COMIRNATY Original & Omicron BA.4/BA.5 does not contain preservative. Below are a few case scenarios you might encounter. The vaccine elicits both neutralizing antibody and cellular immune responses to the spike (S) antigen, which may contribute to protection against COVID-19 disease. Allowing vial(s) to thaw in the refrigerator [2C to 8C (35F to 46F)]. Refer to thawing and dose preparation instructions in the panels below. 1) The manufacturer In the U.S., there are three COVID-19 vaccines authorized for emergency use: Pfizer-BioNTech, Moderna and Johnson & Johnson. Additional data assessed by the MHRA that support the use of COVID-19 mRNA Vaccine BNT162b2 as a heterologous booster dose are based on the COV-Boost study [EudraCT Number: 2021-002175-19), which . 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 (COVID-19 Vaccine, mRNA) is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) in individuals 6 months of age and older. 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. Using either thawing method, vials must reach room temperature before dilution and must be diluted within 2 hours of exposure to room temperature. Store between 2C to 25C (35F to 77F). Vaccine Information Statement (VIS) Lookup Table CDC has added two-dimensional (2D) "data matrix" barcodes to Vaccine Information Statements (VIS). Vials should be discarded 12 hours after dilution (i.e., the first puncture). 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. For details on the primary vaccination course for individuals 5 years to <12 years of age, please refer to the COMIRNATYProduct Monograph, Section 4.2.2 Vaccination Schedule for Individuals Aged 5 Years to <12 Years. Undiluted vials may be stored at room temperature for no more than 2 hours. Table 17 and Table 18 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. 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. It is supplied as a frozen suspension that does not contain preservative. In order to prevent, treat, and identify diseases that disproportionately impact underserved and minority populations, Pfizer believes that research must be directed to the root causes of healthcare disparities. For 12 Years of Age and OlderCOMIRNATY is a suspension for intramuscular injection. Vials should be discarded 12 hours after dilution. Children 5 Years Through12 Years of Age Primary Series (Two Doses). Vials of COMIRNATY intended for individuals 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 5 years to <12 years with an orange cap/orange label border cannot be used to prepare doses for individuals aged 6 months to <5 years. To ensure proper storage and handling, please see cvdvaccine.com. Vials stored at -25C to 15C (-13F to 5F) for up to 2 weeks may be returned one time to the recommended storage condition of -90C to -60C (-130F to -76F). 2023 Pfizer. The FDA approved a request from Pfizer, Inc. to extend the shelf-life of the Pfizer COVID-19 vaccine for an additional three months - from six months to nine months when the vaccine is stored at a temperature of -90 to -60 degrees Celsius. Children 5 Years Through <12 Years of Age Primary Series (Two Doses). Strict adherence to aseptic techniques must be followed. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/ fetal development, parturition, or post-natal development (see 16 NON-CLINICAL TOXICOLOGY). DILUTE PRIOR TO USE (Vial with Maroon Cap and Maroon Label Border). 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. 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 12-month shelf-life. d. Severe: disabling; not interested in usual daily activity. 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. Our distribution is built on a flexible just-in-time system which will ship the frozen vials to the point of vaccination. 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). An Open Letter from Albert Bourla to Pfizer Employees 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. COMIRNATY (for age 6 months to <5 years): A carton of 10 vials may take up to 2 hours to thaw at this temperature. 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. I have been advised to remain on site for 15 minutes after receiving the vaccine. 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. Saving Lives, Protecting People, Understanding the Rules for Creating CVX and MVX Codes, Code Set Viewpoint search/browse website and REST Web Service, COVID-19 Vaccine Lot Number and Expiration Date Tool, National Center for Immunization and Respiratory Diseases, Core Data Elements For IIS Functional Standards v4.0, Clinical Decision Support for Immunization (CDSi), Vaccine 2D Barcode Scanning Implementation Toolkit, Vaccine Management Business Improvement Project (VMBIP), Comprehensive Clinic Assessment Software Application (CoCASA), U.S. Department of Health & Human Services, influenza, live, intranasal, quadrivalent, Influenza virus vaccine, quadrivalent, live (LAIV4), for intranasal use, influenza, injectable, quadrivalent, preservative free, Influenza virus vaccine, quadrivalent (IIV4), split virus, preservative free, 0.5 mL dosage, for intramuscular use, Influenza, injectable, quadrivalent, preservative free, Influenza virus vaccine, quadrivalent (IIV4), split virus, 0.25 mL dosage, for intramuscular use, Influenza virus vaccine, quadrivalent (IIV4), split virus, 0.5 mL dosage, for intramuscular use, influenza, injectable, quadrivalent, contains preservative, Influenza, injectable, MDCK, preservative free, quadrivalent, Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, preservative and antibiotic free, 0.5 mL dosage, for intramuscular use, influenza, recombinant, quadrivalent,injectable, preservative free, Influenza virus vaccine, quadrivalent (RIV4), derived from recombinant DNA, hemagglutinin (HA) protein only, preservative and antibiotic free, for intramuscular use, Influenza, injectable, MDCK, quadrivalent, preservative, Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, antibiotic free, 0.5 mL dosage, for intramuscular use, FLUZONE High-Dose Quadrivalent Northern Hemisphere, Influenza virus vaccine (IIV), split virus, preservative free, enhanced immunogenicity via increased antigen content, for intramuscular use, Influenza vaccine, quadrivalent, adjuvanted, Influenza virus vaccine, quadrivalent (aIIV4), inactivated, adjuvanted, preservative free, 0.5 mL dosage, for intramuscular use, influenza, Southern Hemisphere, pediatric, preservative free, influenza, Southern Hemisphere, preservative free, influenza, Southern Hemisphere, quadrivalent, with preservative, Centers for Disease Control and Prevention. The extension is also applicable to batches that might have expired prior to this amendment. The safety and efficacy of COMIRNATY in children under 6 months of age have not yet been established. The most frequently reported unsolicited adverse event was lymphadenopathy (2.5%). Using aseptic technique, withdraw 1.8 mL of 0.9% Sodium Chloride Injection, USP into a transfer syringe (using 21-gauge or narrower needle). Thank you for taking the time to confirm your preferences. Using aseptic technique, withdraw 1.3mL of diluent into a transfer syringe (using 21gauge or narrower needle). Each dose must contain 0.2mL of vaccine. 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. For Age 5 Years to <12 YearsCOMIRNATY is a suspension for intramuscular injection which must be diluted prior to administration. Here's how to find the expiration date of the different COVID-19 Vaccine Brands. HIV-positive participants are included in safety population disposition but are summarized separately in safety analyses. Check Your COVID-19 Vaccine Expiration Dates Several lots of Pfizer, Moderna, and J&J COVID-19 vaccine product have their expiration dates in June and July. The COMIRNATY multiple dose vial with a purple cap and purple label bordercontains a volume of 0.45 mL. 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. There are no data available on the interchangeability of COMIRNATY with other COVID-19 vaccines to complete the vaccination series. Our distribution approach will be to largely ship from our Kalamazoo and Puurs sites direct to the point of use (POU). Discard any unused vaccine 12 hours after first puncture. Table 16: Study 3 Frequency of Solicited Systemic Reactions Within 7Days After Each Dose Children 2Through <5 Years of Age Safety Population*. The safety evaluation in Study 3 is ongoing. COMIRNATY Original & Omicron BA.4/BA.5 is a suspension for intramuscular injection. During the visual inspection: Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. Frozen Vials Prior to UseCartons of COMIRNATY multiple dose vials (for 12 years and older: DILUTE BEFORE USE)arrive in thermal containers with dry ice. Lymphadenopathy was reported in 13 (0.9%) participants in the COMIRNATY 10 mcg group vs. 1 (0.1%) in the placebo group. b. n = Number of participants with the specified characteristic. Vomiting, diarrhea and fever were the least frequently reported systemic events and occurred at similar frequencies across vaccine groups. Each vial must be thawed and diluted prior to administration. Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. After dilution, the vaccine will be a white to off-white suspension. Do not dilute. Of the total number of COMIRNATY recipients in the study, 20.7 % were 65 years of age and older. 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. Clinical studies of COMIRNATY Original/Omicron BA.1 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). Frozen vials transported at -25C to -15C (13F to 5F) may be returned one time to the recommended storage condition of -90C to -60C (-130F to -76F). 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. Enfermedad por coronavirus (COVID-19) Situacin. 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. Among participants 16 through 55 years of age who received at least one dose of study vaccine, 12,995 of whom received COMIRNATY and 13,026 of whom received placebo, unsolicited adverse events were reported by 4,396 (33.8%) participants in the COMIRNATY group and 2,136 (16.4%) participants in the placebo group. No serious adverse events were reported that were considered related to vaccination. 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. 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. Vials must be kept frozen and protected from light, in the original cartons, until ready to use. Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. Currently available information is insufficient to determine a causal relationship with the vaccine. With COVID-19 cases on the rise around the country, and the holiday season here, many people are considering whether to get a coronavirus test. Of these, approximately 3,100 participants received COMIRNATY 10 mcg and approximately 1,500 participants received placebo in the Phase 2/3 part of the study. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. One serious adverse event of fever (maximum temperature 40.3C) on Day 3 after Dose 2 in a 4-year-old was considered possibly related to vaccination. Thus, each tray of the Pfizer COVID-19 vaccine is now 1,170 does (195 vial x 6 doses/vial). To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information: *If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site. It is supplied as a frozen suspension that does not contain preservative. 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. COMIRNATY (for age 5 years to <12 years): A carton of 10 vials may take up to 4 hours to thaw at this temperature. Pfizer is a proven, reliable multinational vaccine producer, supplying vaccines to more than 165 countries. The storage, preparation and administration information differ depending on which presentation of the vaccine is considered. Do not add more than 1.3 mL of diluent. Of these, 2,171 (95.7%) (1,456 COMIRNATY 10 mcg and 715 placebo) participants have been followed for at least 3 months after Dose 2. Vials of COMIRNATY Original & Omicron BA.4/BA.5 intended for individuals 12 years of age and older (gray cap/gray label border) cannot be used to prepare doses for individuals aged 5 to <12 years of age. 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. Verify that the vial has a gray plastic cap and gray label border. Not all pack sizes may be available. To prevent vaccine from inadvertently being discarded, providers . In the analysis of unblinded follow-up, there were no notable patterns of specific categories of non-serious adverse events that would suggest a causal relationship to COMIRNATY. On a Sunday afternoon in May of 2020, Amy Genests phone rang. 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. 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%). 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. What is the path of a vaccine from Pfizers facilities to where its distributed to patients? Careful attention should be paid to the vial cap colour and label border and the appropriate corresponding instructions must be followed. The median duration was 3.5 days (ranged from 1 to 14 days) in the vaccine group. The Pfizer, UK-made AstraZeneca, Johnson & Johnson and Moderna vaccines are all recognised by the EU's regulator - so those receiving these vaccines are permitted to travel to and across the . Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the vaccine. As SARS-CoV-2 spreads around the globe, it is mutating, in other words it is acquiring genetic changes. Thaw vial(s) of COMIRNATY before use either by: Allowing vial(s) to thaw in the refrigerator (2C to 8C [35F to 46F]). 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). January 31, 2023. 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. 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) . If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume. 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. Cartons of COMIRNATY (for age 5 years to <12 years) and COMIRNATY (for age 6 months to <5 years) may also arrive at 2C to 8C (35F to 46F). Pfizer and Moderna are two-dose vaccines,. It is unknown whether this vaccine has an impact on fertility. Do not dilute. 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. 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. COMIRNATY Original & Omicron BA.4/BA.5 For 12 Years of Age and Older: DO NOT DILUTE, (Vials with Gray Cap and Gray Label Border), Gray plastic cap and label with gray border, Record the date and time of first puncture. Non-serious adverse events from Dose 1 through up to 1 month after Dose 3, in ongoing follow up were reported by 29.1% of COMIRNATY recipients and by 26.3% of placebo recipients. The World Health Organization recently declared a pandemic in the wake of a global outbreak of the novel coronavirus disease (COVID-19). If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. a. N = Number of participants reporting at least 1 yes or no response for the specified event after the specified dose. COMIRNATY is contraindicated in individuals who are hypersensitive to the active substance or to any ingredient in the formulation. COMIRNATY is supplied as a frozen suspension in multiple dose vials. Note: Events and use of antipyretic or pain medication were collected in the electronic diary (e-diary) from Day 1 to Day 7 after each dose. Prior to dilution, the thawed suspension may contain opaque amorphous particles. Do not pool excess vaccine from multiple vials. COMIRNATY Original & Omicron BA.4/BA.5 multiple dose vials (with gray cap and gray label border) are supplied in a carton containing 10 multiple dose vials. A carton of 10 vials may take up to 4 hours to thaw at this temperature. J&J/Janssen Moderna Pfizer Lot Number Expiration Date Lot Number Expiration Date Lot Number Expiration Date. If the vial has a gray plastic cap and gray label border, refer to the preparation instructions for 12 Years of Age and Older: DO NOT DILUTE (Vials with Gray Cap and Gray Label Border). Very rare cases of myocarditis and/or pericarditis following vaccination with COMIRNATY have been reported during post-authorization use. c. n = Number of participants with the specified reaction. Vial labels and cartons may state that a vial should be discarded 6hours after dilution. 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. 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). Cleanse the vaccine vial stopper with a single-use antiseptic swab. Contact your regional poison control centre. We have crossed another milestone in the fight against COVID-19. COMIRNATY is administered intramuscularly as a primary series of two doses (0.3 mL each) 3 weeks apart in individuals 12 years of age and older. Participants >55 Years of Age After a Dose of COMIRNATY Original/Omicron BA.1 as a Second Booster (4th Dose). 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). Once vials are thawed they should not be refrozen. Cartons of COMIRNATY multiple dose vials (for 12 years and older: DO NOT DILUTE) may arrive frozen at ultra cold conditions in thermal containers with dry ice. Local ARs are summarized in Table 3. By. Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw 0.3 mL of COMIRNATY (for 12 years of age and older) preferentially using a low dead-volume syringe and/or needle. 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. Outbreak of the total Number of participants with the specified reaction the Expiration Date of the study COMIRNATY! & # x27 ; s how to find the Expiration Date Lot Number Expiration Date Lot Number Expiration Date,! Instructions in the Phase 2/3 part of the Pfizer COVID-19 vaccine is considered Original... Approach will be to largely ship from our Kalamazoo and Puurs sites to! 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