The Centers for Disease Control and Prevention (CDC) plans to roll out modified COVID-19 boosters for children aged 5 to 11 by mid-October, despite the absence of any human clinical trials showing this vaccine is safe.
The agency said in a document released Tuesday it will issue a recommendation in early- to mid-October if the U.S. Food and Drug Administration (FDA) authorizes the modified booster for this age group.
The CDC said it expects Pfizer-BioNTech’s bivalent booster to be available for children ages 5 to 11 and Moderna’s bivalent booster to be available for children ages 6 to 17, pending authorization by the FDA.
“I’m confident that we’re only a matter of weeks away” from authorizing the 5-11 age range, the FDA’s vaccine chief, Dr. Peter Marks, said during an event with the COVID-19 Vaccine Education and Equity Project. Marks said for kids under 5, the vaccine is still “a few months away” from authorization.
Only 40% of 5- to 11-year-olds and 10% of children 6 months to 4 years old have started their primary COVID-19 vaccination series, according to the American Academy of Pediatrics. Marks urged parents to get their kids vaccinated so they could receive the updated booster when it is authorized.
The bivalent booster targets both the original Wuhan strain that isn’t even in circulation and the Omicron BA.4/BA.5 subvariants which will soon be obsolete. The CDC expects pre-orders of the Pfizer booster to begin next week even though the FDA has not yet signed off on the vaccine for this age group.
Moderna’s booster is the same formula used for children and adults and will not require a separate pre-order period, the agency said.
According to data released Friday by the CDC, as of Sept. 16, there were 39,472 adverse events, including 4,277 rated as serious and 120 reported deaths reported to the Vaccine Adverse Event Reporting system among 12- to 17-year-olds.
There were 269 reports of anaphylaxis among 12- to 17-year-olds where the reaction was life-threatening, required treatment or resulted in death, 1,310 reports of myocarditis and pericarditis and 300 reports of blood clotting disorders.
In the 5- to 11-year-old age group, there were 14,115 adverse events, including 665 rated as serious and 28 reported deaths, 45 reports of myocarditis and pericarditis, 67 reports of blood clotting disorders and 180 reports of seizures since the COVID vaccine was authorized for this age group on October 29, 2021.
Despite the alarming safety signals both the CDC and FDA are choosing to ignore, both agencies plan to go forward full-steam ahead with authorizing the bivalent booster for young children.