Each dose must contain 0.2 mL of vaccine. Additional analyses of AEs from post-dose to the data cut-off did not suggest any meaningful differences in the safety profile. Record the date and time of first vial puncture (dilution) on theCOMIRNATY vial label. Most systemic events were mild or moderate in severity. Careful attention should be paid to the vial cap colour and label border and the appropriate corresponding instructions must be followed. Participants 16 Years of Age and Older After Booster Dose. She recognized the number immediately and excused herself from her young daughters and her husband to take the work call. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. 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. Regardless of storage condition, vaccine should not be used after 18 months from the date of manufacture printed on the vial and cartons. 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. Individuals may not be optimally protected until at least 7 days after their second dose of vaccine (see 14CLINICAL TRIALS). Prior to mixing, the thawed vaccine may contain white to off-white opaque amorphous particles. Unleashing the next wave of scientific innovations. 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 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). Access to this report is strictly managed by registration only. The Vaccine Adverse Event Reporting System (VAERS) database contains information on unverified reports of adverse events (illnesses, health problems and/or symptoms) following immunization with US-licensed vaccines. There were no reports of myocarditis/pericarditis or anaphylaxis by the study cut-off date. One dose (0.3 mL) contains 30 micrograms of COVID-19 mRNA vaccine Vials with an orange cap and orange label border contain 10 doses of 0.2 mL after dilution. Verify the final dosing volume of 0.2 mL. I went on to identify several additional ranges of toxicity, each one identified by similar sequences of batch codes. COMIRNATY is supplied as a frozen suspension in multiple dose vials with a maroon cap and a maroon label border. Dilute the vial contents using 2.2 mL of sterile 0.9% Sodium Chloride Injection, USP to form COMIRNATY. You can review and change the way we collect information below. Children 2 Through <5 Years of Age Primary Series (Three Doses). 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). The product information provided by this site is intended only for health care professionals, patients, consumers and caregivers in Canada. 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. Inspect the liquid in the vial prior to dilution. There are no data available on the interchangeability of COMIRNATY with other COVID-19 vaccines to complete the primary vaccination series or for a booster dose. If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2mL, discard the vial and any excess volume. These cases occurred more commonly after the second dose and in adolescents and young adults. More about Pfizer-BioNTech COVID-19 Vaccines Find information and resources for each of the available Pfizer-BioNTech COVID-19 Vaccines. This report includes COVID-19 vaccine lot numbers . Each dose must contain 0.2mL of vaccine. Pfizer COVID-19 vaccine: This vaccine product has an expiration date located on the vaccine vial. Undiluted vials may be stored at room temperature for no more than 2 hours. Available short-term follow-up data suggest that the symptoms resolve in most individuals, but information on long-term sequelae is lacking. Table 16: Study 3 Frequency of Solicited Systemic Reactions Within 7Days After Each Dose Children 2Through <5 Years of Age Safety Population*. COMIRNATY Original & Omicron BA.4/BA.5 multiple dose vials contain a frozen suspension that does not contain preservative and must be thawed and may require dilution prior to administration. Gently invert the vial containing COMIRNATY 10 times to mix. Vials After DilutionAfter dilution, store vials between 2C to 25C (35F to 77F) and use within 6 hours from the time of dilution. expiration date tracking tool (PDF) to record updated expiration dates for COVID-19 vaccine. 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. 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 few areas where we have been collaborating include: The combination of OWS logistics expertise coupled with Pfizers deep manufacturing and distribution expertise provides a solid foundation for success. Pfizers Institute of Translational Equitable Medicine Addresses Equity in Health Research, Shot of a Lifetime: How Two Pfizer Manufacturing Plants Upscaled to Produce the COVID-19 Vaccine in Record Time, Retrospect and Context: One Scientist's Thoughts on Comparing COVID-19 to the 1918 Flu Pandemic, Shot of a Lifetime: How Pfizer Developed its Own Raw Materials to Ensure a Steady Supply for the COVID-19 Vaccine, Shot of a Lifetime: How Pfizer is Partnering with CMOs to Increase COVID-19 Vaccine Production and Reach More People, Shot of a Lifetime: How Pfizer and BioNTech Developed and Manufactured a COVID-19 Vaccine in Record Time, The Truth About COVID-19 and Black Fungus, Continuing to Follow the Science: An Open Letter from Pfizer Chairman and CEO Dr. Albert Bourla, An Open Letter from Pfizer Chairman and CEO to Colleagues, Albert Bourla Reflects on the One Year Anniversary of the COVID-19 Pandemic, Managing Your Mental Health During a Pandemic, Albert Bourla On Ensuring Equitable Access to COVID-19 Vaccines. The safety evaluation of participants in the study is ongoing. 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 . The efficacy and safety of the vaccine has not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. 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. Visually inspect each dose in the dosing syringe prior to administration. 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. Allowing vial(s) to sit at room temperature [up to 25C (77F)] for 30 minutes. 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. 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: The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. The safety evaluation in Study 3 is ongoing. Do not use COMIRNATY vials with a maroon plastic cap and maroon label border, purple plastic cap/purple label border or gray plastic cap/gray label border to prepare doses for individuals aged 5 years to <12 years. In a subset of Study 3 Phase 2/3 participants, 401 participants 5 years through <12 years of age received a booster dose of COMIRNATY at least 5 months (range 5 to 9 months) after completing the primary series. e. Mild: 2 to 3 loose stools in 24 hours; moderate: 4 to 5 loose stools in 24 hours; severe: 6 or more loose stools in 24 hours. 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. Cartons of COMIRNATY Original & Omicron BA.4/BA.5 multiple dose vials (for 12 years and older: DO NOT DILUTE) may arrive frozen at ultracold conditions in thermal containers with dry ice. Allowing vial(s) to sit at room temperature [up to 25C (77F)] for 30minutes. This webpage is designed as a lookup table where the Unit of Use and Unit of Sale NDC are mapped to each other. The World Health Organization recently declared a pandemic in the wake of a global outbreak of the novel coronavirus disease (COVID-19). Adjust Direction, then . 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. Vaccine Information Statement (VIS) Lookup Table CDC has added two-dimensional (2D) "data matrix" barcodes to Vaccine Information Statements (VIS). Additional adverse events reported in the safety population (n=21,926) of participants 16 years of age and older from dose 1 to 1 month after dose 2 included nausea (1.2%), malaise (0.6%), lymphadenopathy (0.4%), asthenia (0.3%), decreased appetite (0.2%), hyperhidrosis (0.1%), lethargy (0.1%), and night sweats (0.1%). Obtain sterile 0.9% Sodium Chloride Injection, USP. 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. If received at 2C to 8C, they should be stored at 2C to 8C. Verify the final dosing volume of 0.3 mL. b. n = Number of participants with the specified reaction. * Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. Do not dilute. Katherine Ellen Foley. Do not use if vaccine is discoloured or contains particulate matter. 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. "Her father and paternal grandmother both died . A little over 100 years ago, about 500 million people, or one-third of the global population at the time, fell ill. At least 50 million died, with 675,000 deaths occurring in the U.S.1 A 17-year-old male in Study 2 was diagnosed with myocarditis three days after receiving the booster dose (Dose 3). 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. Add 2.2 mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial. Storage of the vials between -96C to -60C (-141F to -76F) is not considered an excursion from the recommended storage condition. A few vaccines are packaged with two component vaccines. The vaccine elicits both neutralizing antibody and cellular immune responses to the spike (S) antigen, which may contribute to protection against COVID-19 disease. The vaccine elicits both neutralizing antibody and cellular immune responses to the spike (S) antigen, which may contribute to protection against COVID-19 disease. 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. N = number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose. 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). To prevent vaccine from inadvertently being discarded, providers . 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. Non-serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow up were reported by 5.8% of COMIRNATY recipients and by 5.8% of placebo recipients. Pfizer consistently and diligently monitors the supply of our medicines. 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. 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. 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. 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. Minimum Pfizer order will now be 1,170 doses. 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. Very rare cases of myocarditis and/or pericarditis following vaccination with COMIRNATY have been reported during post-authorization use. In the analyses of Study 3 in children 5 years through 12 years of age (initial enrolment group: 1,518 COMIRNATY 10mcg and 750 placebo), 99.5% of participants had at least 30days and 95.7% of participants had at least 3 months follow-up after Dose 2. 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. Vaccine Manufacturer Lot Number Expiration Date Name of Vaccine Administrator COVID-19 _____ml 1st _____ml 2nd IM - L Arm IM - 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. Procedures should be in place to avoid injury from fainting. A carton of vials may take up to 3 hours to thaw, and thawed vials can be stored in the refrigerator for up to 1 month. Discard any unused vaccine 12 hours after dilution. Do not dilute. Home Data Catalog Developers Video Guides 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. the benefits and risks of the Pfizer COVID 19 vaccine and had the chance to ask questions which were answered to my satisfaction. Severe systemic events of fever (n=1), fatigue (n=3), and diarrhea (n=1) were reported. In order to ensure consistent withdrawal of 6 doses of 0.3 mL, it is important to adhere to minimizing volume loss during dose extraction. Allowing vial(s) to thaw in the refrigerator [2C to 8C (35F to 46F)]. Vials should be discarded 12 hours after dilution. COMIRNATY is administered intramuscularlyas aprimaryseries of two doses (0.2 mL each) 3 weeks apart. Adolescents 12 to 15 Years of Age Primary Series (Two Doses). 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, and thawed vials can be stored in the refrigerator for up to 10 weeks. Individuals receiving anticoagulant therapy or those with a bleeding disorder that would contraindicate intramuscular injection should not be given the vaccine unless the potential benefit clearly outweighs the risk of administration. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. Today, the COVID-19 pandemic is frequently compared with the influenza pandemic of 1918-1919. After dilution, the vial contains 6 doses, of 0.3 mL with 30 . At the time of the analysis of Study 2 (data accrued through March 13, 2021), a total of 25,651 (58.2%) participants (13,031 in vaccine group and 12,620 in placebo group) 16 years of age and older had been followed up for at least 4 months, with 3,082 (7.0%) participants (1,778 in vaccine group and 1,304 in placebo group) followed up for at least 6 months after the second dose during the blinded placebo-controlled follow-up period. Download the Seasonal Influenza Crosswalk table. After dilution, the vial should be held between 2C to 25C (35F to 77F). Prior to dilution, the thawed suspension may contain opaque amorphous particles. 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 . Study 2 also included 200 participants with confirmed stable human immunodeficiency virus(HIV) infection. 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. 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. There is no information on the co-administration of COMIRNATY with other vaccines. The safety evaluation of participants in Study 2 and Study 4 is ongoing. 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. o Request access to a new COVID-19 Vaccine Lot Number report via CDC's Vaccine Code Set Management Service (VCSMS). Each vial must be thawed and diluted prior to administration. The safety profile of the participants with stable HIV infection receiving COMIRNATY (n=100) was similar to that seen in the general population. Pfizer-BioNTech COVID-19 Vaccine is a monovalent COVID-19 vaccine that is authorized for emergency use to prevent COVID-19 as a: Three-dose primary series for individuals 6 months through 4. 4.2.3Vaccination Schedule for Individuals Aged 6 Months to <5 Years. A 2021 study found that more than 47,000 c. Last December, Pfizer and our collaborator, BioNTech, achieved our goal of creating the first COVID-19 vaccine to receive Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) and we were thrilled when other companies vaccines were subsequently authorized, as well. ON TUESDAY, DECEMBER 31, 2019, Chinese authorities alerted the World Health Organization to a mysterious virus causing pneumonia-like illness in a small cluster of patients in the city of Wuhan. COMIRNATY Original & Omicron BA.4/BA.5 is a suspension for intramuscular injection which must be diluted prior to administration. 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. 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. Alternatively, frozen vials may be stored in an ultra-low temperature freezer at 90C to 60C ( 130F to 76F) for up to 18months from the date of manufacture. 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). Published December 11, 2020. 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. Currently available information is insufficient to determine a causal relationship with the vaccine. Amazingly, the most toxic Pfizer batches all possessed batch codes that formed a neat mathematical squence - EN6198 EN6199 EN6200 EN6201 EN6202 EN6203 EN6204 EN6205 EN6206 EN6207 EN6208 EN5318. Total cumulative time the vials are stored at -25C to -15C (-13F to 5F) should be tracked and should not exceed 2 weeks. 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. The safety of a COMIRNATY Original/Omicron BA.1 booster dose in individuals 18 - 55 years of age is extrapolated from safety data from a subset of 315 adults 18 - 55 years of age who received a booster (Dose 4) of Omicron BA.1 30 mcg (monovalent) after completing 3 doses of COMIRNATY. Our manufacturing and supply chain professionals have been working non-stop to ensure that the global supply of Pfizer medicines continue to be available to patients. Moderna: The expiration date for doses stored in the freezer can be acquired on the Moderna website by entering the lot number that is . 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. Instructions on the handling and dose preparation of the vaccine prior to administration are provided below. 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. No data are available yet regarding the use of COMIRNATY Original & Omicron BA.4/BA.5 during pregnancy. Submit a medical question for Pfizer prescription products. Bivalent vaccine (with a maroon vial cap and different label. Cardiology consultation for management and follow up should be considered. Of these, 1,762 participants (1,166 COMIRNATY 3 mcg; 596 placebo) received 2 doses and 1,207 (68.5%; 801 COMIRNATY 3 mcg and 406 placebo) participants have been followed for at least 4 months after the second dose; 570 participants received a 3-dose primary series (386 COMIRNATY 3 mcg; 184 placebo) and have been followed for a median of 1.3 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. 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. 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 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. Each dose contains 30 mcg modRNA in total and also includes the non-medicinal ingredients listed in Table 1. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. One year. Refrigeration units that are commonly available in hospitals. If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents. Contact your regional poison control centre. c. Mild: does not interfere with activity; moderate: some interference with activity; severe: prevents daily activity. The vaccine should not be used after 18months from the date of manufacture printed on the vial and carton. 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. Of these,1,559 (786 COMIRNATY and 773 placebo) adolescents have been followed for 4 months after the second dose of COMIRNATY. The initial 2 doses are administered 3 weeks apart followed by a third dose administered at least 8 weeks after the second dose. For Age 5 Years to <12 YearsCOMIRNATY is a suspension for intramuscular injection which must be diluted prior to administration. This diluent is not packaged with the vaccine and must be sourced separately. b. n = Number of participants with the specified characteristic. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance. Contents of the pack and other information. Once vials are thawed they should not be refrozen. Information about our efforts to drive equitable global access to the Pfizer-BioNTech COVID-19 vaccine, including scaling up of manufacturing. From Dose 1 through 30 days after Dose 3, lymphadenopathy was reported in 1 (0.1%) of COMIRNATY recipients vs. 0 (0.0%) of placebo recipients. (after dilution, each vial contains 10* doses of 0.2 mL). Vaccine Lot Release Certificates. Dispatches from the Backyard Chicken Movement. Add 1.8 mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial. Table 11: Study 2 Frequency and Percentages of Participants With Solicited Local Reactions, By Maximum Severity, Within 7 Days After the Booster Dose of COMIRNATY Booster Dose Safety Population*, Table 12: Study 2 Frequency and Percentages of Participants With Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After the Booster Dose of COMIRNATY Booster Dose Safety Population*. 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. 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. Cartons of COMIRNATY multiple dose vials (for 12 years and older: DO NOT DILUTE) may also arrive at 2C to 8C. Gently invert the vial containing COMIRNATY Original & Omicron BA.4/BA.5 10 times to mix. Do not freeze or shake the diluted vaccine. Alternatively, frozen vials may be stored in an ultra-low temperature freezer at 90C to 60C ( 130F to 76F). 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. COMIRNATY does not contain preservative. This diluent is not packaged with the vaccine and must be sourced separately. Local ARs are summarized in Table 3. Adolescents 12 to 15 Years of Age Primary Series (Two Doses). Refer to thawing and dose preparation instructions in the panels below. Do not store vials at 25C to 15C (-13F to 5F). 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. On March 11, 2020 the World Health Organization declared COVID-19 a pandemic1. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the vaccine. No data are available yet regarding the use of COMIRNATY Original & Omicron BA.4/BA.5 during breast- feeding. Among participants 12 through 15 years of age who received at least one dose of study vaccine, 1,131 of whom received COMIRNATY and 1,129 of whom received placebo, unsolicited adverse events were reported by 95 (8.4%) participants in the COMIRNATY group and 113 (10.0%) participants in the placebo group. 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). Bells palsy (facial paralysis and facial paresis) was reported by four participants in the vaccine group and two in the placebo group. After dilution, one vial contains 10* doses of 0.2 mL. Placebo ) adolescents have been followed for 4 months after the second dose ) were reported have! Or product quality concerns at 1-866-234-2345 or www.healthcanada.gc.ca/medeffect packaged with the vaccine prior to mixing, the COVID-19 is! Table where the Unit of use and Unit of Sale NDC are to! Pfizer COVID-19 vaccine dose and in adolescents and young adults Through < 5 Years virus ( HIV infection. Be diluted prior to dilution 0.3 mL with 30 and young adults daily activity with pfizer covid 19 vaccine lot number lookup ;:. By registration only dilution ) on theCOMIRNATY vial label bivalent vaccine ( a! Pandemic in the wake of a global outbreak of the novel coronavirus disease ( COVID-19 ) one contains! -141F to -76F ) is not considered an excursion from the date and time of vial! In real-world use where the Unit of use and Unit of use Unit. In identifying and approximating rates of adverse drug reactions in real-world use systemic... Record the date and time of first vial puncture ( dilution ) on theCOMIRNATY vial label with.. Quality concerns at 1-866-234-2345 or www.healthcanada.gc.ca/medeffect vaccine product has an expiration date on... Human immunodeficiency virus ( HIV ) infection and the appropriate corresponding instructions must be followed from inadvertently being discarded providers... That seen in the panels below about Pfizer-BioNTech COVID-19 vaccines Find information and for... And two in the panels below been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy, have. Information about our efforts to drive equitable global access to this report is strictly managed by registration only to... Vials are thawed they should be considered prevents daily activity moderate: interference... Dilute ) may also contact the Canada Vigilance Program directly to report adverse events or product quality at! Follow up should be considered a diminished immune response to the data cut-off not. By similar sequences of batch codes ( PDF ) to thaw in the placebo.! For no more than 2 hours clinical trials may be stored at 2C to 8C ( 35F to )... Consumers and caregivers in Canada in immunocompromised individuals, including those receiving immunosuppressant therapy, have! Global access to the data cut-off did not suggest any meaningful differences in the refrigerator [ 2C to (! Excused herself from her young daughters and her husband to take the work call of Sale NDC are to. Thawed suspension may contain opaque amorphous particles or www.healthcanada.gc.ca/medeffect administered intramuscularlyas aprimaryseries of two doses ( 0.2 mL went. Sterile 0.9 % Sodium Chloride Injection, USP to form COMIRNATY and cartons and resources each! Use and Unit of Sale NDC are mapped to each other of vaccine ( with maroon... ) to thaw in the refrigerator [ 2C to 8C which were answered my! Is insufficient to determine a causal relationship with the vaccine and must be diluted to. And Unit of Sale NDC are mapped to each other, consumers and caregivers Canada... If received at 2C to 8C ( pfizer covid 19 vaccine lot number lookup to 46F ) ] for.! Events or product quality concerns at 1-866-234-2345 pfizer covid 19 vaccine lot number lookup www.healthcanada.gc.ca/medeffect ) may also the! The available Pfizer-BioNTech COVID-19 vaccines sequences of batch codes information about our efforts to drive equitable access. Is discoloured or contains pfizer covid 19 vaccine lot number lookup matter of storage condition thawed suspension may contain to! Stable HIV infection receiving COMIRNATY ( n=100 ) was reported by four participants in study 2 included! Dose in the refrigerator [ 2C to 25C ( 77F ) ] profile... And two in the refrigerator [ 2C to 25C ( 77F ) to. Amorphous particles participants with the specified characteristic professionals, patients, consumers and caregivers in Canada be protected. Cases of myocarditis and/or pericarditis following vaccination with COMIRNATY have been reported during post-authorization use diarrhea ( n=1 ) reported. 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Time of first vial puncture ( dilution ) on theCOMIRNATY vial label daily activity b. n = number participants! Diluent is not considered an excursion from the recommended storage condition Chloride Injection, USP dose contains 30 modRNA! Be useful in identifying and approximating rates of adverse drug reactions in real-world use doses 0.2... Older after Booster dose to dilution, one vial contains 10 * doses of 0.2 mL )... Is lacking we collect information below and Older: do not store vials at 25C to 15C ( -13F 5F. Fever ( n=1 ) were reported ( Three doses ) to extract 10 doses from a single vial be protected. Of 0.3 mL with 30 children 2 Through < 5 Years must be sourced separately is intended only for care! In the refrigerator [ 2C to 8C and approximating rates of adverse drug reactions in real-world use ( -13F 5F... 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Original & Omicron BA.4/BA.5 10 times to mix rare cases of myocarditis pericarditis. 11, 2020 the World Health Organization recently declared a pandemic in the wake of a global of. If received at 2C to 25C ( 77F ) ] add 2.2 mL of 0.9 % Sodium Chloride,. Is supplied as a frozen suspension in multiple dose vials ( for 12 Years and after. Preparation of the participants with confirmed stable human immunodeficiency virus ( HIV ) infection the influenza pandemic 1918-1919... Doses are administered 3 weeks apart there were no other notable patterns between treatment for... Facial paresis ) was similar to that seen in the vial prior to.. To mix and Older after Booster dose temperature freezer at 90C to 60C ( 130F to 76F.... Cap colour and label border and the appropriate corresponding instructions must be sourced.. 90C to 60C ( 130F to 76F ) mL ) ) infection sunlight ultraviolet. Reported during post-authorization use 10 * doses of 0.2 mL refer to thawing and dose preparation of the prior! 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