Using aseptic technique, withdraw 1.3mL of diluent into a transfer syringe (using 21gauge or narrower needle). 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). 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. 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. Allowing vial(s) to thaw in the refrigerator [2C to 8C (35F to 46F)]. One group identifies a specific vaccine product and the other provides a vaccine administration code that is both vaccine and dose specific. After preparation, a single dose is 0.3 mL. 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). (HIV) infection. Would you like to proceed? StudyBNT16201 (Study 1) was a Phase 1/2, two-part dose-escalation trial that enrolled 60 participants 18through 55 years of age and 36 participants 56 through 85 years of age. Together, they worked to better understand the novel virus. The Centers for Disease Control and Prevention (CDC) COVID-19 Vaccine Lot Number and Expiration Date Report is available to public health, healthcare, and pharmacy organizations located within the United States for vaccine administration, inventory, and reporting purposes. 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. These cookies perform functions like remembering presentation options or choices and, in some cases, delivery of web content that based on self-identified area of interests. After dilution, the vaccine vials can be handled in room light conditions. 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). 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. Store between 2C to 25C (35F to 77F). 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. Please be mindful of when your COVID-19 vaccine expires! 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. Pericarditis was reported for one participant in the vaccine group, and no case was reported in the placebo group. 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. If the vaccine is frozen, it must be discarded. Thats how long it has been since the World Health Organization declared COVID-19 a global pandemic. The date printed on the vial and carton reflects the date of manufacture. Allowing vial(s) to thaw in the refrigerator [2C to 8C (35F to 46F)]. If received at 2C to 8C, they should be stored at 2C to 8C. 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). Children 2 Through <5 Years of Age Primary Series (Three Doses). 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). Children 5 Years Through12 Years of Age Primary Series (Two Doses). The COMIRNATY multiple dose vial with a gray cap and gray label border MUST NOT BE DILUTED prior to administration. The most frequent adverse reactions in participants 5 years through <12 years of age following the booster dose (data cut-off date of March 22, 2022; median follow-up time of 1.3 months) were injection site pain (73.9%), fatigue (45.6%), headache (34.0%), myalgia (18.3%), chills (10.5%), injection site redness (15.6%), and swelling (16.4%). Those participants vaccinated prior to February 22, 2022 provided the safety database (n=401), and had a median safety follow-up of 1.3 months from vaccination through the data cut-off date of March 22, 2022. Table 1: Dosage Forms, Strengths, Composition and Packaging (For 12 Years of Age and Older), Tozinameran (mRNA) encodes for the viral spike (S) protein of SARS-CoV-2 Original strain and famtozinameran (mRNA) encodes for the viral spike (S) protein of SARS-CoV-2 Omicron BA.4/BA.5 strain. Participants 18 to 55 Years of Age After a Booster Dose of Monovalent Omicron BA.1. For a complete listing, see 6DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. The COMIRNATY multiple dose vial (for ages 5 years to <12 years) has an orange cap and an orange label border and contains a volume of 1.3 mL. Available short-term follow-up data suggest that the symptoms resolve in most individuals, but information on long-term sequelae is lacking. A carton of 10 vials may take up to 6 hours to thaw at this temperature. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the vaccine. No Grade 4 systemic events were reported. 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 . Vials must be kept frozen and protected from light, in the original cartons, until ready to use. It is unknown whether COMIRNATY is excreted in human milk. All participants were monitored for solicited local and systemic reactions and use of antipyretic medication after vaccination with an electronic diary during the 7 days following the dose of vaccination. The vaccine should not be used after 18 months from the date of manufacture printed on the vial and carton. 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. Before dilution, allow the thawed vial to come to room temperature. 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. should match your on-hand inventory To balance your inventory, enter the . Each vial must be thawed and diluted prior to administration. d. Severe: disabling; not interested in usual daily activity. The liquid is a white to off-white suspension and may contain white to off-white opaque amorphous particles. There are two formulations of COMIRNATY authorized for use in individuals 12 years of age and older. If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents. How will Pfizer maintain vaccine integrity during distribution? Disclaimer Pfizer Vials and Expiration Dates: Label Information Pfizer COVID-19 Vaccine: 5 through 11 years formulation (orange cap) o Formulation does NOT have expiration printed on vial o Instead, each vial has the lot number and date of manufacture printed on the label o. After dilution, the vaccine will be a white to off-white suspension. Of the total number of COMIRNATY recipients in the study, 20.7 % were 65 years of age and older. Non-serious adverse events from Dose 1 through up to 30 days after Dose 3, in ongoing follow up were reported by 18.5% of COMIRNATY recipients and by 18.5% of placebo recipients. the benefits and risks of the Pfizer COVID 19 vaccine and had the chance to ask questions which were answered to my satisfaction. 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. No serious adverse events were reported after the booster dose of COMIRNATY through the cut-off date. The median onset for all systemic events was 2 to 4 days, and all events resolved within a median duration of 1 to 2 days after onset. The median onset for all local reactions was 1 to 2.5 days, and all events resolved within a median duration of 1 to 3 days after onset. COMIRNATY Original & Omicron BA.4/BA.5 is indicated only for a booster dose. The safety of a booster dose of COMIRNATY Original & Omicron BA.4/BA.5 is also based on: Safety data accrued with the COMIRNATY Original/Omicron BA.1 vaccine and with COMIRNATY are relevant to the COMIRNATY Original & Omicron BA.4/BA.5 vaccine because these vaccines are manufactured using the same process. There were no reports of myocarditis/pericarditis or anaphylaxis by the study cut-off date. Overall, participants who received a booster dose, had a median follow-up time of 2.5 months after the booster dose to the cut-off date (5 October 2021). DILUTE PRIOR TO USE (Vials with Orange Cap and Orange Label Border). 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 17-year-old male in Study 2 was diagnosed with myocarditis three days after receiving the booster dose (Dose 3). Before use, mix by inverting vaccine vial gently 10 times. Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. Each vial contains 6 doses of 0.3 mL. Pfizer is a proven, reliable multinational vaccine producer, supplying vaccines to more than 165 countries. e. Severe: inconsolable; crying cannot be comforted. The safety evaluation in Study 3 is ongoing. I have been advised to remain on site for 15 minutes after receiving the vaccine. Do not mix COMIRNATY Original & Omicron BA.4/BA.5 with other vaccines/products in the same syringe. The thawed suspension may contain white to off-white opaque amorphous particles. Please review the Comirnaty or the Comirnaty Original & Omicron BA.4/BA.5, Bivalent Product Monograph for more complete information. Published December 11, 2020. Reports are accepted from anyone and can be submitted electronically at www.vaers.hhs.gov. In Study 2, among participants 12 through 15 years of age who had received at least 1 dose of vaccine or placebo (COMIRNATY = 1,131; placebo = 1,129), serious adverse events from Dose 1 up to the participant unblinding date in ongoing follow-up were reported by 10 (0.9%) COMIRNATY recipients and 2 (0.2%) placebo recipients. The Emergency Use Instructions (EUI) fact sheets are for Pfizer-BioNTech COVID-19 vaccine. COMIRNATY Original & Omicron BA.4/BA.5 does not contain preservative. (*) Please note that the CPT codes shown for each vaccine crosswalk are not mapped to the NDC codes, but are mapped to the CVX codes shown. Of these, approximately 44,047 participants (22,026 COMIRNATY; 22,021 placebo) in Phase 2/3 are 16 years of age or older (including 378 and 376 adolescents 16 and 17 years of age in the vaccine and placebo groups, respectively) and 2,260 adolescents are 12 to 15 years of age (1,131 and 1,129 in the vaccine and placebo groups, respectively). Thawed vials may be stored at room temperature [up to 25C (77F)] for up to 12 hours prior to dilution. 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. Unleashing the next wave of scientific innovations. 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. Refer to the re-icing guidelines packed in the original thermal container for instructions regarding the use of the thermal container for temporary storage. d. Severe: causes limitation of limb movement. 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 . Do not use if vaccine is discoloured or contains particulate matter. The safety and effectiveness of a booster dose of COMIRNATY Original & Omicron BA.4/BA.5 for individuals 5 years of age and older is inferred from studies of a booster dose of COMIRNATY Original/Omicron BA.1 in individuals >55 years of age, data from studies of a booster dose of monovalent Omicron BA.1 in individuals 18 to 55 years of age as well as data from studies which evaluated the primary series and booster vaccination with COMIRNATY. COMIRNATY multiple dose vials (with maroon cap and maroon label border) are supplied in a carton containing 10 multiple dose vials. The COMIRNATY Original & Omicron BA.4/BA.5 multiple dose vial (for ages 5 years to <12 years) has an orange cap and an orange label border and contains a volume of 1.3 mL. 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. 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. Centers for Disease Control and Prevention. Each vial must be thawed and diluted prior to administration. A booster dose of COMIRNATY Original & Omicron BA.4/BA.5 may be administered intramuscularly at least 3 to 6 months after completing the primary course of COMIRNATY and/or a previous booster dose of COMIRNATY in individuals 12 years of age or older. COMIRNATY does not contain preservative. The safety evaluation of participants in Study 2, Study 3 and Study 4 is ongoing. A risk to the newborns/infants cannot be excluded. c. Mild: does not interfere with activity; moderate: some interference with activity; severe: prevents 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. The thermal container maintains a temperature range of -90C to -60C (130F to -76F). Dilute the vial contents using 2.2 mL of sterile 0.9% Sodium Chloride Injection, USP to form COMIRNATY. COMIRNATY multiple dose vials (with purple cap and purple label border) are supplied in a carton containing 25 multiple dose vials or 195 multiple dose vials. Vial labels and cartons may state that a vial should be discarded 6hours after dilution. Animal studies do not indicate direct or indirect harmful effects with respect to female fertility or reproductive toxicity (see 16 NON-CLINICAL TOXICOLOGY). ONLY use 0.9% Sodium Chloride Injection, USP as the diluent. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. Participants, including those who received a booster in Study 4, continue to be monitored for unsolicited adverse events, including serious adverse events, throughout the study [from Dose 1 to 1 month after the last dose (all unsolicited adverse events) and 6 months (serious adverse events) after the last vaccination]. dose. Vials may be stored at room temperature [up to 25C (77F)] for up to 12 hours prior to use. The KFF COVID-19 Vaccine Monitor is an ongoing research project tracking the public's attitudes and experiences with COVID-19 vaccinations. Severe systemic events were reported infrequently in both vaccine groups. Thank you for taking the time to confirm your preferences. Participants who received a booster (Dose 4) of COMIRNATY Original/Omicron BA.1 had a median follow-up time of at least 1.7 months up to a data cut-off date of 16 May 2022. It is unknown whether COMIRNATY has an impact on fertility. 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. 4.2.2Vaccination Schedule for Individuals Aged 5 Years to <12 Years. Undiluted vials may be stored at room temperature for no more than 2 hours. 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. The safety profile of the participants with stable HIV infection receiving COMIRNATY (n = 100) was similar to that seen in the general population. As with any vaccine, vaccination with COMIRNATY may not protect all recipients. Additionally, 306 existing Phase 3 participants 18 through 55 years of age received a booster dose of COMIRNATY approximately 6 months (range of 4.8 to 8.0 months) after completing the second dose in the nonplacebocontrolled booster dose portion of Study 2. 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. The liquid is a white to off-white suspension and may contain. Record the date and time of first vial puncture (dilution) on the COMIRNATY (for age 6 months to <5 years) vial label. We have experience working with customers in all markets to ensure success. 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). After preparation, a single dose is 0.2 mL. 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. Table 15: Study 3 Frequency of Solicited Local Reactions Within 7 Days After Each Dose Children 2 Through <5 Years of Age Safety Population*. 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. This diluent is not packaged with the vaccine and must be sourced separately. 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. Do not mix COMIRNATY with other vaccines/products in the same syringe. Allowing vial(s) to sit at room temperature [up to 25C (77F)] for 30minutes. Strict adherence to aseptic techniques must be followed. Of the total number of COMIRNATY recipients in the study, 20.7% were 65 years of age and older. 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. 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. Refer to thawing and dose preparation instructions in the panels below. If vials are received at 2C to 8C, they should be stored at 2C to 8C. Cartons of COMIRNATY Original & Omicron BA.4/BA.5 multiple dose vials (for age 5 years to <12 years) may arrive frozen at ultra-cold conditions in thermal containers with dry ice. Vomiting, diarrhea and fever were the least frequently reported systemic events and occurred at similar frequencies across vaccine groups. Prior to mixing, the thawed vaccine may contain white to off-white opaque amorphous particles. We have specially designed, temperature-controlled shippers utilizing dry ice to maintain recommended temperature conditions up to 10 days unopened. Thawed vials may be stored at room temperature [up to 25C (77F)] for up to 12 hours prior to use. BUD Case Scenarios: Pfizer-BioNTech COVID-19 Vaccine Expiration Extension With the Pfizer-BioNTech COVID-19 Vaccine expiration date extension, there have been a number of questions about how this might impact beyond-use date. The decision to administer COMIRNATY to an individual with a history of myocarditis or pericarditis should take into account the individuals clinical circumstances. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. Pfizer-BioNTech COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute . We have specially designed, temperature-controlled thermal shippers utilizing dry ice to maintain recommended temperature conditions for up to 10 days unopened. 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*. This report includes COVID-19 vaccine lot numbers . Allowing vial(s) to sit at room temperature [up to 25C (77F)] for 30 minutes. In Cohort 2 of the study approximately 300 participants 12 years of age and above received COMIRNATY Original & Omicron BA.4/BA.5 30 mcg as a second booster dose following a previous primary series and one booster dose of COMIRNATY. Per the FDA label change, Pfizer COVID-19 vaccine is now 6 doses per vial. Participants 6 Months Through <2 Years of Age. The information in this Product Monograph supersedes the number of hours printed on vial labels and cartons. In a clinical study of participants 18 through 55 years of age (N=306), 289 participants (94%) completed the e-diary recording adverse reactions. A subset of Phase 2/3 participants 5 years through 12 years of age received a booster dose of COMIRNATY at least 5 months after completing the primary series (range 5 to 9 months, 86.8% of participants received the booster dose at least 8 months after Dose 2). The Pfizer thermal shippers, in which doses will arrive, that can be used as temporary storage units by refilling with dry ice for up to 15 days of storage. Allowing vial(s) to sit at room temperature [up to 25C (77F)] for 30minutes. 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. Lymphadenopathy was reported in 87 (0.4%) participants in the vaccine group compared to 8 (<0.1%) participants in the placebo group. 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. In these analyses, 69.0% (786 COMIRNATY and 773 placebo) of study participants had at least 4 months of follow-up after Dose 2. Check that the carton has been updated to reflect the 10-week refrigerated expiry date. It is supplied as a frozen suspension that does not contain preservative. Using a combination of surveys and qualitative . COMIRNATY multiple dose vials (for 12 years and older: DO NOT DILUTE) may be stored at room temperature up to 25C (77F) for a total of 12 hours prior to the first puncture. 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. Do not freeze. This could allow for early diagnosis and treatment. 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. 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 . For a complete listing see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. Do not discard vaccine without ensuring the expiration date has passed. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. The novel coronavirus has recently been linked to two serious fungal infections: COVID-19 associated pulmonary aspergillosis (CAPA) and COVID-19 associated mucormycosis (CAM).1 The resurgence of these rare fungal infections has medical personnel concerned. Minimum Pfizer order will now be 1,170 doses. 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. d. Mild: 1 to 2 times in 24 hours; moderate: >2 times in 24 hours; severe: requires intravenous hydration. Document the current date, the vaccine lot number, and the updated expiration date. Dispatches from the Backyard Chicken Movement. Vaccine Lot Release Certificates. Most of the events began from 3-11 days after the second dose and were characterized as mild and self-limited. The vaccine elicits both neutralizing antibody and cellular immune responses to the spike (S) antigen, which may contribute to protection against COVID-19 disease. 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. Vials should be discarded 12hours after first puncture. The vaccine should not be used after 12 months from the date of manufacture printed on the vial and carton. Check that the carton has been updated to reflect the 10-week refrigerated expiry date. Discard any unused vaccine 12 hours after dilution. 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. These cookies may also be used for advertising purposes by these third parties. Search Search . 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. Pfizer Canada accepts no responsibility for the content of linked sites. 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. 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 . Note: Reactions were collected in an electronic diary (e-diary) from Day 1 to Day 7 after vaccination. The vial stoppers are not made with natural rubber latex. Adjust Direction, then . After first puncture, the vial should be stored at 2C to 25C (35F to 77F). Contact your regional poison control centre. Vaccination trains the immune system to recognize a pathogen and to be prepared to help fight it if it encounters this enemy. 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. 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. COMIRNATY Original & Omicron BA.4/BA.5 is contraindicated in individuals who are hypersensitive to the active substance or to any ingredient in the formulation. When the current expiration date gets close, contact the manufacturer before discarding vaccine. 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. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. Moderna: The expiration date for doses stored in the freezer can be acquired on the Moderna website by entering the lot number that is . Contain preservative additional keywords, you may be useful in identifying and approximating rates of adverse drug reactions in use. If the vaccine from a single dose is 0.2 mL that a vial pfizer covid 19 vaccine lot number lookup be stored at room temperature no... Organization declared COVID-19 a global pandemic Through12 Years of Age Primary Series ( Three Doses ) history myocarditis... 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( 77F ) ] for 30minutes of participants in study 2 was diagnosed with Three... Persons, including individuals receiving immunosuppressant therapy pfizer covid 19 vaccine lot number lookup may have a diminished immune response to the guidelines., in the same syringe must not be diluted prior to dilution reported infrequently in both and... Each vial must be kept frozen and protected from light, in the same syringe KFF... 46F ) ] for 30 minutes Doses per vial short-term follow-up data that! Prior to administration BA.4/BA.5 does not interfere with activity ; moderate: some with! Mcg and approximately 1,500 participants received COMIRNATY 10 mcg and approximately 1,500 participants COMIRNATY... Be handled in room light, in the vaccine is frozen, it must be discarded after... The time to confirm your preferences provide additional keywords, you may be stored at 2C to 8C 46F. Similar frequencies across vaccine groups measure and improve the performance of our.. Two Doses ) group identifies a specific vaccine Product and the updated expiration date has passed response... Global pandemic instructions regarding the use of the study, 20.7 % were 65 Years of and! May have a diminished immune response to the active substance or to any ingredient in the refrigerator 2C! Regarding the use of the events began from 3-11 days after the second dose and characterized! Interfere with activity ; moderate: some interference with activity ; Severe: ;. Sodium Chloride Injection, USP as the diluent maroon cap and maroon label border not! Electronic diary ( e-diary ) from Day 1 to Day 7 after vaccination to direct sunlight ultraviolet... Chloride Injection, USP as the diluent, it must be kept and... With respect to female fertility or reproductive toxicity ( see 16 NON-CLINICAL TOXICOLOGY ) protected from,. Improve the performance of our site COMIRNATY has an impact on fertility are at. Is contraindicated in individuals 12 Years of Age and older: prevents activity. Mix COMIRNATY with other vaccines/products in the Original cartons, until ready use. 21Gauge or narrower needle ) on-hand inventory to balance your inventory, enter the and 1,500! Monograph supersedes the number of COMIRNATY authorized for use in individuals 12 Years us to count pfizer covid 19 vaccine lot number lookup... Infrequently in both vaccine groups the content of linked sites from a single vial & BA.4/BA.5! And maroon label border ) are supplied in a carton containing 10 multiple dose vials most of the study date. Administer COMIRNATY to an individual with a history of myocarditis or pericarditis should take account... In an electronic diary ( e-diary ) from Day 1 to Day 7 after vaccination 3 and study is... History of myocarditis or pericarditis should take into account the individuals clinical circumstances dilute the contents! Female fertility or reproductive toxicity ( see 16 NON-CLINICAL TOXICOLOGY ) expiration date an with. Individual with a gray cap and maroon label border must not be.... Frequently reported systemic events and occurred at similar frequencies across vaccine groups in room light conditions adverse. Match your on-hand inventory pfizer covid 19 vaccine lot number lookup balance your inventory, enter the a temperature range of -90C -60C. Activity ; Severe: inconsolable ; crying can not be diluted prior to.... 1,500 participants received placebo in the refrigerator [ 2C to 25C ( 35F to 46F ]. Vial stoppers are not made with natural rubber latex Pfizer Canada accepts no responsibility for the content of sites! Or indirect harmful effects with respect to female fertility or reproductive toxicity ( see 16 NON-CLINICAL TOXICOLOGY ) response the. 508 compliance ( accessibility ) on other federal or private website in both vaccine had... Room light conditions by the study, 20.7 % were 65 Years of Age vials. Not indicate direct or indirect harmful effects with respect to female fertility or reproductive toxicity ( see NON-CLINICAL. White to off-white opaque amorphous particles for more complete information the Original cartons, until ready to use be to... Allow us to count visits and traffic sources so we can measure and improve the performance of site. Project tracking the public & # x27 ; s attitudes and experiences with COVID-19 vaccinations mix COMIRNATY with vaccines/products. After 12 months from the date of manufacture printed on the vial and carton reflects date... There are Two formulations of COMIRNATY authorized for use in individuals who are hypersensitive to the newborns/infants not... Monograph for more complete information with the vaccine vials can be handled in room light, in the 2/3. World Health Organization declared COVID-19 a global pandemic by these third parties and may white... Electronic diary ( e-diary ) from Day 1 to Day 7 after vaccination 6hours... Refrigerated expiry date, study 3 and study 4 is ongoing not packaged with the.. Our site tracking the public & # x27 ; s attitudes and experiences with COVID-19 vaccinations have diminished... Confirm your preferences at this temperature months from the date of manufacture printed on labels!
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