Data presented at the Vaccines and Related Biologics Products Advisory Committee (VRBPAC), June 10 Data and VaST assessment presented at ACIP meeting on June 23. Adverse Reactions Identified in Post Authorization Experience. It clearly states: 1 product insert per carton. Use of unapproved Pfizer-BioNTech COVID-19 Vaccine for active immunization to prevent COVID-19 under this EUA is limited to the following (all requirements must be met): OTHER ADVERSE EVENT REPORTING TO VAERS AND PFIZER INC. Vaccination providers may report to VAERS other adverse events that are not required to be reported using the contact information above. For immediate use, thaw undiluted vials at room temperature [up to 25C (77F)] for 30 minutes. COVID-19 - immunize.org Add 1.8 mL of sterile 0.9% sodium chloride injection, USP. Getting rid of any unwanted vaccine A doctor, nurse or pharmacist will dispose of any unused vaccine. People with COVID-19 have reported a wide range of symptoms, ranging from mild symptoms to severe illness. 3. This information in the package insert supersedes the storage conditions printed on the vial cartons. Throughout the safety follow-up period to date, Bell's palsy (facial paralysis) was reported by 4 participants in the Pfizer-BioNTech COVID-19 Vaccine group. Serious and unexpected side effects may occur. a single booster dose to individuals 12 years of age and older at least 2 months after completion of primary vaccination with any authorized or approved COVID-19 vaccine; or, a single booster dose to individuals 12 years of age and older at least 2 months after receipt of the most recent booster dose with any authorized or approved monovalent, https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html, https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html, https://www.cdc.gov/vaccines/covid-19/provider-enrollment.html, https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization, Clinical Trial Results and Supporting Data for EUA (18.1), https://www.cdc.gov/vaccines/programs/iis/about.html. FDA Approval - 6/3/22. RT @HopeRising19: Canada has just updated its package insert for Comirnaty #pfizer #CovidVaccines Updated in March 2023 it's interesting to see what they are STILL saying about the use of their covid injection in PREGNANT and BREAST FEEDING women It's certainly NOT what their Mininstry of Show more . The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine authorized under Emergency Use Authorization (EUA) for individuals 12 years of age and older, when prepared according to their respective instructions for use, can be used interchangeably.