Pfizer vaccine has the expiration date on the vial; for Moderna and Janssen, scan QR codes. Adverse reactions following administration of any dose in the initial enrolment safety population (n = 1,518) of children 5 years through 12 years of age included pain at the injection site (84.3%), fatigue (51.7%), headache (38.2%), injection site redness (26.4%), injection site swelling (20.4%), muscle pain (17.5%), chills (12.4%), fever (8.3%), joint pain (7.6%), lymphadenopathy (0.9%), rash (0.5%), nausea (0.4%), malaise (0.1%), and decreased appetite (0.1%). For 12 Years and Older: DO NOT DILUTE (Vials with Gray Cap and Gray Label Border). Vials should be discarded 12hours after first puncture. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. 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. There are two formulations of COMIRNATY authorized for use in individuals 12 years of age and older. 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. However, we will also be using our existing distribution centers for the COVID-19 distribution in Pleasant Prairie, WI and in Karlsruhe, Germany. Prior to dilution, the thawed suspension may contain opaque amorphous particles. Orders may be placed either online at www.primevaccines.pfizer.com or through Pfizer Customer Service at 1-800-666-7248. The 10 week refrigerated expiry date should be recorded on the carton at the time of transfer. Visually inspect each dose in the dosing syringe prior to administration. 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. This technology is designed primarily to help immunization providers record information about the VIS as is required by the National Childhood Vaccine Injury Act (NCVIA). ONLY use 0.9% Sodium Chloride Injection, USP as the diluent. Check that the carton has been updated to reflect the 10-week refrigerated expiry date. The most frequent adverse reactions in participants >55 years of age were pain at the injection site (58.1%), fatigue (49.2%), headache (33.6%), myalgia (22.3%), chills (13.0%) and arthralgia (11.3%). Tables 7 through 10 present the frequency and severity of solicited local and systemic reactions, respectively, within 7 days following each dose of COMIRNATY and placebo in the subset of participants 16 years of age and older (n=9,839) in the safety population who were monitored for reactogenicity with an electronic diary. They are included because: a) they represent reactions that are known to occur following immunizations generally; b) they are potentially serious; or c) on the basis of their frequency of reporting. Search for terms Find Studies. Serious adverse events from Dose1 through up to 30 days after Dose2 in ongoing followup in the initial enrolment group were reported by 1 participant (0.1%) in each group after receiving the vaccine or placebo through the data cut-off date. Diagnostic testing is a critical tool in helping to understand and control the spread of the virus. 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 Animal studies do not indicate direct or indirect harmful effects with respect to female fertility or reproductive toxicity (see 16 NON-CLINICAL TOXICOLOGY). The denominators (N) used in the percentage calculations for fever and use of antipyretic or pain medication were 749 after Dose 1 and 741 after Dose 2 in the placebo group, due to an e-diary error. Among participants with confirmed stable HIV infection serious adverse events from Dose 1 up to the participant unblinding date in ongoing follow-up were reported by 2 (2%) COMIRNATY recipients and 2 (2%) placebo recipients. first. 2023 Pfizer. 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). Participants >55 Years of Age After a Dose of COMIRNATY Original/Omicron BA.1 as a Second Booster (4th Dose). How will the Pfizer-BioNTech COVID-19 vaccine be distributed? Use this Symptom Checker for Common Fall and Winter Illnesses. In these analyses, 69.0% (786 COMIRNATY and 773 placebo) of study participants had at least 4 months of follow-up after Dose 2. This could allow for early diagnosis and treatment. 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. In a similar analysis, in participants 56 years of age and older (COMIRNATY = 8,931; placebo = 8,895), serious adverse events were reported by 165 (1.8%) COMIRNATY recipients and 151 (1.7%) placebo recipients who received at least 1 dose of COMIRNATY or placebo, respectively. Shortly after, the novel virus was identified as SARS-CoV-2. The safety evaluation in Study 3 is ongoing. Dispatches from the Backyard Chicken Movement. Do not mix COMIRNATY Original & Omicron BA.4/BA.5 with other vaccines/products in the same syringe. Dilute the vial contents using 1.3 mL of sterile 0.9% Sodium Chloride Injection, USP to form COMIRNATY. Once received, frozen vials may be immediately transferred to the refrigerator [2C to 8C (35F to 46F)], thawed and stored for a single period of up to 10 weeks within the 18-month shelf-life. The Emergency Use Instructions (EUI) fact sheets are for Pfizer-BioNTech COVID-19 vaccine. DO NOT DILUTE (Vials with Gray Cap and Gray Label Border). Centers for Disease Control and Prevention. Lymphadenopathy was reported in 87 (0.4%) participants in the vaccine group compared to 8 (<0.1%) participants in the placebo group. After dilution, the vial contains 6 doses, of 0.3 mL with 30 . Most of the events began from 3-11 days after the second dose and were characterized as mild and self-limited. 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. Do not use COMIRNATY vials with an orange plastic cap/orange label border, purple plastic cap/purple label border or gray plastic cap/gray label border to prepare doses for individuals aged 6 months to <5 years. second. Refer to thawing instructions in the panels below. These distribution centers will have a dedicated area designated to store product that is not going direct from our Kalamazoo or Puurs sites to POU. Skin and subcutaneous tissue disorders (including skin rash, dermatitis, eczema and urticaria) were reported in 17 (1.1%) participants in the vaccine group and 5 (0.7%) participants in the placebo group. For details on the primary vaccination course for individuals 12 years of age and older, please refer to the COMIRNATYProduct Monograph, Section 4.2.1 Vaccination Schedule for Individuals 12 Years of Age and Older. Prior to mixing, the thawed vaccine may contain white to off-white opaque amorphous particles. Participants 12 Years of Age After a Dose of COMIRNATY Original/Omicron BA.4/BA.5 as a Second Booster (4th Dose). The overall safety profile for the booster dose was similar to that seen after 2 doses. 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. This site is intended . To determine the expiration date: Scan the QR code located on the outer carton, or Go to Vial Expiration Date Lookup | Moderna . Bells palsy (facial paralysis and facial paresis) was reported by four participants in the vaccine group and two in the placebo group. As the weather cools, viruses have a tendency to spread with more ease. 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%). COMIRNATY Original & Omicron BA.4/BA.5 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. Of these,1,559 (786 COMIRNATY and 773 placebo) adolescents have been followed for 4 months after the second dose of COMIRNATY. Each vial contains 6 doses of 0.3 mL. Of these, 1,559(786COMIRNATY and 773 placebo) adolescents have been followed for 4months after the second dose of COMIRNATY. Refrigeration units that are commonly available in hospitals. 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. In the analysis of blinded, placebo controlled 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. 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. 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. After dilution, vials of COMIRNATY (for age 6 months to <5 years) contain 10 doses of 0.2 mL of vaccine. You can review and change the way we collect information below. Thawed vials may be stored at room temperature [up to 25C (77F)] for up to 12 hours prior to dilution. Participants 5 Years Through <12 Years of Age. Do not add more than 1.3 mL of diluent. Obtain sterile 0.9% Sodium Chloride Injection, USP. In individuals 1 year of age and older, the recommended injection site is the anterolateral aspect of the thigh or the deltoid muscle. Administer immediately and no later than 12 hours after first puncture. 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. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. Information provided to VAERS which identifies a person who received the vaccine or vaccines will not be made available to the public. Bivalent vaccine (with a maroon vial cap and different label. COMIRNATY does not contain preservative. CIR Total Expected Inventory. Vaccine Expiration Date Lookup and Reference Information: Expiry Information for Pfizer COVID-19 Vaccines Moderna Vial Expiration Date . The vaccine should not be used after 12 months from the date of manufacture printed on the vial and carton. If vials are received at 2C to 8C, they should be stored at 2C to 8C. The liquid is a white to off-white suspension and may contain. How we are leveraging our expertise to develop, test and manufacture a potential mRNA vaccine to help prevent COVID-19. Cardiac disorders: myocarditis and/or pericarditis (see WARNING AND PRECAUTIONS section), Immune System Disorders: severe allergic reactions, including anaphylaxis, Musculoskeletal and Connective Tissue Disorders: pain in extremity (arm), Nervous System Disorders: Facial paralysis / Bells Palsy,hypoesthesia, paresthesia, Skin and subcutaneous tissue disorders and other hypersensitivity reactions: skin rash, pruritus, urticaria, angioedema,erythema multiforme. 4.3.1.1 For 12 Years of Age and Older: DILUTE BEFORE USE (Vials with Purple Cap and Purple Label Border), For 12 Years of Age and Older: DILUTE BEFORE USE (Vials with Purple Cap and Purple Label Border), For 12 Years of Age and Older: DILUTE BEFORE USE (Vials with Purple Cap and Purple Label Border), 4.3.1.2For 12 Years of Age and Older: DO NOT DILUTE (Vials with Gray Cap and Gray Label Border). Table 15: Study 3 Frequency of Solicited Local Reactions Within 7 Days After Each Dose Children 5 Years Through <12Years of Age Safety Population*. 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 Dose1 through up to 30days after Dose2 in ongoing followup in the initial enrolment group were reported by 10.9% of COMIRNATY 10mcg recipients and by 9.1% of placebo recipients. Please review the label carefully to ensure that you select the appropriate vaccine for immunization. The thermal container maintains a temperature range of -90C to -60C (130F to -76F). 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. pfizer-biontech covid-19 vaccine, bivalent (original and omicron ba.4/ba.5) is authorized for emergency use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either: completion of primary vaccination with any authorized or approved covid-19 vaccine, or receipt of the most recent booster dose What is the path of a vaccine from Pfizers facilities to where its distributed to patients? We operate one of the most sophisticated supply chain systems in the industry, with over 40 Pfizer-owned sites and over 200 suppliers globally, which provides capacity and redundancy as needed. Thats because people tend to spend more time indoors, where germs can circulate from one person to another through the air or close contact. 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. Purple Cap: Monovalent Pfizer-BioNTech COVID-19 Vaccines This product (for ages 12 years and older) is no longer being distributed. Pfizer and Moderna are two-dose vaccines,. Allowing vial(s) to thaw in the refrigerator [2C to 8C (35F to 46F)]. Thawed vials may be stored at room temperature [up to 25C (77F)] for up to 12 hours prior to use. Regardless of storage condition, vaccines should not be used after 18 months from the date of manufacture printed on the vial and cartons. This webpage is designed as a lookup table where the Unit of Use and Unit of Sale NDC are mapped to each other. If the vaccine is frozen, it must be discarded. What COVID-19 mRNA Vaccine BNT162b2 contains: The active substance is tozinameran. Refer to dilution and dose preparation instructions in the panels below. Theyve been cited as being as important to keeping communities healthy as having access to clean water and safe sanitation.1 Not all pack sizes may be available. Record the date and time of first vial puncture on the vial label. In order to provide you with relevant and meaningful content we need to know more about you. COVID-19 vaccine codes and crosswalks are provided in anticipation of potential vaccine availability under an approved Biologics License Application (BLA), Emergency Use Authorization (EUA), or as a potential vaccine submission for EUA (Pre-EUA). 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. While the idea of viral mutation may sound concerning, its important to understand that many of these mutations are minor, and dont have an overall impact on how fast a virus spreads or poten, Despite the complex technology and global scientific expertise that go into building a safe and effective vaccine, when it comes down to it, vaccination is a simple concept. How will Pfizer maintain vaccine integrity during distribution? Confirm there are no particulates and that no discolouration is observed. Reports are accepted from anyone and can be submitted electronically at www.vaers.hhs.gov. 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. Submit Please enter a valid lot number Special characters (commas, /, *, &) are not allowed in the Lot numbers OR Scan bar / 2D code 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. After dilution, the vaccine vials can be handled in room light conditions. 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. 4.2.2Vaccination Schedule for Individuals Aged 5 Years to <12 Years. Discard any unused vaccine 12 hours after dilution. Vials may be stored at room temperature [up to 25C (77F)] for up to 12 hours prior to use. We have developed packaging and storage innovations to be fit for purpose to meet the needs of our global network. Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. Each 0.3 mL dose of COMIRNATY Original & Omicron BA.4/BA.5 contains 15 mcg of a nucleoside modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 original strain and 15 mcg of modRNA encoding the S glycoprotein of SARS-CoV-2 Omicron variant lineages BA.4 and BA.5 (Omicron BA.4/BA.5). After preparation, a single dose is 0.2 mL. COMIRNATY is administered intramuscularly as a primary series of three doses (0.2 mL each). The safety profile of the participants with stable HIV infection receiving COMIRNATY (n=100) was similar to that seen in the general 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. The administration of COMIRNATY should be postponed in individuals suffering from acute severe febrile illness. 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. An additional 562 million Moderna, Pfizer, and Johnson & Johnson vaccines are . Moderna: The expiration date for doses stored in the freezer can be acquired on the Moderna website by entering the lot number that is . e. Severe: inconsolable; crying cannot be comforted. Cold chain is used for consumer products like ice cream and other frozen foods, as well as medicines and vaccines. In a clinical study of participants 18 through 55 years of age (N=306), 289 participants (94%) completed the e-diary recording adverse reactions. 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. Before use, mix by inverting vaccine vial gently 10 times. Would you like to proceed? Do not use if vaccine is discoloured or contains particulate matter. Do not freeze or shake the diluted vaccine. Home Data Catalog Developers Video Guides The median onset for all systemic events across both vaccine groups evaluated was 2 to 3 days and all events resolved within a median duration of 1 to 2 days after onset. You will be subject to the destination website's privacy policy when you follow the link. 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. The date printed on the vial and carton reflects the date of manufacture. 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