Thawed vials may be stored at room temperature [up to 25C (77F)] for up to 12 hours prior to dilution. Refer to thawing instructions in the panels below. These cookies may also be used for advertising purposes by these third parties. As with any vaccine, vaccination with COMIRNATY may not protect all recipients. If local redistribution is needed, full cartons containing undiluted vials may be transported at 90C to 60C ( 130F to 76F); full cartons or individual undiluted vials may also be transported at 2C to 8C (35F to 46F). 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. A total of 12,006 (54.5%) participants originally randomized to the vaccine group in Study 2 had been followed up for at least 6 months after the second dose including the blinded and open-label periods. 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. Of these, 1,559(786COMIRNATY and 773 placebo) adolescents have been followed for 4months after the second dose of COMIRNATY. Tables 3 through 6 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. 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. Animal studies do not indicate direct or indirect harmful effects with respect to female fertility or reproductive toxicity (see 16 NON-CLINICAL TOXICOLOGY). 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. Vials should be discarded 12hours after first puncture. Currently available information is insufficient to determine a causal relationship with the vaccine. 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. The 10 week refrigerated expiry date should be recorded on the carton at the time of transfer. There were no notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events that would suggest a causal relationship to COMIRNATY. Adolescents 12 to 15 Years of Age Primary Series (Two Doses). 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. Once vials are thawed they should not be refrozen. Once a POU receives a thermal shipper with our vaccine, they have three options for storage: The shipper can maintain temperature for 10 days unopened which allows for transportation to markets globally to ensure all patients have access. Administer a single 0.3 mL dose of COMIRNATY intramuscularly, preferably in the deltoid muscle. When at room temperature, mix by inverting vaccine vial gently 10 times. Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. Do not add more than 1.3 mL of diluent. Note: Events and use of antipyretic or pain medication were collected in the e-diary and unscheduled clinical assessments from Day 1 through Day 7 after vaccination. d. Severe: requires intravenous hydration. Enfermedad por coronavirus (COVID-19) Situacin. 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 . Study C4591044 is an ongoing study to evaluate the safety, tolerability, and immunogenicity of new bivalent vaccines including COMIRNATY Original & Omicron BA.4/BA.5. The vial stoppers are not made with natural rubber latex. 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. or . Add 1.8 mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial. e. Mild: 2 to 3 loose stools in 24 hours; moderate: 4 to 5 loose stools in 24 hours; severe: 6 or more loose stools in 24 hours. After dilution, one vial contains 10* doses of 0.2 mL. Minimum Pfizer order will now be 1,170 doses. dose. Cartons of COMIRNATY Original & Omicron BA.4/BA.5 multiple dose vials (for 12 years and older: DO NOT DILUTE) may also arrive at 2C to 8C (35F to 46F) . The thawed suspension may contain white to off-white opaque amorphous particles. Home Data Catalog Developers Video Guides Using aseptic technique, withdraw 1.3mL of diluent into a transfer syringe (using 21gauge or narrower needle). Clinical trials are conducted under very specific conditions. Table 1: Dosage Forms, Strengths, Composition and Packaging (For 12 Years of Age and Older), Tozinameran (mRNA) encodes for the viral spike (S) protein of SARS-CoV-2 Original strain and famtozinameran (mRNA) encodes for the viral spike (S) protein of SARS-CoV-2 Omicron BA.4/BA.5 strain. b. n = Number of participants with the specified characteristic. How is Pfizer utilizing a cold chain process to distribute its vaccine? Study 2 also included 200 participants with confirmed stable human immunodeficiency virus (HIV) infection. Bells palsy (facial paralysis and facial paresis) was reported by four participants in the vaccine group and two in the placebo group. The safety of a booster dose of COMIRNATY Original & Omicron BA.4/BA.5 is also based on: Safety data accrued with the COMIRNATY Original/Omicron BA.1 vaccine and with COMIRNATY are relevant to the COMIRNATY Original & Omicron BA.4/BA.5 vaccine because these vaccines are manufactured using the same process. Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website. We have implemented an unprecedented and comprehensive preparedness plan to control our site operations and will continue to provide timely updates if there is any new information to be shared. Participants, including those who received a booster in Study 4, 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]. At the time of authorization, there are no known serious warnings or precautions associated with this product. a. N = Number of participants reporting at least 1 yes or no response for the specified event after the specified dose. We take your privacy seriously. No deaths related to the vaccine were reported in the study. Bells palsy (facial paralysis and facial paresis) was reported by four participants in the vaccine group and two in the placebo group. Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw 0.2 mL of COMIRNATY (for age 6 months to <5 years) preferentially using a low dead-volume syringe and/or needle. Each dose must contain 0.2mL of vaccine. (after dilution, each vial contains 10* doses of 0.2 mL). In analyses of all unsolicited adverse events in Study 2 from Dose 1 up to the participant unblinding date, 69.0% of study participants 12 through 15 years of age had at least 4 months of follow-up after Dose 2. At the time of the analysis of Study 2 (data accrued through March 13, 2021), a total of 25,651 (58.2%) participants (13,031 in vaccine group and 12,620 in placebo group) 16 years of age and older had been followed up for at least 4 months, with 3,082 (7.0%) participants (1,778 in vaccine group and 1,304 in placebo group) followed up for at least 6 months after the second dose during the blinded placebo-controlled follow-up period. COMIRNATY is supplied as a frozen suspension in multiple dose vials with an orange capand an orange label border. Do not dilute. Lymphadenopathy was reported in 13 (0.9%) participants in the COMIRNATY 10 mcg group vs. 1 (0.1%) in the placebo group. 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. Most of the events began from 3-11 days after the second dose and were characterized as mild and self-limited. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. A carton of 10 vials may take up to 6 hours to thaw at this temperature. I went on to identify several additional ranges of toxicity, each one identified by similar sequences of batch codes. Do not dilute. Cold chain is how the temperature of perishable products are managed in order to maintain quality and safety from end to end in the distribution process. 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. 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. The KFF COVID-19 Vaccine Monitor is an ongoing research project tracking the public's attitudes and experiences with COVID-19 vaccinations. Note: Reactions were collected in an electronic diary (e-diary) from Day 1 to Day 7 after vaccination. Table 11 and Table 12 present the frequency and severity of solicited local and systemic reactions, respectively, within 7days following each dose of COMIRNATY and placebo in children 5 years through 12years of age included in the initial enrolment safety population who were monitored for reactogenicity with an electronic diary. 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. For Canadian Healthcare Professionals 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. Bivalent vaccine (with a maroon vial cap and different label. The 10 week refrigerated expiry date should be recorded on the carton at the time of transfer. Document the current date, the vaccine lot number, and the updated expiration date. Vials of COMIRNATY intended for individuals aged 6 months to <5 years (maroon cap/maroon label border) cannot be used to prepare doses for individuals 5 years of age and older. 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