The US Food and Drug Administration has lengthened the emergency use authorisation for the Pfizer and BioNTech COVID-19 vaccine to include those aged twelve to fifteen based on a Phase III trial assessing the vaccine. The brand-new approval makes the Pfizer and BioNTech vaccine the first-of-its-kind to be accepted within the US for people within this age bracket.
The Phase III trial demonstrated that the vaccine generated robust antibody responses and had one-hundred per cent efficacy.
“The US FDA has lengthened the EUA for the Pfizer and BioNTech COVID-19 vaccine to include 12-15-year-olds.“
The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will gather to discuss the recommendations for using the jab in this age bracket, following the FDA’s decision to expand the EUA for the vaccine.
Chairman and CEO, Pfizer, Albert Bourla, stated: “We are grateful to all of our clinical trial volunteers and their families, whose courage helped make this milestone possible. Together, we hope to help bring a sense of normalcy back to young people across the country and around the world.”