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. The manufacture date is printed on the vial (dark blue cap) and carton. Refrigerated at 2C and 8C (36F and 46F) for up to 10 weeks. 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. 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. Vial labels and cartons may state that after dilution, a vial contains 5 doses of 0.3 mL. of Insurance Complaint Resource, Creating Health: Lifestyle & Weight Management, Diabetes Self-Management Education (DSME), NCPA Innovation Center/ CPESN Community Pharmacy Fellowship. 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. Shelf-life expiration dates have been extended multiple times as additional data becomes available. ,W7@M"NV?lG=nVk`SJt*"75Nry"E"nP8%T&v:$'4B5 "WY2Vvf5,psc=l(Zb0|4;"on#t|uL;5p~hn;ZVAJ0yTL)L/d)K.>gb[>FpZ[LRJaRjm7v(HU{K\:{g_%N;plI|~j-;||O-RqISR0jJc[:E*\CB8 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)]. Generally, a claim must be submitted to the CICP within one (1) year from the date of receiving the vaccine. The thermal container maintains a temperature range of -90C to -60C (-130F to -76F). 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. Irrespective of the type of syringe and needle: 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 Full EUA Prescribing Information). https://www.cdc.gov/coronavirus/2019-ncov/index.html. 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. In most of these people, symptoms began within a few days following receipt of the second dose of vaccine. endstream endobj 158 0 obj <>stream As a result of this extension, some batches may be stored for longer from the labeled date of expiry (see Table 1 below). For more information on EUA, see the "What is an Emergency Use Authorization (EUA)?" Refrigerated 2C to 8C (36F to 46F) for up to 6 hoursDiscard 6 hours after puncturing vial. (Federal Register notice). 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. <>/Metadata 258 0 R/ViewerPreferences 259 0 R>> When you get your first COVID-19 vaccine, you will get a vaccination card. SARS-CoV-2 neutralization assay - NT50 (titer). 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). 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#). WHAT YOU NEED TO KNOW BEFORE YOU GET ANY OF THESE VACCINES. Millions of individuals have received the Pfizer-BioNTech COVID-19 Vaccine under EUA since December 11, 2020. Printed Expiry Date Table 7 presents the specific demographic characteristics in the studied population. A carton 0f 10 multiple-dose vials may take up to 6hours to thaw at this temperature. Youll find additional information on Pfizer storage and handling here. The Office of Counterterrorism and Emerging Threats (OCET) collaborates with FDA Centers and federal partners to facilitate access to MCMs. Refrigerated at 2C and 8C (36F and 46F) for up to 10 weeks. 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#). MANDATORY REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINE ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION4. INFORMATION TO PROVIDE TO VACCINE RECIPIENTS/CAREGIVERS. People with COVID-19 have reported a wide range of symptoms, ranging from mild symptoms to severe illness. Do not add more than 1.8 mL of diluent. September 20, 2017: CDC and FDA hosted a webinar to discuss FDAs April 2017 draft guidance Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles. V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. 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 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. Before PAHPRA, the distribution, dispensing, or use of products with extended expiry, and any related labeling adjustments, were possible through an EUA or FDA enforcement discretion. 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. The following adverse reactions have been identified during post authorization use of Pfizer-BioNTech COVID-19 Vaccine. 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. The FDA has approved an extension to the amendment to the EUA for expiration dates for the Pfizer-BioNTech COVID-19 vaccine. States may contact their MCM Specialist or email preparedness@cdc.gov or sns.ops@cdc.gov to confirm the new extended dates for their antiviral drug inventories eligible for extension. The beyond-use time (12 hours) replaces the manufacturer's expiration date but NEVER extends it. As soon as you land on the tool page, You will have to enter 2 things. Pfizer-BioNTech COVID-19 Vaccine, Multiple Dose Vial with Purple Cap, Refer to the re-icing guidelines packed in the original thermal container for instructions regarding the use of the thermal container for temporary storage, Do not use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent, Pfizer-BioNTech COVID-19 Vaccine Vial with Purple Cap . This EUA for the Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY (COVID-19 Vaccine, mRNA) will end when the Secretary of HHS determines that the circumstances justifying the EUA no longer exist or when there is a change in the approval status of the product such that an EUA is no longer needed. Refrigerated (thawed vials) at 2C and 8C (36F and 46F) for up to 10 weeks. The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine authorized under Emergency Use Authorization (EUA) for individuals 12 years of age and older, when prepared according to their respective instructions for use, can be used interchangeably. Purple Cap: Monovalent Pfizer-BioNTech COVID-19 Vaccines This product (for ages 12 years and older) is no longer being distributed. 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. Based on the date the vaccine was placed in the refrigerator, the . Demographic characteristics in Study 2 were generally similar with regard to age, gender, race, and ethnicity among adolescents who received Pfizer-BioNTech COVID-19 Vaccine and those who received placebo. November 2022 - May 31, 2023. COVID-19 vaccines authorized under an emergency use authorization do not have fixed expiration dates, and expiration dates may be This posting and memorandum replace FDAs March 23, 2018, posting and all previous FDA web postings and memoranda notifying health care professionals and emergency responders about the expiration dating of such auto-injectors. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The vaccine expires on the last day of the 18th month. You should not get any of these vaccines if you: WHAT ARE THE INGREDIENTS IN THESE VACCINES? The duration of protection against COVID-19 is currently unknown. For the most recent Fact Sheet, please see www.cvdvaccine.com. The extended expiration date is effective immediately for all currently available batches that have not yet expired. Retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 1.74MB) and the Letter of Authorization for Emergency Use Authorization (EUA) 091 (PDF, 1.03MB). 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. This extension applies only to Tamiflu 30mg, 45mg, and 75mg capsules; it does not apply to generic versions of oseltamivir. 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 10-week refrigerated expiry date should be recorded on the carton at the time of transfer.Thawed vaccine cannot be refrozen. The FDA Center for Drug Evaluation and Research (CDER) Division of Product Quality Research analyzes the data and makes decisions regarding shelf life extensions. The observed risk is higher among adolescent males and adult males under 40 years of age than among females and older males. 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. Get the latest news from the AAP including press statements, the AAP Voices Blog, the Pediatrics OnCall Podcast and more! If received at 2C to 8C, they should be stored at 2C to 8C. The .gov means its official.Federal government websites often end in .gov or .mil. 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. Note: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination. After dilution, 1 vial contains 6 doses of 0.3 mL. 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. The Pfizer-BioNTech COVID-19 Vaccine is a suspension for intramuscular injection. Checker webpage to confirm expiration dates. Pfizer-BioNTech COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older. There may be clinical trials or availability under EUA of other COVID-19 vaccines. Dilute with 1.8 mL sterile 0.9% Sodium Chloride Injection, USP prior to use. If received at 2C to 8C, they should be stored at 2C to 8C. Simply follow the below-given step-by-step tutorial to find the expiry date of your Pfizer COVID vaccine. endobj 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. 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. No. This diluent is not packaged with the vaccine and must be sourced separately. However, stakeholders that apply this extension to their stockpiled products should clearly note in their stockpiles that FDA has allowed for its extension (e.g., by placing a placard on the outside of a pallet or shipping box). 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. FK5127. V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. Providers should track these time frames. Retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 1.38 MB) and the Letter of Authorization (PDF, 488 KB). 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". After dilution, 1 vial contains 6 doses of 0.3 mL. <> Access to this report is strictly managed by registration only. 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. 4 0 obj If you are considering receiving COMIRNATY (COVID-19 Vaccine, mRNA), the Pfizer-BioNTech COVID-19 Vaccine, or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent with other vaccines, discuss your options with your healthcare provider. Study 2 is a multicenter, multinational, Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in participants 12 years of age and older. 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. June 28, 2022: FDA and HHS/ASPR announced the authorization of an extension to the shelf-life from 18 months to 24 months for specific lots of the refrigerated AstraZeneca monoclonal antibody therapy, Evusheld (tixagevimab co-packaged with cilgavimab), which is currently authorized for emergency use for pre-exposure prophylaxis of COVID-19 in certain adults and pediatric individuals. Refrigerator: Between 2C and 8C (36F and 46F). This EUA Prescribing Information pertains only to Pfizer-BioNTech COVID-19 Vaccine supplied in a multiple dose vial with a purple cap, which is authorized for use in individuals 12 years of age and older. 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 . Dates: Are the intervals between the doses of Moderna or Pfizer vaccinations within the appropriate intervals, approximately 21 days apart for the Pfizer vaccination and approximately (within. :v9dvVe0NK2+ Room temperature: Between 15C and 25C (3F and 77F). Cardiac Disorders: myocarditis, pericarditis, Gastrointestinal Disorders: diarrhea, vomiting, Immune System Disorders: severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (e.g., rash, pruritus, urticaria, angioedema), Musculoskeletal and Connective Tissue Disorders: pain in extremity (arm), Nervous System Disorders: syncope, dizziness. Myocarditis and pericarditis have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine. Two vaccines can be given in one appointment. To find the expiry date on your product, please download the data tables (by date or by batch number). Sign In. The formulation supplied in a multiple dose vial with a gray cap and label with a gray border IS NOT DILUTED PRIOR TO USE. For more information about IISs visit: https://www.cdc.gov/vaccines/programs/iis/about.html. 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. MCM Legal, Regulatory and Policy Framework, Recalls, Market Withdrawals and Safety Alerts, MCM Legal, Regulatory and Policy Framework, MCM-Related Legal and Policy Presentations, Publications and Q&As, State, Tribal, Local, and Territorial Public Health Preparedness, Guidance and Other Information of Special Interest to MCM Stakeholders, Availability of Regulatory Management Plans, Vaccine EUA Questions and Answers for Stakeholders. Syncope (fainting) may occur in association with administration of injectable vaccines, in particular in adolescents. Do NOT use vaccine if the expiration date or beyond-use time has passed. 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. Fierce Biotech. https://www.pfizer.com/products/information. Primary Series: The Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY (COVID-19 Vaccine, mRNA) are given for the primary series. 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. The AAP is dedicated to the health of all children and the pediatric professionals who care for them. The vaccine can be used for the full 10 . There is no information on the co-administration of the Pfizer-BioNTech COVID-19 Vaccine with other vaccines. Therefore, REGEN-COV may not be administered for treatment or post-exposure prevention of COVID-19 under the EUA until further notice by the Agency. Please note: the ultra-cold temperature range has been broadened to include-90 C (-130F). This Fact Sheet may have been updated. >l$GO}Un}};]3kvpM[Ogw},O/ge_ua?&mwvGn/WyI}&^ccV.v[:Y~,pb~?+ Pull back plunger to 1.8 mL to remove air from vial. 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. Vaccinations may not provide full immunity to COVID-19 in people who are immunocompromised, and you should continue to maintain physical precautions to help prevent COVID-19. 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. Expiry Checker: Janssen COVID-19 Vaccine Under Emergency Use Authorization. April 25, 2017: FDA announced the availability of a draft guidance for government public health and emergency response stakeholders entitled Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles. 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. L 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. c Regardless of storage condition, vaccines should not be used after 12 months from the date of manufacture printed on the vial and cartons. 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 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. Note: Events and use of antipyretic or pain medication were collected in the electronic diary (e-diary) from Day 1 to Day 7 after each dose. 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. 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. Vaccination providers enrolled in the federal COVID-19 Vaccination Program must report all vaccine administration errors, all serious adverse events, cases of myocarditis, cases of pericarditis, cases of Multisystem Inflammatory Syndrome (MIS) in adults and children, and cases of COVID-19 that result in hospitalization or death following administration of Pfizer-BioNTech COVID-19 Vaccine. In response, FDA has issued an EUA for the unapproved product, Pfizer-BioNTech COVID-19 Vaccine, and for certain uses of FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19. display: contents; 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. 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. KmX;@=VP$Zx_[9AA1&3. The information in this section applies to the Pfizer-BioNTech COVID-19 Vaccine that is supplied in multiple dose vials with a purple cap. Always use the earliest date. Vials must reach room temperature before dilution. Recognizing stakeholders MCM stockpiling challenges, FDA is engaged, when appropriate, in various expiration dating extension activities as described below.