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). The safety profile of the participants with stable HIV infection receiving COMIRNATY (n = 100) was similar to that seen in the general population. Once opened, and if being used as temporary storage by a vaccination center, then it can be used for a total of 15 days with re-icing every five days. We have developed packaging and storage innovations to be fit for purpose to meet the needs of our global network. A 17-year-old male in Study 2 was diagnosed with myocarditis three days after receiving the booster dose (Dose 3). 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. Thank you for taking the time to confirm your preferences. After preparation, a single dose is 0.3 mL. Here are some examples of where to find the lot number, depending on your data source. Few additional AEs were reported from study vaccination from post-dose to the data cut-off date for participants in the COMIRNATY 30 mcg (6.6% vs 5.9%) group. 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. If you don't find vaccine in your area, then you can submit a vaccine order through WAIIS. Inspect vials to confirm there are no particulates and no discolouration is observed. 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. 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. Many of the AEs were consistent with reactogenicity events (e.g., fever and fatigue). Study 2 also included 200 participants with confirmed stable human immunodeficiency virus (HIV) infection. Administer immediately, and no later than 6 hours after dilution. 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. COMIRNATY Original & Omicron BA.4/BA.5 has no or negligible influence on the ability to drive and use machines. 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. The participant was treated and recovered. The denominators (N) used in the percentage calculations for fever and use of antipyretic or pain medication were 749 after Dose 1 and 741 after Dose 2 in the placebo group, due to an e-diary error. The 10 week refrigerated expiry date should be recorded on the carton at the time of transfer. a. N = number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose. 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. Record the date and time of first vial puncture(dilution) on the COMIRNATY (for age 5 years to <12 years) vial label. 2 DOSAGE AND ADMINISTRATION For intramuscular injection only. In a clinical study of participants 18 through 55 years of age (N=306), 289 participants (94%) completed the e-diary recording adverse reactions. 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. Study 2 also included 200 participants with confirmed stable human immunodeficiency virus(HIV) infection. Please choose the category that best describes you. In Study C4591031 (Study 4), a placebo-controlled booster study, 5,081 participants 16 years of age and older were recruited from Study 2 to receive a booster dose of COMIRNATY at least 6 months after the second dose. All information these cookies collect is aggregated and therefore anonymous. 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. 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. Do not use COMIRNATY vials with a maroon plastic cap and maroon label border, purple plastic cap/purple label border or gray plastic cap/gray label border to prepare doses for individuals aged 5 years to <12 years. An analysis of Study 3 Phase 2/3 adverse event data also included another 2,379 participants (safety expansion group: 1,591 COMIRNATY 10 mcg and 788 placebo), of whom 71.2% had a follow-up period for at least 2 weeks after Dose 2. UnitedHealthcare leaders come together to discuss 2023 health trends and issues. The vaccine can be stored for five days at refrigerated 2-8C conditions. Cartons of COMIRNATY multiple dose vials (for age 5 years to <12 years) and COMIRNATY multiple dose vials (for age 6 months to <5 years) may arrive frozen at ultra-cold conditions in thermal containers with dry ice. The decision to administer COMIRNATY Original & Omicron BA.4/BA.5 to an individual with a history of myocarditis or pericarditis should take into account the individuals clinical circumstances. 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. For example, if a provider was getting 975 doses, it will now be 1,170 doses. In an analysis of Study 2, based on data up to the cut-off date of March 13, 2021, a total of 2,260 adolescents (1,131COMIRNATY; 1,129 placebo) were 12 to 15years of age. No withdrawals due to AEs or deaths were reported. If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents. Table 9 and Table 10 present the frequency and severity of solicited local and systemic reactions, respectively, within 7days following each dose of COMIRNATY and placebo in adolescents 12to15years of age included in the safety population who were monitored for reactogenicity with an electronic diary. CIR Total Expected Inventory. Very rare cases of myocarditis and/or pericarditis following vaccination with COMIRNATY have been reported during post-authorization use. Inspect vials to confirm there are no particulates and no discolouration is observed. In Study C4591031 (Study 4), a placebo-controlled booster study, participants 16 years of age and older recruited from Study C4591001 (Study 2) received a booster dose of COMIRNATY (5,081 participants), or placebo (5,044 participants) at least 6 months after the second dose of COMIRNATY. Ultra-cold COVID-19 Vaccine Pfizer-BioNTech Frozen COVID-19 Vaccine Moderna . Check that the carton has been updated to reflect the 10-week refrigerated expiry date. Do not administer if vaccine is discoloured or contains particulate matter. Inspect the liquid in the vial prior to dilution. Transportation of Frozen VialsIf local redistribution is needed and full cartons containing vials cannot be transported at 90C to 60C (130F to 76F), vials may be transported at -25C to 15C (-13F to 5F). Based on accumulating data, the reporting rates of myocarditis and pericarditis after COMIRNATY primary series in children ages 5 through <12 years are lower than in ages 12 through 17 years. 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. * Randomized participants who received at least 1 dose of the study intervention. e. Severe: requires intravenous hydration. 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. We have specially designed, temperature-controlled thermal shippers utilizing dry ice to maintain recommended temperature conditions for up to 10 days unopened. Vials must be kept frozen and protected from light, in the original cartons, until ready to use. The date printed on the vial and carton reflects the date of manufacture. No Grade 4 systemic events were reported in any vaccine groups evaluated. There are no data available on the interchangeability of COMIRNATY with other COVID-19 vaccines to complete the primary vaccination series or for a booster dose. 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 in Study 2. Obtain sterile 0.9% Sodium Chloride Injection, USP. 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)]. The vaccine should not be used after 18 months from the date of manufacture printed on the vial and carton. Irrespective of the type of syringe and needle: Administer a single 0.2 mL dose of COMIRNATY intramuscularly. Study C4591001 (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. Regardless of storage condition, vaccines should not be used after 18 months from the date of manufacture printed on the vial and cartons. Table 16: Study 3 Frequency of Solicited Systemic Reactions Within 7Days After Each Dose Children 5Years Through <12Years of Age Safety Population*. The safety and efficacy of COMIRNATY Original & Omicron BA.4/BA.5 in children under 5years of age have not yet been established (see 8 ADVERSE REACTIONS and 14 CLINICAL TRIALS). 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. There is no information on the co-administration of COMIRNATY Original & Omicron BA.4/BA.5 with other vaccines. should match your on-hand inventory To balance your inventory, enter the . Do not dilute. Procedures should be in place to avoid injury from fainting. After dilution, the vial should be held between 2C to 25C (35F to 77F). Search Search . Clinical studies of COMIRNATY include participants 65 years of age and older, who received the primary series and a booster dose of COMIRNATY, and their data contributes to the overall assessment of safety and efficacy (See 8 ADVERSE REACTIONS and 14 CLINICAL TRIALS). The U.S. has bought 1.41 billion doses in total, and has so far distributed around 390 million across the country. If standard syringes and needles are used, there may not be sufficient volume to extract a 6th dose from a single vial. Administer immediately, and no later than 12 hours after dilution. Prior to mixing, the thawed vaccine may contain white to off-white opaque amorphous particles. second. Theyve been cited as being as important to keeping communities healthy as having access to clean water and safe sanitation.1 Multiple Dose Vial (for 12 years of age and older: DILUTE BEFORE USE), Dilute with 1.8 mL sterile 0.9% Sodium Chloride Injection, USP prior to use, Multiple Dose Vial (for 12 years of age and older: DO NOT DILUTE), COMIRNATY* Multiple Dose Vial (for age 5 years to <12 years: DILUTE PRIOR TO USE), Dilute with 1.3 mL sterile 0.9% Sodium Chloride Injection, USP prior to use, 4.2.1 Vaccination Schedule for Individuals 12 Years of Age and Older. Two formulations of COMIRNATY are available for individuals 12 years of age and older. It is supplied as a frozen suspension that does not contain preservative. 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. These GPS-enabled devices will allow Pfizer to proactively prevent unwanted deviations and act before they happen. In clinical studies with a data cut-off of March 13, 2021, and where 2 doses were administered 3 weeks apart, the most common adverse reactions in the reactogenicity subset (n=4,924) of participants 16 years of age and older after any dose included injection site pain (84.3%), fatigue (64.7%), headache (57.1%), muscle pain (40.2%), chills (34.7%), joint pain (25.0%), fever (15.2%), injection site swelling (11.1%), and injection site redness (9.9%). One year. A subset from Study C4591001 (Study 2) Phase 2/3 participants, of 306 adults 18 through 55 years of age who completed the original COMIRNATY 2-dose series, received a booster dose of COMIRNATY approximately 6 months (range of 4.8 to 8.0 months) after receiving Dose 2. Administer a single 0.3 mL dose of COMIRNATY intramuscularly, preferably in the deltoid muscle. Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. Those participants vaccinated prior to February 22, 2022 provided the safety database (n=401), and had a median safety follow-up of 1.3 months from vaccination through the data cut-off date of March 22, 2022. 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. You will be subject to the destination website's privacy policy when you follow the link. Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw. One dose (0.2 mL) contains 10 micrograms of COVID-19 mRNA vaccine Vials with a maroon cap and maroon label border contain 10 doses of 0.2 mL after dilution. Visually inspect each dose in the dosing syringe prior to administration. Use only this as the diluent. Serious adverse events from Dose 1 through 1 month after Dose 3, with an overall median of 1.3 months follow up after Dose 3, were reported by 1.4% of COMIRNATY recipients and by 2.3% of placebo recipients. Search for Vaccine Lot Release For information on COVID-19 Vaccine, please refer to 'Lot Release of COVID-19' IMOJEV Powder and diluent* for suspension for injection Japanese encephalitis vaccine (live, attenuated) * 0.4 % Sterile Sodium chloride solution 08A2003EA . Each vial must be diluted with 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine, and contains 6 doses of 0.3 mL after dilution. For Age 5 Years to <12 YearsCOMIRNATY is a suspension for intramuscular injection which must be diluted prior to administration. 1) The manufacturer In the U.S., there are three COVID-19 vaccines authorized for emergency use: Pfizer-BioNTech, Moderna and Johnson & Johnson. Vials may be stored at room temperature [up to 25C (77F)] for up to 12 hours prior to use. How will hospitals and pharmacies keep vaccines cold? The thawed suspension may contain white to off-white opaque amorphous particles. Once vials are thawed they should not be refrozen. Any hours used for transport at -25C to -15C (-13F to 5F) count against the 2week limit for storage at -25C to -15C (-13F to 5F). Storage of the vials between -96C to -60C (-141F to -76F) is not considered an excursion from the recommended storage condition. 4.3.1.1 For 12 Years of Age and Older: DILUTE BEFORE USE (Vials with Purple Cap and Purple Label Border), For 12 Years of Age and Older: DILUTE BEFORE USE (Vials with Purple Cap and Purple Label Border), For 12 Years of Age and Older: DILUTE BEFORE USE (Vials with Purple Cap and Purple Label Border), 4.3.1.2For 12 Years of Age and Older: DO NOT DILUTE (Vials with Gray Cap and Gray Label Border). Animal studies do not indicate direct or indirect harmful effects with respect to female fertility or reproductive toxicity (see 16 NON-CLINICAL TOXICOLOGY). Very rare cases of myocarditis and/or pericarditis following vaccination with COMIRNATY have been reported during post-authorization use. Following vaccination with COMIRNATY have been reported during post-authorization use your area, then you can submit a vaccine through! 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