Pfizer (NYSE: PFE) and development partner BioNTech (NASDAQ: BNTX) announced Thursday that the pair has asked the U.S. Food and Drug Administration (FDA) to authorize its COVID-19 vaccine for emergency use in children between the ages of 5- to 11-years-old.
If approved, the vaccine, known as Corminaty, would become the first COVID vaccine for children. This is welcomed news for anxious parents as kids are going back in in-person learning amid the rapid spread of the Delta variant across the United States. The highly contagious strain has led to a surge in U.S. hospitalizations, including among children, with the New York Times reporting nearly 30,000 children were admitted to hospitals with the virus in August, which the Times called a record high.
Last month, Pfizer and BioNTech released new data that showed a two-dose regimen of 10 micrograms, which is a third of the dosage used for teens and adults--is safe and generates a strong immune response in children.
The shots were also well tolerated by clinical trial participants and produced an immune response comparable to those seen in the companies' study of people aged 16- to 26-years-old. Moreover, the side effects of the shot were similar to those in older participants, with common side effects including pain at injection site, fatigue, headache, muscle pain, chills, fever and nausea, according to the U.S. Centers for Disease Control and Prevention (CDC).
Pfizer and BioNTech's COVID vaccine has been fully approved for use in Americans ages 16 years and older, and has received an emergency use authorization (EUA) from the FDA for use in adolescents between the ages of 12- to 15-years-old.
If the FDA spends as much time reviewing the children's clinical trial data as it did for the adolescent age group--Pfizer and BioNTech requested to expand its EUA of their vaccine to adolescents on April 9 and were authorized by the FDA on May 10--the shots won't be available for use until at least November.
The FDA has scheduled a meeting of its key vaccine advisory group, the Vaccine and Related Biological Products Advisory Committee, on Oct. 26 to discuss Pfizer-BioNTech's new data. The shots could be approved shortly after that meeting, similar to how the FDA has acted on other COVID vaccines, depending decisions by the FDA and CDC.