The median onset for all systemic events across both vaccine groups evaluated was 2 to 3 days and all events resolved within a median duration of 1 to 2 days after onset. Each vial must be diluted with 1.3 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine, and contains 10* doses of 0.2 mL after dilution. We have crossed another milestone in the fight against COVID-19. 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. Adolescents 12 to 15 Years of Age Primary Series (Two Doses). HIV-positive participants are included in safety population disposition but are summarized separately in safety analyses. Refer to dilution and dose preparation instructions in the panels below. Typically, the onset of symptoms has been within a few days following receipt of COMIRNATY. Administer immediately and no later than 12 hours after first puncture. Vials may be stored at room temperature [up to 25C (77F)] for up to 12 hours prior to use. The participants were unblinded to offer placebo participants COMIRNATY when they became locally eligible under regulatory approval in December 2020. Do not use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent. In individuals 1 year of age and older, the recommended injection site is the anterolateral aspect of the thigh or the deltoid muscle. Not all pack sizes may be available. From Dose 1 through 30 days after Dose 2, reports of lymphadenopathy plausibly related to the study intervention were imbalanced, with notably more cases in the COMIRNATY group (7) vs. the placebo group (1). a. N = number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose. Contact Pfizer Safety to report an adverse event, side effect or concern about the quality of a Pfizer product: 1 866 723-7111. COMIRNATY Original & Omicron BA.4/BA.5 multiple dose vials (for 12 years and older: DO NOT DILUTE) may be stored at room temperature up to 25C (77F) for a total of 12 hours prior to the first puncture. safety data from clinical trials which evaluated primary and booster vaccination with COMIRNATY (see. 2 DOSAGE AND ADMINISTRATION For intramuscular injection only. Do not inject the vaccine intravascularly, subcutaneously or intradermally. In a similar analysis in participants 56 years of age and older that included 8,931 COMIRNATY recipients and 8,895 placebo recipients, unsolicited adverse events were reported by 2,551 (28.6%) participants in the COMIRNATY group and 1,432 (16.1%) participants in the placebo group. These cases occurred more commonly after the second dose and in adolescents and young adults. There were no reports of myocarditis/pericarditis or anaphylaxis by the study cut-off date. Dr Gina Reghetti Do Pc Inc is a Medical Group that has only one practice medical office located in Warren OH. Using aseptic technique, withdraw 2.2 mL of diluent into a transfer syringe (using 21 gauge or narrower needle). 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%). Allowing vial(s) to thaw in the refrigerator [2C to 8C (35F to 46F)]. Cleanse the vaccine vial stopper with a single-use antiseptic swab. After preparation, a single dose is 0.2 mL. Any vaccine remaining in vials must be discarded after 6 hours. Equalize vial pressure before removing the needle from the vial by withdrawing 2.2 mL air into the empty diluent syringe. Allowing vial(s) to sit at room temperature [up to 25C (77F)] for 30minutes. c. Mild: does not interfere with activity; moderate: some interference with activity; severe: prevents daily activity. Access to this report is strictly managed by registration only. The safety evaluation of participants in Study 2, Study 3 and Study 4 is ongoing. Overall, participants who received a booster dose, had a median follow-up time of 2.5 months after the booster dose to the cut-off date (5 October 2021). We will utilize GPS-enabled thermal sensors in every thermal shipper with a control tower that will track the location and temperature of each vaccine shipment across their pre-set routes. Do not use if vaccine is discoloured or contains particulate matter. Thawed vials can be stored in the refrigerator [2C to 8C (35F to 46F)] for up to 10 weeks prior to use within the expiry date. 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. 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). The date printed on the vial and carton reflects the date of manufacture. Instructions on the handling and dose preparation of the vaccine prior to administration are provided below. The diluted vaccine will be a white to off white suspension. Do not use COMIRNATY vials with an orange plastic cap/orange label border, purple plastic cap/purple label border or gray plastic cap/gray label border to prepare doses for individuals aged 6 months to <5 years. How Do Viruses Mutate and What it Means for a Vaccine? Thats because people tend to spend more time indoors, where germs can circulate from one person to another through the air or close contact. Once vials are thawed they should not be refrozen. This diluent is not packaged with the vaccine and must be sourced separately. The adverse reaction rates observed in the clinical trials, therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance. As of the data cut-off date, any related or any severe AEs were reported across the vaccine groups by 5.1% or 0.9% of participants, respectively. 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 18-month shelf-life. Pfizer consistently and diligently monitors the supply of our medicines. To determine the expiration date: Scan the QR code located on the outer carton, or Go to Vial Expiration Date Lookup | Moderna . Administer a single 0.3 mL dose of COMIRNATY intramuscularly, preferably in the deltoid muscle. Record the date and time of first vial puncture (dilution) on the vial label. Regardless of storage condition, vaccine should not be used after 12 months from the date of manufacture printed on the vial and cartons. ONLY use 0.9% Sodium Chloride Injection, USP as the diluent. Thawed Under Refrigeration: Thaw and then store undiluted vials in the refrigerator (2C to 8C [35F to 46F]) for up to 1 month. Study 2 also included 200 participants with confirmed stable human immunodeficiency virus (HIV) infection. DILUTE PRIOR TO USE (Vial with Orange Cap and Orange Label Border). Verify that the vial has an orange plastic cap and an orange label border. Vials of COMIRNATY intended for 12 years of age or older with a purple cap/purple label border or gray cap/gray label border and vials of COMIRNATY intended for individuals aged 6 months to <5 years with a maroon cap/maroon label border cannot be used to prepare doses for individuals aged 5 years to <12 years. 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. Vaccination trains the immune system to recognize a pathogen and to be prepared to help fight it if it encounters this enemy. Do not add more than 1.8 mL of diluent. Our distribution is built on a flexible just-in-time system which will ship the frozen vials to the point of vaccination. Data.CDC.gov. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. View public records and voter registration of Gina Warren born 1964, includes court and personal records. COMIRNATY Original & Omicron BA.4/BA.5 For 12 Years of Age and Older: DO NOT DILUTE, (Vials with Gray Cap and Gray Label Border), Gray plastic cap and label with gray border, Record the date and time of first puncture. What Makes an RNA Vaccine Different From a Conventional Vaccine? Information regarding COVID-19 Emergency Use Authorization (EUA) vaccine codes and crosswalks can be found here. No serious adverse events were reported that were considered related to vaccination. DILUTE PRIOR TO USE (Vials with Orange Cap and Orange Label Border). Tables 7 through 10 present the frequency and severity of solicited local and systemic reactions, respectively, within 7 days following each dose of COMIRNATY and placebo in the subset of participants 16 years of age and older (n=9,839) in the safety population who were monitored for reactogenicity with an electronic diary. Once vials are thawed they should not be refrozen. Thawed vials may be stored at room temperature [up to 25C (77F)] for up to 12 hours prior to use. Do not mix COMIRNATY with other vaccines/products in the same syringe. 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. The initial 2 doses are administered 3 weeks apart followed by a third dose administered at least 8 weeks after the second dose. b. n = Number of participants with the specified characteristic. Participants 5 Years Through <12 Years of Age. If you don't find vaccine in your area, then you can submit a vaccine order through WAIIS. Among participants with confirmed stable HIV infection serious adverse events from Dose 1 up to the participant unblinding date in ongoing follow-up were reported by 2 (2%) COMIRNATY recipients and 2 (2%) placebo recipients.Pericarditis was reported for one participant in the vaccine group, and no case was reported in the placebo group. These GPS-enabled devices will allow Pfizer to proactively prevent unwanted deviations and act before they happen. The safety of the primary seriesof COMIRNATY was evaluated in participants 6 months of age and older in three clinical studies conducted in the United States, Europe, Turkey, South Africa, and South America. The safety evaluation in Study 3 is ongoing. Our distribution approach will be to largely ship from our Kalamazoo and Puurs sites direct to the point of use (POU). 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 COVID-19 caused by SARS-CoV-2 in individuals 5 years of age and older. 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. Note: Events and use of antipyretic or pain medication were collected in an electronic diary (e-diary) from Day 1 to Day 7 after each dose. From Dose 1 through 30 days after Dose 3, lymphadenopathy was reported in 1 (0.1%) of COMIRNATY recipients vs. 0 (0.0%) of placebo recipients. Table 3: Solicited Local Adverse Reactions Reported for Vaccine Groups Within 7 Days After Study Vaccination, COMIRNATY Original & Omicron BA.4/BA.5 (15 mcg/15 mcg), Solicited Systemic Adverse Reactions (ARs). Lymphadenopathy was reported in 87 (0.4%) participants in the vaccine group compared to 8 (<0.1%) participants in the placebo group, which is plausibly related to vaccination. Total cumulative time the vials are stored at -25C to -15C (-13F to 5F) should be tracked and should not exceed 2 weeks. The vaccine can be stored for five days at refrigerated 2-8C conditions. Lymphadenopathy was reported in 13 (0.9%) participants in the COMIRNATY 10 mcg group vs. 1 (0.1%) in the placebo group. The safety and effectiveness of a booster dose of COMIRNATY Original & Omicron BA.4/BA.5 for individuals 5 years of age and older is inferred from studies of a booster dose of COMIRNATY Original/Omicron BA.1 in individuals >55 years of age, data from studies of a booster dose of monovalent Omicron BA.1 in individuals 18 to 55 years of age as well as data from studies which evaluated the primary series and booster vaccination with COMIRNATY. Drug and vaccine authorizations for COVID-19: List of authorized drugs, vaccines and expanded indications Overview List of applications received List of authorized products Date published: 2022-12-09 Drugs and vaccines that have been authorized by Health Canada for use in relation to the COVID-19 pandemic are listed here. The COMIRNATY Original & Omicron BA.4/BA.5 multiple dose vial with a gray cap and gray label border MUST NOT BE DILUTED prior to administration. After dilution, the vaccine vials can be handled in room light conditions. COMIRNATY multiple dose vials (with maroon cap and maroon label border) are supplied in a carton containing 10 multiple dose vials. By. Cartons of COMIRNATY multiple dose vials (for 12 years and older: DO NOT DILUTE) may also arrive at 2C to 8C. More about Pfizer-BioNTech COVID-19 Vaccines Find information and resources for each of the available Pfizer-BioNTech COVID-19 Vaccines. Use this Symptom Checker for Common Fall and Winter Illnesses. Participants, including those who received a booster in Study 4, continue to be monitored for unsolicited adverse events, including serious adverse events, throughout the study [from Dose 1 to 1 month after the last dose (all unsolicited adverse events) and 6 months (serious adverse events) after the last vaccination]. Careful attention should be paid to the vial cap and label border colour and the appropriate corresponding instructions must be followed under the subsections below. COVID-19 vaccine, receive an additional dose of hat same mRNA . One group identifies a specific vaccine product and the other provides a vaccine administration code that is both vaccine and dose specific. Before dilution, allow the thawed vial to come to room temperature. If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2 mL, discard the vial and any excess volume. 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. Of these, 2,171 (95.7%) (1,456 COMIRNATY 10 mcg and 715 placebo) participants have been followed for at least 3 months after Dose 2. 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. Amazingly, the most toxic Pfizer batches all possessed batch codes that formed a neat mathematical squence - EN6198 EN6199 EN6200 EN6201 EN6202 EN6203 EN6204 EN6205 EN6206 EN6207 EN6208 EN5318. 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