Severe systemic events of fever (n=1), fatigue (n=3), and diarrhea (n=1) were reported. 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. Each vial must be thawed prior to administration. From Dose 1 through 30 days after Dose 3, lymphadenopathy was reported in 2 (0.2%) of COMIRNATY recipients vs. 0 (0%) of placebo recipients. Enter a '0' if you have no vaccine doses to enter Your . the benefits and risks of the Pfizer COVID 19 vaccine and had the chance to ask questions which were answered to my satisfaction. All information these cookies collect is aggregated and therefore anonymous. In participants who received a booster dose the mean duration of pain at the injection site after the booster dose was 2.6 days (range 1 to 8 days), for redness 2.2 days (range 1 to 15 days), and for swelling 2.2 days (range 1 to 8 days). Thawed at Room Temperature: For immediate use, thaw undiluted vials at room temperature (up to 25C (77F)] for 30 minutes. No study participants died. 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. Once vials are thawed they should not be refrozen. Do not administer if vaccine is discoloured or contains particulate matter. 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. 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%)). Table 18: Study 3 Frequency and Percentages of Participants With Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After the Booster Dose of COMIRNATY Children 5 Years through 12 Years of Age Safety Population*. 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. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, thrombotic events, myocarditis or anaphylactic reaction to the vaccine) reported during the blinded placebo-controlled follow-up period of the study. 4.2.3Vaccination Schedule for Individuals Aged 6 Months to <5 Years. Vials may be thawed in the refrigerator at 2C to 8C [35F to 46F] or at room temperature (up to 25C [77F]) (see. This site is intended . Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. CDC's COVID-19 Vaccine Expiration Date Tracking Tool can help providers keep track of the expiration date by lot number. Pfizer and Moderna are two-dose vaccines, while J&J is one dose.2) The lot number and expiration dateThe lot number is a string of numbers and letters that tracks this specific batch of vaccine . a second dose inventory management system. Most frequently reported systemic events in decreasing order of frequency after study vaccination (Table 6) were: Table 6: Solicited Systemic Adverse Reactions Reported for Vaccine Groups Within 7 Days After Study Vaccination, Overview of Adverse Events (AEs) From Study Vaccination to 1 Month Post-Dose. Typically, the onset of symptoms has been within a few days following receipt of COMIRNATY. Obtain sterile 0.9% Sodium Chloride Injection, USP. The initial 2 doses are administered 3 weeks apart followed by a third dose administered at least 8 weeks after the second dose. 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. Not all pack sizes may be available. 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. The overall safety profile for the booster dose was similar to that seen after 2 doses. Verify the final dosing volume of 0.2 mL. 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. We have years of proven experience in supply chain and cold chain management, and we are accelerating the development of innovative technologies to further advance our capabilities as a supply chain leader. Table 16: Study 3 Frequency of Solicited Systemic Reactions Within 7Days After Each Dose Children 5Years Through <12Years of Age Safety Population*. 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. A free web-based tool to manage vaccine administration and registration Information Immunization Systems (IIS) IIS consolidate immunization information into one reliable source VTrckS CDC's vaccine order management system and platform for all COVID-19 vaccine ordering IZ Gateway A cloud-based message routing service intended to enable data exchange 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. 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. The participant was treated and recovered. The COMIRNATY Original & Omicron BA.4/BA.5 multiple dose vial with a gray cap and gray label border MUST NOT BE DILUTED prior to administration. This could allow for early diagnosis and treatment. After dilution, the vaccine will be a white to off-white suspension. These EUIs provide information about emergency use of FDA-approved medical products that may not be included in or differ in some way from the information provided in the FDA-approved labeling. DILUTE PRIOR TO USE (Vial with Orange Cap and Orange Label Border). Drug and vaccine authorizations for COVID-19: List of authorized drugs, vaccines and expanded indications Overview List of applications received List of authorized products Date published: 2022-12-09 Drugs and vaccines that have been authorized by Health Canada for use in relation to the COVID-19 pandemic are listed here. The mRNAs are formulated in lipid nanoparticles, which enable delivery of the RNA into host cells to allow expression of the SARS-CoV-2 S antigen. 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. Study 3 (Phase 2/3) enrolled 2,750 participants 2 through <5 years of age (1,835 COMIRNATY 3 mcg; 915 placebo). Inspect vials to confirm there are no particulates and no discolouration is observed. 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). Currently available information is insufficient to determine a causal relationship with the vaccine. Information regarding COVID-19 Emergency Use Authorization (EUA) vaccine codes and crosswalks can be found here. After dilution, one vial contains 10* doses of 0.2 mL. No Grade 4 local reactions were reported. COMIRNATY Original & Omicron BA.4/BA.5 For Age 5 Years to <12 Years: DILUTE PRIOR TO USE, (Vials with Orange Cap and Orange Label Border), Orange plastic cap and label with orange border. Lymphadenopathy was reported in 13 (0.9%) participants in the COMIRNATY 10 mcg group vs. 1 (0.1%) in the placebo group. 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. We have developed detailed logistical plans and tools to support effective vaccine transport, storage and continuous temperature monitoring. Check that the carton has been updated to reflect the 10-week refrigerated expiry date. 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)]. A carton of 10 vials may take up to 6 hours to thaw. Three Pfizer Partnerships to Get the COVID-19 Vaccine into African Countries and Vaccinations into Arms, Making the COVID-19 Oral Treatment: How 2,000+ Pfizer Team Members Made It Happen, The Meaning of Moonshot: Lessons in Leadership to Last a Lifetime, Feeling Sick? Vials may also be stored at -25C to -15C (13F to 5F) for up to 2 weeks. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. 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). The COMIRNATY multiple dose vial with a purple cap and purple label bordercontains a volume of 0.45 mL. Do not add more than 1.8 mL of diluent. No data are available yet regarding the use of COMIRNATY Original & Omicron BA.4/BA.5 during breast- feeding. Adverse Events (AEs) from Study Vaccination to Data Cut-off Date. 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. The median age of these 401 participants was 8.0 years (range 5 years through 12 years of age), 52.4% were male and 47.6% were female, 70.1% were White, 7.2% were Black or African American, 22.9% were Hispanic/Latino, 7.7% were Asian, and 2.0% were American Indian/Alaska Native. 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. Once vials are thawed they should not be refrozen. These cases occurred more commonly after the second dose and in adolescents and young adults. 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. 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. Do not freeze. However, we will also be using our existing distribution centers for the COVID-19 distribution in Pleasant Prairie, WI and in Karlsruhe, Germany. Cold chain is how the temperature of perishable products are managed in order to maintain quality and safety from end to end in the distribution process. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. There are two formulations of COMIRNATY authorized for use in individuals 12 years of age and older. The date printed on the vial and carton reflects the date of manufacture. Inspect the liquid in the vial prior to dilution. Vaccine Manufacturer Lot Number Expiration Date Name of Vaccine Administrator COVID-19 _____ml 1st _____ml 2nd IM - L Arm IM - Non-serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing followup were reported by 5.8% of COMIRNATY recipients and by 5.8% of placebo recipients. 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 . 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. 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 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. The information in this Product Monograph supersedes the number of hours printed on vial labels and cartons. Search Search . 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 additional information about Pfizer, please see our filings with the U.S. Securities and Exchange Commission, including the information provided in the sections captioned Risk Factors and Forward-Looking Information and Factors That May Affect Future Results. Very rare cases of myocarditis and/or pericarditis following vaccination with COMIRNATY have been reported during post-authorization use. 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. Information provided to VAERS which identifies a person who received the vaccine or vaccines will not be made available to the public. Using aseptic technique, withdraw 1.3mL of diluent into a transfer syringe (using 21gauge or narrower needle). Do not dilute. COMIRNATY does not contain preservative. Each vial must be thawed and diluted prior to administration. 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. In Study 2 and Study 3, all participants 6 months through <5 years of age, 5 through <12 years of age, 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. Fatigue was the most frequently reported systemic event within 7 days after booster dose, followed by headache, muscle pain and less frequently by chills, joint pain, diarrhea, or fever. To determine the expiration date: Scan the QR code located on the outer carton, or Go to Vial Expiration Date Lookup | Moderna . Individuals who have received one dose of COMIRNATY should continue to receive COMIRNATY to complete the vaccination series. Do not use if liquid is discoloured or if particles are observed after mixing. 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. In order to provide you with relevant and meaningful content we need to know more about you. COMIRNATY (for age 5 years to <12 years): A carton of 10 vials may take up to 4 hours to thaw at this temperature. Of these, 2,726 participants (1,819 COMIRNATY 3 mcg; 907 placebo) received 2 doses and 1,369 (50.2%; 910 COMIRNATY 3 mcg and 459 placebo) participants have been followed for at least 4 months after the second dose; 886 participants received a 3-dose primary series (606 COMIRNATY 3 mcg; 280 placebo) and have been followed for a median of 1.4 months after the third dose, based on data in the blinded, placebo-controlled follow-up period up to the cut-off date of April 29, 2022. 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) . Non-serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow up in the initial enrolment group were reported by 10.9% of COMIRNATY 10 mcg recipients and by 9.1% of placebo recipients. expiration date tracking tool (PDF) to record updated expiration dates for COVID-19 vaccine. second. 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. 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. What Makes an RNA Vaccine Different From a Conventional Vaccine? Equalize vial pressure before removing the needle from the vial by withdrawing 1.3mL air into the empty diluent syringe. Note: Reactions were collected in an electronic diary (e-diary) from Day 1 to Day 7 after vaccination. COMIRNATY does not contain preservative. 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). DO NOT administer COMIRNATY Original & Omicron BA.4/BA.5 with Gray Cap and Gray Label Border to children 5 years to <12 years. 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. The vial stoppers are not made with natural rubber latex. Administer a single 0.3 mL dose of COMIRNATY Original & Omicron BA.4/BA.5 intramuscularly, preferably in the deltoid muscle. 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. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. Contact Pfizer Safety to report an adverse event, side effect or concern about the quality of a Pfizer product: 1 866 723-7111. 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. The safety and efficacy of COMIRNATY in pregnant women have not yet been established. Vaccine Lot Release Certificates. 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. Healthcare professionals are advised to consider the possibility of myocarditis and/or pericarditis in their differential diagnosis if individuals present with chest pain, shortness of breath, palpitations or other signs and symptoms of myocarditis and/or pericarditis following immunization with a COVID-19 vaccine. Thats how long it has been since the World Health Organization declared COVID-19 a global pandemic. As with all vaccines, training for immunizers, appropriate medical treatment and supervision after immunization should always be readily available in case of a rare anaphylactic event following the administration of this vaccine. In the four vaccinated participants, events began from 3 to 48 days after their last dose, were mild to moderate in severity, and duration ranged from 3 to 68 days. 09.24.22. Participants >55 Years of Age After a Dose of COMIRNATY Original/Omicron BA.1 as a Second Booster (4th Dose). 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]. Vaccination trains the immune system to recognize a pathogen and to be prepared to help fight it if it encounters this enemy. This diluent is not packaged with the vaccine and must be sourced separately. 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. Adverse reactions were usually mild or moderate in intensity and resolved within a few days after vaccination. The following adverse reactions have been identified during post authorization use of COMIRNATY. When you are uploading your vaccine information (primary vaccine or booster), you will see a new field for lot number. Cleanse the vaccine vial stopper with a singleuse antiseptic swab. 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. COMIRNATY is supplied as a frozen suspension in multiple dose vials. 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. Do not use if vaccine is discoloured or contains particulate matter. We will utilize GPS-enabled thermal sensors in every thermal shipper with a control tower that will track the location and temperature of each vaccine shipment across their pre-set routes. 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. Cartons of COMIRNATY multiple dose vials (for 12 years and older: DO NOT DILUTE) may also arrive at 2C to 8C. 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. Document the current date, the vaccine lot number, and the updated expiration date. Appendicitis was reported as a serious adverse event for 27 participants, 15 vaccine participants and 12 placebo participants. 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. After first puncture, the vial should be stored at 2C to 25C (35F to 77F). They help us to know which pages are the most and least popular and see how visitors move around the site. The vaccine elicits both neutralizing antibody and cellular immune responses to the spike (S) antigen, which may contribute to protection against COVID-19 disease. 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. Very rare cases of myocarditis and/or pericarditis following vaccination with COMIRNATY have been reported during post-authorization use. I went on to identify several additional ranges of toxicity, each one identified by similar sequences of batch codes. Hospitals were filling, and no one was sure how best to treat the people who were sick. If received at 2C to 8C, they should be stored at 2C to 8C. COMIRNATY multiple dose vials (with maroon cap and maroon label border) are supplied in a carton containing 10 multiple dose vials.
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