After dilution, the vaccine will be a white to off-white suspension. Inspect the liquid in the vial prior to dilution. HIV-positive participants are included in safety population disposition but are summarized separately in safety analyses. Refer to thawing instructions in the panels below. January 31, 2023. DILUTE PRIOR TO USE (Vial with Orange Cap and Orange Label Border). Strict adherence to aseptic techniques must be followed. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. 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. 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. When prepared according to their respective instructions, COMIRNATY for 12 years of age and older (DILUTE BEFORE USE: purple cap and purple label border) and COMIRNATY for 12 years of age and older (DO NOT DILUTE: gray cap and gray label border) can be used interchangeably to provide the COVID-19 vaccination series.COMIRNATY and the Interim Order authorized Pfizer-BioNTech COVID-19 Vaccine, for use in individuals 12 years of age and older, have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series.Vials of COMIRNATY intended for individuals 12 years of age and older (purple cap/purple label border or gray cap/gray label border) cannot be used to prepare doses for individuals aged 6 monthsto <12 years. g. Severity was not collected for use of antipyretic or pain medication. 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 (1,131 COMIRNATY; 1,129 placebo) were 12 to 15 years of age. Adolescents 12 to 15 Years of Age Primary Series (Two Doses). 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. 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. A carton of 10 vials may take up to 6 hours to thaw. 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. Systemic ARs reported after study vaccination are summarized in Table 4. Alternatively, frozen vials may be stored in an ultra-low temperature freezer at 90C to 60C ( 130F to 76F). 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. ONLY use 0.9% Sodium Chloride Injection, USP as the diluent. The COMIRNATY multiple dose vial with a gray cap and a gray label border contains a volume of 2.25 mL, and is supplied as a frozen suspension that does not contain preservative. Appendicitis was reported as a serious adverse event for 27 participants, 15 vaccine participants and 12 placebo participants. Together, they worked to better understand the novel virus. Confirm there are no particulates and that no discolouration is observed. DILUTE PRIOR TO USE (Vial with Maroon Cap and Maroon Label Border). A carton of 10 vials may take up to 4 hours to thaw at this temperature. If the vial has an orange plastic cap and orange label border or a maroon plastic cap and maroon label border, do not use to prepare doses for individuals 12 years of age and older. Thaw vial(s) of COMIRNATY before use either by: Allowing vial(s) to thaw in the refrigerator (2C to 8C [35F to 46F]). Administer a single 0.3 mL dose of COMIRNATY Original & Omicron BA.4/BA.5 intramuscularly, preferably in the deltoid muscle. Lymphadenopathy was reported in 13 (0.9%) participants in the COMIRNATY 10mcg group vs. 1 (0.1%) in the placebo group. As with any vaccine, vaccination with COMIRNATY may not protect all recipients. 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. In the analysis of Study 2 of all unsolicited adverse events reported following any dose, through 1 month after Dose 2, in adolescents 12 to 15 years of age (N=2260; 1,131 COMIRNATY group vs. 1,129 placebo group), those assessed as adverse reactions not already captured by solicited local and systemic reactions were lymphadenopathy (9 (0.8%) vs. 2 (0.2%)), and nausea (5 (0.4%) vs. 1 (0.1%)). For a complete listing see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. COVID-19 Vaccine Lot Number and Expiration Date Tool. a second dose inventory management system. 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. COMIRNATY multiple dose vials (with maroon cap and maroon label border) are supplied in a carton containing 10 multiple dose vials. We have crossed another milestone in the fight against COVID-19. Skin and subcutaneous tissue disorders (including skin rash, dermatitis, eczema and urticaria) were reported in 17 (1.1%) participants in the vaccine group and 5 (0.7%) participants in the placebo group. 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. To find the expiration date for any Pfizer-BioNTech COVID-19 Vaccine lot number, enter the lot number found on the vial or the carton. The initial 2 doses are administered 3 weeks apart followed by a third dose administered at least 8 weeks after the second dose. the vial has an orange plastic cap and a label with an orange border. The safety profile in 545 participants receiving COMIRNATY that were seropositive for SARS-CoV-2 at baseline was similar to that seen in the general population. 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. Verify that the vial has a purple plastic cap and purple label border. Not all pack sizes may be available. Thank you for taking the time to confirm your preferences. All cases were considered to be mild, with a median onset of 3 days after Dose 1, and 2 days after Dose 2 in the vaccine group. Safety data from studies in individuals 12 years of age using bivalent formulations of COMIRNATY at 30 mcg are considered supportive. If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2mL, discard the vial and any excess volume. Our distribution is built on a flexible just-in-time system which will ship the frozen vials to the point of vaccination. 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. 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 b. Each dose contains 30 mcg modRNA in total and also includes the non-medicinal ingredients listed in Table 1. Vaccines are one of the greatest health interventions ever developed. Emergency uses of the vaccines have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID 19) in: "Filter Update: if you insinuate Lisa Marie Presley went into cardiac arrest because of the COVID-19 vaccine, that's an #instablock," they commented. Centers for Disease Control and Prevention (U.S.) Description: Use this tracking tool to record updated expiration dates for COVID-19 vaccine as additional stability data are available from the manufacturer. Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. Obtain sterile 0.9% Sodium Chloride Injection, USP. ONLY use 0.9% Sodium Chloride Injection, USP as the diluent. In an analysis of all unsolicited adverse events reported following the booster dose of COMIRNATY, through 1 month after the booster dose, in participants 16 through 87 years of age (N = 5,055), adverse reactions included headache (5%), fever (4.8%), lymphadenopathy (2.8%), decreased appetite (0.2%), malaise (0.7%), nausea (0.9%), and pain in extremity (1.1%). No Grade 4 systemic events were reported in any vaccine groups evaluated. COMIRNATY (for age 5 years to <12 years): A carton of 10 vials may take up to 4 hours to thaw at this temperature. Thawed vials can be handled in room light conditions. No Grade 4 systemic events were reported. 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. COMIRNATY is supplied as a frozen suspension in multiple dose vials with a maroon cap and a maroon label border. Please review the label carefully to ensure that you select the appropriate vaccine for immunization. The novel coronavirus has recently been linked to two serious fungal infections: COVID-19 associated pulmonary aspergillosis (CAPA) and COVID-19 associated mucormycosis (CAM).1 The resurgence of these rare fungal infections has medical personnel concerned. As the potential threat of COVID-19 became clear by early 2020, teams across Pfizer sprang into action. The overall safety profile for the booster dose was similar to that seen after the primary series. COMIRNATY multiple dose vial contain a frozen suspension that does not contain preservative and must be thawed and may require dilution prior to administration. Reports are accepted from anyone and can be submitted electronically at www.vaers.hhs.gov. 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. There were no other notable patterns between treatment groups for specific categories of non-serious adverse events that would suggest a causal relationship to COMIRNATY. The safety and efficacy of COMIRNATY Original & Omicron BA.4./BA.5 in children under 5years of age have not yet been established. DO NOT administer COMIRNATY Original & Omicron BA.4/BA.5 with Gray Cap and Gray Label Border to children 5 years to <12 years. Each vial must be thawed prior to administration. Table 2: Dosage Forms, Strengths, Composition and Packaging (For Age 5 Years to <12 Years), Multiple dose vial(after dilution, each vial contains 10* doses of 0.2 mL). CIR Total Expected Inventory. However, some of the effects mentioned under 8 ADVERSE REACTIONS may temporarily affect the ability to drive or use machines. 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. Where is the Pfizer-BioNTech COVID-19 vaccine made? The 10 week refrigerated expiry date should be recorded on the carton at the time of transfer. 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)]. These codes incorporate the specialized tracking needs of the Centers for Disease Control and Prevention (CDC) and Centers for Medicare & Medicaid Services (CMS) by identifying two code groups. 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). 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. Very rare cases of myocarditis and/or pericarditis following vaccination with COMIRNATY have been reported during post-authorization use. 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