FDA panel recommends Pfizer and Moderna vaccines for youngest children

FDA panel recommends Pfizer and Moderna vaccines for youngest children

WASHINGTON — The only Americans who are still ineligible for coronavirus vaccines — babies, toddlers and preschoolers — are on the verge of finally being allowed to receive them, according to a Food and Drug Administration advisory panel on Wednesday voted unanimously to recommend Pfizer and Moderna vaccines for the group.

The FDA appears poised to approve Moderna’s vaccine for children under 6 and Pfizer’s for children under 5 as early as Friday. States have already ordered millions of doses, and White House officials said shots could be introduced as early as next week.

The committee’s 21-0 votes came after days of reviewing clinical trial data and signaled the end of a process that included months of false starts and dashed hopes of a vaccine for the youngest Americans. With the exception of the approximately 20 million children under the age of 5, everyone has had access to coronavirus vaccinations for many months and are now entitled to booster shots.

The FDA and the Centers for Disease Control and Prevention joined forces to push for a positive recommendation, showering the committee with 230 pages of data they said showed the vaccines were safe and would elicit a strong immune response in children. Regulators also stressed that although young children are generally at low risk of serious illness from the virus, vaccinating the group would save lives.

“We have to be careful not to go numb with the number of pediatric deaths because of the overwhelming number of elderly deaths here,” said Dr. Peter Marks, the FDA’s Chief Vaccine Authority. “The intervention we’re talking about here is something that we’ve accepted in the past to try to prevent deaths from influenza,” he added.

CDC officials said more than half of infants hospitalized with Covid had no underlying medical conditions. During the winter Omicron wave, young children were more likely to be hospitalized than older children and adolescents, and their illness was usually at least as severe. More than 200 children aged 6 months to 4 years have died from Covid, according to death certificate data, one of the most conservative estimates.

Panel members, some of whom have treated hospitalized children for Covid and comforted terrified parents, appeared poised to act.

“There are so many parents who are desperate to get this vaccine,” said Dr. Jay Portnoy, Professor of Pediatrics at the University of Missouri-Kansas City School of Medicine. “I think we owe it to them to give them a choice.”

dr Arthur Reingold, an epidemiologist at the University of California, Berkeley, School of Public Health, said the nation is already vaccinating children against diseases “where the risk of a child dying from those diseases or being hospitalized is pretty close to zero.” lay”.

The CDC’s own panel of vaccine experts will be considering the matter for two days this weekend. If this committee also makes a positive recommendation, Dr. Rochelle P. Walensky, the agency’s director, making her decision, the final step in the process.

None of the vaccines have been tested against new sub-variants circulating in the United States. Most of the clinical trials were conducted when the Omicron variant caught on. Two subvariants, BA.4 and BA.5, could become dominant within a month.

The virus is evolving so rapidly that some panellists expressed concern that the clinical trial results on which their decisions were based were already out of date. “We’re really trying to predict the future,” said Dr. Paul Offit, a vaccines expert at Children’s Hospital of Philadelphia and an FDA panellist, in an interview. “That’s a problem.”

But the panel’s main concern seemed to be whether Pfizer’s three-dose vaccine, which it developed with its German partner BioNTech, would be effective enough. Pfizer has reported that two doses of its vaccine were only about 28 percent effective in preventing symptomatic disease; dr Susan Wollersheim, an FDA reviewer, said the company’s data did not conclusively show that two doses reduced the incidence of Covid.

Pfizer argued that three doses were 80 percent effective, but the finding was based on just 10 cases from a subgroup of 1,678 study participants. and dr Doran Fink, acting deputy director of the FDA’s office of vaccines, questioned the company’s estimate, calling it “preliminary” and “inaccurate.”

Still, he said the FDA is “very confident” based on the immune response data that Pfizer’s vaccine, like Moderna’s, meets the criteria for emergency use approval, which requires the benefits to outweigh the risks. However, some members of the panel were clearly concerned that parents could be misled.

dr Amanda Cohn, a senior CDC official and panel member, said she has “no idea” what the efficacy rate will be after three doses of Pfizer and that officials shouldn’t accept the 80 percent estimate.

Jeannette Y. Lee, a biostatistician at the University of Arkansas for Medical Sciences, expressed another concern: Some parents may miss the crucial third dose for their children. “As we know, getting people for two is a struggle,” she said.


Jun 15, 2022 4:52pm ET

Pfizer officials said the data showed the vaccine’s effectiveness built up over time. “It’s not like there’s no efficacy at all,” said Dr. William C. Gruber, senior vice president at Pfizer.

For some parents, the bar is low. Some of the more than 1,600 parents who responded to a New York Times inquiry about living with an unvaccinated young child said they would accept any efficacy above zero to provide some level of protection for their children.

“To protect them from illness and potential death or lifelong hardship? Why is that a question?” wrote Cayla Miller, a mother in Swanville, Maine. “We’ve waited so long to protect our entire family. I almost lost my job and my wits tried to protect her.”

Scientists and federal officials have warned against directly comparing Moderna and Pfizer vaccines. Not only did the companies conduct their clinical trials at different times and with different populations, but the dosages and treatment regimens also differed.

Pfizer has proposed a three-dose regimen at one-tenth the strength of its adult dose, with the first two doses given three weeks apart and the third at least two months after the second. Moderna wants to offer two doses of the vaccine four weeks apart at a quarter the strength of its adult dose. Moderna’s adult dose is significantly stronger than Pfizer’s.

dr The FDA’s Wollersheim declined to respond when a panelist asked about comparing the vaccines’ effectiveness in young children. But as some parents might do, some members of the panel have tried to make their own matchup.

dr Offit noted that Moderna’s efficacy data was slightly stronger than Pfizer’s: about 51 percent effective at preventing symptomatic infections in children ages 6 months to 2 years and 37 percent effective in children ages 2 to 5 years.

Although protection against symptomatic infection is limited, Moderna’s vaccine is predicted to ward off serious illnesses.

“I’m not sure you can predict that with Pfizer’s vaccine,” he said. “I fear they may be underdosed.”

Both vaccines elicited levels of neutralizing or virus-blocking antibodies in children comparable to those in young adults. Pfizer’s vaccine has been approved for children ages 5 to 15 since last year, and regulators said it helped prevent hospitalizations and deaths.

Still, both appear to be significantly less effective against symptomatic infections than the adult vaccines when they were introduced 18 months ago. The FDA said that’s because Omicron has proven to be far more adept at dodging the vaccines’ defenses against infection than previous versions of the virus.

Given the waning effectiveness over time, the FA has said young children who receive Pfizer and Moderna vaccines are likely to need booster shots, just like older recipients. That would mean Pfizer’s vaccine could end up in four doses, while Moderna’s could be three.

None of the vaccines raised serious safety concerns. The vast majority of side effects were mild – irritability and crying, drowsiness, fatigue and loss of appetite. Recipients of Moderna’s vaccine seemed more likely to have fevers, but consistent with those produced by other pediatric vaccines, the FDA said.

Federal health officials have said they expect many children under the age of 5 to be vaccinated by pediatricians and general practitioners, as opposed to older age groups. But uptake is expected to be low; Children aged 5 to 11 were eligible for vaccination late last year, but only about 37 percent of them have received at least one dose.

Cans are packed in hundreds to reach smaller practices and rural locations. The Biden administration has also promoted a network of other sites that would reach families, including pharmacies and children’s hospitals, while groups like the Association of Children’s Museums and the National Diaper Bank Network will help with education efforts.

A topic of discussion among FDA panel members was how to address the many parents whose children have already acquired some natural immunity. Federal health officials presented data to the committee this week that suggests more than two-thirds of children ages 1 to 4 are already infected with the virus.

A Moderna official told the committee that the company’s study found that young children who had contracted the virus and been vaccinated had higher levels of protection, a conclusion supported by external research.

dr James EK Hildreth, committee member and president of Meharry Medical College in Nashville, noted that many children have been infected “and are doing well.”

“But for the parents who choose to do this, especially the parents of children with underlying conditions,” he added, “this is a choice they should have.”

Emily Erdos contributed to the reporting.