FDA full approval for Pfizer

FDA Approves First COVID-19 VaccineUploaded 24-08-21EUA since December 11, 2020https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccineU.S. Food and Drug AdministrationPfizer-BioNTech COVID-19 VaccineWill now be marketed as Comirnaty (koe-mir’-na-tee)for the prevention of COVID-19 disease in individuals 16 years of age and olderContinues to be available under emergency use authorization (EUA), 12 to 15sand for a third dose in immunocompromiseActing FDA Commissioner Janet Woodcock, M.DWhile 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 productwe 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 statementThe 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 recipientsVaccine was 91% effective in preventing COVID-19 diseaseSafety, approximately 12,000 recipients have been followed for at least 6 months.The most commonly reported side effectsPain, redness and swelling at the injection siteFatigue, headache, muscle or joint pain, chills, and feverRigorous evaluation of the post-authorization safety surveillance dataMyocarditis and pericarditisChest pain, shortness of breath, or feelings of having a fast-beating, fluttering, or pounding hearthttps://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-june-25-2021https://www.cdc.gov/mmwr/volumes/70/wr/mm7027e2.htm52 million doses to 12–29 years1,226 reports of myocarditis after mRNA vaccination 42,414One in 42,414Data 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 malesRisk is highest in males 12 through 17 years of ageShort-term follow-up suggest that most individuals have had resolution of symptomsSome individuals required