The country’s youngest age group eligible for COVID-19 vaccination — children younger than 5 years old — can now get an updated COVID-19 shot.
The Food and Drug Administration granted Pfizer’s bivalent COVID-19 vaccine emergency use authorization for babies 6 months through children 4 years of age for a third dose as part of their three-dose primary vaccine series on Dec. 8, according to a news release. Additionally, babies 6 months through children 5 years of age can get a single booster of Moderna’s updated vaccine. The modified vaccines target two versions of the omicron variant (BA.4 and BA.5).
Pfizer’s updated doses for children under 5 will replace its original, or “monovalent,” vaccines which were already authorized for children under 5, according to the company.
These newer shots are already available as boosters for children 5 years and older, as well as adults, according to the Centers for Disease Control and Prevention. Children 5 through 11 can get a bivalent booster made by Pfizer, and anyone older can get an updated booster made by Pfizer or Moderna.
The FDA’s latest authorization for the country’s youngest children provides a chance for parents and pediatricians to protect them as pediatric hospitals are getting overwhelmed with respiratory illnesses including the flu, RSV and “potentially even COVID-19,” Pfizer’s Chief Medical Officer Dr. Aida Habtezion told McClatchy News.
When it comes to COVID-19 and the potential for severe disease, “children are not immune,” according to Habtezion.
“With the high level of respiratory illnesses currently circulating among children under 5 years of age, updated COVID-19 vaccines may help prevent severe illness and hospitalization,” a Dec. 5 Pfizer news release said.
So far, nearly 13% of the U.S. population, those older than 5, has gotten an updated shot as a booster dose, according to the latest CDC data. About 1.6 million children younger than 5 have gotten at least one COVID vaccine dose since June 18.
What parents need to know
Children 6 months through 4 years of age can only get Pfizer’s updated shot if they haven’t “begun their three-dose primary series” yet, the FDA says. So if they’ve already gotten three COVID-19 vaccines made by Pfizer, this makes them ineligible.
As for Moderna’s updated booster, children 6 months through 5 years of age can get it “two months after completing their vaccine primary series” with the company’s original vaccine, the FDA said.
The updated COVID-19 vaccines were developed to better protect against the omicron variant, according to the FDA. Each dose includes a piece of the original virus strain, which the original vaccines were made of, and a second component targeting omicron BA. 4 and BA.5 specifically.
The FDA’s decision to authorize Pfizer’s updated shots as a third dose for children under 5 came after the company released clinical trial data showing the vaccines provided “stronger protection against the Omicron BA.4 and BA.5 sublineages,” according to a Nov. 4 news release.
For Moderna, the FDA “relied on immune response data that it had previously evaluated from a clinical study in adults of a booster dose of (the company’s) investigational bivalent COVID-19 vaccine,” the agency said.
“It’s important that we can expand this protection to children that are under the age of 5,” Habtezion said.
There are several omicron sublineages spreading in the U.S., CDC data shows. The BA.5 subvariant made up about 13.8% of cases for the week ending Dec. 3, according to the data.
The FDA says the bivalent vaccines provide better protection against the omicron variant as a whole.
Additionally, Pfizer found that “safety and tolerability” of the newer shots were “favorable and similar to the original COVID-19 vaccine,” according to its Nov. 4 release.
“Safety is important, and this is something that we take seriously,” Habtezion said.
There is the potential for vaccine side effects considered less common, including a severe allergic reaction and inflammation of the heart such as myocarditis and pericarditis, the company acknowledged in seeking the FDA’s authorization.
The safety of Moderna’s booster dose for children “is supported by safety data from a clinical study which evaluated a booster dose of Moderna’s investigational bivalent COVID-19 vaccine (original and omicron BA.1)“ as well as additional safety data, the FDA said.
Severe COVID-19 can be unpredictable for children
When asked whether certain groups of children under 5 can benefit from a third, bivalent vaccine dose the most, Habtezion said it’s good for all children to get it.
“The unfortunate thing is that some children do run into problems with the severity of the disease,” Habtezion said, adding that “we don’t know which children develop these complications.”
One complication she pointed out was multisystem inflammatory syndrome, or MIS-C, in children.
This is “a condition where different body parts can become inflamed, including the heart, lungs, kidneys, brain, skin, eyes, or gastrointestinal organs,” and its causes are unknown, according to the CDC.
“However, we know that many children with MIS-C had the virus that causes COVID-19, or had been around someone with COVID-19,” the CDC says.
Now that the FDA authorized the shots for the nation’s youngest, Pfizer hopes to prevent severe illness and hospitalization in these children, Habtezion said.
With children going to school and the upcoming holidays, “we are learning to live with COVID-19,” she said.
Before the FDA’s authorization, one study found that older adults may benefit more from the latest COVID-19 boosters and future updates to the vaccines as they’re being disproportionately affected by the virus in the U.S., McClatchy News previously reported.