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Refrigerated at 2C and 8C (36F and 46F) for up to 10 weeks. There were no notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine. 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 0.1% of placebo recipients. PDF IMMUNIZATION COVID-19 UPDATE - Louisiana Department of Health The manufacture date is printed on the vial (gray cap). For the most recent Fact Sheet, please see www.cvdvaccine.com. Storage and Handling Overview Ensure staff are knowledgeable about correct storage of the vaccines. 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. 2023 National Community Pharmacists Association, FDA extends Pfizer vaccine expiration dates, The FDA has approved an extension to the amendment to the EUA for expiration dates for the Pfizer-BioNTech COVID-19 vaccine. 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 observed risk is highest in males 12 through 17 years of age. 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. 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. Vials should be discarded 12 hours after dilution. For immediate use, thaw undiluted vials at room temperature [up to 25C (77F)] for 30 minutes. Available Vaccines for COVID-19 include: PFIZER's NEW BOOSTER & MODERNA's NEW BOOSTER Appointment * Name * First Name Last Name Date of Birth * Month Day Year Phone Number * Please enter a valid phone number. 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. Once received, remove the vial cartons immediately from the thermal container and preferably store in an ultra-low temperature freezer between -90C to -60C (-130F to -76F) until the expiry date printed on the label. August 23, 2021. Count out 18 months, using the month printed on the vial as month 1. As the vaccination provider, you must communicate to the recipient or their caregiver, information consistent with the "Vaccine Information Fact Sheet for Recipients and Caregivers" (and provide a copy or direct the individual to the website www.cvdvaccine.com to obtain the Vaccine Information Fact Sheet for Recipients and Caregivers) prior to the individual receiving each dose of the Pfizer-BioNTech COVID-19 Vaccine, including: For information on clinical trials that are testing the use of the Pfizer-BioNTech COVID-19 Vaccine to prevent COVID-19, please see www.clinicaltrials.gov. SARS-CoV-2 neutralization assay - NT50 (titer). Allow vial(s) to thaw at room temperature [up to 25C (77F)] for 30 minutes. Thawed vials can be handled in room light conditions. This authorization is based on safety and effectiveness data in this age group and adults. The study excluded participants who were immunocompromised and those who had previous clinical or microbiological diagnosis of COVID-19. Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients. July 26, 2022 When FDA first issued the EUA authorizing Paxlovid (nirmatrelvir tablets and ritonavir tablets co-packaged for oral use), it established a 12-month product shelf-life. Vaccine may be thawed in the refrigerator or at room temperature. 7`xk j "d%%%%`2sA09!--psT(r9e"GQ(r9:_E9+]P+{W]wE = FOi4x= FOi4xX,2H}6i[}oim ~pi>_ ?# 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."&| As a result of this extension, some batches may be stored for an additional 6 months from the labeled date of expiry. A product authorized for emergency use has not undergone the same type of review by FDA as an FDA-approved product. Four lots of Paxlovid manufactured prior to the EUA issuance were labeled with a 9-month expiry. 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. Each vial must be thawed before dilution. After dilution, vials of Pfizer-BioNTech COVID-19 Vaccine with purple caps contain 6 doses of 0.3 mL of vaccine. Generally, a claim must be submitted to the CICP within one (1) year from the date of receiving the vaccine. Do NOT use vaccine if the expiration date or beyond-use time has passed. June 3, 2020: On February 11, 2020, 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. May be stored at room temperature (8C to 25C [46F to 77F]) for a total of 12 hours prior to dilution (including thaw time). Sign up to receive email alerts on emergency preparedness and response topics from FDA, including medical countermeasures and emerging infectious diseases. In these analyses, 91.6% of study participants had at least 30 days of follow-up after Dose 2. 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. Your close contacts should be vaccinated as appropriate. The modRNA in the Pfizer-BioNTech COVID-19 Vaccine is formulated in lipid particles, which enable delivery of the RNA into host cells to allow expression of the SARS-CoV-2 S antigen. Two vaccines can be given in one appointment. Pfizer-BioNTech COVID-19 Lot Expiry The FDA Center for Drug Evaluation and Research (CDER) Division of Product Quality Research analyzes the data and makes decisions regarding shelf life extensions. Vial contains 1 dose FK5127. Frozen vials stored at -25C to -15C and refrigerated vials (2C to 8C) are NOT eligible for extension. Randomization was stratified by age: 12 through 15 years of age, 16 through 55 years of age, or 56 years of age and older, with a minimum of 40% of participants in the 56-year stratum. Room temperature: Between 15C and 25C (3F and 77F). For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination. In these analyses, 91.6% of study participants had at least 30 days of follow-up after Dose 2. To find the expiry date on your product, please download the data tables (by date or by batch number). Currently available information is insufficient to determine a causal relationship with the vaccine. Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients. You should not get any of these vaccines if you: WHAT ARE THE INGREDIENTS IN THESE VACCINES? Tables 1 through 6 present the frequency and severity of solicited local and systemic reactions, respectively, within 7 days following each dose of Pfizer-BioNTech COVID 19 Vaccine and placebo. Pfizer-BioNTech COVID-19 Vaccine at least 3 to 8 weeks after the first dose. Refrigerator: Between 2C and 8C (36F and 46F). 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. To help prepare for public health emergencies, medical countermeasures (MCMs) may be stockpiled by governments and even by some private sector partners. Do not discard vaccine without ensuring the expiration date has passed. The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients. display: contents; Simply follow the below-given step-by-step tutorial to find the expiry date of your Pfizer COVID vaccine. Participants are planned to be followed for up to 24 months, for assessments of safety and efficacy against COVID-19. Patients should still be counselled to maintain physical precautions to help prevent COVID-19. Solicited Local and Systemic Adverse Reactions. No. <> [Note: this guidance was finalized on April 24, 2019.] As noted below, the Tamiflu extensions do not apply to generic versions of oseltamivir. In some cases, the expiration date for a test may be extended. a 2-dose primary series to individuals 12 years of age and older; and. At this time, the provider cannot charge you for a vaccine dose and you cannot be charged an out-of-pocket vaccine administration fee or any other fee if only receiving a COVID-19 vaccination. This reflects the time period during which the product is expected to remain stable, or retain its identity, strength, quality, and purity, when it is properly stored according to its labeled storage conditions. Count out 18 months, using the month printed on the vial as month 1. Read below to find the specifics on COVID-19 vaccine storage and expiry. For more information about CICP regarding the Pfizer-BioNTech COVID-19 Vaccine used to prevent COVID-19, visit www.hrsa.gov/cicp/, email cicp@hrsa.gov, or call: 1-855-266-2427. See Overall Safety Summary (Section 6) for additional information. 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. When shelf-life expiration dates are extended for devices that have already been distributed, the IVD manufacturer typically sends a notice to customers to inform them of the extension so they are aware of how long they can continue to use in-stock devices. 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. 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. CAN I BE CHARGED AN ADMINISTRATION FEE FOR RECEIPT OF THESE COVID-19 VACCINES? In order to mitigate the risks of using this unapproved product under EUA and to optimize the potential benefit of Pfizer-BioNTech COVID-19 Vaccine, the following items are required. N Engl J Med), a single arm study has been conducted in 101 individuals who had undergone various solid organ transplant procedures (heart, kidney, liver, lung, pancreas) 978 months previously. FDA alerts health care providers and emergency responders of expiration date extension updates for certain auto-injectors manufactured by Meridian Medical Technologies. Vial labels and cartons may state that after dilution, a vial contains 5 doses of 0.3 mL. PFIZER.COM. Pfizer-BioNTech COVID -19 Vaccine Products . Refrigerated 2C to 8C (36F to 46F) for up to 6 hoursDiscard 6 hours after puncturing vial. Pfizer Expiration Date Lookup Tutorial - All Latest Updates SLEP is the federal, fee-for-service program through which the labeled shelf life of certain federally stockpiled medical materiel (e.g., in the SNS) can be extended after select products undergo periodic stability testing conducted by FDA. It does not start in Purple Cap: Monovalent Pfizer-BioNTech COVID-19 Vaccines This product (for ages 12 years and older) is no longer being distributed. After dilution, 1 vial contains 6 doses of 0.3 mL. Fierce Life Sciences Events. Janssen COVID-19 Vaccine Expiry Checker This includes working to ensure that MCM-related policy supports programs like SLEP. 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. The vial stoppers are not made with natural rubber latex. Of the total number of Pfizer-BioNTech COVID-19 Vaccine recipients in Study 2 (N=20,033), 21.4% (n=4,294) were 65 years of age and older and 4.3% (n=860) were 75 years of age and older. In clinical studies of participants 16 years of age and older who received Pfizer-BioNTech COVID-19 Vaccine containing 30 mcg of a nucleoside-modified messenger RNA encoding the viral spike (S) glycoprotein of SARS-CoV-2 (30 mcg modRNA), adverse reactions following administration of the primary series included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%). Allow vials to thaw at room temperature for 30 minutes. The chance of having this occur is very low. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. A descriptive efficacy analysis of Study 2 has been performed in approximately 2,200 adolescents 12 through 15 years of age evaluating confirmed COVID-19 cases accrued up to a data cutoff date of March 13, 2021. Some vials also may have a purple label border on the label. endstream endobj 159 0 obj <>stream Any hours used for transport at -25C to -15C (-13F to 5F) count against the 2-week limit for storage at -25C to -15C (-13F to 5F). Marketing. Symptoms may appear 2 to 14 days after exposure to the virus. Participants are being monitored for unsolicited adverse events, including serious adverse events, throughout the study [from Dose 1 through 1 month (all unsolicited adverse events) or 6 months (serious adverse events) after the last vaccination]. This Vaccine Information Fact Sheet for Recipients and Caregivers comprises the Fact Sheet for the authorized Pfizer-BioNTech COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, and also includes information about the U.S. Food and Drug Administration (FDA)-licensed vaccine, COMIRNATY (COVID-19 Vaccine, mRNA) for use in individuals 12 years of age and older9. A third primary series dose may be administered at least 4 weeks after the second dose to individuals with certain kinds of immunocompromise. 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. November 26, 2019: This posting and FDAs November 18, 2019, memorandum (PDF, 230 KB) provide expiration dating updates for health care professionals and emergency responders for certain lots of MMT AtroPen (atropine), CANA (diazepam), DuoDote, Morphine Sulfate, and Pralidoxime Chloride auto-injectors for use during nerve agent emergencies. Advise recipient or caregiver that more information about IISs can be found at: https://www.cdc.gov/vaccines/programs/iis/about.html. The updated 12-hour timeline from the Fact Sheet supersedes the number of hours printed on vial labels and cartons. Sign In. This Fact Sheet may have been updated. Frozen vials stored at -25C to -15C and refrigerated vials (2C to 8C) are, State Dept. FDA is not requiring or recommending that such stockpiled Tamiflu or Relenza product be relabeled with the new use date. This authority is limited to medical products for CBRN emergencies. The vaccination provider may include your vaccination information in your state/local jurisdiction's Immunization Information System (IIS) or other designated system. endstream endobj 158 0 obj <>stream Checker webpage to confirm expiration dates. Please include either "COMIRNATY (COVID-19 Vaccine, mRNA)", "Pfizer-BioNTech COVID-19 Vaccine EUA", or "Pfizer-BioNTech COVID-19 Vaccine, Bivalent EUA" as appropriate, in the first line of box #18 of the report form. Although some cases required intensive care support, available data from short-term follow-up suggest that most individuals have had resolution of symptoms with conservative management. Also see: Expiration date extensions of certain lots of doxycycline hyclate. Vial labels and cartons may state that a vial should be discarded 6 hours after the first puncture. In Study 2, all participants 12 through 15 years of age, and 16 years of age and older in the reactogenicity subset, were monitored for solicited local and systemic reactions and use of antipyretic medication after each vaccination in an electronic diary. ARE OTHER CHOICES AVAILABLE FOR PREVENTING COVID-19 BESIDES COMIRNATY (COVID-19 VACCINE, mRNA), THE PFIZER-BIONTECH COVID-19 VACCINE, OR THE PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT? It is approved as a 2-dose series for prevention of COVID-19 in individuals 12 years of age and older. Kindly take a deep look at the above given updated expiry of Pfizer vaccines. FK5127 HIGH TOXICITY WARNING Vaccines possessing these codes may result in a HIGH risk of DEATH, DISABILITY or SERIOUS ILLNESS . In most of these people, symptoms began within a few days following receipt of the second dose of vaccine. FDA will not take enforcement action with regard to the storage or emergency use of these lots of Tamiflu capsules, provided that the products have been stored under labeled storage conditions. vaccine's BUD is 2/12/2023. Cartons and vials of Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with purple caps with an expiry date of December 2021 through December 2022 printed on the label may remain in use beyond the printed date until the updated expiry date shown below; as long as approved storage conditions have been maintained. Theres a place for you in the Academy no matter where you are in your career. Please see the REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS section for details on reporting to VAERS and Pfizer Inc. The above-given button will directly take you to the official website of Pfizer, and the tool is also launched by the . A carton of 10 vials may take up to 4 hours to thaw at refrigerator temperature (2C to 8C [35F to 46F]). WHERE CAN I REPORT CASES OF SUSPECTED FRAUD? Expiry Checker: Janssen COVID-19 Vaccine Under Emergency Use Authorization. HOWEVER, with this extension, the expiration date is now AFTER the BUD. TERMS OF USE. 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". 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. All pregnancies have a risk of birth defect, loss, or other adverse outcomes. Storage of the vials between -96C to -60C (-141F to -76F) is not considered an excursion from the recommended storage condition. 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. Adverse reactions following administration of the Pfizer-BioNTech COVID-19 Vaccine that have been reported in clinical trials include injection site pain, fatigue, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, malaise, lymphadenopathy, decreased appetite, rash, and pain in extremity (see Full EUA Prescribing Information). Pfizer-biontech Covid-19 Vaccine 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 . Pfizer-BioNTech COVID-19 Vaccine | Pfizer Retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 1.4MB) and the Letter of Authorization (PDF, 375KB). People with COVID-19 have reported a wide range of symptoms, ranging from mild symptoms to severe illness. Healthcare providers must enroll as providers in the Vaccination Program and comply with the provider requirements. 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. 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. Count out 18 months, using the month printed on the vial as month 1. Pfizer-BioNTech COVID-19 Vaccine is a suspension for injection. This finalizes the draft guidance published on April 25, 2017. <> These vaccines do not contain SARS-CoV-2 and cannot give you COVID-19. 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. This extension applies to all unopened vials of bebtelovimab that have been held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 433 KB) and the EUA Letter of Authorization (PDF, 111 KB) for bebtelovimab. Home Page - COVID-19 VACCINE LOT NUMBER AND EXPIRATION DATES WHERE WILL MY VACCINATION INFORMATION BE RECORDED? Please note: the ultra-cold temperature range has been broadened to include-90 C (-130F). 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. As the expiration date approaches, contact the manufacturer to determine if it has been extended. Get the latest news from the AAP including press statements, the AAP Voices Blog, the Pediatrics OnCall Podcast and more! Please enter another Lot # or contact Pfizer Customer Service at8006667248, option 8 OR [emailprotected]. 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#). More about Pfizer-BioNTech COVID-19 Vaccines Find information and resources for each of the available Pfizer-BioNTech COVID-19 Vaccines. FDA has authorized Pfizer-BioNTech COVID-19 Vaccine, Bivalent to provide better protection against COVID-19 caused by the Omicron variant of SARS-CoV-2. During the visual inspection. 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. H310F@lpXBU / endstream endobj 72 0 obj <>/Metadata 3 0 R/OpenAction 73 0 R/Outlines 7 0 R/PageLayout/SinglePage/Pages 69 0 R/StructTreeRoot 12 0 R/Type/Catalog/ViewerPreferences<>>> endobj 73 0 obj <> endobj 74 0 obj <. PDF Pfizer Batch Codes and Toxicity Levels - FrihedsBevgelsens Fllesrd Sorry! Pfizer-BioNTech COVID-19 Vaccine is authorized for use in individuals 6 months through 17 years of age. May be stored at room temperature (8C to 25C [46F to 77F]) for a total of 12 hours prior to dilution (including thaw time). FDA will continue to evaluate the available data and provide updated information as soon as possible. Pfizer-BioNTech vaccine expiration date extension and beyond-use date Some vaccine storage conditions are associated with beyond-use dates and times. No vaccine-related adverse effects on female fertility, fetal development, or postnatal development were reported in the study. V-safe also provides second-dose reminders if needed and live telephone follow-up by CDC if participants report a significant health impact following COVID-19 vaccination. 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). 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 FDA has approved an extension to the amendment to the EUA for expiration dates for the Pfizer-BioNTech COVID-19 vaccine. Under the EUA, it is your choice to receive or not receive any of these vaccines. The manufacture date is printed on the vial (dark blue cap) and carton. This draft guidance was prepared in response to requests from States asking FDA what would be necessary to provide confidence that stockpiled doxycycline tablets and capsules have retained their original quality beyond the manufacturers labeled expiration date so the replacement of stockpiled product could be deferred. Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine. Heres an FDA fact sheet for vaccination providers. Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. October 2022 - April 30, 2023. >l$GO}Un}};]3kvpM[Ogw},O/ge_ua?&mwvGn/WyI}&^ccV.v[:Y~,pb~?+ [-130F to -76F]). The top 15 blockbuster patent expirations coming this decade The duration of protection against COVID-19 is currently unknown. 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. For the most recent Fact Sheet, please see www.cvdvaccine.com. 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.