Published December 11, 2020. There is no information on the co-administration of COMIRNATY with other vaccines. From study vaccination to the data cut-off date (16 May 2022), the proportions of participants with any AEs were generally similar. Any vaccine remaining in vials must be discarded after 6 hours. The COMIRNATY multiple dose vial with a purple cap and purple label bordercontains a volume of 0.45 mL. It is unknown whether COMIRNATY has an impact on fertility. 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. 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). This new format includes all seasonal influenza vaccines for the 2022/2023 season in a single Excel crosswalk table that provides the CVX, MVX, NDC Unit of Sale, NDC Unit of Use, and CPT (*) codes for each vaccine. Shortly after, the novel virus was identified as SARS-CoV-2. DILUTE PRIOR TO USE (Vials with Orange Cap and Orange Label Border). Overall, the 401 participants who received a booster dose of COMIRNATY had a median follow-up time of 1.3 months after the booster dose through the cut-off date. At the time of authorization, there are no known serious warnings or precautions associated with this product. Non-serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow up in the initial enrolment group were reported by 10.9% of COMIRNATY 10 mcg recipients and by 9.1% of placebo recipients. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. StudyC4591001 (Study 2) is a Phase 1/2/3, multicenter, multinational, randomized, saline placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection (Phase 1) and efficacy (Phase 2/3) study that has enrolled approximately 46,000 participants, 12 years of age or older. Today, Pfizer manufactures more than 200 million doses of Pfizer vaccines annually and is one of the largest sterile injectables suppliers in the world, producing more than 1 billion sterile units per year. Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. Most of the additional AEs reported after 1 month post-dose up to the data cut-off date consisted of unrelated events such as spinal osteoarthritis, ischaemic stroke, breast tenderness and tooth extraction. Vials may be thawed in the refrigerator (2C to 8C [35F to 46F])or at room temperature (up to 25C [77F]) (see. These cases occurred more commonly after the second dose and in adolescents and young adults. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. Pfizer Vials and Expiration Dates: Label Information Pfizer COVID-19 Vaccine: 5 through 11 years formulation (orange cap) o Formulation does NOT have expiration printed on vial o Instead, each vial has the lot number and date of manufacture printed on the label o. No serious adverse events were reported that were considered related to vaccination. Using aseptic technique, withdraw 1.3mL of diluent into a transfer syringe (using 21gauge or narrower needle). Do not use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent. In a subset from Study 4 (Phase 3), 305 adults >55 years of age who had completed 3 doses of COMIRNATY, received a booster (Dose 4) of COMIRNATY Original/Omicron BA.1, 4.7 to 11.5 months after receiving Dose 3. dose. Vials of COMIRNATY Original & Omicron BA.4/BA.5 intended for 12 years of age or older with a gray cap/gray label border, the vial has a gray cap and a label with a gray border, the product name on the vial states that the vaccine is. A Life-Saving Education: The Bodys Response to a Vaccine, Research and Business Development Partnerships, COVID-19 Vaccine U.S. Distribution Fact Sheet, Scaling-Up to Manufacture a Potential COVID-19 Vaccine, COVID-19 Vaccines Access, Manufacturing, and Trade. After storage for 15 days in the Pfizer thermal shipper, vaccination centers can transfer the vials to 2-8C storage conditions for an additional five days, for a total of 20 days. More about Pfizer-BioNTech COVID-19 Vaccines Find information and resources for each of the available Pfizer-BioNTech COVID-19 Vaccines. Pfizer consistently and diligently monitors the supply of our medicines. It is supplied as a frozen suspension that does not contain preservative. Thank you for taking the time to confirm your preferences. e. Severe: requires intravenous hydration. Participants 5 Years Through <12 Years of Age. Vials may also be stored at -25C to -15C (13F to 5F) for up to 2 weeks. Many of the AEs were consistent with reactogenicity events (e.g., fever and fatigue). Regardless of storage condition, vaccines should not be used after 12 months from the date of manufacture printed on the vial and cartons. A booster dose of COMIRNATY (0.2 mL) may be administered intramuscularly at least 6 months after completion of the primary series in individuals 5 years through 12 years of age. There are no data available on the interchangeability of COMIRNATY with other COVID-19 vaccines to complete the vaccination series. Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. Individuals should be advised to bring symptoms (e.g., dizziness, increases in heart rate, feeling short of breath, tingling sensations or sweating) to the attention of the vaccination provider for evaluation. Do not add more than 1.8 mL of diluent. The safety evaluation of participants in Study 2 and Study 4 is ongoing. Allowing vial(s) to thaw in the refrigerator [2C to 8C (35F to 46F)]. 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 of the events began from 3-11 days after the second dose and were characterized as mild and self-limited. Record the date and time of first vial puncture on the vial label. Adverse reactions following administration of any dose in the initial enrolment safety population (n = 1,518) of children 5 years through <12 years of age included pain at the injection site (84.3%), fatigue (51.7%), headache (38.2%), injection site redness (26.4%), injection site swelling (20.4%), muscle pain (17.5%), chills (12.4%), fever (8.3%), joint pain (7.6%), lymphadenopathy (0.9%), rash (0.5%), nausea (0.4%), malaise (0.1%), and decreased appetite (0.1%). 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. Table 7: Study 2 Frequency of Solicited Local Reactions Within 7 Days After Each Dose of COMIRNATY Participants 16-55 Years of Age (Reactogenicity Subset of the Safety Population*), Table 8: Study 2 Frequency of Solicited Systemic Reactions Within 7 Days After Each Dose of COMIRNATY Participants 16-55 Years of Age (Reactogenicity Subset of the Safety Population*), Table 9: Study 2 Frequency of Solicited Local Reactions Within 7 Days After Each Dose of COMIRNATY Participants 56 Years of Age and Older (Reactogenicity Subset of the Safety Population*), Table 10: Study 2 Frequency of Solicited Systemic Reactions Within 7 Days After Each Dose of COMIRNATY Participants 56 Years of Age and Older (Reactogenicity Subset of the Safety Population*), Study 2 also included 200 participants with confirmed stable human immunodeficiency virus. Thawed vials may be stored at room temperature [up to 25C (77F)] for up to 12 hours prior to dilution. If vials are received at 2C to 8C, they should be stored at 2C to 8C. Of the participants who received a booster dose of COMIRNATY or placebo (COMIRNATY = 5,055; placebo = 5,020) to the cut-off date (October 5, 2021), serious adverse events were reported by 0.3% of COMIRNATY recipients and 0.5% by placebo recipients. The COMIRNATY Original & Omicron BA.4/BA.5 multiple dose vial (for ages 5 years to <12 years) has an orange cap and an orange label border and contains a volume of 1.3 mL. Regardless of storage condition, vaccine should not be used after 18 months from the date of manufacture printed on the vial and cartons. Verify the final dosing volume of 0.3 mL. This report includes COVID-19 vaccine lot numbers . Adjust Direction, then . Participants 18 to 55 Years of Age After a Booster Dose of Monovalent Omicron BA.1. These cases occurred more commonly after the second dose and in adolescents and young adults. This technology is designed primarily to help immunization providers record information about the VIS as is required by the National Childhood Vaccine Injury Act (NCVIA). In order to ensure consistent withdrawal of 10 doses of 0.2 mL, it is important to adhere to minimizing volume loss during dose extraction. Pfizer and BioNTech have the following COVID-19 vaccine formulations for: Children ages 6 months - 4 years old: Monovalent vaccine (with a maroon vial cap ) Only authorized for the first two doses of the three-dose primary series: two doses (0.2 mL), at least three to eight weeks apart. Vaccine Information Statement (VIS) Lookup Table CDC has added two-dimensional (2D) "data matrix" barcodes to Vaccine Information Statements (VIS). 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. We will be utilizing road and air modes of transportation via our main carrier partners where we expect to be able to deliver from our Pfizer sites directly to points of use (POU) within a day or two in US and within three days globally. COMIRNATY is administered intramuscularly as a primary series of two doses (0.3 mL each) 3 weeks apart in individuals 12 years of age and older. Home Data Catalog Developers Video Guides Typically, the onset of symptoms has been within a few days following receipt of COMIRNATY. 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. Refer to thawing and dose preparation instructions in the panels below. Prior to dilution, the thawed suspension may contain opaque amorphous particles. post marketing safety data with COMIRNATY. . Safety data from studies in individuals 12 years of age using bivalent formulations of COMIRNATY at 30 mcg are considered supportive. for a specific lot number: Pfizer COVID-19 Vaccine: The expiration date is located on the vaccine vial and packaging. Contact your regional poison control centre. During the visual inspection: After dilution, vials of COMIRNATY (for age 5 years to <12 years) contain 10 doses of 0.2 mL of vaccine. 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. The most frequently reported unsolicited adverse event was lymphadenopathy (2.5%). Route Site Code Dosage mL MFG Code Lot Number IM 0.3 cc 301308A Expiration 11PFR -30 2021 MFG Codes: PFR=Pfizer, MOD=Moderna, ASZ=AstraZeneca, JSN=Janssen, NVX=Novavax, MSD=Merck It is unknown whether COMIRNATY Original & Omicron BA.4/BA.5 is excreted in human milk. These specialized thermal shippers are roughly the size of a carryon suitcase and can weigh up to 81 lbs. g. Severity was not collected for use of antipyretic or pain medication. Each vial must be thawed and diluted prior to administration. Undiluted vials may be stored at room temperature for no more than 2 hours. Read . The safety evaluation of participants in Study 2, Study 3 and Study 4 is ongoing. Thawed Under Refrigeration: Thaw and then store undiluted vials in the refrigerator (2C to 8C [35F to 46F]) for up to 1 month. Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw. COMIRNATY Original & Omicron BA.4/BA.5 For Age 5 Years to <12 Years: DILUTE PRIOR TO USE, (Vials with Orange Cap and Orange Label Border), Orange plastic cap and label with orange border. Once vials are thawed they should not be refrozen. 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. Dilute the vial contents using 1.3 mL of sterile 0.9% Sodium Chloride Injection, USP to form COMIRNATY. We have specially designed, temperature-controlled shippers utilizing dry ice to maintain recommended temperature conditions up to 10 days unopened. In the analysis of blinded, placebo controlled follow-up, 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 COMIRNATY. Do not use if vaccine is discoloured or contains particulate matter. Reports are accepted from anyone and can be submitted electronically at www.vaers.hhs.gov. Children 5 Years Through12 Years of Age Primary Series (Two Doses). Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. This informationincluding product informationis intended only for residents of the United States. c. Mild: 0.5 to 2.0 cm; moderate: >2.0 to 7.0 cm; severe: >7.0 cm. In the analysis of blinded, placebo-controlled follow-up, there were no notable patterns between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to COMIRNATY. The analysis of the Study 3 Phase 2/3 subset is based on data up to the cut-off date of March 22, 2022 (median follow-up time of 1.3 months). c. n = Number of participants with the specified reaction. Verify that the vial has an orange plastic cap and an orange label border. Do not store vials at 25C to 15C (-13F to 5F). The mRNAs are formulated in lipid nanoparticles, which enable delivery of the RNA into host cells to allow expression of the SARS-CoV-2 S antigen. After preparation, a single dose is 0.3 mL. On a Sunday afternoon in May of 2020, Amy Genests phone rang. The administration of COMIRNATY Original & Omicron BA.4/BA.5 should be postponed in individuals suffering from acute severe febrile illness. If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume. After dilution the vials should be stored at 2C to 25C (35F to 77F). Do not store vials at 25C to 15C (-13F to 5F). No serious adverse events were reported after the booster dose of COMIRNATY through the cut-off date. Please review the label carefully to ensure that you select the appropriate vaccine for immunization. After first puncture, the vial should be stored at 2C to 25C (35F to 77F). COMIRNATY is a suspension for intramuscular injection which must be diluted prior to administration. 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