A Covid vaccine for kids aged five to 11 just got another step closer to authorization, with Pfizer-BioNTech announcing on Twitter that the full application has been submitted to the US Food and Drug Administration (FDA).
Experts say authorization of the vaccine for children will be key to controlling the pandemic. Nearly 850,000 cases were confirmed among US children in the past four weeks, and kids still account for a disproportionate share of weekly cases.
More than 500 children in the US have died from confirmed cases of Covid-19, according to the American Academy of Pediatrics. And they have suffered particularly from the Delta variant, with 35% of all deaths coming in the past three months.
The FDA’s advisory committee, known as VRBPAC, plans to discuss the vaccine application on 26 October. If authorization is granted, shots would be expected in the following weeks.
The FDA stated to the Guardian on Thursday: “As Pfizer has announced, the company has submitted a request to FDA to amend its emergency use authorization (EUA) for the Pfizer-BioNTech Covid-19 Vaccine for the prevention of Covid-19 in children five through 11 years of age…the agency will review the EUA request as expeditiously as possible.”
But questions linger about how to administer the vaccine dose for children, which is one-third the adult dose. The doses could be diluted, or a different syringe may be used. It’s not as simple as cracking open an adult vial, since pediatric vaccines will need their own labels for tracking safety and quality. Clear guidance will need to be given soon in order to avoid delays if the vaccine is authorized.
The application for emergency use authorization is expected to contain answers to these and other questions on the vaccines’ safety and efficacy. More than 2,200 children received the vaccines in the trial, and they mounted similar levels of antibodies with a “favorable” safety profile, Pfizer announced on 20 September.
A Pfizer spokesperson told the Guardian that the full application would be shared “soon”. The FDA did not return a request for comment. “As far as I know, VRBPAC is still on track to discuss this on October 26,” said Dr Paul Offit, one of the independent advisers on vaccines for the FDA.
“We know from our vast experience with other pediatric vaccines that children are not small adults, and we will conduct a comprehensive evaluation of clinical trial data submitted in support of the safety and effectiveness of the vaccine used in a younger pediatric population, which may need a different dosage or formulation from that used in an older pediatric population or adults,” the acting FDA commissioner, Janet Woodcock, said in a statement about the meeting.
Covid vaccines for kids can’t come soon enough, said Mark Schleiss, a pediatrician and professor in the University of Minnesota Medical School. “Even one unnecessary death in a child is a tragedy,” he said. “With Covid, for reasons that I don’t fully understand, our society has been a little bit dismissive and frankly a little bit cavalier about the number of deaths that we’ve seen.
“It’s not too late to do better, we need to do better, and I think this hopefully imminent emergency use authorization for children and then formal licensure for children will help reverse that,” Schleiss said.
Pediatric illness is “climbing a lot in the US, with significant illness and death”, Dr Stanley Plotkin, professor emeritus of pediatrics at the University of Pennsylvania, told the Guardian in an email.
Preventing Covid among kids doesn’t protect only them; it also helps cut back on community transmission, Plotkin said: “I strongly support vaccination to stop illness in children but also to prevent them from being a reservoir for infection of adults.”
As many as 140,000 children lost caregivers to Covid, according to a study the medical journal Pediatrics published on Thursday, and widespread transmission is interrupting children’s education and lives. Some children are also plagued with long Covid even after mild bouts of the virus.
“When we talk about risk, it’s not just deaths,” Travis Whitfill, a pediatric research scientist in the Yale School of Medicine, told the Guardian. “That gets missed by a lot of people, but the risk is also the long-term side-effects: long Covid, these lingering problems that occur with like 30% of patients are infected with Covid.”
Myocarditis, an inflammation of the heart muscle that can lead to death, is another major concern with Covid infection – and it is much more common and severe after Covid than after the vaccine, Whitfill said.
He would like to see more follow-up data on the risk of myocarditis after vaccination compared to recovering from Covid, as well as the prevention of Covid infection after kids’ vaccination.
“I wish they had more data, but of the data that we’ve seen so far, [the vaccine is] safe, it’s effective,” Whitfill said.
The emergency authorization of vaccines for younger children could also lead to new school mandates, which have had mixed support from parents. One of the largest school districts in the country, Los Angeles Unified, announced on 9 September that all students aged 12 and up were required to get vaccinated, the first district to do so.
“I absolutely think we have to have mandates,” Schleiss said. Mandatory vaccines for school-aged children is “not a new idea”, he said. “We know that this has been safe and successful.”
In the early 1990s, the new hepatitis B vaccines were “strongly” encouraged for those at risk, but cases continued rising, he pointed out. It wasn’t until they were mandated for children at birth that new cases flattened. “That’s been fabulously successful,” he said, and the mandates quickly brought the virus “to its knees”.
“We live in a society where there is a utilitarian imperative to take care of each other. The decisions that we make, the actions that we take, impact others,” Schleiss said.