COVID-19 Vaccine For Kids Under 5 Likely Available By March: Gottlieb

Former FDA Commissioner Dr. Scott Gottlieb has said that a COVID-19 vaccine for children under the age of 5 could be approved by March.

During an appearance on CBS’s “Face the Nation” on Sunday, Gottlieb said the vaccine developed by Pfizer and BioNTech for younger children could be approved by early March. However, he added that the eligibility of children aged 4 and under for the vaccine would depend on whether federal officials move forward with a two-dose regimen instead of three doses.

“Getting two doses into a child can provide baseline immunity that protects them from severe disease [and] from hospitalization,” the former FDA commissioner said.

“And I think that may be why federal health officials are rethinking this if, in fact, they decide to authorize this on the basis of two doses. It could be out much sooner, perhaps as early as early March,” he added.

Pfizer and BioNTech in mid-December switched to testing a three-dose regimen of their COVID-19 vaccine in a clinical trial of children aged 6 months to 4 years. The companies said that while their two-dose regimen produced a strong immune response in children under 2, those between the ages of 2 to 4 had lower antibody levels.

The change in the protocol means that Pfizer would not be expected to submit data until the first half of 2022.

Despite data from the trials, Gottlieb said a two-dose regimen may still be enough to prevent severe disease, hospitalizations and deaths as opposed to fully preventing an infection.

“If the goal of the vaccine is to get baseline immunity in the kids to prevent really bad outcomes, and you’re really not using the vaccine as a tool to prevent infection in the first place, two doses could do that,” Gottlieb added.

His comments come as the Omicron variant and its subvariant, dubbed “stealth Omicron,” continue to spread across the United States.

According to a joint report from the American Academy of Pediatrics and the Children’s Hospital Association, at least 1,150,543 child COVID-19 cases were reported between Jan. 13 and 20, representing 25.5% of the week’s over 4.5 million new infections.

As of Sunday, a total of 10,603,034 COVID-19 infections have been recorded in children since the beginning of the pandemic, representing 14.2% of the country’s 74,315,639 cases.