NEW YORK – The American drug company Pfizer and its German partner BioNTech, whose coronavirus vaccine was the first to receive emergency approval in the United States, have requested permission for more adolescents.
The companies have asked the U.S. Food and Drug Administration (FDA) to extend emergency use authorization of their vaccine to adolescents between the ages of 12 and 15. In mid-December, the emergency use of the two-dose vaccine was approved for use in people 16 years and older.
BREAKING: Today, with @BioNTech_Groupwe have filed a request with the US FDA to extend emergency use of our COVID-19 vaccine to adolescents 12 to 15 years of age. pic.twitter.com/AHjc2khnUj
– Pfizer Inc. (@pfizer) April 9, 2021
Pfizer and BioNTech said they are working closely with the FDA and regulators in other countries to get conditional emergency approval for teens 12 to 15 years old as soon as possible.
Both companies stressed in a statement that preliminary results up to March 31 of clinical trials in that age group show that the vaccine is safe and 100% effective in preventing infections. They said the side effects were similar to those of tests with volunteers ages 16 to 25: pain and swelling at the injection site, fatigue, headache, fever, and nausea.
Pending a regulatory decision, we hope to make this vaccine available to the 12-15 age group before the start of the 2021 school year.
– Pfizer Inc. (@pfizer) April 9, 2021
All study participants, volunteers aged 12-15, will be observed for two years after the second dose is given to monitor any safety issues and determine how long the vaccine protects them.
