Of these, approximately 43,448 participants [21,720 Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2; 21,728 placebo] in Phase 2/3 are 16 years of age or older (including 138 and 145 adolescents 16 and 17 years of age in the vaccine and placebo groups, respectively) and 2,260 adolescents are 12 through 15 years of age (1,131 and 1,129 in the vaccine and placebo groups, respectively). Due to the high frequency of variants circulating within the United States that are not susceptible to sotrovimab, it is not currently authorized in any U.S. region until further notice by FDA and may not be administered for the treatment of COVID-19 under the Emergency Use Authorization (EUA). WHAT SHOULD YOU MENTION TO YOUR VACCINATION PROVIDER BEFORE YOU GET ANY OF THESE VACCINES? For example, if the manufacture date is August 2021 (8/21), include August as one of the 12 months; the expiration date will be January 2023 (1/31/23). See "MANDATORY REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINE ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION" for reporting requirements. Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. This extension applies to all unopened vials of Evusheld that have been held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers and the Letter of Authorization for Emergency Use Authorization (EUA) 104 for Evusheld. Frozen vials transported at -25C to -15C (-13F to 5F) may be returned one time to the recommended storage condition of -90C to -60C (-130F to -76F). *Cartons of Pfizer-BioNTech COVID-19 Vaccine multiple dose vials may also arrive at refrigerator temperature 2C to 8C. 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#). HOWEVER, with this extension, the expiration date is now AFTER the BUD. As required by the EUA, of Evusheld (150 mg/1.5 mL of tixagevimab and 150 mg/1.5 mL of cilgavimab), must be stored under refrigerated temperature at 2C to 8C (36F to 46F) in the original carton to protect from light. N Engl J Med), in 99 individuals who had undergone various solid organ transplant procedures (heart, kidney, liver, lung, pancreas) 978 months previously who received a third vaccine dose, the adverse event profile was similar to that after the second dose and no grade 3 or grade 4 events were reported in recipients who were followed for 1 month following post Dose 3. The Pfizer-BioNTech COVID-19 Vaccine is administered intramuscularly as a primary series of 2 doses (0.3 mL each) 3 weeks apart in individuals 12 years of age and older. FDA will continue to evaluate the available data and provide updated information as soon as possible. All pregnancies have a risk of birth defect, loss, or other adverse outcomes. For the authorized uses, although limited scientific information is available, based on the totality of the scientific evidence available to date, it is reasonable to believe that the Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY (COVID-19 Vaccine, mRNA) may be effective for the prevention of COVID-19 in individuals as specified in the Full EUA Prescribing Information. SSL Certificate. If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital. This shelf-life extension applies to refrigerated vials of J&J/Janssen COVID-19 vaccine that have been held in accordance with the manufacturer's storage conditions. As a result of this extension, some batches may be stored for an additional 6 months from the labeled date of expiry (see Table 1 here). 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. The storage, preparation, and administration information in this Prescribing Information apply to the Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older, which is supplied in a multiple dose vial with a purple cap and MUST BE DILUTED before use. (Primary series completed) If the recipient has received 2 or more doses of a monovalent COVID-19 vaccine (Pfizer-BioNTech or Moderna), administer 1 booster dose of bivalent Pfizer-BioNTech COVID-19 Vaccine at least 8 weeks (2 months) after the previous dose. These vaccines do not contain SARS-CoV-2 and cannot give you COVID-19. When FDA grants or authorizes a shelf-life extension, that information may be found either in the granting letters or re-issued letters of authorization available in the listing of EUA authorized products on FDAs website. All rights reserved. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Currently available information is insufficient to determine a causal relationship with the vaccine. January 17, 2013: Before PAHPRA, in addition to FDAs June 2010 letter below, a CDC message to states in 2013 regarding spot shortages of Tamiflu for seasonal influenza noted that, [b]ased on FDAs review of scientific data, FDA has concluded that, provided the products have been stored under labeled storage conditions, it is scientifically supportable for certain lots of Tamiflu capsules held in strategic stockpiles to be used for a maximum of ten [10] years beyond their date of manufacture, June 22, 2010: Before PAHPRA, following the 2009-2010 H1N1 influenza response, FDA issued a letter [ARCHIVED] to CDC leadership regarding the disposition of Tamiflu and Relenza lots. Pfizer-BioNTech COVID-19 Vaccine is a suspension for injection. The beyond-use time (12 hours) replaces the manufacturer's expiration date but NEVER extends it. December 14, 2022: On April 28, 2022, HHS issued a message (PDF, 162 KB) to state stakeholders holding antiviral drug products (Tamiflu and Relenza) about additional expiry dating extensions for properly held product. hb``f``Vc```)a@@,&
L8zf0edRg2gea`%QX` The manufacture date is printed on the vial (gray cap). Emergency uses of Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent have not been approved or licensed by FDA but have been authorized by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals aged 6 months and older as appropriate. As noted below, the Tamiflu extensions do not apply to generic versions of oseltamivir. Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). Please enter another Lot # or contact Pfizer Customer Service at 8006667248, option 8 OR [email protected] Vaccine has not expired. The vaccination provider enrolled in the federal COVID-19 Vaccination Program is responsible for MANDATORY reporting of the listed events following Pfizer-BioNTech COVID-19 Vaccine to the Vaccine Adverse Event Reporting System (VAERS): The vaccination provider enrolled in the federal COVID-19 Vaccination Program should complete and submit a VAERS form to FDA using 1 of the following methods: IMPORTANT: When reporting adverse events or vaccine administration errors to VAERS, please complete the entire form with detailed information. In the Phase 2/3 portion of Study 2, based on data accrued through November 14, 2020, approximately 44,000 participants 12 years of age and older were randomized equally and received 2 doses of Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA) or placebo separated by 21 days. Information is not yet available about potential long-term sequelae. Following are several examples of how FDA has addressed expiry dating challenges following PAHPRAs enactment and before PAHPRA: Vaccines authorized for emergency use as products that are not approved under a biologics license application and are still being studied under investigational new drug applications do not have fixed expiry dates. Follow good vaccine storage and practices by outlined by the. https://www.pfizer.com/products/information. MANDATORY REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINE ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION4. Administer the Pfizer-BioNTech COVID-19 Vaccine intramuscularly. The Pfizer-BioNTech and Moderna COVID-19 vaccines both have a shelf life of up to six months, but Pfizer's requires ultra-cold storage to last that long, the company said in November. Do not refreeze. 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. To confirm extension dates, please provide the following information: drug name, NDC, strength, lot number, and original labeled expiration date. It is also authorized under EUA to provide: The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to provide: The Pfizer-BioNTech COVID-19 Vaccine, Bivalent has received EUA from FDA to provide either: This Vaccine Information Fact Sheet contains information to help you understand the risks and benefits of COMIRNATY (COVID-19 Vaccine, mRNA), the Pfizer-BioNTech COVID-19 Vaccine, and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, which you may receive because there is currently a pandemic of COVID-19. The following adverse reactions have been identified during post authorization use of Pfizer-BioNTech COVID-19 Vaccine. Do not use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent. The observed risk is highest in males 12 through 17 years of age. The vaccine elicits an immune response to the S antigen, which protects against COVID-19. The formulation supplied in a multiple dose vial with a purple cap MUST BE DILUTED PRIOR TO USE. Manufactured for BioNTech Manufacturing GmbH An der Goldgrube 12 55131 Mainz, Germany, Manufactured by Pfizer Inc., New York, NY 10017, Long Version (Full EUA Prescribing Information) Begins On Next Page, FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION, FULL EMERGENCY USE AUTHORIZATION PRESCRIBING INFORMATION: CONTENTS*. Because these reactions are reported voluntarily, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. 3 0 obj
Please refer to the table on this page for updates. An additional 1 DuoDote lot is no longer useable and should be properly disposed of.