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. It undergoes rigorous internal medical review and is updated regularly to reflect new information. Most of the additional AEs reported after 1 month post-dose up to the data cut-off date consisted of unrelated events such as spinal osteoarthritis, ischaemic stroke, breast tenderness and tooth extraction. Severe local reactions were reported by 1 (1.0%) participant in the 12 to 17 years of age group who received a booster dose of COMIRNATY Original & Omicron BA.4/BA.5 30 mcg. The intent is to utilize Pfizer-strategic transportation partners to ship by air to major hubs within a country/region and by ground transport to dosing locations. 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. Of the total number of COMIRNATY recipients in the study, 20.7% were 65 years of age and older. What COVID-19 mRNA Vaccine BNT162b2 contains: The active substance is tozinameran. Each vial must be thawed and diluted prior to administration. 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. The World Health Organization recently declared a pandemic in the wake of a global outbreak of the novel coronavirus disease (COVID-19). 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. It is unknown whether COMIRNATY Original & Omicron BA.4/BA.5 is excreted in human milk. No serious adverse events were reported after the booster dose through the cut-off date. Together, they worked to better understand the novel virus. Allowing vial(s) to sit at room temperature [up to 25C (77F)] for 30minutes. The participant was treated and recovered. The analysis of the Study 3 Phase 2/3 subset is based on data up to the cut-off date of March 22, 2022 (median follow-up time of 1.3 months). The products discussed herein may have different labeling in different countries. The U.S. has bought 1.41 billion doses in total, and has so far distributed around 390 million across the country. COMIRNATY is supplied as a frozen suspension in multiple dose vials. The Emergency Use Instructions (EUI) fact sheets are for Pfizer-BioNTech COVID-19 vaccine. General Gustave Perna and the Operation Warp Speed team have offered any and all support and we are grateful for that as what we are tasked with is no simple feat. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. It is supplied as a frozen suspension that does not contain preservative. 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. Published December 11, 2020. Each vial must be thawed and diluted prior to administration. 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. Would you like to proceed? It is unknown whether this vaccine has an impact on fertility. The safety of a booster dose of COMIRNATY Original & Omicron BA.4/BA.5 at 10 mcg in children 5 to < 12 years of age is inferred primarily from the safety profile of COMIRNATY at 10 mcg administered as a booster dose in this age bracket. In an analysis of Study 3 Phase 2/3, based on data up to the cut-off date of October 8, 2021, 2,268 participants (initial enrolment group: 1,518 COMIRNATY 10 mcg and 750 placebo) were 5 years through 12 years of age. Cumulative safety follow-up to at least 6 months after Dose 2 for approximately 12,000 participants who received COMIRNATY showed no other safety signals arising from longer-term follow-up of the study. Pfizer: Vials stored in an utlracold storage unit can be used until the last day of the month printed on the tray and each vial. The vaccine should not be used after 12 months from the date of manufacture printed on the vial and carton. Vials may be thawed in the refrigerator (2C to 8C [35F to 46F]) or at room temperature (up to 25C [77F]) (see. 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. The storage, preparation and administration information differ depending on which presentation of the vaccine is considered. . The liquid is a white to off-white suspension and may contain. 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. Data.CDC.gov. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine and will now be marketed as Comirnaty (koe-mir'-na-tee), for the prevention of COVID . Access to this report is strictly managed by registration only. The intent is to utilize Pfizer-strategic transportation partners to ship by air to major hubs within a country/region and by ground transport to dosing locations. 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. Pfizer-BioNTech COVID-19 Vaccine (also known as BNT162b2) This product information is intended only for residents of the United States. The various storage options at the POU allow for equitable access to the Pfizer vaccine to areas with differing infrastructure. Each dose must contain 0.2 mL of vaccine. New Search . 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. COVID-19 vaccine codes and crosswalks are provided in anticipation of potential vaccine availability under an approved Biologics License Application (BLA), Emergency Use Authorization (EUA), or as a potential vaccine submission for EUA (Pre-EUA). Refrigeration units that are commonly available in hospitals. 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. * Randomized participants who received at least 1 dose of the study intervention. 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. Clinical studies of COMIRNATY and COMIRNATY Original/Omicron BA.1 include participants 65 years of age and older and their data contributes to the overall assessment of safety and efficacy (see 8 ADVERSE REACTIONS and 14 CLINICAL TRIALS). Reports are accepted from anyone and can be submitted electronically at www.vaers.hhs.gov. 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. Participants 6 Months Through <2 Years of Age. Using aseptic technique, withdraw 1.3mL of diluent into a transfer syringe (using 21gauge or narrower needle). If not previously thawed at 2C to 8C (35F to 46F), allow vials to thaw at room temperature [up to 25C (77F)] for 30 minutes. Do not add more than 1.3 mL of diluent. a. N = number of participants reporting at least 1 yes or no response for the specified event after the specified dose. 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). 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. Please review the label carefully to ensure that you select the appropriate vaccine for immunization. If refrigerated, allow the diluted vaccine to come to room temperature prior to use. Vials must be kept frozen and protected from light, in the original cartons, until ready to use. second. Available short-term follow-up data suggest that the symptoms resolve in most individuals, but information on long-term sequelae is lacking. VAERS data is accessible by downloading raw data in comma-separated value (CSV) files for import into a database, spreadsheet, or text editing program, or by using the CDC WONDER online search tool. COMIRNATY does not contain preservative. A risk to the newborns/infants cannot be excluded. January 31, 2023. 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. How will the Pfizer-BioNTech COVID-19 vaccine be distributed? Orders may be placed either online at www.primevaccines.pfizer.com or through Pfizer Customer Service at 1-800-666-7248. Sometimes it feels like the year went by in the blink of an eye. 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. After preparation, a single dose is 0.3 mL. 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. Is Pfizer working with Operation Warp Speed? Vaccines are one of the greatest health interventions ever developed. DILUTE PRIOR TO USE (Vial with Orange Cap and Orange Label Border). CIR Total Expected Inventory. Refer to the re-icing guidelines packed in the original thermal container for instructions regarding the use of the thermal container for temporary storage. Note: Reactions were collected in an electronic diary (e-diary) from Day 1 to Day 7 after vaccination. The administration of COMIRNATY Original & Omicron BA.4/BA.5 should be postponed in individuals suffering from acute severe febrile illness. 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. 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. Each Product Monograph is available below, at www.pfizer.ca/products, or www.cvdvaccine.ca. 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. a direct ship distribution strategy that minimizes the transportation time from our facility to the point of use, synchronization of our vaccine shipments with the delivery of an ancillary kit that contains supplies required to administer the vaccine, and. COMIRNATY Original & Omicron BA.4/BA.5 is indicated only for a booster dose. Verify that the vial has an orange plastic cap and an orange label border. There are two formulations of COMIRNATY authorized for use in individuals 12 years of age and older. After mixing, the vaccine should appear as a white to off-white suspension with no visible particles. For 12 Years and Older: DO NOT DILUTE (Vials with Gray Cap and Gray Label Border). Participants 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]. The overall safety profile for the booster dose was similar to that seen after 2 doses. Local ARs are summarized in Table 3. Irrespective of the type of syringe and needle: Administer a single 0.2 mL dose of COMIRNATY intramuscularly, preferably in the deltoid muscle. In these analyses, 69.0% (786 COMIRNATY and 773 placebo) of study participants had at least 4 months of follow-up after Dose 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). Here's how to find the expiration date of the different COVID-19 Vaccine Brands. Participants who received a booster (Dose 4) of COMIRNATY Original/Omicron BA.1 had a median follow-up time of at least 1.7 months up to a data cut-off date of 16 May 2022. How is Pfizer utilizing a cold chain process to distribute its vaccine? 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). Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. Each 0.3 mL dose of COMIRNATY contains 30 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 1. 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%). In order to provide you with relevant and meaningful content we need to know more about you. Most of the events began from 3-11 days after the second dose and were characterized as mild and self-limited. The bivalent vaccine is available in vials with gray cap and gray label border (for individuals 12 years of age and older) and in vials with an orange cap and orange label border (for individuals 5 to <12 years of age). Among the participants, the median age was 53.0 years (range 16 through 87 years of age), including 1,175 booster dose recipients (23.1%) who were 65 years of age, 49.1% were male and 50.9% were female, 79.0% were White, 14.9% were Hispanic/Latino, 9.2% were Black or African American, 5.5% were Asian, and 1.7% were American Indian/Alaska Native. Typically, the onset of symptoms has been within a few days following receipt of COMIRNATY. Each 0.2 mL dose of COMIRNATY Original & Omicron BA.4/BA.5 contains 5 mcg of a nucleoside modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 original strain and 5 mcg of modRNA encoding the S glycoprotein of SARS-CoV-2 Omicron variant lineages BA.4 and BA.5 (Omicron BA.4/BA.5) and the non-medicinal ingredients listed in Table 2. Pfizer COVID-19 vaccine: This vaccine product has an expiration date located on the vaccine vial. No data are available yet regarding the use of COMIRNATY Original & Omicron BA.4/BA.5 during pregnancy. Clinical studies of COMIRNATY include participants 65 years of age and older and their data contributes to the overall assessment of safety and efficacy (see 8 ADVERSE REACTIONS and 14 CLINICAL TRIALS). You may also contact the Canada Vigilance Program directly to report adverse events or product quality concerns at 1-866-234-2345 or www.healthcanada.gc.ca/medeffect. Contact Pfizer Safety to report an adverse event, side effect or concern about the quality of a Pfizer product: 1 866 723-7111. Overall, the AE profiles after study vaccination (Dose 4) with COMIRNATY (30 mcg) or COMIRNATY Original/BA.1 (30 mcg) reflected mostly reactogenicity events and did not suggest any clinically important short-term safety concerns. ALC-0315 = ((4-hydroxybutyl) azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), ALC-0159 = 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-distearoyl-sn-glycero-3-phosphocholine, ALC-0315 = ((4-hydroxybutyl) azanediyl)bis (hexane-6,1-diyl)bis(2-hexyldecanoate). The administration of COMIRNATY should be postponed in individuals suffering from acute severe febrile illness. However, some of the effects mentioned under 8 ADVERSE REACTIONS may temporarily affect the ability to drive or use machines. 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. The safety and efficacy of COMIRNATY in children under 6 months of age have not yet been established (see 8 ADVERSE REACTIONS and 14CLINICAL TRIALS). 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%). Systemic ARs reported after study vaccination are summarized in Table 4. Please choose the category that best describes you. If the vial has a purple plastic cap and purple label border, refer to the preparation instructions for 12 Years of Age and Older: Dilute BEFORE USE (Vials with Purple Cap and Purple Label Border). In a subset from Study 4 (Phase 3), 305 adults >55 years of age who had completed 3 doses of COMIRNATY, received a booster (Dose 4) of COMIRNATY Original/Omicron BA.1, 4.7 to 11.5 months after receiving Dose 3. 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. Vaccine Lot Release Certificates. The Pfizer thermal shippers, in which doses will arrive, that can be used as temporary storage units by refilling with dry ice for up to 15 days of storage. In the analysis of blinded, placebo-controlled follow-up, there were no notable patterns between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to COMIRNATY. Vials of COMIRNATY intended for individuals aged 5 years to <12 years (orange cap/orange label border) cannot be used to prepare doses for individuals 6 months to <5 years or 12 years of age and older. 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. 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. From study vaccination to the data cut-off date (16 May 2022), the proportions of participants with any AEs were generally similar. Search Search . Anaphylaxis has been reported. Table 17 and Table 18 present the frequency of solicited local and systemic reactions, respectively, within 7 days following each dose of COMIRNATY and placebo in children 6 months through <2 years of age who were monitored for reactogenicity with an electronic diary. COMIRNATY is contraindicated in individuals who are hypersensitive to the active substance or to any ingredient in the formulation. 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. Document the current date, the vaccine lot number, and the updated expiration date. 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 freeze or shake the diluted vaccine. A booster dose of COMIRNATY Original & Omicron BA.4/BA.5 may be administered intramuscularly at least 6 months after completing the primary course of COMIRNATY in children 5 years through <12 years of age. I have been advised to remain on site for 15 minutes after receiving the vaccine. In a clinical study of approximately 10,000 participants 16 years of age and older, unsolicited adverse reactions following administration of a booster dose included headache (5%), fever (4.8%), lymphadenopathy (2.8%), pain in extremity (1.1%), nausea (0.9%), malaise (0.7%), and decreased appetite (0.2%). COMIRNATY is administered intramuscularly as a primary series of three doses (0.2 mL each). We have specially designed, temperature-controlled thermal shippers utilizing dry ice to maintain recommended temperature conditions for up to 10 days unopened. Animal studies do not indicate direct or indirect harmful effects with respect to female fertility or reproductive toxicity (see 16 NON-CLINICAL TOXICOLOGY). No withdrawals due to AEs or deaths were reported. COMIRNATY is a suspension for intramuscular injection which must be diluted prior to administration. Administer immediately, and no later than 12. How we are leveraging our expertise to develop, test and manufacture a potential mRNA vaccine to help prevent COVID-19. We operate one of the most sophisticated supply chain systems in the industry, with over 40 Pfizer-owned sites and over 200 suppliers globally, which provides capacity and redundancy as needed. Are hypersensitive to the re-icing guidelines packed in the study, 20.7 % were years! = number of participants with any AEs were generally similar develop, test and manufacture a potential vaccine! To room temperature [ up to 10 days unopened here & # x27 s. Age and older: do not add more than 1.3 mL of diluent into transfer. 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