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FDA Approves First COVID-19 Vaccine EUA since December 11, 2020 https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine U.S. Food and Drug Administration Pfizer-BioNTech COVID-19 Vaccine Will now be marketed as Comirnaty (koe-mir’-na-tee) for the prevention of COVID-19 disease in individuals 16 years of age and older Continues to be available under emergency use authorization (EUA), 12 to 15s and for a third dose in immunocompromise Acting FDA Commissioner Janet Woodcock, M.D While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, 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 we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S. FDA statement The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into - nor does it alter - an individual’s genetic material. Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart. Analyzed effectiveness and safety data from 20,000 vaccine and 20,000 placebo recipients Vaccine was 91% effective in preventing COVID-19 disease Safety, approximately 12,000 recipients have been followed for at least 6 months. The most commonly reported side effects Pain, redness and swelling at the injection site Fatigue, headache, muscle or joint pain, chills, and fever Rigorous evaluation of the post-authorization safety surveillance data Myocarditis and pericarditis Chest pain, shortness of breath, or feelings of having a fast-beating, fluttering, or pounding heart https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-june-25-2021 https://www.cdc.gov/mmwr/volumes/70/wr/mm7027e2.htm 52 million doses to 12–29 years 1,226 reports of myocarditis after mRNA vaccination 42,414 One in 42,414 Data demonstrate increased risks, particularly within the seven days following the second dose The observed risk is higher among males under 40 years of age compared to females and older males Risk is highest in males 12 through 17 years of age Short-term follow-up suggest that most individuals have had resolution of symptoms Some individuals required intensive care support Information is not yet available about potential long-term health outcomes FDA and CDC, monitoring systems in place for early detection Pfizer will Conduct postmarketing studies to further assess the risks of myocarditis and pericarditis Include an evaluation of long-term outcomes Conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after vaccination during pregnancy

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