Pfizer, BioNTech Ask US FDA to Clear Updated COVID-19 Vaccine for Babies and Toddlers

Pfizer CEO Albert Bourla in Davos on May 25, 2022. (Fabrice Coffrini/AFP via Getty Images)

Pfizer and its German partner have asked U.S. regulators to clear their updated COVID-19 vaccine for children as young as 6 months of age, the companies announced on Dec. 5.

The companies want emergency clearance for the administration of the new shot as a third dose to children aged 6 months to 4 years.

People above 4 are currently able to receive the updated vaccine as a booster.

The new vaccine contains components of both the Wuhan virus strain and the BA.4/BA.5 subvariants of the Omicron strain. The old vaccine features only the Wuhan variant, which has not been in circulation since 2020.

The application for emergency use authorization (EUA), lodged with the U.S. Food and Drug Administration (FDA), is for a 3-microgram dose. The dose would be the third in what is described as a three-dose primary series. Pfizer added a third dose to its primary regimen for young children after two doses failed to trigger an adequate immune response. The primary series for all ages above 5 is two doses, with additional doses being called booster doses.

“With the high level of respiratory illnesses currently circulating among children under 5 years of age, updated COVID-19 vaccines may help prevent severe illness and hospitalization,” Pfizer and BioNTech said in a statement.

There is no clinical evidence to support that claim.

The FDA did not respond to a request for comment.

The regulatory agency on Aug. 31 authorized the Omicron bivalent as a booster for people aged 12 and older. It expanded the emergency authorization to children as young as 5 on Oct. 12.

Neither move was based on clinical data. Instead, the agency cited preclinical data—testing on mice—and data from a different bivalent that is not and has never been administered in the United States.

“The FDA considers such data as relevant and supportive of vaccines containing a component of the omicron variant BA.4 and BA.5 lineages,” the agency said in a previous statement.

The data from the BA.1/Wuhan bivalent showed that it triggered a better immune response than the old vaccine did as a fourth shot, or second booster. The data was only from participants above the age of 55 and did not include efficacy estimates.

The preclinical testing in mice also found a jump in neutralizing antibodies, thought to be a marker of protection against COVID-19 when compared to the levels triggered by the old vaccine.

An updated version of Moderna’s COVID-19 vaccine is currently available for children as young as 6. The company has not yet asked for an EUA for the updated shot for young children. Both the Pfizer and Moderna vaccines are built on messenger RNA (mRNA) technology.

The only effectiveness data on the updated vaccines come from the U.S. Centers for Disease Control and Prevention (CDC). The agency found the updated shots improve protection against symptomatic infection but that the protection is at or below 50 percent.

A healthcare worker prepares Pfizer COVID-19 vaccine doses in Portland, Ore., in a file photograph. (Nathan Howard/Getty Images)

Expert Says FDA Shouldn’t Authorize

The authorization of the old vaccines for young children drew strong pushback, as children face little risk from COVID-19 and the efficacy estimates were substandard or unreliable. Some experts also questioned clearing the new shots in light of the lack of clinical data.

Dr. Harvey Risch, a professor emeritus of epidemiology at the Yale School of Public Health, said that the vaccines should not have been authorized for young children and that the FDA should not grant the new request.

“The FDA should never have approved the mRNA vaccines for general use in this age group in the first place. The FDA should not now approve the updated vaccine for general use here either,” Risch told The Epoch Times in an email.

Multiple countries have approved updated COVID-19 vaccines that target the BA.1 subvariant in addition to the Wuhan strain, but U.S. regulators asked vaccine makers to quickly switch the BA.1 component to a BA.4/BA.5 component. The justification was those subvariants were becoming more dominant in the United States.

Two other strains, BQ.1 and BQ1.1., are increasingly edging out BA.4 and BA.5. The former combined to represent 35.3 percent of the cases in the country as of Nov. 12, compared to 46.7 percent, according to CDC data. Based on modeling, the agency projects BQ.1 and BQ1.1 as jumping to 62.8 percent as of Dec. 3, and the others dropping to just 13.8 percent.

Risch had warned previously that the strains would change, which he said would render the new booster outdated.

CDC

The CDC said in a recent operational planning guide (pdf) that the bivalent vaccine would be available for young children in December, pending FDA authorization.

“At this time, it is expected that children in these age groups will be required to receive two doses of monovalent COVID-19 vaccine before receiving a dose of bivalent COVID-19 vaccine,” the agency said.

The CDC also said that children who received three doses of Pfizer’s old vaccine would likely not be able to get a dose of the updated shot.