The above-given button will directly take you to the official website of Pfizer, and the tool is also launched by the . 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. =RpB_\n6Z.7I yn\i(hI(kcVs3&LIh \. To help prepare for public health emergencies, medical countermeasures (MCMs) may be stockpiled by governments and even by some private sector partners. Symptoms may appear 2 to 14 days after exposure to the virus. Data are not available to assess the effects of Pfizer-BioNTech COVID-19 Vaccine on the breastfed infant or on milk production/excretion. Based on FDA's review of scientific data, FDA has concluded for emergency responses that, provided the products have been stored under labeled storage conditions, it is scientifically supportable for certain lots of Relenza inhalation powder held in strategic stockpiles to be used for a maximum of 10 years beyond their date of manufacture. In an analysis of Study 2, based on data up to the cutoff date of March 13, 2021, 2,260 adolescents (1,131 Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA); 1,129 placebo) were 12 through 15 years of age. However, vaccination providers may seek appropriate reimbursement from a program or plan that covers COVID-19 vaccine administration fees for the vaccine recipient (private insurance, Medicare, Medicaid, Health Resources & Services Administration [HRSA] COVID-19 Uninsured Program for non-insured recipients). Remember: You dont need ultra-cold storage to carry Pfizer-BioNTech COVID-19 vaccine. When you get your first COVID-19 vaccine, you will get a vaccination card. Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine. endobj AAP original research, including a robust practice-based research network, addresses important questions regarding pediatric practice and the health and well being of children. See Overall Safety Summary (Section 6) for additional information. Program participants are U.S. Federal agencies that sign a Memorandum of Agreement with the Department of Defense, and SLEP remains limited to federal stockpiles at this time. 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."&| Thawed vials can be handled in room light conditions. Due to the high frequency of the omicron BA.2 variant, sotrovimab is not currently authorized in any U.S. region. Copyright 2023 American Academy of Pediatrics. 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. Some vials also may have a purple label border on the label. Room temperature: Up to 25C (77F). PDF IMMUNIZATION COVID-19 UPDATE - Louisiana Department of Health FDA Fact Sheet for Health Care Providers Administering Vaccine (5 through 11 years), BIVALENT (Original and Omicron) CDC US COVID-19 Vaccine Product InformationCDC Storage and Handling of Pfizer-BioNTech COVID-19 Vaccines. If you are pregnant or breastfeeding, discuss your options with your healthcare provider. Storage of the vials between -96C to -60C (-141F to -76F) is not considered an excursion from the recommended storage condition. FDA is not requiring or recommending that such stockpiled Tamiflu or Relenza product be relabeled with the new use date. Record the date and time of first use on the Moderna COVID-19 Vaccine label. Thawed vaccine cannot be refrozen. M&D will begin redistributing Pfizer vaccine with the updated expiration dates detailed below, until all of these doses with extended dates have been ordered: Lot Number (EP6955): New Expiration Date: 9/30/2021 Lot Numbers (EN6207, ER8734, EW0150, ER8729, EW0158, ER8727, EW0162, ER8733): New Expiration Date: 10/31/2021 Pfizer-BioNTech COVID-19 Vaccine is a suspension for injection. Click here to view and download this information in a table. The extended expiration date is effective immediately for all currently available batches that have not yet expired. During the visual inspection. The lot number you entered (AB0000) does not exist. 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 (PDF, 694KB) and the EUA Letter of Authorization (PDF, 293KB) for Evusheld. 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. Click here to view this information in a table. KmX;@=VP$Zx_[9AA1&3. It is important that the information reported to FDA be as detailed and complete as possible. PFIZER CUSTOMER SERVICE. As a result of this extension, lots of Paxlovid with dates of expiry from July 2022 to May 2023 may be stored for an additional six months from the labeled date of expiry (see Table 1 below) when stored according to the storage conditions detailed in the authorized Fact Sheet for Health Care Providers. From Dose 1 through 30 days after Dose 2, reports of lymphadenopathy plausibly related to the study intervention were imbalanced, with notably more cases in the Pfizer-BioNTech COVID-19 Vaccine group (7) vs. the placebo group (1). The manufacture date is printed on the vial (dark blue cap) and carton. Do not discard vaccine without ensuring the expiration date has passed. Primary Series (Monovalent)6 months 5 years: Dark Blue Cap / Magenta Label6-11 years primary series: Dark Blue Cap / Purple Label 12 years and up: Red Cap / Light Blue Label, Updated (Bivalent) Booster 6 months 5 years: Dark Pink Cap/Label with Yellow Box6 years and up: Dark Blue Cap / Gray Border LabelNote: Both 0.25mL (6 11 years) and 0.5mL (12+ years older) doses may be withdrawn from the same multiple-dose vial. Vaccine expires 18 months after the manufacture date. Vials should be discarded 12 hours after dilution. https://www.pfizer.com/products/information. Set id: 908ecbe7-2f1b-42dd-94bf-f917ec3c5af8, PRIMARY SERIES FOR 12 YEARS OF AGE AND OLDER. In addition to the identification of specific lots, batches, or other units covered and the duration of the extension, FDA can require appropriate conditions related to any extensions under this authority, including appropriate storage, sampling, recordkeeping, periodic testing or retesting, product disposition, and labeling. The formulation supplied in a multiple dose vial with a purple cap MUST BE DILUTED PRIOR TO USE. *Cartons of Pfizer-BioNTech COVID-19 Vaccine vials may also arrive at refrigerator temperature 2C to 8C. Solicited reactogenicity data in 16 and 17 year-old participants are limited. Access to this report is strictly managed by registration only. This authorization is based on safety and effectiveness data in this age group and adults. Another way FDA can approach expiration dating challenges is through FDAs expiration dating extension authority under section 564A(b) of the FD&C Act, which was established by PAHPRA in 2013. Two vaccines can be given in one appointment. Severe allergic reactions, including anaphylaxis, have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine. 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 EUA. Pfizer Expiration Date Lookup Process in Simple Steps [Vaccine/Booster The vaccine expires 18 months after manufacture date if stored frozen at ultra-cold temperatures (-90C to -60C [-130F to -76F]). The vaccination provider may include your vaccination information in your state/local jurisdiction's Immunization Information System (IIS) or other designated system. COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine intended for individuals 12 years of age and older should not be used for individuals 6 months through 11 years of age because of the potential for vaccine administration errors, including dosing errors. Check Expiry simply click on the above-given button which will directly take you to the Pfizer expiration date lookup tool. Shelf-life expiration dates have been extended multiple times as additional data becomes available. The population for the analysis of the primary efficacy endpoint included, 36,621 participants 12 years of age and older (18,242 in the Pfizer-BioNTech COVID-19 Vaccine group and 18,379 in the placebo group) who did not have evidence of prior infection with SARS-CoV-2 through 7 days after the second dose. Printed Expiry Date Storage and Handling of Pfizer-BioNTech COVID-19 Vaccines A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose. Please see the most recent updates above for the latest information. Do NOT use vaccine if the expiration date or beyond-use time has passed. N Engl J Med), safety and effectiveness of a third dose of the Pfizer-BioNTech COVID-19 vaccine have been evaluated in persons that received solid organ transplants. HOWEVER, with this extension, the expiration date is now AFTER the BUD. However, it is the recommendation of the U.S. Government that product be retained in the event that future SARS-CoV-2 variants, which may be susceptible to sotrovimab, emerge and become prevalent in the United States. GLCP Vaccine Sign Up - Jotform August 23, 2021. V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. Refrigerated at 2C and 8C (36F and 46F) for up to 10 weeks. Refrigerated 2C to 8C (36F to 46F) for up to 6 hoursDiscard 6 hours after puncturing vial. PDF Pfizer-BioNTech COVID-19 Vaccine - cdc.gov Retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers. Primary Series: The Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY (COVID-19 Vaccine, mRNA) are given for the primary series. Use Pfizer expiration date tool at https://lotexpiry.cvdvaccine.com Check beyond-use date/times Unpunctured vials may be stored between 2C and 8C (36F- 46F) for up to 10 weeks Unpunctured vials may be stored between 8C and 25C (46F and 77F) for a total of 12 hours On April 13, 2022, FDA granted an extension (PDF, 374 KB) for the shelf life of the authorized Pfizer-BioNTech COVID-19 Vaccine.FDA is extending the expiration date of the Pfizer-BioNTech COVID-19 . For additional information about Emergency Use Authorization visit FDA at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization. Symptoms may appear 2 to 14 days after exposure to the virus. FDA extends Pfizer vaccine expiration dates | NCPA Pfizer-BioNTech COVID-19 Vaccine supplied in a multiple dose vial with a purple cap is authorized for use to provide: COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech that is indicated for active immunization to prevent COVID-19 in individuals 12 years of age and older. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of non-serious adverse events that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine. An official website of the United States government, : COVID-19 vaccines authorized under an emergency use authorization do not have fixed expiration dates, and expiration dates may be An extended expiration date means the manufacturer provided data. 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. *Cartons of Pfizer-BioNTech COVID-19 Vaccine multiple dose vials may also arrive at refrigerator temperature 2C to 8C. The VAERS toll-free number is 1-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html. Currently available information is insufficient to determine a causal relationship with the vaccine. Room temperature: Between 15C and 25C (3F and 77F). Each vial must be thawed before dilution. La FDA autoriza vacuna contra el COVID-19 de Pfizer-BioNTech para uso PFIZER.COM. helix-grid, helix-mega-menu, helix-layout-container, helix-core-grid, helix-core-header, helix-core-page-break, helix-core-card-group, helix-core-footer, helix-core-band { Manufacturing. Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine. January 1, 2020: FDA is alerting civilian health care professionals and emergency responders of 2 additional DuoDote lots that are no longer useable and should be properly disposed of. Study BNT162-01 (Study 1) was a Phase 1/2, 2-part, dose-escalation trial that enrolled 60 participants, 18 through 55 years of age. The expiration date for the Pfizer-BioNTech COVID-19 vaccine for children ages 5-11 (orange cap) is NOT printed on the vaccine vial. You may also be given an option to enroll in v-safe. After preparation, each dose of the Pfizer-BioNTech COVID-19 Vaccine supplied in vials with purple caps is 0.3 mL for individuals 12 years of age and older [see Dosage and Administration (2.1)]. Reagent stability studies are needed to support shelf-life expiration dates for in vitro diagnostics (IVDs) authorized under an EUA for emergency use during the COVID-19 pandemic, however they generally do not need to be completed at the time of initial review of the EUA request and/or EUA issuance, but should be initiated immediately following authorization, if not before. body > div[data-webbuilder-block-is-swe] { 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 may not protect all vaccine recipients. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine. Each vial MUST BE DILUTED before administering the vaccine. Vaccine expires 18 months after the manufacture date. FDA will continue to evaluate the available data and provide updated information as soon as possible. If not stored between -90C to -60C (-130F to -76F), vials may be stored at -25C to -15C (-13F to 5F) for up to 2 weeks. You can get COVID-19 through contact with another person who has the virus. 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. The FDA Center for Drug Evaluation and Research (CDER) Division of Product Quality Research analyzes the data and makes decisions regarding shelf life extensions. February 15, 2023: FDA and HHS/ASPR authorized an additional extension to the shelf-life for all lots of the refrigerated GlaxoSmithKline LLCs monoclonal antibody, sotrovimab, from 24 months to 30 months. October 2022 - April 30, 2023. The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Pfizer-BioNTech COVID-19 Vaccine, for active immunization to prevent COVID-19 in individuals 6 months of age and older. 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". July 2, 2021: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. CAN I BE CHARGED AN ADMINISTRATION FEE FOR RECEIPT OF THESE COVID-19 VACCINES? Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older when prepared according to their respective instructions for use can be used interchangeably.2, COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine intended for individuals 12 years of age and older should not be used for individuals 6 months through 11 years of age because of the potential for vaccine administration errors, including dosing errors.3, SUMMARY OF INSTRUCTIONS FOR COVID-19 VACCINATION PROVIDERS. Vials should be discarded 12 hours after dilution.). PFIZER-BIONTECH COVID-19 VACCINE- bnt162b2injection, suspensionPfizer Manufacturing Belgium NV, FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE (VACCINATION PROVIDERS), EMERGENCY USE AUTHORIZATION (EUA) OF THE PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19), PRIMARY SERIES FOR 12 YEARS OF AGE AND OLDER DILUTE BEFORE USE. What is an Emergency Use Authorization (EUA)? The prevalence of anti-SARS-CoV-2 antibodies was 68% (67 of 99 patients) 4 weeks after the third dose. Add 1.8 mL of sterile 0.9% sodium chloride injection, USP. Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients. May 20, 2022: FDA and HHS/ASPR announced the authorization of an extension to the shelf-life from 12 months to 18 months for specific lots of the refrigerated Eli Lilly monoclonal antibody, bebtelovimab, which is currently authorized for emergency use. FDA issued this EUA, based on Pfizer-BioNTech's request and submitted data. 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. In 2018, FDA approved TPOXX (tecovirimat) for treatment of smallpox in adults and children. Schedule Vaccines at GLCP | Grass Lake Community Pharmacy For more information on how to sign up, visit: www.cdc.gov/vsafe. Purple Cap: Monovalent Pfizer-BioNTech COVID-19 Vaccines This product (for ages 12 years and older) is no longer being distributed. An EUA is in effect for the duration of the COVID-19 EUA declaration justifying emergency use of this product, unless terminated or revoked (after which the product may no longer be used). Recently the Food and Drug Administration (FDA) extended the expiration date for Pfizer-BioNTech COVID-19 Vaccine (monovalent and bivalent) from 12 to 18 months from manufacturer date. The diluent (sterile 0.9% Sodium Chloride Injection, USP) contributes an additional 2.16 mg sodium chloride per dose. Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients. We're 67,000 pediatricians committed to the optimal physical, mental, and social health and well-being for all infants, children, adolescents, and young adults. COVID-19 disease is caused by a coronavirus called SARS-CoV-2. Four lots of Paxlovid manufactured prior to the EUA issuance were labeled with a 9-month expiry. A recording of this webinar, slides and Q&A(under Resources tab) are available in CDC TRAIN (free account required). WHAT IS THE COUNTERMEASURES INJURY COMPENSATION PROGRAM? For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination. Please refer to the table on this page for updates. 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. No. endobj From an independent report (Kamar N, Abravanel F, Marion O, et al. From an independent report (Kamar N, Abravanel F, Marion O, et al. Count out 18 months, using the month printed on the vial as month 1. COMIRNATY (COVID-19 Vaccine, mRNA), Pfizer-BioNTech COVID-19 Vaccine, and Pfizer-BioNTech COVID-19 Vaccine, Bivalent include the following ingredients: Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older contains 1 of the following sets of additional ingredients; ask the vaccination provider which version is being administered: Pfizer-BioNTech COVID-19 Vaccine, Bivalent for individuals 12 years of age and older contains the following additional ingredients: COMIRNATY (COVID-19 Vaccine, mRNA) contains 1 of the following sets of additional ingredients; ask the vaccination provider which version is being administered: In clinical trials, approximately 23,000 individuals 12 years of age and older have received at least 1 dose of Pfizer-BioNTech COVID-19 Vaccine. Do not refreeze. The vaccine is administered as a 2-dose series, 3 weeks apart. No cases of Bell's palsy were reported in the placebo group. CPT Codes - Ages 12 & Up Covid-19 Vaccination (Pfizer) 91300 ____ Administration FIRST Dose 0001A____ Administration SECOND Dose 0002A____ Diagnosis Code Encounter for Immunization Z23____ Product Name: COVID 19 Vaccine Mcf: . Shelf-life Extension for the Pfizer Pediatric Vaccine - Iowa May be stored at room temperature (8C to 25C [46F to 77F]) for a total of 12 hours prior to dilution (including thaw time).Thawed vaccine cannot be refrozen. Procedures should be in place to avoid injury from fainting. FDA alerts health care providers and emergency responders of expiration date extension updates for certain auto-injectors manufactured by Meridian Medical Technologies. The Pfizer-BioNTech COVID-19 Vaccine is a suspension for intramuscular injection. Fact Sheet for Healthcare Providers Administering Vaccine - Novavax, Janssen COVID-19 Vaccine Storage and Handling Summary, COVID-19 Vaccine Lot Number and Expiration Date Report, COVID-19 Vaccine Quick Reference Guide for Healthcare Professionals, COVID-19 Vaccine Lot Number and Expiration Date Report from the CDC. 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. Vials stored at -25C to -15C (-13F to 5F) for up to 2 weeks may be returned one time to the recommended storage condition of -90C to -60C (-130F to -76F). Please note: the ultra-cold temperature range has been broadened to include-90 C (-130F). 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. [Note: this guidance was finalized on April 24, 2019.] In addition, the FDA decision is based on the totality of the scientific evidence available showing that the product may be effective to prevent COVID-19 during the COVID-19 pandemic and that the known and potential benefits of the product outweigh the known and potential risks of the product. 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. Individuals becoming aware of any potential violations of the CDC COVID-19 Vaccination Program requirements are encouraged to report them to the Office of the Inspector General, U.S. Department of Health and Human Services, at 1-800-HHS-TIPS or https://TIPS.HHS.GOV. Following approval, the FDA revised its fact sheet for health care providers administering vaccines to note cartons and vials of the Pfizer vaccine with an expiration date of August 2021 through . At the time of the analysis of Study 2 for the EUA, 37,586 [18,801 Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA) and 18,785 placebo] participants 16 years of age or older had been followed for a median of 2 months after the second dose. The site is secure. CN&0: September 2022 - March 31, 2023. The Countermeasures Injury Compensation Program (CICP) is a federal program that may help pay for costs of medical care and other specific expenses of certain people who have been seriously injured by certain medicines or vaccines, including these vaccines. The Secretary of Health and Human Services (HHS) has declared a public health emergency that justifies the emergency use of drugs and biological products during the COVID-19 pandemic. You can find the latest versions of these browsers at https://browsehappy.com. Each vial must be thawed before dilution. The efficacy information in adolescents 12 through 15 years of age is presented in Table 9. } :v9dvVe0NK2+ Please refer to the table on this page for the new updates. If an ultra-low temperature freezer is not available, the thermal container in which the Pfizer-BioNTech COVID-19 Vaccine arrives may be used as temporary storage when consistently re-filled to the top of the container with dry ice. The possible side effects of these vaccines are still being studied. Checker webpage to confirm expiration dates. The vaccine expires on the last day of the 18th month. If not stored between -90C to -60C (-130F to -76F), vials may be stored at -25C to -15C (-13F to 5F) for up to 2 weeks. (Federal Register notice). 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#). Any vaccine remaining in vials must be discarded after 6 hours. c|D|b9P$AMXb.a }, Special characters (commas, /, *, &) are not allowed in the Lot numbers. People with COVID-19 have had a wide range of symptoms reported, ranging from mild symptoms to severe illness leading to death. The FDA has approved an extension to the amendment to the EUA for expiration dates for the Pfizer-BioNTech COVID-19 vaccine. The manufacture date is printed on the vial (gray cap). You are being offered either COMIRNATY (COVID-19 Vaccine, mRNA), the Pfizer-BioNTech COVID-19 Vaccine, or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), hereafter referred to as the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, to prevent Coronavirus Disease 2019 (COVID-19) caused by SARS-CoV-2. Refer to the re-icing guidelines packed in the original thermal container for instructions regarding the use of the thermal container for temporary storage. May 12, 2022: Statement Regarding Shelf-Life Extension of Sotrovimab (from HHS/ASPR and FDA) On September 21, 2021, FDA and ASPR authorized an extension of the shelf-life from 12 months to 18 months for all lots of the refrigerated GSK monoclonal antibody, sotrovimab. If received at 2C to 8C, they should be stored at 2C to 8C.
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