Pfizer COVID-19 vaccine approved for kids aged 5 to 11 in the US
Rochelle Walensky, director of the US Centers for Disease Control and Prevention (CDC), has formally endorsed an independent advisory panel’s recommendation to allow use of Pfizer’s COVID-19 vaccine in children aged between five and 11 years old. The endorsement is the final regulatory hurdle to be overcome allowing a special pediatric formulation of the mRNA vaccine to be administered to children across the United States.
Just days after the US Food and Drug Administration’s (FDA) independent vaccine advisory committee unanimously voted to recommend emergency use authorization of Pfizer’s COVID-19 vaccine in children aged five to 11, the CDC’s own expert panel followed up with another united vote for vaccinating this pediatric age group. Now, with Walensky’s formal thumbs-up, children can immediately begin receiving Pfizer’s COVID-19 vaccine.
“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,” says Walensky. “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.”
The approval is based on data from a large trial encompassing more than 4,500 children testing the safety and efficacy of a reduced mRNA vaccine dose in children aged between five and 11. The trial found a pediatric dose, one third of what is in an adult dose, was safe and effective in children.
Compared to placebo the trial found two pediatric doses of the vaccine, separated by three weeks, was 90.7 percent effective at preventing COVID-19 infection in children aged between five and 11. The trial also did not detect any serious adverse effects from the vaccine in this younger age group.
Both the FDA and CDC advisory panels discussed in detail the potential rare mRNA vaccine side effect of heart inflammation, seen mostly in young males. Current data indicates this side effect is detected in about one in 20,000 people aged between 16 and 30.
Most of these cases of heart inflammation are mild, short in duration, easily treated and have not resulted in any deaths in children to date. Pediatric cardiologist Matt Oster reported to the CDC advisory panel that risk of heart damage from COVID-19 in children is greater than any vaccine-induced heart problems.
Another issue discussed by both advisory panels was the fundamental benefit of COVID-19 vaccines in children. Severe disease or death from COVID-19 is rare in children. Since the beginning of the pandemic there have been 94 COVID-19 deaths in children aged between five and 11 in the US.
Camille Nelson Kotton, from Massachusetts General Hospital and a member of the CDC’s Advisory Committee on Immunization Practices (ACIP), highlighted one specific slide to help explain why the panel unanimously recommended COVID-19 vaccines for children despite the low mortality figures in that age group. The data illustrates how a number of diseases we currently vaccinate children against are much less dangerous than COVID-19.
Lee Savio Beers, president of the American Academy of Pediatrics, quickly followed the CDC’s recent announcement with a broad recommendation for all children over the age of five to get vaccinated. The AAP’s recommendations also urge children with prior COVID-19 infections to get vaccinated to prevent reinfection.
“We know from our experience with the Delta variant that this virus is unpredictable, and we cannot afford to be complacent,” says Beers. “It is critical to use science and data to guide our decisions about the pandemic and school COVID-19 plans. We have also entered flu season, and now have an opportunity for children to receive vaccinations for both the flu and COVID-19, which can be done during a single visit.”
The White House announced it has been logistically preparing for this approval. Pfizer is manufacturing the pediatric vaccine in unique packaging to avoid dose mix-ups, so the novel formulation must now be delivered to tens of thousands of sites around the country.
As of next week there should be 15 million pediatric doses available around the United States, and more are on the way. With around 28 million children aged between five and 11 in the country the White House says there will be enough supply for every eligible child in the country to be vaccinated over the coming weeks.
Data from clinical trials testing the vaccine in two younger age groups is expected over the next few months. These cohorts span six months to two years and two to five years.