NEW YORK – American pharmacist Pfizer and his German partner BioNTech, whose coronavirus vaccine was the first to receive emergency use authorization in the United States, have asked to be allowed to apply to more teens.
The companies have asked the US Food and Drug Administration (FDA) to extend the authorization for the emergency use of the vaccine to include adolescents between the ages of 12 and 15. In mid-December, emergency use of his two-dose vaccine was authorized for use in people 16 years of age and older.
BREAKING: Today, with @BioNTech_Group, we have filed a request with the US FDA to extend the emergency use of our COVID-19 vaccine to adolescents between the ages of 12 and 15. 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 obtain a conditional emergency permit as soon as possible for teens between the ages of 12 and 15.
Both companies said in a statement that preliminary results by March 31 of clinical trials in this age group show that the vaccine is safe and 100% effective in preventing infections. They said the side effects match those in tests with volunteers between the ages of 16 and 25: pain and swelling at the injection site, fatigue, headache, fever and nausea.
Pending the regulatory decision, our hope is 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 between the ages of 12 and 15, will be under observation for two years after the second dose to monitor any safety concerns and to determine how long the vaccine protects them.
