FDA authorizes booster for children aged 5-11

WASHINGTON (The Hill) — The Food and Drug Administration on Tuesday authorized a booster dose of the Pfizer-BioNTech COVID-19 vaccine to children between the ages of 5 and 11, extending booster doses to the youngest age group yet. Experts have stressed the importance of booster shots for older age groups as a key way to increase protection in the face of waning immunity over time from the initial shots, as well as the increased evasiveness of the omicron variant currently circulating.

Now, children 5 to 11 will be eligible for boosters for the first time. Data released by Pfizer last month found a 36-fold increase in the level of neutralizing antibodies against the omicron variant, compared to two doses.

“These data reinforce the potential function of a third dose of the vaccine in maintaining high levels of protection against the virus in this age group,” Pfizer said then, adding: “The vaccine was well tolerated with no new safety signals observed.”

Still, uptake for even the initial two shots for children 5 to 11 has been lagging, indicating that many parents will not get booster shots for their children either. Only 28% of that age group have received the first two shots, according to data compiled by the Centers for Disease Control and Prevention.  

While COVID-19 is less severe on average in children, there still can be some severe cases and even deaths. Between 0.1 and 1.5% of child COVID-19 cases resulted in hospitalization according to data from the American Academy of Pediatrics.

There is still no vaccine authorized for children under 5, a source of frustration to some parents. It is possible that move could come in June, given that FDA advisory committees are set to meet then to consider the vaccine for the youngest children. The FDA has pointed to the low vaccination rates in older children to show that it must be thorough in its review for the youngest age group and seek to instill confidence in vaccines.  

“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,” said FDA Commissioner Robert Califf.

“Vaccination continues to be the most effective way to prevent COVID-19 and its severe consequences, and it is safe,” he added. The booster shot is intended to be received at least five months after the initial doses.