Pfizer (NYSE:PFE) has announced that its COVID-19 vaccine is "robustly effective" in children, demonstrating 100% efficacy in phase three clinical trials conducted on adolescents aged 12 to 15.
Pfizer said it plans to submit the new data on the vaccine, which is developed in partnership with German drugmaker BioNTech (NASDAQ:BNTX), to the U.S. Food and Drug Administration (FDA) and other regulators "as soon as possible," with the hope that kids in the age group will be able to get vaccinated before the start of the new school year this coming September.
The trial involved 2,260 participants in the United States. There were 18 confirmed COVID-19 infections observed in the placebo group and no confirmed infections in the group that received the vaccine, the company said. That resulted in a vaccine efficacy of 100%. Pfizer added that its vaccine was well-tolerated among young people, with side effects generally consistent with those seen in adults.
The company also said the vaccine elicited a "robust antibody response" in children, exceeding those recorded earlier in vaccinated participants aged 16 to 25 years old.
Vaccinating children is crucial to ending the pandemic, public health officials and infectious disease experts agree. Pfizer’s vaccine has already been authorized for use in the U.S. and Canada in people aged 16 and older. Clinical trial studies testing the vaccine in kids, whose immune systems can respond differently than adults, still needed to be completed.
