Pfizer and partner BioNTech are expected to request the Food and Drug Administration soon to authorize a coronavirus vaccine for children 6 months to 4 years of age as a two-dose regimen while they continue to study whether the three how the dose works.
According to multiple people familiar with the discussions, federal regulators are anxiously reviewing the data in the hope of possibly authorizing emergency vaccinations for young children as early as late February. If Pfizer waits for data on the three-dose regimen, the data won’t be sent out until the end of March and the vaccine may not be licensed for that age group until several weeks later, according to multiple people familiar with the situation. Figure.
Federal officials and Pfizer executives have suggested for days that an emergency application for a vaccine for the youngest children is being worked on. Scott Gottlieb, a Pfizer board member and former commissioner of the Food and Drug Administration, told CBS News on Sunday that the vaccine could be licensed as early as March. The development is the first Washington Post newspaper.
When the Omicron variant flooded the country, there was a dramatic increase in cases of the virus among children, based on The American Academy of Pediatrics, which collects state-level data. Although young children tend to fight off viruses well, some children can get very sick. Federal officials are anxious to start a vaccination program for the youngest children because studies show no safety concerns with the two doses.
Pfizer and BioNTech in mid-December announced that two doses of the vaccine, given as one-tenth the dose of an adult dose, do not produce a strong enough immune response in children 2 to 4 years of age.
https://www.nytimes.com/2022/01/31/science/pfizer-is-expected-to-ask-the-fda-to-authorize-its-covid-vaccine-for-children-under-5.html Pfizer is expected to ask the FDA to authorize a Covid vaccine for children under the age of 5.