The Food and Drug Administration on Friday approved both the Moderna and Pfizer-BioNTech coronavirus vaccines for the nation’s youngest children, a relief for many parents who wanted their children 18 months after the injections were first made available to adults. to protect.
Regulators followed the recommendation of independent experts in an advisory panel, which voted unanimously in favor of both vaccines on Wednesday. All Americans, except for the roughly 20 million children under the age of 5, have had months of opportunity to protect themselves from Covid-19 and are eligible for booster shots. Moderna’s two-dose vaccine is for children 6 months through 5 years of age, while Pfizer’s three-dose vaccine is for children 6 months through 4 years of age.
A separate advisory panel from the Centers for Disease Control and Prevention will meet Friday and Saturday to discuss the issue. After that, CDC director Rochelle P. Walensky will make her own recommendation, the final step before the doses are rolled out, likely early next week.
The uptake could be low, which would be especially concerning for children with underlying conditions that could make them more vulnerable to being hospitalized with the virus.
Both the Pfizer and Moderna studies showed that the Omicron variant of the virus greatly blunted the vaccines’ power to prevent symptomatic infection in young children, just as it does in adults.
Pfizer has said that two doses of its vaccine were only about 28 percent effective at preventing disease, while three doses were 80 percent effective. But that 80 percent estimate was based on just 10 cases in a subset of 1,678 trial participants. Moderna’s vaccine was about 51 percent effective in children 6 months to 2 years old and 37 percent effective in children 2 to 5.
Yet said Dr. FDA Commissioner Robert M. Califf said in a statement: “As we have seen in older age groups, we expect vaccines for younger children to protect against the most severe effects of Covid-19, such as hospitalization and death. .”
FDA officials will hold a briefing at 10:30 a.m. Eastern, which you can stream here.
After the federal government made 10 million doses available to states, pharmacies and health care providers in recent weeks, the response has been muted, according to data collected by federal officials. Only 2.5 million doses of the vaccine from Pfizer-BioNTech have been claimed, about half of what was available. And about 1.3 million Moderna doses had been ordered, about a quarter of what was on offer.
Federal officials have said states typically increase orders gradually as vaccination campaigns evolve. But fewer than 40 percent of children ages 5 to 11 have received at least one dose of a coronavirus vaccine, a sign that families, including those whose adult members were eagerly vaccinated, are hesitant to vaccinate their children at least right away. .
Pfizer’s vaccine regimen is three doses at one-tenth the strength of the adult dose. The first two doses are three weeks apart; the third dose is at least two months after the second. That means it would take three months to be fully vaccinated.
Moderna’s vaccine consists of two doses, four weeks apart, and one-fourth the strength of the adult dose. The dose is significantly stronger than Pfizer’s, and the time frame is shorter, which might appeal to parents eager for kids to finish the series.
The FDA has said both vaccines may need boosters. That would mean that Pfizer-BioNTech’s vaccine would contain four doses and Moderna’s three.
Some pediatric and vaccine experts have said it’s a mistake to try to compare the two vaccines, especially as to which one is more effective.
“I don’t think there’s convincing enough data to say one is better than the other,” said Dr. Kristin Moffitt, a physician at Boston Children’s Hospital who has treated young Covid-19 patients. “We all have to recognize that it’s very tricky to directly compare the two as they’ve been studied differently.”
dr. James Conway, an expert on childhood infections at the University of Wisconsin-Madison, said the two vaccines were studied at different times, when different variants were in circulation.
He also said it was difficult to determine how much protection any vaccine could provide, given the newer, more contagious versions of the virus that continue to mutate. “You’re kind of playing Whac-a-Mole,” he said.
Pfizer’s efficacy estimate, said Dr. Moffitt, was particularly unreliable because there were so few cases of the virus among trial participants after the third dose. “We will have to wait and be patient to understand the true effectiveness of each of these vaccines.”
Pfizer’s vaccine is approved for children over 5 years of age for many months, while Moderna’s is limited to adults.
dr. Moffitt and other pediatric experts said that since it had been given to millions of older children, some parents might feel more comfortable with the Pfizer-BioNTech vaccine, even if it took longer for children to be fully vaccinated. Others, hoping for faster results and potentially vulnerable relatives, may prefer Moderna’s vaccine.
Some families may go with the brand siblings and parents received, or take what’s available nearby.
Some pediatricians, nurses and pharmacists may be more familiar with Pfizer and do not want to introduce another product.
dr. Conway said his advice to parents is that “something is better than nothing.”