CDC panel recommends Pfizer-BioNTech vaccine for kids 12 to 15 years old
A CDC advisory panel voted Wednesday to recommend using the Pfizer-BioNTech COVID-19 vaccine in children aged 12 to 15 years, lowering the age of availability for the country’s only coronavirus vaccine available to kids.
The vote by the Advisory Committee on Immunization Practices was 14-0 in favor of the recommendation, with one recusal due to a conflict of interest. The vote came 2 days after the FDA expanded the emergency use authorization (EUA) for the vaccine to include the younger age group.
“This is truly an exciting development that allows us to protect a large population of children and help them regain their lives after a really rough year,” American Academy of Pediatrics (AAP) President Lee Savio Beers, MD, FAAP, said in a statement.
The vaccine was previously available for people aged 16 years or older under an EUA issued in December. Pfizer and BioNTech asked the FDA last month to expand the EUA based on phase 3 data showing that the messenger RNA-based vaccine is safe and effective in children aged 12 to 15 years. Many of those data were presented during Wednesday’s meeting.
According to the EUA, the vaccine regimen for children aged 12 to 15 years is the same as that for the older, previously authorized age group: two doses of 0.3 mL each, given 3 weeks apart.
In a new policy statement, the AAP said COVID-19 vaccines can be administered at the same time — or within 14 days — as other vaccines. Likewise, Kate Woodworth, MD, MPH, from the CDC’s COVID-19 maternal and child heath team, said during a presentation on clinical considerations that COVID-19 vaccines “may now be administered, without regard to timing” with other vaccines in both children and adults.
This is contrary to a previous recommendation that COVID-19 vaccines not be given within 14 days of other vaccines — a recommendation made out of an abundance of caution rather than any safety or immunogenicity concerns, Woodworth said.
A number of voting and nonvoting ACIP members expressed surprise at the new guidance, saying there were not enough data to change the previous recommendation. Other members noted how the pandemic has disrupted other vaccination efforts, leaving many children behind on routine immunizations, which may now be offered at the same time as a COVID-19 vaccine.
“I’m very reassured by the AAP statement of support,” said Sandra A. Fryhofer, MD, who represents the American Medical Association during ACIP meetings.
According to a CDC slide presented during the meeting, “Although data are not available for COVID-19 vaccines administered simultaneously with other vaccines, extensive experience with non-COVID-19 vaccines has demonstrated that immunogenicity and adverse event profiles are generally similar when vaccines are administered simultaneously as when they are administered alone.”
The new language regarding the timing of COVID-19 vaccination with other vaccines was not voted on by the ACIP. A CDC slide said that when providers are deciding whether to give a COVID-19 vaccine at the same time as another vaccine, they “could consider whether the patient is behind or at risk of becoming behind on recommended vaccines and the reactogenicity profile of the vaccines.”
Higher proportion of cases
In a presentation, Sara Oliver, MD, MSPH, who leads the ACIP’S COVID-19 vaccines work group, noted that the proportion of U.S. cases occurring among adolescents has increased in recent weeks as older Americans continue to get vaccinated. In April, for instance, 9% of new cases occurred among children aged 12 to 17 years — a larger proportion than that reported among adults aged 65 years or older, according to Oliver.
Over the past 2 months, there also has been a “gradual increase” in the COVID-19 hospitalization rate among adolescents, Oliver said. Additionally, 127 children aged 12 to 17 years have died from COVID-19 between Jan. 1 and April 30 — which “may seem low,” Oliver said, but would rank among the top 10 causes of death among children in 2019, the last year such data were available.
According to more recent data compiled by the AAP, more than 72,000 new pediatric COVID-19 cases were reported during the week ending May 6, representing 24% of all new cases in the United States.
Oliver noted that SARS-CoV-2 transmission among children is rare but more likely to occur in high schools than in elementary schools. Under the two EUAs, all high school students are now eligible to receive the Pfizer-BioNTech vaccine.
“This will help us close a difficult chapter for many kids & families,” White House senior COVID-19 response advisor Andy Slavitt tweeted.
The White House has said previously that vaccinating children aged 12 to 15 years would be a major part of its push to have 160 million Americans vaccinated by July 4.