The efficacy of Pfizer and BioNTech’s two-dose vaccine against COVID-19 “declined rapidly” for children during the Omicron wave in New York, according to a new preprint study from the New York State Department of Health.
According to the study, vaccine effectiveness against infection for children ages 12-17 declined from 66% on Dec. 13, 2021 to 51% on Jan. 30, 2022. For children ages 5-11, vaccine effectiveness against infection declined from 68% to 12% during that same period.
During that period, vaccine effectiveness against hospitalization similarly declined from 85% to 73% for children ages 12-17, and from 100% to 48% for children ages 5-11. By the end of the period analyzed, the hospitalization rate for vaccinated children ages 5-11 was 3.1 per million, compared to 6 per million for unvaccinated children in that age group.
The study concludes that the efficacy of the vaccine “declined rapidly for children, particularly those 5-11 years,” during the Omicron wave.
However, while it is extremely unlikely for even an unvaccinated child to develop a severe case of COVID-19, “vaccination of children 5-11 years was protective against severe disease and is recommended. These results highlight the potential need to study alternative vaccine dosing for children and the continued importance layered protections, including mask wearing, to prevent infection and transmission.”
The news comes shortly after Pfizer and BioNTech announced that they would be postponing their application to the FDA for their COVID-19 vaccine to be approved for children ages six months to four years old.
According to Axios, the companies said they “will wait for the three-dose data” because they “believe it may provide a higher level of protection in this age group.”
“The trial in children 6 months through 4 years of age is ongoing and data on the first two … doses in this age group are being shared with the FDA on an ongoing basis,” Pfizer said in a statement.
“Cases continue to accumulate according to the study protocol and more data are being generated because rates of infection and illness remain high in children of this age, especially due to the recent Omicron surge,” the company added. “The extension allows the FDA time to receive updated data on the two and three-dose regimen, conduct a thorough evaluation of it and facilitate a robust, public discussion.”
The company is expected to release data on a third dose of the vaccine by April. As noted by The New York Times, Pfizer’s head of vaccine research has said that the company’s goal is to get approval for a three-dose vaccine regimen for children ages six months to four years old.
However, according to former FDA Commissioner Dr. Scott Gottlieb, two doses of the vaccine is sufficient to prevent severe disease in children.
“I think the decision matrix has changed around the vaccine for [ages] 6 months to 4 years old and so far as we know that the vaccine isn’t as protective at preventing infection,” Gottlieb said. “Previously, we had data showing that the childhood vaccine for 6 months to 4 years wasn’t as protective against infection as the adult vaccine.”
“That’s the reason why they pushed it out and asked for that third dose. But now, 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,” he added.