WASHINGTON – The only Americans who are not yet eligible for coronavirus vaccines – children, infants and kindergartens – are finally on the verge of receiving the Food and Drug Administration on Wednesday by an advisory panel authorized to recommend Pfizer and Moderna vaccines. for the group.
The FDA seems ready to allow the Modern vaccine for children under 6 and Pfizer for children under 5 as soon as Friday. States have already ordered millions of doses, and White House officials say the shooting could take place from next week.
The Commission’s 21-0 vote came after a full-day analysis of clinical trial data and marked the end of a process that for months had led to false starts and the loss of hope for a vaccine to cover younger Americans. With the exception of about 20 million children under the age of 5, all of them have had coronary artery disease for many months and are now eligible for boosters.
The FDA and the Centers for Disease Control and Prevention jointly pushed for a positive recommendation, saying the vaccines were safe and had a strong immune response in children, the 230-page data said. Regulators also stressed that although young children are generally at low risk for serious illnesses with the virus, the group’s vaccines would save lives.
“We need to be careful not to be fooled by the number of pediatric deaths because of the sheer number of older deaths here,” Dr. Peter Marks, the FDA’s chief vaccine regulator, said. “The intervention we’re talking about here is something we’ve accepted in the past to try to prevent flu deaths,” he added.
CDC officials said more than half of the young children hospitalized with Covid had no underlying medical condition. During the winter on the Omicron wave, young children were hospitalized at a higher rate than older children and adolescents, and their illness was usually at least as severe. More than 200 children between the ages of 6 months and 4 years have died as a result of Covid, according to death certificate data, one of the most conservative estimates.
Panel members, some of whom have treated hospitalized children for Covida and consoled the frightened parents, seemed eager to act.
“There are a lot of parents who are completely desperate to get this vaccine,” 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 it a try.”
Dr. Arthur Reingold, an epidemiologist at the University of California, Berkeley, School of Public Health, said the nation is already vaccinating children against the disease, “when the risk of killing or hospitalizing a child for these diseases is close to zero.”
The CDC Vaccine Expert Panel will take up the topic over two days this weekend. If this committee also makes a favorable recommendation, Dr. Agency Director Rochelle P. Walensky would give her decision, the final step in the process.
No vaccine has been tested against new subtypes circulating in the United States. Clinical trials were largely conducted when the Omicron variant predominated. Two sub-variants, BA.4 and BA.5, could become dominant in a month.
The virus is evolving so fast that some team members expressed fear that the results of the clinical trials on which their decisions were based were already obsolete. “We’re trying to predict the future,” Dr. Paul Offit, a vaccination expert at Children’s Hospital Philadelphia and an FDA panelist, said in an interview. “This is a problem.”
But the panel’s biggest concern was whether Pfizer’s three-dose vaccine, which BioNTech developed with its German partners, was effective enough. Pfizer reported that only about 28 percent of its two vaccine doses were effective in preventing symptomatic disease; Dr. Susan Wollersheim, an FDA reviewer, said the company’s data did not make it clear that two doses reduced the incidence of Covid.
Pfizer argued that the three doses were 80 percent effective, but the finding was based on only 10 cases in a subset of 1,678 test participants. And Dr. Doran Fink, the acting director of the FDA’s immunization office, questioned the company’s estimate, describing it as “unpredictable” and “inaccurate.”
However, he said the FDA was “very confident” that Pfizer’s vaccine, like Modern’s, met the criteria for granting emergency permits, as the benefits outweigh the risks. But some members of the panel were clearly concerned that their parents might be mistaken.
Dr. Amanda Cohn, a CDC official and member of the panel, said she had “no idea” what the effectiveness rate would be after three doses of Pfizer, and officials did not have to accept the 80 percent estimate.
Jeannette Y. Lee, a biostatistician in the medical sciences at the University of Arkansas, raised another concern that some parents may skip the decisive third dose for their children. “As far as we know, it’s a struggle to get people into two people,” he said.
Pfizer officials said the data showed the effectiveness of the vaccine built over time. “It’s not as if it’s ineffective,” Dr. William C. Gruber, vice president of Pfizer, said.
For some parents, the bar is low. More than 1,600 parents who responded to a New York Times question about life with an unvaccinated child said they would accept any effectiveness above zero in protecting their children.
“To protect yourself from illness and possible death or life-threatening difficulties? Why is this a question?” “We’ve waited so long to protect our whole family. I’ve almost lost my job and tried to save myself,” wrote Cayla Miller of Swanville, Maine.
Scientists and federal officials have been warned to compare Moderna and Pfizer vaccines directly. Not only did the companies conduct clinical trials at different times, but with different populations, the dosage and regimens differed.
Pfizer has proposed a three-dose regimen in one-tenth of the strength of the adult dose, with the first two doses divided into three weeks and the third at least two months after the second. Modern wants to offer two doses of vaccine, for four weeks, at a quarter of the strength of the adult dose. The adult dose of modern is significantly higher than that of Pfizer.
Dr. The FDA’s Wollersheim declined to respond when asked by a panelist to compare the effectiveness of vaccines in young children. But as some parents may have done, some members of the panel tried to reunite.
Dr. Offit noted that Modern’s efficacy data were slightly stronger than Pfizer’s: 51 percent effective in preventing symptomatic infection in children 6 to 2 months of age and 37 percent effective in children 2 to 5 years of age.
Although protection against symptomatic infection was limited, he said it was possible to predict that the Modern vaccine would ward off serious illness.
“I’m not so sure you can predict that with the Pfizer vaccine,” he said. “I’m afraid they may have low doses.”
Both vaccines resulted in levels of antibody neutralization or virus blocking that were comparable to those of young adults among children. Pfizer’s vaccine has been allowed for children between the ages of 5 and 15 since last year, regulators said it helped prevent hospitalization and death.
However, both appear to be much more effective against symptomatic infection than adult vaccines when they were introduced 18 months ago. The FDA said Omicron was much more adept at defending against vaccine infections than previous versions of the virus.
Proven that power is declining over time, FD.A. he said small children receiving Pfizer and Moderna shots will likely need booster shots, as will the main recipients. This would mean that Pfizer’s vaccine can end up with four doses, while Modern’s can be three doses.
The vaccines did not cause any serious safety concerns. Most of the side effects were mild: irritability and crying, loss of sleep, fatigue and hunger. Modern vaccine recipients were more likely to have a fever, but in line with those caused by other pediatric vaccines, the FDA said.
Federal health officials say many children under the age of 5 are expected to be vaccinated by pediatricians and primary care physicians, in contrast to older age groups. But adoption is projected to be low; Children between the ages of 5 and 11 were vaccinated late last year, but only about 37% of them have received at least one dose.
Hundreds of doses are packaged to reach smaller practices and rural locations. The Biden administration has also announced a network of other locations that would work to reach out to families, including pharmacies and children’s hospitals, and groups such as the Children’s Museum Association and the National Diaper Bank Network will support educational efforts.
One of the topics discussed by FDA panel members was how many of these parents have acquired natural immunity. Federal health officials have released data to the commission this week, suggesting more than two-thirds of children between the ages of 1 and 4 are already infected with the virus.
A modern official told the company that they had found a virus commission at the company’s trial and that they had found it in small children who had been vaccinated with a higher level of protection, a conclusion backed by outside research.
Dr. James EK Hildreth, a board member and chair of Meharry Medical College in Nashville, said many of the children were infected “and did well.”
“But for parents who choose to do so, especially for parents of children with underlying conditions,” he added, “this is an opportunity they should have.”
Emily Erdos accompanied by reports.