FDA next week will consider authorizing Pfizer-BioNTech's Covid-19 vaccine for children under 5 years old —even as clinical trials on the shot's efficacy and safety in this age group are ongoing.

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FDA will consider authorizing Covid-19 vaccines for young children

FDA last week asked Pfizer and BioNTech to submit an application for emergency use authorization (EUA) for two doses of its Covid-19 vaccine in children under the age of 5—although clinical trial data suggests that a third dose may be necessary for adequate protection.

In December, the companies announced that children between the ages of 6 months and 2 years who were given two doses of the Covid-19 vaccine at a tenth of the adult dosage saw a robust immune response, but the same response did not occur among children ages 2 to 4. As a result, Pfizer and BioNTech are currently evaluating how effective a third dose of the vaccine will be for this age group, with results expected in late March.

According to the New York Times, FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on Feb. 15 to weigh the current data on Pfizer-BioNTech's two-dose vaccine regimen for children under 5, which will be released later today.

Increase in infections among kids drives FDA review

According to FDA spokesperson Abby Capobianco, the agency's decision to evaluate the vaccine's authorization without complete clinical trial data was influenced by the recent increase in infections and hospitalizations among children in this age group.

Data from the American Academy of Pediatrics shows that children accounted for almost 23% of new Covid-19 cases and made up between 1.6% and 4.4% of all Covid-19 hospitalizations at the end of January.

"We are also concerned by the notable increase in reports of children experiencing Covid-19 long haul symptoms, including in some cases children developing autoimmune diseases and Type 1 diabetes after having had Covid-19," said Stephanie Caccomo, a spokesperson for FDA.

In addition, some parents are eager to start vaccinating their children. Paul Offit, a vaccine expert at Children's Hospital of Philadelphia and VRBPAC member, said, "They want us to have the option of giving parents the choice to do this, pending the third dose … It's unheard of, but then again, the pandemic is novel."

Separately, a person familiar with FDA's decision said the EUA application is aimed at getting children two shots for now, with a possible third dose later.

"We know that two doses [aren’t] enough, and we get that," the person said. "The idea is, let's go ahead and start the review of two doses. If the data holds up in the submission, you could start kids on their primary baseline months earlier than if you don't do anything until third-dose data comes in."

Some health experts voice concern

Several health experts have expressed alarm about FDA's current authorization plan, arguing that the lack of data on third doses may undermine the public's trust in vaccines and deter parents from vaccinating their children.

Natalie Dean, a biostatistician at Emory University, said, "On one side, parents are desperate to get their kids protected. On another side, there is extreme distrust … The whole process will need to be approached with care and a lot of transparency."

Separately, Angela Rasmussen, a virologist at the Vaccine and Infectious Disease Organization at the University of Saskatchewan, agreed. She noted that any regulatory missteps during the authorization process could be used to discredit the vaccines.

Norman Baylor, president and CEO of Biologics Consulting and a former head of FDA's Office of Vaccines, ultimately thinks authorizing two vaccine doses for children in this age group won't convince parents to vaccinate their children absent proof of effectiveness. "If the vaccine in this age cohort is a three-dose vaccine, FDA should review the data from the three-dose series before authorizing the vaccine," he said.

However, Offit said committee members will likely recommend the vaccine only if they "felt comfortable that two doses offered something significant to those children" and not just "the promise that three doses [will be] of value."

Federal officials prepare for a quick authorization and rollout

Although neither VRBPAC's recommendation nor FDA's authorization of Pfizer-BioNTech's vaccine for young children is guaranteed, federal health officials are already laying the groundwork to send states millions of doses of the vaccines in the next few weeks, CNBC reports.

According to a CDC document, the U.S. government is planning to ship out 10 million doses of the vaccines to states and other entities beginning Feb. 21, with areas where children are at highest risk for severe Covid-19 being prioritized. Second and third shipments will begin on Feb. 23 and Feb. 25 respectively.

Although the shots cannot be administered without FDA's authorization and CDC's endorsement, Jeffrey Zients, the White House Covid-19 response coordinator, said local officials can start preparing by identifying where and how the vaccine will be distributed.

"We're working closely with pediatricians and family doctors and children's hospitals and pharmacies to make sure the vaccine is available at thousands of locations across the country, locations that parents know and trust," Zients said. (Mandavilli, New York Times, 2/9; Branswell, STAT News, 2/2; Irfan, Vox, 2/3; Wu, The Atlantic, 2/2; Owens, Axios, 2/7; Fiore, MedPage Today, 2/3; Jarvis, Washington Post, 2/7; Kimball, CNBC, 2/9; Reuters, 2/9)