Note: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination. 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). In Study 2, an analysis of SARS-CoV-2 50% neutralizing titers (NT50) 1 month after Dose 2 in a randomly selected subset of participants demonstrated non-inferior immune responses (within 1.5-fold) comparing adolescents 12 through 15 years of age to participants 16 through 25 years of age who had no serological or virological evidence of past SARS-CoV-2 infection up to 1 month after Dose 2 (Table 10). Access to this report is strictly managed by registration only. Each 0.3 mL dose of the Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with purple caps also includes the following ingredients: lipids (0.43 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.2 mg cholesterol), 0.01 mg potassium chloride, 0.01 mg monobasic potassium phosphate, 0.36 mg sodium chloride, 0.07 mg dibasic sodium phosphate dihydrate, and 6 mg sucrose. Pfizer-BioNTech COVID-19 Vaccine Vial with Purple Cap WITHDRAWAL OF INDIVIDUAL 0.3 mL DOSES. 'g}/kM&Mg a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. In most of these people, symptoms began within a few days following receipt of the second dose of vaccine. N Engl J Med), Table 5: Study 2 Frequency and Percentages of Adolescents With Solicited Local Reactions, by Maximum Severity, Within 7 Days After Each Dose Adolescents 12 Through 15 Years of Age Safety Population, Table 6: Study 2 Frequency and Percentages of Adolescents with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose Adolescents 12 Through 15 Years of Age Safety Population, Table 7: Demographics (population for the primary efficacy endpoint), Table 8: Vaccine Efficacy First COVID-19 Occurrence From 7 Days After Dose 2, by Age Subgroup Participants Without Evidence of Infection and Participants With or Without Evidence of Infection Prior to 7 Days After Dose 2 Evaluable Efficacy (7 Days) Population, First COVID-19 occurrence from 7 days after Dose 2 in participants without evidence of prior SARS-CoV-2 infection, Table 9: Vaccine Efficacy First COVID-19 Occurrence From 7 Days After Dose 2: Without Evidence of Infection and With or Without Evidence of Infection Prior to 7 Days After Dose 2 Blinded Placebo-Controlled Follow-up Period, Adolescents 12 Through 15 Years of Age Evaluable Efficacy (7 Days) Population, 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, Table 10: Summary of Geometric Mean Ratio for 50% Neutralizing Titer Comparison of Adolescents 12 Through 15 Years of Age to Participants 16 Through 25 Years of Age (Immunogenicity Subset) Participants Without Evidence of Infection up to 1 Month After Dose 2 Dose 2 Evaluable Immunogenicity Population, 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 older. Click here to view this information in a table. A product authorized for emergency use has not undergone the same type of review by FDA as an FDA-approved product. The extended expiry date for each lot can be found in Table 1 below. The formulation supplied in a multiple dose vial with a gray cap and label with a gray border IS NOT DILUTED PRIOR TO USE. Storage and Handling of Pfizer-BioNTech COVID-19 Vaccines Dilute with 1.8 mL sterile 0.9% Sodium Chloride Injection, USP prior to use. For information on clinical trials that are testing the use of the Pfizer-BioNTech COVID-19 Vaccine for active immunization to prevent COVID-19, please see www.clinicaltrials.gov. COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine, when prepared according to their respective instructions for use, can be used interchangeably. The expiration date for the Pfizer-BioNTech COVID-19 vaccine for children ages 5-11 (orange cap) . 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. More information, April 2019 guidance: Extending Expiration Dates of Stockpiled Doxycycline for Anthrax Preparedness, Expiration date extensions of certain lots of doxycycline hyclate, February 10, 2023: Update on Expiration Date Extensions of Certain Lots of Doxycycline Hyclate 100 mg Capsules Held in Strategic Stockpiles (PDF, 221 KB) - On February 1, 2023, FDA issued a memo to government public health and emergency response stakeholders providing an important update about expiration date extensions of certain lots of doxycycline hyclate 100 mg capsules manufactured by West-Ward Pharmaceuticals (West-Ward) held in strategic stockpiles for anthrax emergency preparedness and response purposes. These multiple dose vials are supplied in a carton containing 25 multiple dose vials (NDC 59267-1000-3) or 195 multiple dose vials (NDC 59267-1000-2). 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. Sign In. Symptoms may appear 2 to 14 days after exposure to the virus. Severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (e.g., rash, pruritus, urticaria, angioedema), diarrhea, vomiting, pain in extremity (arm), syncope, and dizziness have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine. 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: . 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. Millions of individuals have received the Pfizer-BioNTech COVID-19 Vaccine under EUA since December 11, 2020. PDF Child COVID-19 Vaccine Administration Record - Revize Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine. 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. For patients for whom enrollment in this trial is not feasible (e.g., a clinical trial site is not geographically accessible), use of tecovirimat under CDCs expanded access protocol (EA-IND) should be consistent with CDCs guidelines for tecovirimat use. Vials must be kept frozen and protected from light, in the original cartons, until ready to use. The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients. May be stored at room temperature (8C to 25C [46F to 77F]) for a total of 12 hours prior to dilution (including thaw time). 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. Other vaccines to prevent COVID-19 may be available under EUA, including bivalent vaccines that contain an Omicron component of SARS-CoV-2. 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. Undiluted vials may be stored at room temperature for no more than 2 hours. Provide the v-safe information sheet to vaccine recipients/caregivers and encourage vaccine recipients to participate in v-safe. endobj } The expiry date on the vaccine vile might be different as compared to the online platform. The 24-month expiry date is based on the earliest date of manufacture between nirmatrelvir and ritonavir. 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. 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. However, before FDA can issue an EUA, a specific type of determination must be in place, the HHS Secretary must issue a declaration to justify the issuance of the EUA, the section 564 statutory criteria for issuing an EUA must be met, and FDA must determine that it is safe to use the product beyond its labeled expiration date. Vaccine Site - Pfizer 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. There are multiple COVID-19 vaccines authorized for use across several brands (Moderna, Pfizer-BioNTech, Janssen, Novavax) . 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. 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. 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. COMIRNATY (COVID-19 Vaccine, mRNA) and SPIKEVAX (COVID-19 Vaccine, mRNA) are FDA-approved vaccines to prevent COVID-19 caused by SARS-CoV-2. From Dose 1 through 30 days after Dose 2, reports of lymphadenopathy were imbalanced with notably more cases in the Pfizer-BioNTech COVID-19 Vaccine group (64) vs. the placebo group (6), which is plausibly related to vaccination. Verify that the vial of Pfizer-BioNTech COVID-19 Vaccine has a purple plastic cap. Symptoms may appear 2 to 14 days after exposure to the virus. It is MANDATORY for vaccination providers to report to the Vaccine Adverse Event Reporting System (VAERS) 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 hospitalized or fatal cases of COVID-19 following vaccination with the Pfizer-BioNTech COVID-19 Vaccine.7 To the extent feasible, provide a copy of the VAERS form to Pfizer Inc. 7`xk j "d%%%%`2sA09!--psT(r9e"GQ(r9:_E9+]P+{W]wE = FOi4x= FOi4xX,2H}6i[}oim ~pi>_ ?# 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). Do not refreeze. Healthcare providers must enroll as providers in the Vaccination Program and comply with the provider requirements. HOW ARE COMIRNATY (COVID-19 VACCINE, mRNA), THE PFIZER-BIONTECH COVID-19 VACCINE, AND THE PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT RELATED? display: contents; Coronavirus disease 2019 (COVID-19) is an infectious disease caused by the novel coronavirus, SARS-CoV-2, that appeared in late 2019. Checker webpage to confirm expiration dates. Refrigerated at 2C and 8C (36F and 46F) for up to 10 weeks. For more information about IISs visit: https://www.cdc.gov/vaccines/programs/iis/about.html. The AAP is dedicated to the health of all children and the pediatric professionals who care for them. 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. COVID-19 vaccines authorized under an emergency use authorization do not have fixed expiration dates, and expiration dates may be If you have product questions, please contact us. 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. As soon as you land on the tool page, You will have to enter 2 things. Before discarding any vaccine, providers should check the expiration date using Pfizer-BioNTech's expiration date tool at PfizerBioNTech COVID-19 Lot Expiry . Total cumulative time the vials are stored at -25C to -15C (-13F to 5F) should be tracked and should not exceed 2 weeks. 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 Fact Sheet may have been updated. First of all, you will have to enter the lot number along with the country you live in. FAQs: What happens to EUAs when a public health emergency ends? CDC Pfizer-BioNTech COVID-19 Vaccine: Storage and Handling Summary (cdc.gov)FDA EUA Fact Sheet for Providers. Fierce Life Sciences Events. All rights reserved. Count out 18 months, using the month printed on the vial as month 1. The Centers for Disease Control and Prevention (CDC) COVID-19 Vaccine Lot Number and Expiration Date Report is available to public health, healthcare, and pharmacy organizations located within the United States for vaccine administration, inventory, and reporting purposes. FDA will not take enforcement action with regard to the storage or emergency use of these lots of Relenza, provided that the products have been stored under labeled storage conditions. 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 Information is not yet available about potential long-term sequelae. The manufacture date is printed on the vial (dark blue cap) and carton. FK5127. V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine have been shown to prevent COVID-19. PDF EXPIRATION EXTENSION: PFIZER-BIONTECH COVID-19 VACCINE - Michigan Learn more about the American Academy of Pediatrics including our mission, leadership and commitment to the optimal health and well-being of all children. If received at 2C to 8C, they should be stored at 2C to 8C. To learn more about this program, visit http://www.hrsa.gov/cicp/ or call 1-855-266-2427. 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. The vaccine efficacy information is presented in Table 8. 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. Pfizer does not have an expiration date look -up tool. WHERE WILL MY VACCINATION INFORMATION BE RECORDED? 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? PRIVACY POLICY. Storage and Handling Overview Ensure staff are knowledgeable about correct storage of the vaccines. Login with Single Sign On . 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). Pfizer-biontech Covid-19 Vaccine CAN I BE CHARGED AN ADMINISTRATION FEE FOR RECEIPT OF THESE COVID-19 VACCINES? Simply follow the below-given step-by-step tutorial to find the expiry date of your Pfizer COVID vaccine. Each vial must be thawed before dilution. After dilution, the vial should be held between 2C to 25C (35F to 77F). 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. Thaw and then store undiluted vials in the refrigerator [2C to 8C (35F to 46F)] for up to 1 month. Set id: 908ecbe7-2f1b-42dd-94bf-f917ec3c5af8, PRIMARY SERIES FOR 12 YEARS OF AGE AND OLDER. In addition, if extended Tamiflu or Relenza product is dispensed during an influenza emergency response, stakeholders should inform health care providers and recipients about this products expiration dating extension. Remember to bring your card when you return. Pfizer-BioNTech COVID-19 Vaccine Vial with Purple Cap VIAL VERIFICATION. January 17, 2013: Before PAHPRA, in addition to FDAs June 2010 letter below, a CDC message to states in 2013 regarding spot shortages of Tamiflu for seasonal influenza noted that, [b]ased on FDAs review of scientific data, FDA has concluded that, provided the products have been stored under labeled storage conditions, it is scientifically supportable for certain lots of Tamiflu capsules held in strategic stockpiles to be used for a maximum of ten [10] years beyond their date of manufacture, June 22, 2010: Before PAHPRA, following the 2009-2010 H1N1 influenza response, FDA issued a letter [ARCHIVED] to CDC leadership regarding the disposition of Tamiflu and Relenza lots. V-safe also provides dose reminders if needed and live telephone follow-up by CDC if participants report a significant health impact following COVID-19 vaccination. IuaPmrE&n-W.2Icy^&PM | ,5A^D|"c%&g;'hy,/A Hr|G,,NNS!YFcZ. Pfizer-BioNTech COVID-19 Vaccine at least 3 to 8 weeks after the first dose. Postmarketing data with Pfizer-BioNTech COVID-19 Vaccine demonstrate increased risks of myocarditis and pericarditis, particularly within the period 0 through 7 days following the second dose of the primary series. Once punctured, vials can be stored between 2C to 25C (36F to 77F) for up to 12 hours. Among the 59 patients who had been seronegative before the third dose, 26 (44%) were seropositive at 4 weeks after the third dose. 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. 2 0 obj 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. The FDA Center for Drug Evaluation and Research (CDER) Division of Product Quality Research analyzes the data and makes decisions regarding shelf life extensions. You may also be given an option to enroll in v-safe. June 1, 2020: FDA is alerting civilian health care professionals and emergency responders of 4 additional DuoDote lots that are no longer useable and should be properly disposed of. 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. Pfizer-BioNTech COVID-19 Vaccine | Pfizer Thawed vials can be handled in room light conditions. 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. Myocarditis and pericarditis have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine. You should not get any of these vaccines if you: WHAT ARE THE INGREDIENTS IN THESE VACCINES? [-130F to -76F]). 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)]. PDF Pfizer-BioNTech COVID-19 Vaccines - CDC This document provides guidance to government stakeholders on testing to extend the shelf life (i.e., expiration date) under the FD&C Act of stockpiled doxycycline tablets and capsules for public health emergency preparedness and response purposes for an anthrax emergency. 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. Overall, among the adolescents who received the Pfizer-BioNTech COVID-19 Vaccine, 50.1% were male and 49.9% were female, 85.9% were White, 4.6% were Black or African American, 11.7% were Hispanic/Latino, 6.4% were Asian, and 0.4% were American Indian/Alaska Native. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of non-serious adverse events (including other neurologic or neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to 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. In a clinical study in adolescents 12 through 15 years of age who received Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA), adverse reactions following administration of the primary series included pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever (24.3%), joint pain (20.2%), injection site swelling (9.2%), injection site redness (8.6%), lymphadenopathy (0.8%), and nausea (0.4%). Pfizer-BioNTech COVID-19 Vaccine Vial with Purple Cap DILUTION. Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients. Storage of the vials between -96C to -60C (-141F to -76F) is not considered an excursion from the recommended storage condition. |/FWjSZl;u!hU$xO=6 :sfuoHDZ-Uqw&+q;#"To-C*HRgZ^lw?BG:+Y7ZBJnw{%8q|\TM|tiv zGjt7e Appendicitis was reported as a serious adverse event for 12 participants, and numerically higher in the vaccine group, 8 vaccine participants and 4 placebo participants. )$p-M?4s6.1K@, i Solicited Local and Systemic Adverse Reactions. 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#). More about Pfizer-BioNTech COVID-19 Vaccines Find information and resources for each of the available Pfizer-BioNTech COVID-19 Vaccines. 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. It is important that the information reported to FDA be as detailed and complete as possible. 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. 1-800-666-7248. 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. Syncope (fainting) may occur in association with administration of injectable vaccines, in particular in adolescents. Administer the Pfizer-BioNTech COVID-19 Vaccine intramuscularly. The expiration date is set at the end of the shelf-life. Select What Vaccine (s) You Wish To Receive (Maximum of 2 Vaccines per Appointment) 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. Record the date and time of first use on the Moderna COVID-19 Vaccine label.