On August 23, 2021, the U.S. Food and Drug Administration (FDA) approved the Pfizer-BioNTech COVID-19 vaccine, now marketed as Comirnaty, for the prevention of COVID-19 coronavirus infection in individuals aged 16 years and older. The vaccine is still under emergency use authorization (EUA) for individuals aged 12–15 years and as a third dose in certain immunocompromised individuals.
To support the full approval, FDA reviewed updated data from the clinical trial that had supported the EUA. The new effectiveness data were from a longer duration of follow-up in a larger clinical trial population of approximately 20,000 vaccine and 20,000 placebo recipients aged 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. The safety evaluation used data from approximately 22,000 people who received the vaccine and 22,000 people who received a placebo aged 16 years and older.
Based on those clinical trial results, the vaccine was 91% effective in preventing COVID-19 infections. More than half of the participants were followed for safety outcomes for at least four months after the second dose, and overall, approximately 12,000 recipients were followed for at least six months.
The vaccine’s most commonly reported side effects were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. The vaccine is effective in preventing COVID-19 infections and potentially serious outcomes, including hospitalization and death.
Additionally, FDA conducted an evaluation of the postauthorization safety surveillance data for myocarditis and pericarditis and determined that the data demonstrate increased risks, particularly within the seven days following the second dose. The observed risk is higher among assigned males younger than 40 and highest in assigned males aged 12–17 years. Available data from short-term follow-up suggest that symptoms resolve with no intervention in most individuals. However, some required intensive care support. Information is not yet available about potential long-term health outcomes. The prescribing information includes a warning about these risks.
View the full prescribing information for the vaccine.
FDA granted the application priority review. A description of FDA expedited programs is in the Guidance for IndustryꟷExpedited Programs for Serious ConditionsꟷDrugs and Biologics.
Healthcare professionals should report all serious adverse events they suspect to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 800-FDA-1088.
For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.