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The FDA panel recommends Pfizer and Moderna vaccines for youngest children

WASHINGTON – The only Americans still unqualified for coronavirus vaccines – babies, toddlers and preschoolers – appear to be cleared to receive them after a Food and Drug Administration advisory panel unanimously voted Wednesday to recommend Pfizer and The modern vaccines for the group.

The FDA appears to approve Moderna’s vaccine for children under 6 and Pfizers for those under 5 as soon as Friday. States have already ordered millions of doses, and White House officials have said shots could roll out as early as next week.

The committee’s 21[ads1]-0 vote came after a day-long review of data from clinical trials and signaled the end of a process that involved months of false starts and shattered hopes of a vaccine to cover the youngest Americans. Except for the approximately 20 million children under the age of 5, all have had access to coronavirus shots for many months and are now eligible for booster shots.

The FDA and the Centers for Disease Control and Prevention jointly made a strong push for a positive recommendation, and flooded the committee with 230 pages of data that they said showed the vaccines were safe and provoked a strong immune response in children. Regulators also stressed that although young children generally have a low risk of serious disease from the virus, vaccination of the group will save lives.

“We need to be careful not to get numb from the number of pediatric deaths due to the overwhelming number of elderly deaths here,” said Dr. Peter Marks, the FDA’s top vaccine regulator. “The intervention we are talking about here is one that we have accepted in the past to try to prevent deaths from the flu,” he added.

CDC officials said more than half of young children hospitalized with Covid did not have any underlying medical conditions. During the Omicron wave in winter, young children were hospitalized at a higher rate than older children and adolescents, and their disease tended to be 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.

The panel members, some of whom have treated children in hospital for Covid and comforted terrified parents, seemed eager to act.

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

Dr. Arthur Reingold, an epidemiologist at the University of California, Berkeley, School of Public Health, said the nation already vaccinates children against diseases “where the risk of a child dying or being hospitalized for these diseases was fairly close to zero.”

The CDC’s own panel of vaccine experts will take up the matter over two days this weekend. If that committee also makes a positive recommendation, Dr. Rochelle P. Walensky, the agency’s director, will give his decision, the final step in the process.

None of the vaccines have been tested against new subvariants circulating in the United States. The clinical trials were largely performed when the Omicron variant won. Two sub-variants, BA.4 and BA.5, can become dominant within a month.

The virus develops so rapidly that some panelists expressed fears that the results of clinical trials on which their decisions were based were already outdated. “We’re really trying to predict the future,” Dr. Paul Offit, a vaccine expert at the Children’s Hospital of Philadelphia and an FDA panelist, said in an interview. “This is a problem.”

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

Pfizer claimed that three doses were 80 percent effective, but the finding was based on only 10 cases of a subset of 1678 trial participants. And Dr. Doran Fink, acting deputy director of the FDA’s vaccine office, casts doubt on the company’s estimates, describing it as “preliminary” and “imprecise.”

Nevertheless, he said that the FDA was “very sure” from the immune response data that Pfizer’s vaccine, like Modernas’, met the criteria for emergency use approval, which requires that the benefits outweigh the risks. But some panelists were clearly concerned that parents could be misled.

Dr. Amanda Cohn, a top CDC official and panelist, said she had “no idea” what the three-dose Pfizer effect would be, and that officials should not embrace the 80 percent estimate.

Jeannette Y. Lee, a biostatistician at the University of Arkansas of Medical Sciences, raised another concern: that some parents may skip the crucial third dose for their children. “As we know, it’s a struggle to get people in for two,” she said.

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

For some parents, the bar is low. Some of the more than 1,600 parents who responded to a New York Times request for life with an unvaccinated young child said they would accept any effect above zero to give their children some protection.

“To keep her safe from illness and potential death or lifelong adversity? Why is this a question? “Wrote Cayla Miller, a mother in Swanville, Maine.” We have been waiting so long to protect our entire family. I have almost lost my job and my mind is trying to keep her safe. “

Researchers and federal officials have warned against directly comparing Moderna and Pfizer vaccines. Not only did the companies conduct their clinical trials at different times, with different populations, but the dosage and regimens are different.

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

Dr. Wollersheim from the FDA refused to answer when a panelist asked for a comparison of the efficacy of vaccines in young children. But as some parents can do, some panelists tried to make their own matchup.

Dr. Offit noted that Moderna’s efficacy data were somewhat stronger than Pfizers’: approximately 51 percent effective in preventing symptomatic infection in children 6 months to 2 years of age and 37 percent effective in children 2 to 5 years old.

Although protection against symptomatic infection was limited, he said, it was possible to predict that Moderna’s vaccine would prevent serious illness.

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

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

Nevertheless, both seem significantly less effective against symptomatic infection than the adult vaccines when they were introduced 18 months ago. The FDA said that was because Omicron proved to be far more capable of avoiding vaccines’ defenses against infection than previous versions of the virus.

Given evidence of diminishing strength over time, the FD.A. has said that young children who receive Pfizer and Moderna shots are likely to need booster shots, just as older recipients have done. This means that Pfizer’s vaccine can end up as four doses, while Modernas can be three.

None of the vaccines triggered 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 experience fever, but in line with those provoked by other pediatric vaccines, the FDA said.

Federal health authorities have said they expect many children under the age of 5 to be vaccinated by pediatricians and primary care physicians, in contrast to older age groups. But the recording is expected to be low; Children aged 5 to 11 were eligible to be vaccinated late last year, but only around 37 percent of them have received at least one dose.

Doses are packed in hundreds to reach smaller practices and rural locations. The Biden administration has also announced a network of other places that will work to reach families, including pharmacies and children’s hospitals, while groups such as the Association of Children’s Museums and the National Diaper Bank Network will help with educational efforts.

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

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

Dr. James EK Hildreth, a committee member and president of Meharry Medical College in Nashville, noted that many children had been infected “and were doing well.”

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

Emily Erdos contributed with reporting.

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