US FDA authorizes updated COVID-19 boosters for younger groups ahead of potential fall wave
The US Food and Drug Administration (FDA) on Wednesday authorized updated Moderna and Pfizer-BioNTech COVID-19 booster shots for children as young as 5.
The updated booster shots aim to provide better protection against COVID-19 caused by the Omicron variant, according to the FDA.
The FDA had authorized updated Pfizer-BioNTech boosters for children ages 5 to 11, and Moderna's shots for kids ages 6 through 17.
The shots are administered at least two months following completion of the two-dose primary series or the most recent booster shot with the first generation vaccines.
The Pfizer-BioNTech new boosters were authorized for people ages 12 and up in September, while Moderna's shots were previously authorized for adults ages 18 and older.
The US Centers for Disease Control and Prevention (CDC), which recommends how vaccines are used, also signed off immediately after the FDA authorization.
Updated COVID-19 vaccines add Omicron BA.4 and BA.5 spike protein components to the current vaccine composition, helping to restore protection that has waned since previous vaccination and targeting recent Omicron variants that are more transmissible and immune-evading, said the CDC in a statement.
FDA's authorization of updated COVID-19 vaccines for this younger age group, and CDC's recommendation for use, are critical next steps forward in US vaccination program, said the statement.
Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said children face an increased risk of exposure to the virus as they head back to school in person and families return to their pre-pandemic lives.
Although COVID-19 tends to be less severe in children than adults, kids do get hospitalized with the disease, Marks said. Health officials are also concerned about the potential risk of long COVID even in children who have had mild illness from the virus.
"We encourage parents to consider primary vaccination for children and follow-up with an updated booster dose when eligible," Marks said.
Pfizer said it will ship up to 6 million booster doses for kids within the next week, according to a company statement.
As of October 6, about 68 percent of the US population is fully vaccinated with their initial series, according to the latest CDC data. But less than half of the fully vaccinated population has received a booster dose.
An analysis published by The Commonwealth Fund found that if more people in the United States get their booster by the end of the year, about 90,000 COVID-19 deaths could be prevented this fall and winter.
But if booster vaccinations continue at their current pace, the nation could see a peak of more than 1,000 COVID-19 deaths per day this winter, according to the study.