FDA panel recommends Pfizer and Moderna vaccines for youngest children

WASHINGTON – The only Americans still ineligible for the coronavirus vaccine – infants, toddlers and preschoolers – appear to have finally been approved to receive them after an advisory panel for The Food and Drug Administration voted unanimously on Wednesday to recommend the Pfizer and Moderna vaccines to the group.

The FDA appears to be getting ready to authorize Moderna’s vaccine for children under 6 years of age and Pfizer’s vaccine for children under 5 years old as soon as Friday. Countries have ordered millions of doses, and White House officials say the shots could be rolled out as early as next week.

The committee’s 21-0 vote came after a day-long review of clinical trial data and signaled the end of a months-long process that falsely started and dashed hopes for a future. a vaccine that could cover the youngest Americans. With the exception of about 20 million children under the age of 5, everyone has been vaccinated against coronavirus for many months and is now eligible for a booster shot.

The FDA and the Centers for Disease Control and Prevention together strongly pushed for a positive recommendation, providing the committee with 230 pages of data that they believe the vaccine is safe and stimulates a strong immune response. strong in children. Regulators also stress that although young children are generally at low risk of serious illnesses caused by the virus, vaccination of this group will save many lives.

“We have to be careful not to become crippled in terms of child deaths because of the larger number of deaths here,” said Dr Peter Marks, the FDA’s top vaccine regulator. . He added: “The intervention we are talking about here is one that we have adopted in the past to try to prevent deaths from influenza.

Officials from the CDC say more than half of the young children hospitalized for Covid do not have an underlying medical condition. During winter Omicrons, younger children are more likely to be hospitalized than older children and adolescents, and their illnesses tend to be at least more 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 jurors, some of whom have treated children hospitalized for Covid and have comforted frightened parents, seemed eager to act.

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

Dr. Arthur Reingold, an epidemiologist at the University of California, Berkeley, School of Public Health, said the nation has vaccinated children against the disease “when there is a high risk of the child dying or being hospitalized for diseases that cause disease.” It’s almost zero.”

The CDC’s Vaccine Expert Panel will address the issue over two days later this week. If that committee also makes a favorable recommendation, Dr. Rochelle P. Walensky, the agency’s director, will make its decision, the final step in the process.

Neither vaccine has been tested against the new sub-variants circulating in the United States. Clinical trials are mainly conducted when the Omicron variant predominates. Two sub-variables, BA.4 and BA.5, could become dominant within a month.

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

But the panel’s biggest worry seems to be whether Pfizer’s three-dose vaccine, developed in conjunction with German partner BioNTech, will be effective enough. Pfizer reported that two doses of their vaccine were only about 28% effective at preventing symptomatic disease; Susan Wollersheim, FDA reviewer, said the company’s data does not clearly show that two doses of the drug reduced the incidence of Covid.

Pfizer argued that three doses were 80% effective, but the finding was based on only 10 cases out of 1,678 trial participants. And Dr. Doran Fink, acting deputy director of the FDA’s vaccine office, cast doubt on the company’s estimate, describing it as “preliminary” and “inaccurate.”

However, he said the FDA is “very confident” from immune response data that Pfizer’s vaccine, like Moderna’s, meets the criteria for an emergency use authorization, where the benefits outweigh the risks. . But some jurors were clearly worried that parents might be misled.

Dr. Amanda Cohn, a top CDC official and panel member, said she doesn’t have “any idea” about what the effectiveness rate after the last three doses of Pfizer will be, and officials should not hold the estimate of 80%.

Jeannette Y. Lee, a biostatistician at the University of Arkansas for Medical Sciences, raises another concern: that some parents may skip an important third dose for their child. “As we all know, it’s hard to get two people involved,” she said.

Pfizer officials said the data shows the vaccine’s effectiveness builds over time. Dr. William C. Gruber, senior vice president at Pfizer, said: “It’s not without effect.

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

“To keep her safe from potential illness and death or lifelong hardship? Why is this a question? ” wrote Cayla Miller, a mother in Swanville, Maine. “We have waited a long time to protect our whole family. I almost lost my job and my mind was trying to keep her safe.”

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

Pfizer recommended a three-dose regimen at one-tenth the adult dose, with the first two doses three weeks apart and the third dose at least two months after the second dose. Moderna wants to deliver two doses of the vaccine, four weeks apart, at one-quarter the strength of the adult dose. The adult dose of Moderna is significantly more potent than that of Pfizer.

The FDA’s Dr Wollersheim declined to answer when a panelist asked to compare the vaccine’s effectiveness on young children. But as some parents might do, some board members have tried to make their own match.

Offit notes that the efficacy data for Moderna are somewhat stronger than that of Pfizer: about 51% effective in preventing symptomatic infections in children 6 months to 2 years of age, and 37% effective in children from 2 to 5.

While its ability to protect against symptomatic infection is limited, he said, it can be expected that Moderna’s vaccine will prevent severe illness.

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

Both vaccines produced levels of antibodies that neutralized or suppressed the virus in children comparable to those in young adults. Pfizer’s vaccine has been approved for use in children ages 5 to 15 since last year, and regulators say it has helped prevent hospitalizations and deaths.

However, both appear to be significantly less effective at fighting symptomatic infections than the adult vaccines when they were introduced 18 months ago. The FDA attributed that to the fact that Omicron was far more adept at evading the vaccine’s defenses against infection than earlier versions of the virus.

Given evidence of potency waning over time, the FD.A. said that young children receiving Pfizer and Moderna injections will likely require additional injections, just like older people. That means Pfizer’s vaccine could have four doses, while Moderna’s could have three.

Neither vaccine poses serious safety concerns. The majority of side effects are mild – irritability and irritability, drowsiness, fatigue and loss of appetite. People who received Moderna’s vaccine appeared to be more likely to develop a fever, but consistent with the manifestations of other childhood vaccines, the FDA said.

Federal health officials say they expect more children under the age of 5 to be vaccinated by pediatricians and primary care physicians, as opposed to older age groups. But absorption is expected to be low; Children aged 5 to 11 were eligible to be vaccinated late last year, but only about 37% of them had received at least one dose.

Dosages are packaged in hundreds to reach smaller practices and rural locations. The Biden administration has also touted a network of other locations that could work to reach families, including pharmacies and children’s hospitals, while groups like the Children’s Museum Association and the Children’s Museum Network The National Diaper Bank will help in education efforts.

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

A Moderna official told the committee that the company’s testing found that young children who had contracted the virus and were vaccinated had a higher degree of protection, a conclusion supported by outside research.

Dr James EK Hildreth, a committee member and president of the Meharry Medical College in Nashville, noted that many children have been infected “and have done a great job”.

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

Emily Erdos contribution report.

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