Ongoing trials have looked at the potential impact of extending vaccine use to those babies and small children. The process hasn’t been a simple one, however. Back in December 2021, for example, early data indicated that those 6 months to 4 years of age would likely need a third dose in the vaccine regimen, given less than robust responses from the initial two-dose series.
Today, Pfizer announced, it would “extend their rolling submission” for the Pfizer-BioNTech vaccine.
“The trial in children 6 months through 4 years of age is ongoing and data on the first two 3 µg doses in this age group are being shared with the FDA on an ongoing basis,” Pfizer said. “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.”
It’s the third dose which is adding the delay. “Given that the study is advancing at a rapid pace, the companies will wait for the three-dose data as Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group,” Pfizer explains. “This is also supported by recent observations of three dose booster data in several other age groups that seems to meaningfully augment neutralizing antibody levels and real world vaccine protection for omicron compared to the two-dose regimen.”
It means that, rather than having authorization for expansion to younger people within a matter of days or weeks, it’ll now be later in 2022 before that happens. Pfizer says it expects to have the three-dose protection data available sometime in early April. After that, the FDA and CDC will give their verdict on deployment.
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