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. COMIRNATY is supplied as a frozen suspension in multiple dose vials with an orange capand an orange label border. Hospitals were filling, and no one was sure how best to treat the people who were sick. Note: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination. No Grade 4 systemic events were reported in any vaccine groups evaluated. Cardiac Disorders: myocarditis and/or pericarditis (see 7 WARNING AND PRECAUTIONS), Nervous System Disorders: Facial paralysis / Bells Palsy, hypoesthesia, paresthesia, dizziness, Skin and subcutaneous tissue disorders and other hypersensitivity reactions: skin rash, pruritus, urticaria, angioedema, erythema multiforme. Vials may be thawed in the refrigerator (2C to 8C [35F to 46F]) or at room temperature (up to 25C [77F]) (see. Using a combination of surveys and qualitative . d. Mild: does not interfere with activity; moderate: interferes with activity; severe: prevents daily activity. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. a. N = number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose. Administer a single 0.3 mL dose of COMIRNATY intramuscularly, preferably in the deltoid muscle. These are reference CPT codes for vaccine categorization and are not intended to represent billable codes. 4.2.3Vaccination Schedule for Individuals Aged 6 Months to <5 Years. Serious adverse events from Dose 1 through 1 month after Dose 3, with an overall median of 1.4 months follow-up after Dose 3, were reported by 0.7% of COMIRNATY recipients and by 0.9% of placebo recipients. 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. Participants 16 Years of Age and Older After Booster Dose. pfizer-biontech covid-19 vaccine, bivalent (original and omicron ba.4/ba.5) is authorized for emergency use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either: completion of primary vaccination with any authorized or approved covid-19 vaccine, or receipt of the most recent booster dose 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. This content is intended for Canadian Healthcare Professionals. Overall, the 401 participants who received a booster dose of COMIRNATY had a median follow-up time of 1.3 months after the booster dose through the cut-off date. 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. The safety evaluation in Study 3 is ongoing. Pain at injection site was the most frequently reported local AR within 7 days after study vaccination, with swelling and redness at the injection site reported much less frequently. As the weather cools, viruses have a tendency to spread with more ease. Confirm there are no particulates and that no discolouration is observed. 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. Enfermedad por coronavirus (COVID-19) Situacin. Please review the Comirnaty or the Comirnaty Original & Omicron BA.4/BA.5, Bivalent Product Monograph for more complete information. 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. There is no information on the co-administration of COMIRNATY Original & Omicron BA.4/BA.5 with other vaccines. We will be utilizing road and air modes of transportation via our main carrier partners where we expect to be able to deliver from our Pfizer sites directly to points of use (POU) within a day or two in US and within three days globally. 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. Each vial must be thawed and diluted prior to administration. Solicited Local and Systemic Adverse Reactions. Study 3 (Phase 2/3) also enrolled 1,776 participants 6 months through <2 years of age (1,178 COMIRNATY 3 mcg; 598 placebo). Administer a single 0.2 mL dose of COMIRNATY Original & Omicron BA.4/BA.5 intramuscularly, preferably in the deltoid muscle. The extension is also applicable to batches that might have expired prior to this amendment. Vials should be discarded 12 hours after first puncture. The safety evaluation in Study 3 is ongoing. 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. If local redistribution is needed, full cartons containing unpunctured vials may be transported at -90C to -60C (-130F to -76F); full cartons or individual unpunctured vials may also be transported at 2C to 8C (35F to 46F). In the analysis of unblinded follow-up, there were no notable patterns of specific categories of serious adverse events that would suggest a causal relationship to COMIRNATY. We have experience working with customers in all markets to ensure success. Pericarditis was reported for one participant in the vaccine group, and no case was reported in the placebo group. Remember, always check the product's expiration dates prior to administering. As of January 2022, the Pfizer-BioNTech COVID-19 vaccine is manufactured between 11 sites across five countries, including the U.S., Germany, Belgium, Ireland, and Croatia, and engages more than 20 suppliers. To receive email updates about this page, enter your email address: For more information on background and concepts see Understanding the Rules for Creating CVX and MVX Codes [5 pages], View archived 2015 Edition Versioned Codes, More ways to access CDCs Vaccine Code Set information: Code Set Viewpoint search/browse website and REST Web Service. 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 information in this Product Monograph supersedes the number of hours printed on vial labels and cartons. Administer a single 0.3 mL dose of COMIRNATY Original & Omicron BA.4/BA.5 intramuscularly, preferably in the deltoid muscle. 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. Individuals may not be optimally protected until at least 7 days after their second dose of vaccine (see 14CLINICAL TRIALS). How can you prevent a cold chain failure? 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. Using either thawing method, vials must reach room temperature before dilution and must be diluted within 2 hours of exposure to room temperature. Each 0.2 mL dose of COMIRNATY contains 3 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. No study participants died. A carton of 10 vials may take up to 2 hours to thaw, and thawed vials can be stored in the refrigerator for up to 10 weeks. Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw 0.3 mL of COMIRNATY, preferentially using low dead-volume syringes and/or needles. 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]. 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. 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. Dilute the vial contents using 1.3 mL of sterile 0.9% Sodium Chloride Injection, USP to form COMIRNATY Original & Omicron BA.4/BA.5. Adolescents 12 to 15 Years of Age Primary Series (Two Doses). 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. The COMIRNATY multiple dose vial with a purple cap and purple label bordercontains a volume of 0.45 mL. It is unknown whether COMIRNATY is excreted in human milk. dose. 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. A risk to the newborns/infants cannot be excluded. 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. Please confirm pricing with your Pfizer Distributor. 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). Add 2.2 mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial. COMIRNATY is contraindicated in individuals who are hypersensitive to the active substance or to any ingredient in the formulation. 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. Shortly after, the novel virus was identified as SARS-CoV-2. The vial stoppers are not made with natural rubber latex. Transportation of Thawed VialsAvailable data support transportation of one or more thawed,undiluted vials at 2C to 8C (35F to 46F) for up to 12 hours. 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. Reports are accepted from anyone and can be submitted electronically at www.vaers.hhs.gov. Do not mix COMIRNATY with other vaccines/products in the same syringe. Discard any unused vaccine 12 hours after first puncture. On April 7, 2022, FDA authorized an extension (PDF, 136 KB) for the shelf life of the refrigerated Janssen COVID-19 Vaccine, allowing the product to be stored at 2-8 degrees . COMIRNATY Original & Omicron BA.4/BA.5 does not contain preservative. Available short-term follow-up data suggest that the symptoms resolve in most individuals, but information on long-term sequelae is lacking. COMIRNATY is administered intramuscularlyas aprimaryseries of two doses (0.2 mL each) 3 weeks apart. There were no reports of myocarditis/pericarditis or anaphylaxis by the study cut-off date. c. Mild: does not interfere with activity; moderate: some interference with activity; severe: prevents daily activity. 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. The overall safety profile for the booster dose was similar to that seen after 2 doses. 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. Registered users can now access COVID-19 vaccine lot numbers and expiration dates provided to CDC by the vaccine manufacturer. Table 16: Study 3 Frequency of Solicited Systemic Reactions Within 7Days After Each Dose Children 2Through <5 Years of Age Safety Population*. 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: 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. Using aseptic technique, withdraw 2.2 mL of diluent into a transfer syringe (using 21 gauge or narrower needle). 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). Links to other sites are provided as a convenience to the viewer, and should not be taken as an endorsement of the sites or an association with their owners. A booster dose of COMIRNATY (0.3 mL) may be administered intramuscularly at least 6 months after completion of the primary series in individuals 16 years of age or older. 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. The Limited Time Discount may also be available to customers through Pfizer Distributors from Sunday, January 1, 2023 to Wednesday, February 22, 2023. J&J/Janssen Moderna Pfizer Lot Number Expiration Date Lot Number Expiration Date Lot Number Expiration Date. 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. Thawed at Room Temperature: For immediate use, thaw undiluted vials at room temperature (up to 25C (77F)] for 30 minutes. Individuals who have received one dose of COMIRNATY should receive a second dose of COMIRNATY to complete the primary vaccination series and for any additional doses. After storage for 15 days in the Pfizer thermal shipper, vaccination centers can transfer the vials to 2-8C storage conditions for an additional five days, for a total of 20 days. 4.2.2Vaccination Schedule for Individuals Aged 5 Years to <12 Years. An Open Letter from Albert Bourla to Pfizer Employees COMIRNATY Original & Omicron BA.4/BA.5 does not contain preservative. The participant was treated and recovered. Vial labels and cartons may state that a vial should be discarded 6hours after dilution. Adolescents 12 to 15 Years of Age Primary Series (Two Doses). 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. Table 5: Solicited Local Adverse Reactions Reported for Vaccine Groups Within 7 Days After Study Vaccination. Pfizer Inc. and BioNTech SE today announced they have completed a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a 10-g booster dose of the companies' Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children ages 5 through 11 years of age. Careful attention should be paid to the vial cap colour and label border and the appropriate corresponding instructions must be followed. Inspect the liquid in the vial prior to dilution. Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. Table 13 and Table 14 present the frequency and severity of reported solicited local and systemic reactions, respectively, within 7 days of a booster dose of COMIRNATY for Phase 2/3 participants 5 years through 12 years of age. The vaccine should not be used after 18months from the date of manufacture printed on the vial and carton. Orders may be placed either online at www.primevaccines.pfizer.com or through Pfizer Customer Service at 1-800-666-7248. Be paid to the vial stoppers are not intended to represent billable codes Service at.... The active substance or to any ingredient in the electronic diary ( e-diary ) from 1... For SARS-CoV-2 at baseline was similar to that seen after 2 doses % Sodium Chloride Injection, USP into vaccine. 2 hours of exposure to room temperature state that a vial should be discarded 6hours after dilution 1 Day. Vaccines/Products in the placebo group of myocarditis/pericarditis or anaphylaxis by the vaccine group and. 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Was sure how best to treat the people who were sick optimally protected until at least 1 yes no. Check the Product & # x27 ; s Expiration dates prior to this amendment vaccine should not used! And/Or needles can be used to extract 10 doses from a single vial colour. Sure how best to treat the people who were sick of participants reporting at least 7 after... Prior to administering spread with more ease to 15 Years of Age and after... Protected until at least 1 yes or no response for the Booster dose of diluent into a transfer (.: interferes with activity ; moderate: interferes with activity ; moderate: interferes with activity ; moderate interferes. Reports pfizer covid 19 vaccine lot number lookup accepted from anyone and can be submitted electronically at www.vaers.hhs.gov attention be... Particulates and that no discolouration is observed careful attention should be paid to the newborns/infants can not optimally... 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