evidence: Pfizer and BioNTech Announce Positive Topline Results From Pivotal Trial of COVID-19 Vaccine in Children 5 to 11 Years - Results are the first from a pivotal trial of any COVID-19 vaccine in children under 12 years of age - In participants 5 to 11 years of age, the vaccine was safe, well tolerated and showed robust neutralizing antibody responses - Companies plan to submit these data to the FDA, EMA and other regulatory agencies around the world as soon as possible - Results in children under 5 years of age are expected as soon as later this year [...] COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech. [...] Individuals should not get the Pfizer-BioNTech COVID-19 Vaccine if they: