Disclosures: Creech was a principal investigator for Moderna's KidCove study. Gottlieb is a board member for Pfizer. Beers and Romero report no relevant financial disclosures.
September 01, 2021
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Young children could have access to COVID-19 vaccines by early winter

Disclosures: Creech was a principal investigator for Moderna's KidCove study. Gottlieb is a board member for Pfizer. Beers and Romero report no relevant financial disclosures.
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With the delta variant threatening children as they return to school, a COVID-19 vaccine for kids aged younger than 12 years could be approved by December, according to several experts.

The AAP has ramped up efforts to convince parents to vaccinate eligible children, including through a CDC-backed advertising campaign, but it also has discouraged providers from administering the Pfizer-BioNTech vaccine off-label to children aged younger than 12 years since it won full approval last week.

Source: Adobe Stock
Experts estimate that vaccines for children aged younger than 12 years could be approved by December. Source: Adobe Stock.

In an interview on ABC’s Face the Nation this past Sunday, former FDA commissioner Scott Gottlieb, MD, a member of the Pfizer board of directors, said Pfizer “would be in a position to file data” from ongoing trials of the vaccine in young children “at some point in September,” and to file a formal application as early as October.

Scott Gottlieb

“That'll put us on a time frame where the vaccine could be available at some point late fall, more likely early winter, depending on how long FDA takes to review the application,” Gottlieb said. “Historically they've taken 4 to 6 weeks to review these authorizations.”

C. Buddy Creech, MD, MPH, an associate professor of pediatrics at Vanderbilt University School of Medicine and director of the school’s Vaccine Research Program, agreed with that rough timeline in an interview with Healio, and suggested that Moderna would have data for its vaccine around the same time.

C. Buddy Creech

“There are a lot of things that have to line up in order for that to happen,” said Creech, an Infectious Diseases in Children Editorial Board Member, adding that because Pfizer began its studies a little earlier and the dosing interval is a week shorter, “that gives them a little bit of a time advantage” to get the vaccine authorized in younger children.

“I think the question will simply be, Will they have sufficient data to have confidence that they have the exact right dose?” Creech said. “I think all indications are that they will. But at the same time, we also have other companies like Moderna that are also doing these studies, and these data will be rolling out around the same time, I hope.”

It’s crucial, though, that the process is not rushed, said Arkansas health secretary José R. Romero, MD, who until recently was chair of the CDC’s Advisory Committee on Immunization Practices.

José Romero

“It's important that we not rush this this process because there is already significant hesitancy for use of vaccine in our country, and it's getting worse,” said Romero, an Infectious Diseases in Children Editorial Board Member. “If we do anything that undermines that, that leaves the public to doubt that these vaccines are not being evaluated appropriately, it opens the door for more loss of confidence and distrust in the vaccine system.”

In an Aug. 5 letter, AAP President Lee Savio Beers, MD, urged acting FDA acting Commissioner Janet Woodcock, MD, “to continue working aggressively toward authorizing safe and effective COVID-19 vaccines for children under age 12 as soon as possible” in light of data showing that cases among children had nearly doubled in the previous week.

“Simply stated, the delta variant has created a new and pressing risk to children and adolescents across this country, as it has also done for unvaccinated adults,” Beers wrote.

Beers asked Woodcock to consider accepting 2-month safety follow-up data for clinical trial participants rather than 6-month follow-up data in order to facilitate a faster authorization.

“Assuming that the 2-month safety data [do] not raise any new safety concerns and that immunogenicity data are supportive of use, we believe that this is sufficient for authorization in this and any other age group,” Beers wrote. “Waiting on a 6-month follow-up will significantly hinder the ability to reduce the spread of the hyperinfectious COVID-19 delta variant among this age group because it would add 4 additional months before an authorization decision can be considered.

“Based on the evidence from the over 340 million doses of COVID-19 [vaccine] administered to adults and adolescents aged 12 to17, as well as among adults 18 and older, there is no biological plausibility for serious adverse immunological or inflammatory events to occur more than 2 months after COVID-19 vaccine administration.”

Creech said clinical studies take additional time to identify the proper dose to get the right immune response with the fewest side effects.

“I think the other piece of that is that we're spending a lot of time thinking about the side effect profiles that might be unique to children, such as multisystem inflammatory syndrome, or things like myocarditis,” Creech said. “And those studies that are underway are designed with those special side effects in mind, so that we can give parents a lot of confidence when the vaccine is recommended to that age group.”

According to the AAP, after declining in early summer, pediatric cases of COVID-19 have increased exponentially, with a more than fivefold increase in the past month, rising from about 38,000 cases during the week ending July 22 to nearly 204,000 during the week ending Aug. 26. COVID-19 has sent more than 19,000 children to the hospital.

References:

AAP. Children and COVID-19: State-level data report. https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/children-and-covid-19-state-level-data-report/. Accessed August 31, 2021.

Beers, LS. Letter to Commissioner Woodcock. August 5, 2021.

Gottlieb, S. Face the Nation. August 29, 2021.