On August 23, 2021 the Food and Drug Administration (FDA) gave full approval for the Pfizer-BioNTech COVID-19 vaccine, now marketed as Comirnaty, for the prevention of COVID-19 in people 16 years and older. In granting the approval, the FDA noted:
• The public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product
• Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease.
• The vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death.
Pfizer’s Comirnaty remains available for children aged 12 to 15 under the FDA’s Emergency Use Authorization (EAU) while studies on it’s used in children under 12 years of age are ongoing.
The FDA’s announcement confirms that the Pfizer vaccine is both safe and effective and our single best defense against COVID. If you have questions about the vaccine, consult your healthcare provider.
You can read the FDA’s statement on the vaccine’s approval here.