Update 7:45 p.m. EDT: The director of the Centers for Disease Control and Prevention Rochelle Walensky today signed the unanimous vote of the agency’s advisors to recommend the pediatric formulation of the Pfizer-BioNTech COVID-19 vaccine for children ages 5-11.
That final step means the US now has its first pediatric COVID-19 vaccine. Administration can begin.
“Together, under the leadership of science, we have taken another major step forward in our nation’s fight against the virus that causes COVID-19,” Walensky said in a statement. “We know that millions of parents are anxious to have their children vaccinated, and with that decision we have now recommended vaccination for COVID-19 to approximately 28 million children. As a mother, I encourage parents with questions to speak to their pediatrician or their school nurse or local pharmacist to learn more about the vaccine and the importance of vaccinating their children. “
Original story 5:10 p.m. EDT: A committee of medical experts advising the Centers for Disease Control and Prevention voted unanimously (14-0) to recommend a low dose of the Pfizer-BioNTech COVID-19 vaccine for children ages 5-11.
In particular, the committee voted to offer two doses of vaccine – 10 micrograms each, one-third the dose for people 12 years and older – three weeks apart. This regimen produced comparable antibody levels to SARS-CoV-2 in children aged 5 to 11 years as in adolescents and young adults after vaccination. And in a clinical study of about 2,250 children ages 5-11, the vaccine was 91 percent effective in preventing symptomatic COVID-19.
“We are all very excited about this vaccine in this age group,” said Beth Bell, an eligible CDC advisor and public health expert at the University of Washington, after the vote. “But we also understand that parents have legitimate concerns and legitimate questions … Our voice is a way to tell the American public that, because of our expertise and information, we are all excited about the way we talk about our children and grandchildren vaccinate.”
The CDC committee vote was the penultimate hurdle before the US received its first pediatric COVID-19 vaccine. Late Friday, the Food and Drug Administration completed another major step and issued Emergency Authorization (EUA) for the Pediatric Formulation of Pfizer BioNTech Vaccine in Children Ages 5-11 Practices (ACIP) – has for use in This age group voted, the only remaining step is for CDC director Rochelle Walensky to sign the recommendation. It is expected that she will announce this deregistration quickly, possibly within hours. Once that happens, vaccine providers are allowed to start administering the vaccine.
The federal government has ensured sufficient vaccine supplies to fully vaccinate all approximately 28 million children ages 5-11 in the United States. As soon as the FDA issued the EEA last Friday, the government began preparing and shipping cans to states for distribution. In a press conference Monday, White House COVID-19 Response Coordinator Jeff Zients reported that several million doses are already on their way to the states and that approximately 15 million doses are expected to be stored at vaccine distribution sites nationwide over the next week.
The pediatric vaccine is being rolled out to pharmacies, pediatrician offices, temporary vaccination clinics in communities and schools, and other locations. The federal government has pointed this out to parents vaccines.gov to find local vendors offering the COVID-19 vaccine to children ages 5-11.
Prior to today’s vote, ACIP carefully reviewed all safety and efficacy data for the pediatric formulation. Data from around 3,100 children found no serious side effects from the pediatric formulation. Modeling the rare risk of myocarditis (inflammation of the heart) in young men concluded that the benefits of vaccination far outweighed this risk and other risks. Vaccine-associated myocarditis cases were generally mild and mostly resolved on their own. Pediatric cardiologist Matthew Oster, who in today’s committee meeting carefully reviewed all data on vaccination-related myocarditis cases, concluded that the cardiac risks associated with contracting COVID-19 outweigh the risks of vaccines. He found that most patients with vaccine-related myocarditis only need over-the-counter pain relievers such as ibuprofen.
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