WASHINGTON, D.C. — The Pfizer COVID-19 vaccine could get approval for use in adolescents as early as next week.
The New York Times reported federal officials as saying that the Food and Drug Administration (FDA) is expected to grant expanded emergency use authorization to allow children as young as 12 to receive the coronavirus vaccine developed by Pfizer and the German firm BioNTech.
The vaccine is currently approved for people over 16 years of age, If the FDA’s emergency use authorization for the Pfizer vaccine is amended to include children, a Centers for Disease Control and Prevention (CDC) advisory panel could meet the next day to give its recommendations on the vaccine’s use among adolescents to the agency.
A spokesperson from the FDA told the Times she could not comment on the timing of the agency’s decision.
Pfizer announced results of its study on the effectiveness of its vaccine among younger people earlier this year. The results showed total effectiveness among that age group, meaning families can have hope their children would be protected against the virus that can make children sick and spread through schools. Children are at lower risk of serious complications from the virus, but experts see immunization among adolescents as an important component in curbing its spread.
In a trial of 2,260 U.S. volunteers ages 12 to 15, preliminary data showed that there were no COVID-19 cases among fully vaccinated adolescents compared to 18 volunteers who were given dummy shots.
The company said that volunteers produced strong antibody responses and experienced about the same side effects seen in people ages 16 to 25.
The FDA has already allowed both Pfizer and Moderna to begin U.S. studies in children 11 and younger, and on to children as young as 6-months-old, to test the vaccine’s efficacy and safety. Moderna expects results soon from its trial involving adolescents ages 12 to 17, followed by results for children 6-months- to 12-years-old, later this year.
The U.S. is in a good position when it comes to vaccine supplies. Tens of millions more Pfizer-BioNTech doses have been manufactured and are in various stages of readiness, awaiting final tests before being shipped. Some 313 million doses of a coronavirus vaccine has been distributed in the U.S. as of Monday, according to the CDC. Almost 250 million people have taken a shot.