NEW YORK – The American pharmaceutical company Pfizer and its German partner BioNTech, the coronavirus vaccine was the first to receive authorization for emergency use in the United States, have requested that it be allowed to be applied to more adolescents.
The companies have asked the U.S. Food and Drug Administration (FDA) to extend the emergency use of their vaccine to include teens among 12 and 15 years. In mid-December, emergency use of his two-dose vaccine was authorized for use in people 16 and older.
BREAKING: Today, with @BioNTech_Group, we sent a request to the US FDA to expand the emergency use of our COVID-19 vaccine to teens ages 12 to 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 nations to get conditional emergency clearance as soon as possible for teens ages 12 to 15.
The two companies stressed in a statement that preliminary results as of 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 matched those of the tests with volunteers aged 16 to 25: pain and inflammation at the injection site, fatigue, headache, fever and nausea.
Pending the regulatory decision, we expect this vaccine to be available for the 12-15 age group before the start of the 2021 school year.
– Pfizer Inc. (@pfizer) April 9, 2021
All study participants, volunteers ages 12 to 15, will be under observation for two years from the time they are given the second dose to follow up on any safety issues and determine how long the vaccine protects them.
