WASHINGTON – Only Americans are not yet eligible for the coronavirus vaccine – children, toddlers and preschoolers – after a Food and Drug Administration advisory panel voted unanimously Wednesday to recommend the Pfizer and modern vaccines, finally approving them. For the team.
The FDA is expected to approve the Moderna vaccine for children under 6 and Pfizer for children under 5 by Friday. States have already ordered millions of doses, and White House officials say the shots could roll out early next week.
The committee’s 21-0 vote came after a day-long review of clinical trial data and signaled the end of a process that began a few months later and shattered hopes of a vaccine to cover the youngest Americans. With the exception of about 20 million children under the age of 5, everyone has had access to coronavirus shots for many months and is now eligible for booster shots.
The FDA and the Center for Disease Control and Prevention jointly pushed for a positive recommendation, raining down on the committee 230 pages of data they said vaccines were safe and stimulating a strong immune system in children. Regulators further stressed that although young children are generally at risk of serious illness from the virus, vaccinating the group could save lives.
“We need to be careful that we do not become overwhelmed with the number of pediatric deaths due to the overwhelming number of adult deaths here,” said Dr. Peter Marks, the FDA’s top vaccine regulator. “The intervention we are talking about here is something we have taken in the past to try to prevent deaths from influenza,” he added.
CDC officials say more than half of the children admitted to the hospital with Kovid have no underlying treatment. During the Omicron waves in the winter, young children were hospitalized at a higher rate than older children and adolescents, and their illness was at least as severe. More than 200 children between the ages of 6 months and 4 years have died of covid, one of the most conservative estimates, according to the death certificate.
The panel members, some of whom have treated hospitalized children for covid and comforted panicked parents, seemed keen to act.
“There are many parents who are desperate to get this vaccine,” said Dr. J. Portnoy, a professor of pediatrics at Missouri-Kansas City Medical School. “I think we owe them a debt of gratitude.”
Dr. Arthur Ringold, an epidemiologist at the University of California, Berkeley, School of Public Health, said the nation was already vaccinating children against the disease “where the risk of a child dying or being hospitalized was close to zero.”
The CDC’s own panel of vaccine experts will take up the matter within two days this weekend. If that committee also makes a favorable recommendation, Dr. Rochelle P. Walensky, the agency’s director, will issue his decision, the final step in the process.
No vaccines have been tested against the new submarines released in the United States. Clinical trials were conducted primarily when the Omicron variant prevailed. Two variants, BA.4 and BA.5, can become effective within a month.
The virus is evolving so rapidly that some panelists have expressed concern that the results of clinical trials based on them are already outdated. “We’re really trying to predict the future,” said Drs. Paul Offitt said in an interview “That’s a problem.”
But the panel’s biggest concern is whether Pfizer’s three-dose vaccine, which it developed with its German partner, BioNTech, was effective enough. Pfizer reported that two doses of its vaccine were about 28 percent effective in preventing significant diseases; Dr. Susan Olarsheim, an FDA reviewer, said the company’s data did not clearly show that two doses reduced the incidence of covid.
Pfizer argued that the three doses were 80 percent effective, but the investigation was based on only 10 cases out of a subset of 1,678 trial participants. And Dr. Doran Fink, acting deputy director of the FDA’s vaccine office, expressed skepticism, describing the company’s estimates as “preliminary” and “incomplete.”
Nevertheless, he said he was “very confident” from the FDA’s Immune Response Data that Pfizer’s vaccine, like Modern, met the criteria for approval of emergency use, for which the benefits outweighed the risks. But some members of the panel were clearly concerned that parents might be misled.
Dr Amanda Cohen, a top CDC official and panel member, said there was “no idea” what the efficacy rate would be after three doses of Pfizer and that officials should not accept 80 percent estimates.
Janet Y. Lee, a biostatist at the University of Arkansas for Medical Sciences, raises another concern: Some parents may miss the important third dose for their children. “As far as we know, it’s a struggle to bring people together for two,” he said.
Pfizer officials said the data showed the effectiveness of vaccines made over time. Dr. William C., a senior vice president at Pfizer. “It’s not that it doesn’t work,” Gruber said.
For some parents, the bar is low. Of the more than 1,600 parents who answered the New York Times question about the life of an immunized child, they said they would take any action above zero to give their children some protection.
“To keep him safe from illness and potential death or lifelong suffering? Why is that a question?” “We’ve been waiting so long to save our whole family. I’ve almost lost my job and I’m trying to keep her safe,” wrote Kela Miller, a mother in Swanville, Maine.
Scientists and federal officials have warned against direct comparisons with the Moderna and Pfizer vaccines. Companies have not only conducted their clinical trials at different times, with different populations, but also at different doses and regulations.
Pfizer has proposed a three-dose rule of one-tenth of the strength of its adult doses, with the first two doses at three-week intervals and the third at least two months later. Moderna wants to give two doses of the vaccine at four-week intervals, one-fourth of its adult dose. Moderna’s adult dose is significantly stronger than Pfizer’s.
When a panelist asked to compare the effectiveness of the vaccine among young children, Dr. Olarsheim of the FDA declined to answer. But as some parents can do, some panel members have tried to make their own matchup.
Dr. Affitt noted that Moderna’s efficacy data were somewhat stronger than Pfizer’s: about 51 percent effective in preventing significant infections in children 6 months to 2 years old and 37 percent effective in children 2 to 5 years old.
Although protection against notable infections was limited, he said, it was possible to predict that the modern vaccine would protect against serious diseases.
“I’m not so sure you can predict this with the Pfizer vaccine,” he said. “I’m afraid they lowered the dose.”
Both vaccines stimulate antibody levels, which are neutral, or virus-blocking, in children compared to younger adults. The Pfizer vaccine has been approved for children ages 5 to 15 since last year, and regulators say it has helped prevent hospitalization and death.
Nevertheless, both appear to be significantly less effective against significant infections than adult vaccines 18 months ago. The FDA says the vaccine has proven to be much more efficient at defending against infections than previous versions of the Omicron virus.
There has been evidence of a decline in power over time, the F.D.A. Says younger kids who get Pfizer and Moderna shots will probably need booster shots, just like older recipients do. This means that the Pfizer vaccine can last up to four doses, whereas Modern can have three doses.
None of the vaccines raised serious security concerns. Most of the side effects were mild – nausea and crying, drowsiness, fatigue and loss of appetite. Vaccine recipients of Moderna were more likely to have a fever, but were more likely to be provoked by other pediatric vaccines, the FDA said.
Federal health officials say they expect many children under the age of 5 to be vaccinated by pediatricians and primary care physicians, in contrast to the older age group. But the uptake is expected to be low; Children aged 5 to 11 became eligible for the vaccine late last year, but only 37 percent of them received at least one dose.
Doses are packaged by hundreds to reach small habitations and rural locations. The Biden administration has also advertised a network of other locations 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 support educational efforts.
One topic of discussion among FDA panel members was how to address many parents whose children have already acquired some natural immunity. Federal health officials presented information to the committee this week that suggested that more than two-thirds of children between the ages of 1 and 4 were already infected with the virus.
An official at Moderner told the committee that the company’s trials had shown that young children who had received the virus and had been vaccinated had a higher level of protection, a conclusion supported by outside research.
Committee member and president of Nashville Meheri Medical College. James Ike Hildreth noted that many children were infected “and they did.”
“But for those parents who like to do it, especially for parents of children with underlying conditions,” he added, “it should be theirs.”
Emily Erdos Contributing Reporting.