U.S. Food and Drug Administration (FDA) documents show that stipulations for the licensing for the COVID-19 mRNA vaccines is set to be completed in 2023 and beyond.
In May of 2021 Amit Patel, director of regulatory lead for Pfizer in the U.S., submitted a Biologics License Application (BLA) to the FDA for licensure of Pfizer’s novel injection.
The FDA responded with stipulations around the licensure in August that detailed clinical trial data submission dates.
A pediatric study to evaluate the safety and efficacy of Comirnaty, the company's vaccine, in children 12 to 15 years of age. The study will be completed on May 31, 2023 with the final report submitted on October 31, 2023.
For babies and children aged six months to 12 years of age, a pediatric study will be completed by November 30, 2023 with final report submissions by May 31, 2024.
In infants less than six months of age, a study will be completed on July 31, 2024 with a submission report to follow on October 31, 2024.
In the post marketing requirements of the licence, the FDA notes that they will not be able to “sufficiently assess known serious risks of myocarditis and pericarditis and identify an unexpected serious risk of subclinical myocarditis,” so they further request Pfizer conduct these studies.
They instruct Pfizer to complete a study to “evaluate the occurrence of myocarditis and pericarditis following administration of Comirnaty,” to be completed by June 30, 2025 with a final report submission date of October 31, 2025.
A similar study will take place in Europe and is set to be completed by March 31, 2024 with final submissions by September 30, 2024.
Further, they ask for a “substudy to describe the natural history of myocarditis and pericarditis following administration of Comirnaty,” that is to be completed by March 31, 2024.
Finally, at least five years of follow up “for potential long-term sequelae of myocarditis after vaccination (in collaboration with Pediatric Heart Network),” is requested to be completed by December 31, 2026 with final reports by May 31, 2027.
Two additional studies will evaluate myocarditis after the second and third doses of Comirnaty respectively.
The first will assess incidences of subclinical myocarditis after a second dose of Comirnaty in a “subset of participants five through 15 years of age” with a completion date of November 30, 2023.
The second will “assess the incidence of subclinical myocarditis following administration of a third dose of Comirnaty in a subset of participants 16 to 30 years of age.” This was to be completed by June 30, 2022 and the final report submission is due in approximately one week, on December 31, 2022.
A study on pregnant women to establish safety and pregnancy outcomes will be completed in June 2025.