Pfizer asked the FDA on Tuesday to approve their COVID-19 vaccine for children under the age of five. As reported by the New York Times, federal regulators urged the company to submit the request, even though two doses failed to produce the anticipated immune response among children two to four years old in a clinical […]
Pfizer asked the FDA on Tuesday to approve their COVID-19 vaccine for children under the age of five.
As reported by the New York Times, federal regulators urged the company to submit the request, even though two doses failed to produce the anticipated immune response among children two to four years old in a clinical trial.
The trial results, announced in December, prompted the companies to test a third low dose of the vaccine in that age group, which includes more than 19 million children.
Rather than wait until the end of March for the results of the trial, federal regulators encouraged Pfizer to apply for the authorization in hopes of getting a head start.
An emergency FDA advisory group meeting is scheduled for February 15th, when they will discuss the request and make a recommendation.
Pfizer’s chairman and chief executive Albert Bourla said in a statement that they “believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants.”
But, he said that if two doses are authorized in the meantime, “parents will have the opportunity to begin a Covid-19 vaccination series for their children while awaiting potential authorization of a third dose.”
Despite the request for emergency authorization, among states reporting numbers, children only ranged from 1.6%-4.4% of total accumulated hospitalizations, and only 0.1%-1.5% of all their child COVID-19 cases resulted in hospitalization, according to data from the American Academy of Pediatrics.
