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The vaccine expires on the last day of the 18th month. Refrigerator: Between 2C and 8C (36F and 46F)A carton of 10 single-dose vials may take up to 2 hours to thaw at this temperature. In Study 2, among participants 16 through 55 years of age who had received at least 1 dose of vaccine or placebo (Pfizer-BioNTech COVID-19 Vaccine = 10,841; placebo = 10,851), serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow-up were reported by 0.4% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 0.3% of placebo recipients. November 2022 - May 31, 2023. If not previously thawed at 2C to 8C (35F to 46F), allow vials to thaw at room temperature [up to 25C (77F)] for 30 minutes. PRODUCT INFORMATION. COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine have been shown to prevent COVID-19. First COVID-19 occurrence from 7 days after Dose 2 in participants without evidence of prior SARS-CoV-2 infection*, Pfizer-BioNTech COVID-19 VaccineN=18,198 Casesn1Surveillance Time (n2#), Placebo N=18,325 Casesn1Surveillance Time (n2#), First COVID-19 occurrence from 7 days after Dose 2 in participants with or without evidence of prior SARS-CoV-2 infection, Pfizer-BioNTech COVID-19 VaccineN=19,965Casesn1Surveillance Time (n2#), PlaceboN=20,172Casesn1Surveillance Time (n2#). To access the most recent Fact Sheets, please scan the QR code provided below. PDF Pfizer Vials and Expiration Dates: Label Information There is no information on the co-administration of the Pfizer-BioNTech COVID-19 Vaccine with other vaccines. Pfizer-BioNTech COVID-19 Vaccine is a monovalent COVID-19 vaccine that is authorized for emergency use to prevent COVID-19 as: The first two doses of the three-dose primary series for children 6. You should not get any of these vaccines if you: WHAT ARE THE INGREDIENTS IN THESE VACCINES? Sign up to receive email alerts on emergency preparedness and response topics from FDA, including medical countermeasures and emerging infectious diseases. A third primary series dose of the Pfizer-BioNTech COVID-19 Vaccine (0.3 mL) at least 28 days following the second dose is authorized for administration to individuals at least 12 years of age with certain kinds of immunocompromise. An EUA is a mechanism to facilitate the availability and use of medical products, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. After dilution, 1 vial contains 6 doses of 0.3 mL. In addition, you can report side effects to Pfizer Inc. at the contact information provided below. Pfizer Expiration Date Lookup Process in Simple Steps [Vaccine/Booster 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. Cartons and vials of Pfizer-BioNTech COVID-19 vaccine with an expiry date of August 2021 through February 2022 printed on the label may remain in use for three months beyond the printed date as long as authorized storage conditions between -90C to -60C (-130F to -76F) have been maintained. Pfizer-BioNTech COVID-19 Vaccine Vial with Purple Cap THAWING PRIOR TO DILUTION. October 21, 2020:FDA is alerting civilian health care professionals and emergency responders of 1 pralidoxime chloride and 5 CANA (diazepam) auto-injector lots for which the new use date has passed; however, FDA recommends that stakeholders retain such lots in the event that additional scientific information becomes available to support additional extensions. Heres an FDA fact sheet for vaccination providers. From an independent report (Kamar N, Abravanel F, Marion O, et al. CDC Pfizer-BioNTech COVID-19 Vaccine: Storage and Handling Summary (cdc.gov)FDA EUA Fact Sheet for Providers. Vial labels and cartons may state that a vial should be discarded 6 hours after the first puncture. [-130F to -76F]). Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine [see Description (13)]. The efficacy information in adolescents 12 through 15 years of age is presented in Table 9. To confirm extension dates, please provide the following information: drug name, NDC, strength, lot number, and original labeled expiration date. Thawed vials can be handled in room light conditions. )$p-M?4s6.1K@, i Appendicitis was reported as a serious adverse event for 12 participants, and numerically higher in the vaccine group, 8 vaccine participants and 4 placebo participants. Manufactured forBioNTech Manufacturing GmbHAn der Goldgrube 1255131 Mainz, Germany, Manufactured byPfizer Inc., New York, NY 10017, VACCINE INFORMATION FACT SHEET FOR RECIPIENTS AND CAREGIVERS ABOUT COMIRNATY (COVID-19 VACCINE, mRNA), THE PFIZER-BIONTECH COVID-19 VACCINE, AND THE PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19) FOR USE IN INDIVIDUALS 12 YEARS OF AGE AND OLDER. Please refer to the table on this page for updates. Refrigerated at 2C and 8C (36F and 46F) for up to 10 weeks. Based on the date the vaccine was placed in the refrigerator, the . V-safe is a new voluntary smartphone-based tool that uses text messaging and web surveys to check in with people who have been vaccinated to identify potential side effects after COVID-19 vaccination. The Fact Sheets for both orange and gray cap vials provided by the FDA now reads, "regardless of storage conditions, vaccines should not be used after 9 months from the date of manufacture printed on the vial and cartons". Additionally, see The Vaccine Storage and Handling Toolkit, developed by experts at the CDC, for additional information. There is a remote chance that these vaccines could cause a severe allergic reaction. To find the expiry date on your product, please download the data tables (by date or by batch number). Count out 18 months, using the month printed on the vial as month 1. For information regarding provider requirements and enrollment in the CDC COVID-19 Vaccination Program, see https://www.cdc.gov/vaccines/covid-19/provider-enrollment.html. The manufacture date is printed on the vial (gray cap). endstream endobj 158 0 obj <>stream Total cumulative time the vials are stored at -25C to -15C (-13F to 5F) should be tracked and should not exceed 2 weeks. A third dose of the Pfizer-BioNTech COVID-19 vaccine was administered to 99 of these individuals approximately 2 months after they had received a second dose. An extended expiration date means the manufacturer provided data. Patients should still be counselled to maintain physical precautions to help prevent COVID-19. Vials should be discarded 12 hours after dilution. It is predominantly a respiratory illness that can affect other organs. Verify that the vial of Pfizer-BioNTech COVID-19 Vaccine has a purple plastic cap. Because these reactions are reported voluntarily, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. The 10-week refrigerated expiry date should be recorded on the carton at the time of transfer.Thawed vaccine cannot be refrozen. The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html). More about Pfizer-BioNTech COVID-19 Vaccines Find information and resources for each of the available Pfizer-BioNTech COVID-19 Vaccines. HWrF+H, rZRJlqI)B@EE4zzz^^8|.II_x2Mi4eYrv[n^IL#NLI{owb7'g^[ g|\Z0dF]/QXbFL@UWu7ZSV8l9'caP)gpSL^: ]N]?2W7A(&5#4?&QFb:h\Q9ov?v FReZG+,LGe[pHv2nK::pWF[lmGd-G^1O'DxpZJj/k9s#a_dMv."&| September 6, 2022: FDA and HHS/ASPR authorized an extension to the shelf life from 12 months to 18 months for certain lots of the Pfizer antiviral therapy, Paxlovid (nirmatrelvir tablets and ritonavir tablets co-packaged for oral use). Vial labels and cartons may state that after dilution, a vial contains 5 doses of 0.3 mL. Storage for longer than 10 weeks requires an Ultra Cold freezer. Symptoms may include: fever or chills; cough; shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea. To help prepare for public health emergencies, medical countermeasures (MCMs) may be stockpiled by governments and even by some private sector partners. All sotrovimab vials may continue to be retained regardless of the current labeled expiry date or the previously provided extension dates, unless otherwise notified by the Agency. May be stored at room temperature (8C to 25C [46F to 77F]) for a total of 12 hours prior to dilution (including thaw time). This finalizes the draft guidance published on April 25, 2017. No further extensions are anticipated beyond 10 years.Also see, from FDA: Influenza (Flu) Antiviral Drugs and Related Information, and from HHS/ASPR:HHS Increases Access to Tamiflu through the Strategic National Stockpile (December 21, 2022), andImproving Access to Influenza Countermeasures for U.S. Jurisdictions. Information is not yet available about potential long-term sequelae. In Study 2 in which 10,841 participants 16 through 55 years of age received Pfizer-BioNTech COVID-19 Vaccine and 10,851 participants received placebo, non-serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow-up were reported in 29.3% of participants who received Pfizer-BioNTech COVID-19 Vaccine and 13.2% of participants in the placebo group, for participants who received at least 1 dose. You can get COVID-19 through contact with another person who has the virus. 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. For the most recent Fact Sheet, please see www.cvdvaccine.com. In a clinical trial, approximately 300 individuals greater than 55 years of age received one dose of a bivalent vaccine that differs from the Pfizer-BioNTech COVID-19 Vaccine, Bivalent in that it contains a different Omicron component. An additional 1 DuoDote lot is no longer useable and should be properly disposed of. To access the most recent Pfizer-BioNTech COVID-19 Vaccine Fact Sheets, please scan the QR code provided below. The lot number you entered (AB0000) does not exist. All sotrovimab vials may continue to be retained regardless of the current labeled expiry date or the previously provided extension dates, unless otherwise notified by the Agency. Follow good vaccine storage and practices by outlined by the. Storage and Handling of Pfizer-BioNTech COVID-19 Vaccines Refrigerator: Between 2C and 8C (36F and 46F) A carton of 10 vials may take up to 6hours to thaw at this temperature. What is an Emergency Use Authorization (EUA)? The top 15 blockbuster patent expirations coming this decade If received at 2C to 8C, they should be stored at 2C to 8C.