Washington — the only American not yet qualified for the corona virus vaccine — babies, toddlers, preschoolers — unanimously voted Wednesday by the Food and Drug Administration’s advisory board to recommend the Pfizer and Moderna vaccines. Later, for a group that will eventually appear on the verge of being allowed to receive them.
The FDA appears ready to approve the Moderna vaccine for children under the age of 6 and the Pfizer vaccine for children under the age of 5 as soon as Friday. The state has already ordered millions of doses, and White House officials say the shot could be rolled out as early as next week.
The Commission’s 21-0 vote, which took place after a one-day review of clinical trial data, ended a process that shattered expectations for a vaccine that would cover the youngest Americans with a false start for months. Shown. Everyone has been accessing Coronavirus Shots for months and is eligible for Booster Shots, with the exception of about 20 million children under the age of five.
The FDA and the Centers for Disease Control and Prevention jointly urged positive recommendations and exposed the committee to 230 pages of data they said showed that the vaccine was safe and elicited a strong immune response in children. .. Regulators also emphasized that babies can save lives by vaccination of groups, even though infants are generally at low risk of serious viral illness.
“Here we need to be careful not to be insensitive to child deaths due to the overwhelming number of elderly deaths,” said Dr. Peter Markes, FDA’s premier vaccine regulator. increase. “The intervention we’re talking about is something we’ve accepted in the past to prevent death from the flu,” he added.
CDC officials said more than half of the infants admitted to Covid had no underlying medical condition. During the winter Omicron wave, infants were hospitalized at a higher rate than older children and adolescents, and their illness tended to be at least as severe. More than 200 children between the ages of 6 months and 4 have died from Covid, according to data from one of the most conservative estimates, the death certificate.
Panel members who treated hospitalized children for Covid and comforted their feared parents appeared to be enthusiastic about their actions.
Dr. Jay Portnoy, a professor of pediatrics at the University of Missouri, Kansas City Medical College, said: “I think we have a duty to give them choices.”
“There was almost no risk of a child dying or being hospitalized for these illnesses,” said Dr. Arthur Raingold, an epidemiologist at the Department of Public Health at the University of California, Berkeley. He said he was inoculating.
The CDC’s own panel of vaccine experts will address this issue for two days this weekend. If the committee also makes favorable recommendations, the director of the institution, Dr. Rochelle P. Wallensky, will make her decision at the final stage of the process.
Neither vaccine has been tested against new submutants that are endemic in the United States. Clinical trials were conducted primarily when Omicron variants became widespread. Two subvariants, BA.4 and BA.5, can become dominant within a month.
The virus is evolving so rapidly that some panelists have expressed fear that the results of the clinical trials that underpin their decisions are already out of date. “We are really trying to predict the future,” Dr. Paul Offit, a vaccine expert and FDA panelist at the Philadelphia Children’s Hospital, said in an interview. “This is a problem.”
However, the panel’s biggest concern seemed to be whether Pfizer’s triple-dose vaccine, developed in collaboration with German partner BioNTech, was sufficiently effective. Pfizer reports that two doses of the vaccine were only about 28% effective in preventing symptomatic treatment. FDA reviewer Dr. Susan Wallersheim said the company’s data do not clearly show that the two doses reduced the incidence of Covid.
Pfizer claimed that three doses were 80% effective, but the finding was based on only 10 of a subset of the 1,678 study participants. Dr. Doran Fink, deputy director of the FDA’s Vaccine Department, questioned the company’s estimates and said they were “provisional” and “inaccurate.”
Still, the FDA said from immune response data that it was “extremely confident” that Pfizer vaccines like Modana meet the criteria for emergency use authorization. However, some panel members were clearly worried that their parents might be misunderstood.
Dr. Amanda Korn, CDC Chief Executive Officer and Panel Member, said he was “not thinking” about what the efficacy rate would be after three doses of Pfizer, and authorities should not accept an 80% estimate. Said.
Jeannette Y. Lee, a biostatistician at the University of Arkansas Medical School, raised another concern. Some parents may skip the third dose, which is important for their child. “As we know, it’s hard to get people together,” she said.
Pfizer officials said the data showed that vaccine efficacy was built up over time. Dr. William C. Gruber, Senior Vice President of Pfizer, said:
For some parents, the bar is low. Some of the more than 1,600 parents who answered the New York Times question about living with unvaccinated young children said they would accept more than zero effects to give their children some protection.
“To protect her from illness, potential death and lifelong difficulties? Why is this the question?” Written by Keila Miller, mother of Swanville, Maine. “We have been waiting for a long time to protect her whole family. I almost lost her job and lost her heart to keep her safe.”
Scientists and federal officials have warned against a direct comparison of Moderna and Pfizer vaccines. Not only did companies conduct clinical trials in different populations at different times, but they also had different dosing and regimens.
Pfizer proposes a three-dose regimen that is one-tenth of the adult dose, with the first two doses every three weeks and the third at least two months after the second. Moderna wants to provide two doses of vaccine at four-week intervals, one-quarter strength for adults. Adult doses in Moderna are significantly higher than those in Pfizer.
When a panelist asked for a comparison of vaccine efficacy in young children, FDA Dr. Wollersheim refused to answer. However, as some parents do, some panel members have attempted their own matches.
Dr. Ofitt stated that Modana’s efficacy data is somewhat more powerful than Pfizer’s validity data. It is about 51% effective in preventing symptomatic infections in children aged 6 months to 2 years and 37% in children aged 2 to 5 years.
Although protection against symptomatic treatment was limited, he said it was possible to predict that the Moderna vaccine would prevent serious illness.
“I don’t know if Pfizer’s vaccine can predict that,” he said. “I’m worried they may be underdose.”
Both vaccines caused levels of neutralization or virus blocking antibodies among children comparable to those of young adults. Pfizer’s vaccine has been approved for children aged 5 to 15 years since last year, and regulators say they helped prevent hospitalization and death.
Still, when introduced 18 months ago, both appear to be significantly less effective against symptomatic treatment than adult vaccines. The FDA said it was because Omicron proved to be far more proficient in evading vaccine protection against infections than previous versions of the virus.
Given the evidence that efficacy declines over time, the FD.A. Toddlers who get shots of Pfizer and Modana say they are likely to need booster shots, just like older recipients. This means that Pfizer’s vaccine can be given four times and Moderna’s vaccine can be given three times.
Neither vaccine raised serious safety concerns. Most of the side effects were mild — hypersensitivity and crying, drowsiness, malaise, loss of appetite. According to the FDA, Moderna vaccinated people are more likely to experience fever, which is consistent with those caused by other pediatric vaccines.
Federal health officials say many children under the age of five expect to be vaccinated by pediatricians and primary care physicians, as opposed to older people. However, uptake is expected to be low. Children between the ages of 5 and 11 were eligible for vaccination at the end of last year, but only about 37% received at least one vaccination.
Dosages are packaged in hundreds to reach small clinics and rural locations. The Byden administration also promotes networks of other places where it works to contact families, such as pharmacies and children’s hospitals, and groups such as the Children’s Museum Association and the National Diaper Bank Network support educational activities.
One of the topics discussed among FDA panel members was how to deal with many parents whose children already have innate immunity. Federal health officials have presented data to the Commission this week, suggesting that more than two-thirds of children aged 1 to 4 years are already infected with the virus.
A Moderna official told the committee that the company’s trial found a high level of protection for infants infected with the virus and vaccinated. External research..
Dr. James EK Hildress, a member of the committee and president of Meharry Medical College in Nashville, said many children “have done well.”
“But for parents who choose to do so, especially for parents of children with underlying conditions, this is the choice they should have,” he added.
Emily Eldos Report that contributed.
