J. Novavax monovalent vaccine may be used as a first booster in an adult patient People with COVID-19 have reported a wide range of symptoms, ranging from mild symptoms to severe illness. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. * Sections or subsections omitted from the full emergency use authorization prescribing information are not listed. 1 . Pfizer-BioNTech COVID-19 VaccineDose 1N=2291n (%), Pfizer-BioNTech COVID-19 VaccineDose 2N=2098n (%). Dilute the vial contents using 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP (not provided) to form the Pfizer-BioNTech COVID-19 Vaccine. To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information: Under the EUA, it is your choice to receive or not receive any of these vaccines. Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine. Vials must be kept frozen and protected from light, in the original cartons, until ready to use. (package insert). Tell the vaccination provider about all of your medical conditions, including if you: The Pfizer-BioNTech COVID-19 Vaccine, the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, or COMIRNATY (COVID-19 Vaccine, mRNA) will be given to you as an injection into the muscle. Janssen's website has detailed descriptions and images of its COVID-19 vaccine labeling and packaging. First COVID-19 occurrence from 7 days after Dose 2 in adolescents 12 through 15 years of age without evidence of prior SARS-CoV-2 infection*, Pfizer-BioNTech COVID-19 VaccineN=1005Casesn1Surveillance Time (n2#), PlaceboN=978Casesn1Surveillance Time (n2#), First COVID-19 occurrence from 7 days after Dose 2 in adolescents 12 through 15 years of age with or without evidence of prior SARS-CoV-2 infection, Pfizer-BioNTech COVID-19 VaccineN=1119Casesn1Surveillance Time (n2#), PlaceboN=1110Casesn1Surveillance Time (n2#). Of these, 1,308 (660 Pfizer-BioNTech COVID-19 Vaccine and 648 placebo) adolescents have been followed for at least 2 months after the second dose. ___ I. Administer a dose of Pfizer or Moderna bivalent COVID-19 vaccine according to ACIP recommendations and the vaccine package insert. Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention (CDC) guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html). AZULFIDINE (sulfasalazine) | Pfizer Medical Information - US For immediate use, thaw undiluted vials at room temperature [up to 25C (77F)] for 30 minutes. Individuals 12 years of age and older may receive a booster dose with Pfizer-BioNTech COVID-19 Vaccine, Bivalent. PDF Immunization Pharmacy Protocol - Oregon See Overall Safety Summary (Section 6) for additional information. This is the Product Information that was approved with the submission described in this AusPAR.

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