FDA, CDC greenlight updated COVID-19 booster for kids 5 to 11

WASHINGTON — The federal government on Wednesday recommended an updated COVID-19 booster for kids between 5 and 11, expanding use of the new bivalent shots beyond people 12 and older. 

The U.S. Food and Drug Administration first authorized the updated vaccines use in the morning before the Centers for Disease Control and Prevention recommended them in the afternoon, completing the two-step process needed before shots could begin 

CDC Director Rochelle Walensky announced her recommendation in a tweet, saying it’s “a critical step in our fight against COVID-19.”

I just recommended expanding updated #COVID19 vaccines to children 5-11 years. This is a critical step in our fight against COVID-19. An updated vaccine can help bolster protection for our children this winter. Talk to your child’s healthcare provider for more information.

— Rochelle Walensky, MD, MPH (@CDCDirector) October 12, 2022

“An updated vaccine can help bolster protection for our children this winter,” she added, encouraging parents to talk to their child’s healthcare provider. 

The announcement Wednesday for kids between 5 and 11 follows the FDA authorizing and the CDC recommending the bivalent booster dose for people 12 and older in early September. 

“While it has largely been the case that COVID-19 tends to be less severe in children than adults, as the various waves of COVID-19 have occurred, more children have gotten sick with the disease and have been hospitalized,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. 

“Children may also experience long-term effects, even following initially mild disease,” Marks added. 

The shot is updated to provide protection against the latest omicron variants of COVID-19, known as BA.4 and BA.5. 

The move comes as public health officials are monitoring new variants that could cause disruptions this winter during the annual cold and flu season. 

Winter surge in cases possible

White House COVID-19 Response Coordinator Ashish Jha said Tuesday during a press briefing that everyone eligible for the latest booster should get it as soon as they can, though he declined to list any goals for the new shot. 

Jha then warned that a surge of COVID-19 cases could be on the horizon this winter. 

“We have seen an increase in COVID infections, hospitalizations, and deaths each of the last two winters. And we are carefully monitoring the rise of several subvariants that are evolving rapidly and emerging around the world, including ones that evade some of our treatments,” Jha said. 

The Biden administration, he said, is tracking COVID-19 variants that “either have a lot more immune invasiveness or they render many of our treatments ineffective.”

The good news, however, is that the variants public health officials are tracking come from omicron strains BA.2 and BA.5, Jha said. 

“That means our updated bivalent vaccines should provide a much higher degree of protection than the original prototype vaccine would have,” he said. “Obviously, we’re going to do the studies to figure out how much protection, but I’m confident that our vaccines will continue to work very well.”

No vaccine goals set

Despite encouraging everyone eligible for the updated COVID-19 bivalent booster dose to get vaccinated, Jha said the White House hasn’t set any goals for how many people it wants to get the shot. 

“We’re not setting targets,” Jha said. “We are focused on driving deaths down, getting more people vaccinated.”

The U.S. Centers for Disease Control and Prevention’s website shows that 11.5 million people have received the updated booster dose, a fraction of those eligible. 

The COVID-19 boosters are expected to become an annual recommendation for most people, similar to the annual flu shot.