Do not mix COMIRNATY Original & Omicron BA.4/BA.5 with other vaccines/products in the same syringe. Table 17 and Table 18 present the frequency and severity of reported solicited local and systemic reactions, respectively, within 7 days of a booster dose of COMIRNATY for Phase 2/3 participants 5 years through 12 years of age. Please review the label carefully to ensure that you select the appropriate vaccine for immunization. Participants continue to be monitored for unsolicited adverse events (AEs), including serious adverse events (SAEs), throughout the study [from Dose 1 to 1 month after the last dose (all AEs) and 6 months (SAEs) after the last vaccination]. Most frequently reported systemic events in decreasing order of frequency after study vaccination (Table 6) were: Table 6: Solicited Systemic Adverse Reactions Reported for Vaccine Groups Within 7 Days After Study Vaccination, Overview of Adverse Events (AEs) From Study Vaccination to 1 Month Post-Dose. Two additional severe AEs, also reported as SAEs (pneumonia, ischaemic stroke) were reported in the COMIRNATY 30 mcg group. Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. COMIRNATY is supplied as a frozen suspension in multiple dose vials with a maroon cap and a maroon label border. We have crossed another milestone in the fight against COVID-19. Irrespective of the type of syringe and needle: Administer a single 0.2 mL dose of COMIRNATY intramuscularly. You can review and change the way we collect information below. Dilute the vial contents using 2.2 mL of sterile 0.9% Sodium Chloride Injection, USP to form COMIRNATY. Submit a medical question for Pfizer prescription products. Pfizer Canada accepts no responsibility for the content of linked sites. For important information on handling and preparation for administration, please refer to 11 STORAGE, STABILITY AND DISPOSAL and 4 DOSAGE AND ADMINISTRATION. Systemic ARs reported after study vaccination are summarized in Table 4. One year. Pfizer-BioNTech COVID-19 Vaccine (also known as BNT162b2) This product information is intended only for residents of the United States. To prevent vaccine from inadvertently being discarded, providers . Non-serious adverse events from Dose1 through up to 30days after Dose2 in ongoing followup in the initial enrolment group were reported by 10.9% of COMIRNATY 10mcg recipients and by 9.1% of placebo recipients. Regardless of storage condition, vaccines should not be used after 18 months from the date of manufacture printed on the vial and cartons. They are included because: a) they represent reactions that are known to occur following immunizations generally; b) they are potentially serious; or c) on the basis of their frequency of reporting. Children 2 Through <5 Years of Age Primary Series (Three Doses). Among participants 12 through 15 years of age who received at least one dose of study vaccine, 1,131 of whom received COMIRNATY and 1,129 of whom received placebo, unsolicited adverse events were reported by 95 (8.4%) participants in the COMIRNATY group and 113 (10.0%) participants in the placebo group. The COMIRNATY multiple dose vial with a purple cap and purple label bordercontains a volume of 0.45 mL. The administration of COMIRNATY Original & Omicron BA.4/BA.5 should be postponed in individuals suffering from acute severe febrile illness. Our distribution approach will be to largely ship from our Kalamazoo and Puurs sites direct to the point of use (POU). Dilute the vial contents using 1.3 mL of sterile 0.9% Sodium Chloride Injection, USP to form COMIRNATY. In a similar analysis, in participants 56 years of age and older (COMIRNATY = 8,931; placebo = 8,895), serious adverse events were reported by 165 (1.8%) COMIRNATY recipients and 151 (1.7%) placebo recipients who received at least 1 dose of COMIRNATY or placebo, respectively. Allowing vial(s) to thaw in the refrigerator [2C to 8C (35F to 46F)]. Among participants with confirmed stable HIV infection that included 100 COMIRNATY recipients and 100 placebo recipients, unsolicited adverse events were reported by 29 (29%) participants in the COMIRNATY group and 15 (15%) participants in the placebo group. Before dilution, allow the thawed vial to come to room temperature. Local ARs are summarized in Table 3. Administer immediately, and no later than 12 hours after dilution. BUD Case Scenarios: Pfizer-BioNTech COVID-19 Vaccine Expiration Extension With the Pfizer-BioNTech COVID-19 Vaccine expiration date extension, there have been a number of questions about how this might impact beyond-use date. Fatigue was the most frequently reported systemic AR reported within 7 days after study vaccination, followed by headache, and less frequently chills, muscle and joint pain. For further assistance with reporting to VAERS, call 1-800-822-7967. Contact your regional poison control centre. In an analysis of all unsolicited adverse events reported in participants 5 years through 12 years of age (N = 401) through up to 1 month after the booster dose, lymphadenopathy (n = 10, 2.5%) was an adverse reaction not already captured by solicited local and systemic reactions. From study vaccination to the data cut-off date (16 May 2022), the proportions of participants with any AEs were generally similar. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. This could allow for early diagnosis and treatment. There are no data available on the interchangeability of COMIRNATY with other COVID-19 vaccines to complete the vaccination series. After Pfizer and BioNtech signed a letter of intent in March 2020 to work together on a vaccine, two Pfizer facilities were swiftly selected for developing the processes and manufacturing the product at an industrial scale. Many of the AEs were consistent with reactogenicity events (e.g., fever and fatigue). Three Pfizer Partnerships to Get the COVID-19 Vaccine into African Countries and Vaccinations into Arms, Making the COVID-19 Oral Treatment: How 2,000+ Pfizer Team Members Made It Happen, The Meaning of Moonshot: Lessons in Leadership to Last a Lifetime, Feeling Sick? We have specially designed, temperature-controlled thermal shippers utilizing dry ice to maintain recommended temperature conditions for up to 10 days unopened. 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 . Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. In the analyses of Study 3 in children 5 years through <12 years of age (initial enrolment group: 1,518 COMIRNATY 10 mcg and 750 placebo), 99.5% of participants had at least 30 days and 95.7% of participants had at least 3 months follow-up after Dose 2. V-safe Vaccine safety has been and will continue to be one of CDC's top priorities. The most frequent adverse reactions in participants >55 years of age were pain at the injection site (58.1%), fatigue (49.2%), headache (33.6%), myalgia (22.3%), chills (13.0%) and arthralgia (11.3%). Thawed vials may be stored at room temperature [up to 25C (77F)] for up to 12 hours prior to use. If vials are received at 2C to 8C, they should be stored at 2C to 8C. Below are a few case scenarios you might encounter. The median duration was 3.5 days (ranged from 1 to 14 days) in the vaccine group. Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw 0.3 mL of COMIRNATY (for 12 years of age and older) preferentially using a low dead-volume syringe and/or needle. Pfizer and Moderna are two-dose vaccines, while J&J is one dose.2) The lot number and expiration dateThe lot number is a string of numbers and letters that tracks this specific batch of vaccine . After dilution, the vaccine will be a white to off-white suspension. Each 0.3 mL dose of COMIRNATY contains 30 mcg of a nucleoside modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 (original strain) and the non-medicinal ingredients listed in Table 1. Centers for Disease Control and Prevention. f. Severity was not collected for use of antipyretic or pain medication. 2 DOSAGE AND ADMINISTRATION For intramuscular injection only. Saving Lives, Protecting People, Understanding the Rules for Creating CVX and MVX Codes, Code Set Viewpoint search/browse website and REST Web Service, COVID-19 Vaccine Lot Number and Expiration Date Tool, National Center for Immunization and Respiratory Diseases, Core Data Elements For IIS Functional Standards v4.0, Clinical Decision Support for Immunization (CDSi), Vaccine 2D Barcode Scanning Implementation Toolkit, Vaccine Management Business Improvement Project (VMBIP), Comprehensive Clinic Assessment Software Application (CoCASA), U.S. Department of Health & Human Services, influenza, live, intranasal, quadrivalent, Influenza virus vaccine, quadrivalent, live (LAIV4), for intranasal use, influenza, injectable, quadrivalent, preservative free, Influenza virus vaccine, quadrivalent (IIV4), split virus, preservative free, 0.5 mL dosage, for intramuscular use, Influenza, injectable, quadrivalent, preservative free, Influenza virus vaccine, quadrivalent (IIV4), split virus, 0.25 mL dosage, for intramuscular use, Influenza virus vaccine, quadrivalent (IIV4), split virus, 0.5 mL dosage, for intramuscular use, influenza, injectable, quadrivalent, contains preservative, Influenza, injectable, MDCK, preservative free, quadrivalent, Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, preservative and antibiotic free, 0.5 mL dosage, for intramuscular use, influenza, recombinant, quadrivalent,injectable, preservative free, Influenza virus vaccine, quadrivalent (RIV4), derived from recombinant DNA, hemagglutinin (HA) protein only, preservative and antibiotic free, for intramuscular use, Influenza, injectable, MDCK, quadrivalent, preservative, Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, antibiotic free, 0.5 mL dosage, for intramuscular use, FLUZONE High-Dose Quadrivalent Northern Hemisphere, Influenza virus vaccine (IIV), split virus, preservative free, enhanced immunogenicity via increased antigen content, for intramuscular use, Influenza vaccine, quadrivalent, adjuvanted, Influenza virus vaccine, quadrivalent (aIIV4), inactivated, adjuvanted, preservative free, 0.5 mL dosage, for intramuscular use, influenza, Southern Hemisphere, pediatric, preservative free, influenza, Southern Hemisphere, preservative free, influenza, Southern Hemisphere, quadrivalent, with preservative, Centers for Disease Control and Prevention. We have years of proven experience in supply chain and cold chain management, and we are accelerating the development of innovative technologies to further advance our capabilities as a supply chain leader. If local redistribution is needed, full cartons containing unpunctured vials may be transported at -90C to -60C (-130F to -76F); full cartons or individual unpunctured vials may also be transported at 2C to 8C (35F to 46F). One serious adverse event of fever (maximum temperature 40.3C) on Day 3 after Dose 2 in a 4-year-old was considered possibly related to vaccination. To find the expiration date for any Pfizer-BioNTech COVID-19 Vaccine lot number, enter the lot number found on the vial or the carton. Based on current projections we expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021. Prior to mixing, the thawed vaccine may contain white to off-white opaque amorphous particles. How is Pfizer utilizing a cold chain process to distribute its vaccine? Shortly after, the novel virus was identified as SARS-CoV-2. No interaction studies have been performed. Vaccine Lot Release Certificates. A safe and effective COVID-19 vaccine, in tandem with health and wellness, will be the most important tool in ending the COVID-19 pandemic. Adverse Events (AEs) from Study Vaccination to Data Cut-off Date. Here's how to find the expiration date of the different COVID-19 Vaccine Brands. In participants who received a booster dose, the mean duration of pain at the injection site after the booster dose was 2.4 days (range 1 to 35 days), for redness 2.3 days (range 1 to 12 days), and for swelling 2.3 days (range 1 to 9 days). COMIRNATY is supplied as a frozen suspension in multiple dose vials. Non-serious adverse events from Dose 1 through up to 1 month after Dose 3, in ongoing follow up were reported by 29.1% of COMIRNATY recipients and by 26.3% of placebo recipients. In a similar analysis, in participants 56 years of age and older (COMIRNATY = 8,931; placebo = 8,895), serious adverse events were reported by 165 (1.8%) COMIRNATY recipients and 151 (1.7%) placebo recipients who received at least 1 dose of COMIRNATY or placebo, respectively. COMIRNATY multiple dose vials (with orange cap and orange label border) are supplied in a carton containing 10 multiple dose vials or 195 multiple dose vials. Table 16: Study 3 Frequency of Solicited Systemic Reactions Within 7Days After Each Dose Children 5Years Through <12Years of Age Safety Population*. COMIRNATY Original & Omicron BA.4/BA.5 multiple dose vials contain a frozen suspension that does not contain preservative and must be thawed and may require dilution prior to administration. In 2020, as Pfizer and BioNTech were still developing the COVID-19 vaccine, Julie Jenson was thinking about how to distribute that vaccine to every country around the world, regardless of that countrys means. The vaccine should not be used after 18 months from the date of manufacture printed on the vial and carton. The administration of COMIRNATY should be postponed in individuals suffering from acute severe febrile illness. The efficacy and safety of the vaccine has not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. In an analysis of Study 3 Phase 2/3, based on data up to the cut-off date of October 8, 2021, 2,268 participants (initial enrolment group: 1,518 COMIRNATY 10 mcg and 750 placebo) were 5 years through <12 years of age. Bivalent vaccine (with a maroon vial cap and different label. *Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. You can order COVID-19 vaccines through the Washington State Immunization Information System (WAIIS). Clinical studies of COMIRNATY include participants 65 years of age and older and their data contributes to the overall assessment of safety and efficacy (see 8 ADVERSE REACTIONS and 14 CLINICAL TRIALS). Each component vaccine of a multiple component vaccine will have a unique NDC which also differs from the NDC of the unit of sale. Instructions on the handling and dose preparation of the vaccine prior to administration are provided below. Do not use if liquid is discoloured or if particles are observed after mixing. COVID-19 vaccine, receive an additional dose of hat same mRNA . Discoloured or if particles are observed after mixing 2.2 mL of sterile 0.9 % Sodium Chloride,... No data available on the interchangeability of COMIRNATY with other vaccines/products in fight. Vial cap and different label 77F ) ] for up to 10 days unopened the virus. 2C to 8C discoloured or if particles are observed after mixing information System ( )... 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