FDA authorizes booster dose of Pfizer and BioNTech's Covid-19 vaccine in 5- to 11-year-olds
The latest wave of the pandemic — marked by Omicron and its sub-variants — has seen higher hospitalization rates for young children, health agencies have observed. That’s part of the reason why the FDA is authorizing a booster shot for kids between 5 and 11 years old.
Regulators on Tuesday OK’d a single booster dose of Pfizer and BioNTech’s mRNA vaccine for children who received their primary series with the same vaccine at least five months ago. By Pfizer’s count, that makes more than 8 million 5- to 11-year-olds eligible for another dose.
“While it has largely been the case that Covid-19 tends to be less severe in children than adults, the Omicron wave has seen more kids getting sick with the disease and being hospitalized, and children may also experience longer term effects, even following initially mild disease,” FDA commissioner Robert Califf said in a press release. “Vaccination continues to be the most effective way to prevent Covid-19 and its severe consequences, and it is safe.”
The news comes months after the FDA lowered the age requirement for a Pfizer/BioNTech booster dose to include 12- to 15-year-olds.
Regulators based their decision on Phase II/III data, which showed that a single booster dose of the vaccine triggered a “strong immune response” in the younger age group, with no new safety signals observed, according to Pfizer.
Pfizer and BioNTech have also filed for authorization of a booster dose in the same age group in Europe, and are planning other submissions around the world, the companies announced.
Their Covid-19 vaccine remains the only option for children as young as five years old, as Moderna pushes for authorization in the youngest kids under 6 years old. Pfizer is currently conducting a study for a 3-µg formulation of its original vaccine on a three-dose schedule in kids between 6 months and 4 years old, with initial data coming in the coming weeks, according to the company.
“Since authorizing the vaccine for children down to 5 years of age in October 2021, emerging data suggest that vaccine effectiveness against Covid-19 wanes after the second dose of the vaccine in all authorized populations,” CBER director Peter Marks said in a news release.