Each 0.2 mL dose of COMIRNATY contains 3 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 2. After dilution, the vial contains 6 doses, of 0.3 mL with 30 . Cardiology consultation for management and follow up should be considered. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the vaccine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to product exposure. On April 7, 2022, FDA authorized an extension (PDF, 136 KB) for the shelf life of the refrigerated Janssen COVID-19 Vaccine, allowing the product to be stored at 2-8 degrees . A few vaccines are packaged with two component vaccines. Do not store vials at 25C to 15C (-13F to 5F). * Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. The 10week refrigerated expiry date should be recorded on the carton at the time of transfer. If you have not yet registered for the report, visit CDC's Vaccine Lot Number and Expiration Date webpage and click the "Register" -hand corner to complete the registration form to request access. For a complete listing see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. After dilution, the vaccine will be a white to off-white suspension. b. Adolescents 12 to 15 Years of Age Primary Series (Two Doses). After preparation, a single dose is 0.2 mL. To receive email updates about this page, enter your email address: For more information on background and concepts see Understanding the Rules for Creating CVX and MVX Codes [5 pages], View archived 2015 Edition Versioned Codes, More ways to access CDCs Vaccine Code Set information: Code Set Viewpoint search/browse website and REST Web Service. The safety and efficacy of COMIRNATY in pregnant women have not yet been established. Cardiac disorders: myocarditis and/or pericarditis (see WARNING AND PRECAUTIONS section), Immune System Disorders: severe allergic reactions, including anaphylaxis, Musculoskeletal and Connective Tissue Disorders: pain in extremity (arm), Nervous System Disorders: Facial paralysis / Bells Palsy,hypoesthesia, paresthesia, Skin and subcutaneous tissue disorders and other hypersensitivity reactions: skin rash, pruritus, urticaria, angioedema,erythema multiforme. In Study 2, all participants 12 to 15 years of age and 16 years of age and older in the reactogenicity subset, and a subset of 306 participants 18 through 55 years of age who received a booster dose in Study 2, were monitored for solicited local and systemic reactions and use of antipyretic medication after each vaccination with an electronic diary during the 7 days following any dose of vaccination. 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. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. Administer a single 0.3 mL dose of COMIRNATY intramuscularly, preferably in the deltoid muscle. The COMIRNATY multiple dose vial (for age 6 months to <5 years) has a maroon cap and a maroon label border and contains a volume of 0.4 mL. 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. Inspect vials to confirm there are no particulates and no discolouration is observed. No deaths related to the vaccine were reported in the study. 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 . Once received, frozen vials may be immediately transferred to the refrigerator [2C to 8C (35F to 46F)], thawed and stored for a single period of up to 10 weeks within the 12-month shelf-life. 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 . COMIRNATY Original & Omicron BA.4/BA.5 is supplied as a frozen suspension in multiple dose vials with an orange cap and an orange label border. Disclaimer This informationincluding product informationis intended only for residents of the United States. Of these, 1,762 participants (1,166 COMIRNATY 3 mcg; 596 placebo) received 2 doses and 1,207 (68.5%; 801 COMIRNATY 3 mcg and 406 placebo) participants have been followed for at least 4 months after the second dose; 570 participants received a 3-dose primary series (386 COMIRNATY 3 mcg; 184 placebo) and have been followed for a median of 1.3 months after the third dose, based on data in the blinded, placebo-controlled follow-up period up to the cut-off date of April 29, 2022. No serious adverse events were reported after the booster dose through the cut-off date. View public records and voter registration of Gina Warren born 1964, includes court and personal records. No serious adverse events were reported after the booster dose of COMIRNATY through the cut-off date. The liquid is a white to off-white suspension and may contain. Animal studies do not indicate direct or indirect harmful effects with respect to female fertility or reproductive toxicity (see 16 NON-CLINICAL TOXICOLOGY). In the analyses of Study 3 in participants 2 through <5 years of age (606 COMIRNATY; 280 placebo), 76.6% of participants had at least 30 days of follow-up after Dose 3. Vials of COMIRNATY Original & Omicron BA.4/BA.5 intended for individuals aged 5 years to <12 years (orange cap/orange label border) cannot be used to prepare doses for individuals 12 years of age and older. The median duration was 3.5 days (ranged from 1 to 14 days) in the vaccine group. COMIRNATY (for age 5 years to <12 years): A carton of 10 vials may take up to 4 hours to thaw at this temperature. No serious adverse events were reported that were considered related to vaccination. However, we will also be using our existing distribution centers for the COVID-19 distribution in Pleasant Prairie, WI and in Karlsruhe, Germany. Thaw vial(s) of COMIRNATY Original & Omicron BA.4/BA.5 before use either by: Allowing vial(s) to thaw in the refrigerator [2C to 8C (35F to 46F)]. Participants 12 Years of Age After a Dose of COMIRNATY Original/Omicron BA.4/BA.5 as a Second Booster (4th Dose). Sometimes it feels like the year went by in the blink of an eye. For important information on handling and preparation for administration, please refer to 11 STORAGE, STABILITY AND DISPOSAL and 4 DOSAGE AND ADMINISTRATION. c. Mild: does not interfere with activity; moderate: some interference with activity; severe: prevents daily activity. 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. ONLY use 0.9% Sodium Chloride Injection, USP as the diluent. first. Cookies used to enable you to share pages and content that you find interesting on CDC.gov through third party social networking and other websites. The median age of these 401 participants was 8.0 years (range 5 years through 12 years of age), 52.4% were male and 47.6% were female, 70.1% were White, 7.2% were Black or African American, 22.9% were Hispanic/Latino, 7.7% were Asian, and 2.0% were American Indian/Alaska Native. (HIV) infection. Just six days later, on March 17, Pfizer signed a letter of intent with BioNTech to co-develop a potential COVID-19 vaccine2. e. Severe: 6 or more loose stools in 24 hours. In the analysis of unblinded follow-up, there were no notable patterns of specific categories of non-serious adverse events that would suggest a causal relationship to COMIRNATY. Thawed at Room Temperature: For immediate use, thaw undiluted vials at room temperature (up to 25C (77F)] for 30 minutes. Home Data Catalog Developers Video Guides DILUTE PRIOR TO USE (Vial with Orange Cap and Orange Label Border). The most commonly reported adverse reactions (10%) following administration of a booster dose were pain at the injection site (83.0%), fatigue (63.7%), headache (48.4%), muscle pain (39.1%), chills (29.1%), and joint pain (25.3%). A 2021 study found that more than 47,000 c. Last December, Pfizer and our collaborator, BioNTech, achieved our goal of creating the first COVID-19 vaccine to receive Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) and we were thrilled when other companies vaccines were subsequently authorized, as well. The following adverse reactions have been identified during post authorization use of COMIRNATY. Each 0.2 mL dose of COMIRNATY contains 10 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 2. 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). I went on to identify several additional ranges of toxicity, each one identified by similar sequences of batch codes. In order to ensure consistent withdrawal of 6 doses of 0.3 mL, it is important to adhere to minimizing volume loss during dose extraction. In order to ensure consistent withdrawal of 6 doses of 0.3 mL, it is important to adhere to minimizing volume loss during dose extraction. Most systemic events were mild or moderate in severity. Each vial must be thawed prior to administration. The overall safety profile for the COMIRNATY Original/Omicron BA.1 booster (Dose 4) was similar to that seen after the COMIRNATY booster (Dose 3). The safety evaluation in Study 3 is ongoing. Table 18: Study 3 Frequency of Solicited Systemic Reactions Within 7Days After Each Dose Children 6Months Through <2 Years of Age Safety Population*. A booster dose of COMIRNATY Original & Omicron BA.4/BA.5 may be administered intramuscularly at least 3 to 6 months after completing the primary course of COMIRNATY and/or a previous booster dose of COMIRNATY in individuals 12 years of age or older. 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. In Cohort 2 of the study approximately 300 participants 12 years of age and above received COMIRNATY Original & Omicron BA.4/BA.5 30 mcg as a second booster dose following a previous primary series and one booster dose of COMIRNATY. Table 15 and Table 16 present the frequency and severity of solicited local and systemic reactions, respectively, within 7 days following each dose of COMIRNATY and placebo in children 5 years through <12 years of age included in the initial enrolment safety population who were monitored for reactogenicity with an electronic diary. d. Mild: 1 to 2 times in 24 hours; moderate: >2 times in 24 hours; severe: requires intravenous hydration. Cartons of COMIRNATY Original & Omicron BA.4/BA.5 multiple dose vials (for 12 years and older: DO NOT DILUTE) may arrive frozen at ultracold conditions in thermal containers with dry ice. A carton of 10 vials may take up to 4hours to thaw, and thawed vials can be stored in the refrigerator for up to 10weeks. Do not use if vaccine is discoloured or contains particulate matter. She recognized the number immediately and excused herself from her young daughters and her husband to take the work call. After dilution, the vaccine will be an off-white suspension. Add 1.8 mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial. This diluent is not packaged with the vaccine and must be sourced separately. This webpage is designed as a lookup table where the Unit of Use and Unit of Sale NDC are mapped to each other. Data.CDC.gov. COMIRNATY Original & Omicron BA.4/BA.5 (COVID-19 mRNA Vaccine, Bivalent (Original and Omicron BA.4/BA.5)) is indicated as a booster dose for active immunization against coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) in individuals 5 years of age and older (see 4.2 Recommended Dose and Dosage Adjustment). The administration of COMIRNATY Original & Omicron BA.4/BA.5 should be postponed in individuals suffering from acute severe febrile illness. To report and adverse reaction, or concern about the quality of a Pfizer product, please call Pfizer 1 866 723-7111 or visit www.healthcanada.gc.ca/medeffect or call Canada Vigilance Program at 1-866-234-2345. Children who will turn from 4 to 5 years of age between their doses in the vaccination series should receive their age-appropriate dose at the time of the vaccination and the interval between doses is determined by the childs age at the start of the vaccination series. a. N = Number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose. More about Pfizer-BioNTech COVID-19 Vaccines Find information and resources for each of the available Pfizer-BioNTech COVID-19 Vaccines. The median onset for all local reactions was 1 to 2.5 days, and all events resolved within a median duration of 1 to 3 days after onset. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, thrombotic events, myocarditis or anaphylactic reaction to the vaccine) reported during the blinded placebo-controlled follow-up period of the study. Not all pack sizes may be available. The 10 week refrigerated expiry date should be recorded on the carton at the time of transfer. Verify that the vial has a gray plastic cap and gray label border. Undiluted vials may be stored at room temperature for no more than 2 hours. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/ fetal development, parturition, or post-natal development (see 16 NON-CLINICAL TOXICOLOGY). The nucleoside-modified messenger RNA in tozinameran encodes for the viral spike (S) protein of SARS-CoV-2 Original strain and famtozinameran (mRNA) encodes the viral spike of SARS-CoV-2 Omicron variant lineages BA.4 and BA.5 (Omicron BA.4/BA.5). Alternatively, frozen vials may be stored in an ultra-low temperature freezer at 90C to 60C ( 130F to 76F) for up to 12 months from the date of manufacture. The decision to administer COMIRNATY to an individual with a history of myocarditis or pericarditis should take into account the individuals clinical circumstances. In the four vaccinated participants, events began from 3 to 48 days after their last dose, were mild to moderate in severity, and duration ranged from 3 to 68 days. Refrigeration units that are commonly available in hospitals. These GPS-enabled devices will allow Pfizer to proactively prevent unwanted deviations and act before they happen. How will Pfizer maintain vaccine integrity during distribution? Preparation for AdministrationDO NOT DILUTE, For 12 Years of Age and Older: DO NOT DILUTE (Vials with Gray Cap and Gray Label Border), 4.3.2 For Age 5 Years to <12 Years: DILUTE PRIOR TO USE (Vials with Orange Cap and Orange Label Border), For Age 5 Years to <12 Years: DILUTE PRIOR TO USE (Vials with Orange Cap and Orange Label Border), 4.3.3For Age 6 Months to <5 Years: DILUTE PRIOR TO USE (Vials with Maroon Cap and Maroon Label Border), For Age 6 Months to <5 Years: DILUTE PRIOR TO USE (Vials with Maroon Cap and Maroon Label Border). COVID-19 Vaccine Lot Number and Expiration Date Tool Seasonal Influenza Codes and Crosswalk 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. Vials stored at -25C to 15C (-13F to 5F) for up to 2 weeks may be returned one time to the recommended storage condition of -90C to -60C (-130F to -76F). Alternatively, frozen vials may be stored in an ultra-low temperature freezer at 90C to 60C ( 130F to 76F) for up to 18months from the date of manufacture. Submit Please enter a valid lot number Special characters (commas, /, *, &) are not allowed in the Lot numbers OR Scan bar / 2D code Bells palsy (facial paralysis and facial paresis) was reported by four participants in the vaccine group and two in the placebo group. Please confirm pricing with your Pfizer Distributor. In the analysis of blinded, placebocontrolled 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. 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