Pfizer requests vaccine authorization for children between 6 months and 5 years

The American pharmaceutical company Pfizer and its partner BioNtech requested this Tuesday the emergency authorization in the United States of its vaccine against covid-19 for children between six months and five years , the companies announced in a statement. 

“Following a request from the US Food and Drug Administration (FDA), the companies have initiated a filing to modify the emergency use authorization, to include children between the ages of six months and five years, in response to an urgent need”, assure the companies. 

If approved, this would be the first coronavirus vaccine for children of those ages. 

Shortly after the announcement was made, the FDA called its advisory committee meeting for February 15 to review the data provided by Pfizer for the vaccine for children six months to five years. 

According to Pfizer and BioNtech, they have provided information on the safety and efficacy of two 3-microgram doses in children in this age range, as part of a three-dose series. 

However, Pfizer warned that information on the booster dose in this age range will not be released for a few months.

“Having a safe and effective vaccine available for children in this age group is a priority for the agency and we are committed to a timely review of the data,” Acting FDA Commissioner Janet Woodcock said in a separate statement. 

Last October, the FDA authorized the vaccine from these pharmaceutical companies for children between five and eleven years old and, recently, gave the green light to a booster dose for those between twelve and fifteen years old. 

Until the vaccine arrives, “the best way to protect children, even when they are in school or in daycare, is to practice social distancing and the use of masks, in accordance with public health recommendations,” Woodcock added.