Pfizer has now submitted a request to the FDA to expand the use of its COVID-19 vaccine to children aged 12-15.
It is the first step towards approval to vaccinate children under 16 in the U.S.
Pfizer and its partner BioNTech announced last week that its vaccine was 100% effective in a trial of 2,260 adolescents. In a previous trial, Pfizer considered its vaccine effective if it prevented someone from developing a symptomatic case of COVID-19.
Pfizer says the side effects in adolescents were similar to side effects in people 16-25: pain and swelling at the injection site, fatigue, headaches, fever and nausea.
The two companies say they are working closely with the FDA to expand its emergency use authorization as quickly as possible.
Now that Pfizer has submitted its data to the FDA, scientists and experts with the agency will review the data and issue its own report. The FDA’s Vaccine Advisory Committee will then hold a public hearing to examine the data and issue a recommendation to agency officials, who will decide whether or not expand the emergency use authorization.
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Pfizer says it will continue to follow people who participated in the clinical trial for two years to monitor efficacy and watch for any safety issues.
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