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www.fdanews.com/articles/199556-pfizer-to-enroll-children-as-young-as-12-in-covid-19-trial

Pfizer to Enroll Children as Young as 12 in COVID-19 Trial

October 15, 2020

Pfizer said it will add participants as young as 12 to the global phase 3 trial of its COVID-19 vaccine candidate to glean more information on how the treatment affects different age groups.

Developed in partnership with BioNTech, the promising messenger RNA vaccine delivers a small part of the genetic code of the SARS-CoV-2 virus that induces an immune system response.

In September, Pfizer expanded enrollment in the study to include adolescents as young as 16 years old, but said it now has the FDA’s permission to enroll participants as young as 12.

“By doing so, we will be able to better understand the potential safety and efficacy of the vaccine in individuals from more ages and backgrounds,” the company said.