reason is that the appropriate dosage for this age group has yet to be determined.
"We do not have data on the proper dose nor do we have full data on the safety in children younger than what is in the EUA," explained Acting FDA Commissioner Dr. Janet Woodcock during a briefing call after approval for those aged 16 years and older.
"So that would be a great concern that people would vaccinate children because we don't have the proper dose and we don't have the safety data, nor do we have all the efficacy data, as well," Dr. Woodcock said. "We are not recommending that children younger than age 12 be vaccinated with this vaccine. It would not be appropriate."
The Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals aged 16 years and older since December 11, 2020, and the authorization was expanded to include those aged 12 through 15 years on May 10, 2021.
While mild local and systemic reactions are common among adolescents following vaccination with the Pfizer-BioNTech vaccine, serious adverse events are rare, according to the study.
The Advisory Committee on Immunization Practices (ACIP) conducted a risk-benefit assessment and continues to recommend the Pfizer-BioNTech COVID-19 vaccine for all persons aged 12 years and older, the CDC notes.
The article points out that beginning in June 2021, cases of myocarditis and myopericarditis after receipt of Pfizer-BioNTech vaccine began to be reported, especially among young males after getting the second dose.
Later that month, CDC's ACIP reviewed available data and concluded that the benefits of COVID-19 vaccination to individual persons and the population outweigh the risks for myocarditis and recommended continued use of the vaccine in people aged 12 years and older.
This study looked at adverse events documented after receipt of Pfizer-BioNTech vaccine and reported to the Vaccine Adverse Event Reporting System (VAERS) and adverse events and health-impact assessments reported in v-safe (a smartphone-based safety surveillance system). CDC researchers reviewed those reports for U.S. adolescents aged 12 to 17 years from December 14, 2020, to July 16, 2021.
The researchers advise that as of July 16, 2021, about 8.9 million U.S. adolescents aged 12 to 17 years had received Pfizer-BioNTech vaccine. VAERS received 9,246 reports after Pfizer-BioNTech vaccination in this age group, with 90.7% of them for nonserious adverse events. The remaining 9.3% were for serious adverse events, including myocarditis (4.3%).
In addition, with about 129,000 U.S. adolescents aged 12 to 17 years enrolling in v-safe after Pfizer-BioNTech vaccination, 63.4% of the reports were for local and 48.9% were for systemic reactions—all similar to preauthorization clinical trials.
The authors emphasize that no adverse events were reported disproportionately to VAERS in association with Pfizer-BioNTech vaccination in adolescents. The most commonly reported conditions among all reports were dizziness (1,862; 20.1%), syncope (1,228; 13.3%), and headache (1,027; 11.1%).
Of the 863 (9.3%) reports of serious events, including death, 609 (70.6%) were among males, and median age was 15 years. The most commonly reported conditions and diagnostic findings among reports of serious events were chest pain (56.4%), increased troponin levels (41.7%), myocarditis (40.3%), increased c-reactive protein (30.6%), and negative SARS-CoV-2 test results (29.4%). Myocarditis was listed among 4.3% (397) of all VAERS reports.
The CDC reviewed 14 reports of death after vaccination, but none were determined to be caused by myocarditis, and little causal relationship was found with the vaccine.
"The findings summarized in this report are consistent with the safety data observed in preauthorization trials for Pfizer-BioNTech after vaccination among persons aged 12Ð25 years, with the exception of myocarditis, a serious adverse event detected in post-authorization safety monitoring," the researchers write.
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