An advisory panel of the US Centers for Disease Control and Prevention (CDC) on Wednesday voted 14-0, with one recusal, to endorse the FDA’s recent decision to extend use of Pfizer and BioNTech’s COVID-19 vaccine BNT162b2 to 12- to 15-year-olds, according to FirstWord. The recommendation by the Advisory Committee on Immunization Practices (ACIP) was quickly adopted by CDC director Rochelle Walensky, who stated “providers may begin vaccinating [people in this age group] right away.”
The vaccine was initially granted an emergency-use authorization (EUA) in December for people ages 16 years and older. Pfizer and BioNTech’s supplemental filing was supported by topline data from a phase 3 study of adolescents aged 12 to 15, showing that BNT162b2 was safe and 100% effective at protecting against the disease. The analysis was calculated based on 18 cases of COVID-19, all of which were among placebo recipients.
Hesitancy among parents
Sara Oliver of the CDC’s National Center for Immunization and Respiratory Diseases briefed ACIP on the risks and benefits of the vaccine. She noted that among adolescents aged 12 to 17 years of age, the hospitalization rate for COVID-19 is higher than the influenza-associated hospitalization rate for the same age group during the H1N1 pandemic in 2009. It is also significantly higher than it was for influenza seasons in 2017, 2018, 2019 and 2020, she said.
Nevertheless, CDC officials pointed to research indicating that only about 46% to 60% of parents wanted their children to get the vaccine, citing concerns about safety, its rapid development, and not having enough information. Commenting on the expanded EUA for younger teens, FDA Commissioner Janet Woodcock said parents and guardians could “rest assured that the agency undertook a rigorous and thorough review of all available data.”
No serious adverse events
CDC officials said during the ACIP meeting there were no serious adverse events associated with BNT162b2 among 12- to 15- year olds out of more than 2200 children participating in the phase 3 study. Still, 91% experienced side effects of some kind, the most common being pain at the injection site and in muscles/joints, fatigue, headache, chills and fever, according to Pfizer scientist John Perez. He noted that more adolescents reported side effects after the second dose, but they typically resolved within a day or two.
Perez said that in the trial, there were seven cases of lymphadenopathy considered to be related to BNT162b2, versus two in the placebo group. There were no cases of anaphylaxis, according to a slide presented at the ACIP meeting, while Perez said there were no cases of Bell’s Palsy or blood clots either.
Last week, Pfizer disclosed plans to seek a further expansion of the EUA for BNT162b2 in September to include children ages two to 11. A study of the vaccine in children ages six months to 11 years old is currently under way. The FDA also scheduled an advisory committee meeting for June 10 to discuss the potential EUA extension in under-12s.