Update 7:45 pm EDT: Director of the Centers for Disease Control and Prevention Rochelle Walensky has signed off on the unanimous vote earlier today by agency advisors to recommend the pediatric formulation of the Pfizer-BioNTech COVID-19 vaccine for children ages 5 to 11.

This final step means that the US now has its first pediatric COVID-19 vaccine. Administration can begin.

“Together, with science leading the charge, we have taken another important step forward in our nation’s fight against the virus that causes COVID-19,” Walensky said in a statement. “We know millions of parents are eager to get their children vaccinated and with this decision, we now have recommended that about 28 million children receive a COVID-19 vaccine. As a mom, I encourage parents with questions to talk to their pediatrician, school nurse or local pharmacist to learn more about the vaccine and the importance of getting their children vaccinated.”

Original story 5:10 pm EDT: A committee of medical experts advising the Centers for Disease Control and Prevention voted unanimously (14 to 0) in favor of recommending a low dose of the Pfizer-BioNTech COVID-19 vaccine for children ages 5 to 11.

Specifically, the committee voted in favor of offering two vaccine doses—which are 10 micrograms each, a third of the dose for people ages 12 and up—three weeks apart. This regimen produced comparable levels of antibodies against SARS-CoV-2 in children ages 5 to 11 as seen in adolescents and young adults after vaccination. And in a clinical trial involving about 2,250 children ages 5 to 11, the vaccine was 91 percent effective at preventing symptomatic COVID-19.

“We all have a lot of enthusiasm for this vaccine in this age group,” Beth Bell, a voting CDC advisor and a public health expert at the University of Washington, said after the vote. “But we also understand that parents have legitimate concerns and legitimate questions… Our vote is a way of telling the American public that, based on our expertise and the information that we have, we’re all very enthusiastic. We’ve all talked about how we’re getting our kids and our grandkids vaccinated.”

The CDC committee’s vote was the penultimate hurdle before the US gets its first pediatric COVID-19 vaccine. Late Friday, the Food and Drug Administration completed another key step, issuing the emergency use authorization (EUA) for the pediatric formulation of the Pfizer-BioNTech vaccine in children ages 5 to 11. Now that the CDC’s advisory committee—the Advisory Committee on Immunization Practices (ACIP)—has voted in favor of use in that age group, the only remaining step is for CDC Director Rochelle Walensky to sign off on the recommendation. She is expected to announce that sign-off quickly, possibly within hours. Once that occurs, vaccine providers are allowed to begin administering the vaccine.

The federal government has secured enough vaccine supply to fully vaccinate all of the approximately 28 million children ages 5 to 11 in the US. As soon as the FDA issued the EUA last Friday, the government began preparing and shipping doses to states for distribution. In a press briefing Monday, White House COVID-19 Response Coordinator Jeff Zients reported that several million doses were already en route to states, and approximately 15 million doses are expected to be stocked at vaccine distribution sites nationwide over the next week or so.

The pediatric vaccine will roll out of pharmacies, pediatrician offices, temporary vaccination clinics in communities and schools, and other sites. The federal government has pointed parents to vaccines.gov to find local providers offering the COVID-19 vaccine to children ages 5 to 11.

Before today’s vote, the ACIP carefully reviewed all of the safety and efficacy data for the pediatric formulation. Data from around 3,100 children found no serious side effects from the pediatric formulation. Modeling of the rare risk of myocarditis (heart inflammation) cases in young males concluded that the benefits of vaccination clearly outweigh that risk and others. Vaccine-associated cases of myocarditis have been generally mild, and they largely resolved on their own. Pediatric Cardiologist Matthew Oster, who carefully reviewed all of the data on vaccine-related myocarditis cases in today’s committee meeting, concluded that the cardiac risks associated with getting COVID-19 exceeded the risks from vaccines. He noted that most patients with vaccine-related myocarditis need only be treated with over-the-counter pain killers, such as ibuprofen.

https://arstechnica.com/?p=1809743