Panel endorses vaccines for youngest Americans
FDA could authorize shots as soon as Friday
The only Americans still not eligible for coronavirus vaccines — babies, toddlers and preschoolers — appear on the verge of finally getting cleared to receive them after an advisory panel to the Food and Drug Administration voted unanimously Wednesday to recommend the Pfizer and Moderna vaccines for the group.
The FDA appears poised to authorize Moderna’s vaccine for children younger than 6 and Pfizer’s for those younger than 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 21-0 votes came after a daylong review of clinical trial data and signaled the end of a process that involved months of false starts and dashed hopes for a vaccine to cover the youngest Americans. Except for the roughly 20 million children under 5, everyone has had access to coronavirus shots for many months and is eligible now for booster shots.
The FDA and the Centers for Disease Control and Prevention jointly made a strong push for a positive recommendation, showering the committee with 230 pages of data that they said showed the vaccines are safe and provoke a strong immune response in children. Regulators also emphasized that even though young children are generally at low risk for serious illness from the virus, vaccinating the group would save lives.
“We have to be careful that we don’t become numb to the number of pediatric deaths because of the overwhelming number of older deaths here,” said Dr. Peter Marks, the FDA’S top vaccine regulator. “The intervention we’re talking about here is one that is something that we have accepted in the past to try to prevent deaths from influenza,” he
added.
CDC officials said that more than half of young children hospitalized with COVID -19 had no existing medical conditions. During the omicron wave in the winter, young children 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 ages 6 months through 4 years old have died of COVID, according to death certificate data, which is one of the most conservative estimates.
The panel members, some of whom have treated hospitalized children for COVID and have comforted terrified parents, seemed eager to act.
“There are so many parents who are absolutely 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.”
The CDC’S own panel of vaccine experts is set to take up the matter over two days this weekend. If that committee also gives a favorable recommendation, Dr. Rochelle Walensky, the agency’s director, would issue her decision, the final step in the process.
Neither vaccine has been tested against new subvariants that are circulating in the United States. The clinical trials were largely conducted when the omicron variant prevailed.
“We’re really trying to predict the future,” Dr. Paul Offit, a vaccine expert with the Children’s Hospital of Philadelphia and an FDA panelist, said in an
interview. “This is a problem.”
But the panel’s biggest worry seemed to be whether Pfizer’s threedose vaccine was effective enough. Pfizer has reported that two doses of its vaccine were only about 28 percent effective in preventing symptomatic disease; Dr. Susan Wollersheim, an FDA reviewer, said the company’s data did not clearly show that two doses drove down the incidence of COVID.
Pfizer argued that three doses were 80 percent effective, but the finding was based on only 10 cases out of a subset of 1,678 trial participants. Dr. Doran Fink, a senior FDA vaccine regulator, cast doubt on the company’s estimate.
He said the FDA was “very confident” from the immune response data that Pfizer’s vaccine, like Moderna’s, met the criteria for emergency use authorization, which requires that benefits outweigh risks. But some panel members were clearly worried that parents might be misled.
Jeannette Y. Lee, a biostatistician at the University of Arkansas for Medical Sciences, raised another concern: that some parents might skip the crucial third dose for their children. “As we know, it’s a struggle to get people in for two,” she said.
Pfizer has proposed a three-dose regimen at one-tenth the strength of its adult dosage, with the first two doses spaced by three weeks and the third at least two months after the second. Moderna wants to offer two doses of vaccine, four weeks apart, at one-fourth the strength of its adult dose.