Each vial must be thawed and diluted prior to administration. Submit Please enter a valid lot number Special characters (commas, /, *, &) are not allowed in the Lot numbers OR Scan bar / 2D code Our track record gives us confidence in our ability to quickly scale and manufacture and distribute large quantities of a high-quality COVID-19 vaccine, leveraging multiple sites in the US and Europe. Purple Cap: Monovalent Pfizer-BioNTech COVID-19 Vaccines This product (for ages 12 years and older) is no longer being distributed. Verify the final dosing volume of 0.2 mL. In clinical studies with a data cut-off of March 13, 2021, and where 2 doses were administered 3 weeks apart, the most common adverse reactions in the reactogenicity subset (n=4,924) of participants 16 years of age and older after any dose included injection site pain (84.3%), fatigue (64.7%), headache (57.1%), muscle pain (40.2%), chills (34.7%), joint pain (25.0%), fever (15.2%), injection site swelling (11.1%), and injection site redness (9.9%). The COMIRNATY Original & Omicron BA.4/BA.5 multiple dose vial with a gray cap and a gray label border contains a volume of 2.25 mL, and is supplied as a frozen suspension that does not contain preservative. Prior to dilution, the thawed suspension may contain opaque amorphous particles. In clinical studies with a data cut-off of March 13, 2021, and where 2 doses were administered 3 weeks apart, the most common adverse reactions in the reactogenicity subset (n=4,924) of participants 16 years of age and older after any dose included injection site pain (84.3%), fatigue (64.7%), headache (57.1%), muscle pain (40.2%), chills (34.7%), joint pain (25.0%), fever (15.2%), injection site swelling (11.1%), and injection site redness (9.9%). 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. Pfizer-BioNTech COVID-19 Vaccine (also known as BNT162b2) This product information is intended only for residents of the United States. Inspect the liquid in the vial prior to dilution. Vials should be discarded 12 hours after dilution. Visually inspect each dose in the dosing syringe prior to administration. Clinical studies of COMIRNATY and COMIRNATY Original/Omicron BA.1 include participants 65 years of age and older and their data contributes to the overall assessment of safety and efficacy (see 8 ADVERSE REACTIONS and 14 CLINICAL TRIALS). Do not store vials at 25C to 15C (-13F to 5F). Contact your regional poison control centre. The Limited Time Discount may also be available to customers through Pfizer Distributors from Sunday, January 1, 2023 to Wednesday, February 22, 2023. From study vaccination to the data cut-off date (16 May 2022), the proportions of participants with any AEs were generally similar. The initial 2 doses are administered 3 weeks apart followed by a third dose administered at least 8 weeks after the second dose. Safety data from studies in individuals 12 years of age using bivalent formulations of COMIRNATY at 30 mcg are considered supportive. 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. Vial labels and cartons may state that a vial should be discarded 6 hours after the first puncture. d. Severe: requires intravenous hydration. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. Information about our efforts to drive equitable global access to the Pfizer-BioNTech COVID-19 vaccine, including scaling up of manufacturing. Participants 12 Years of Age After a Dose of COMIRNATY Original/Omicron BA.4/BA.5 as a Second Booster (4th Dose). M&D will begin redistributing Pfizer vaccine with the updated expiration dates detailed below, until all of these doses with extended dates have been ordered: Lot Number (EP6955): New Expiration Date: 9/30/2021 . The U.S. has bought 1.41 billion doses in total, and has so far distributed around 390 million across the country. Add 2.2 mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial. Study 2 also included 200 participants with confirmed stable human immunodeficiency virus (HIV) infection. 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. 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. 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. Two formulations of COMIRNATY are available for individuals 12 years of age and older. 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. If refrigerated, allow the diluted vaccine to come to room temperature prior to use. Data.CDC.gov. In individuals 1 year of age and older, the recommended injection site is the anterolateral aspect of the thigh or the deltoid muscle. Among participants 16 through 55 years of age who received at least one dose of study vaccine, 12,995 of whom received COMIRNATY and 13,026 of whom received placebo, unsolicited adverse events were reported by 4,396 (33.8%) participants in the COMIRNATY group and 2,136 (16.4%) participants in the placebo group. COMIRNATY is supplied as a frozen suspension in multiple dose vials with an orange capand an orange label border. 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 . StudyC4591001 (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. Preparation for AdministrationDO NOT DILUTE, For 12 Years of Age and Older: DO NOT DILUTE (Vials with Gray Cap and Gray Label Border), 4.3.2 For Age 5 Years to <12 Years: DILUTE PRIOR TO USE (Vials with Orange Cap and Orange Label Border), For Age 5 Years to <12 Years: DILUTE PRIOR TO USE (Vials with Orange Cap and Orange Label Border), 4.3.3For Age 6 Months to <5 Years: DILUTE PRIOR TO USE (Vials with Maroon Cap and Maroon Label Border), For Age 6 Months to <5 Years: DILUTE PRIOR TO USE (Vials with Maroon Cap and Maroon Label Border). 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%). During the visual inspection: After dilution, vials of COMIRNATY (for age 5 years to <12 years) contain 10 doses of 0.2 mL of vaccine. COMIRNATY does not contain preservative. 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 Study 2. The safety evaluation in Study 3 is ongoing. The administration of COMIRNATY Original & Omicron BA.4/BA.5 should be postponed in individuals suffering from acute severe febrile illness. 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. fully loaded. 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). Table 7: Study 2 Frequency of Solicited Local Reactions Within 7 Days After Each Dose of COMIRNATY Participants 16-55 Years of Age (Reactogenicity Subset of the Safety Population*), Table 8: Study 2 Frequency of Solicited Systemic Reactions Within 7 Days After Each Dose of COMIRNATY Participants 16-55 Years of Age (Reactogenicity Subset of the Safety Population*), Table 9: Study 2 Frequency of Solicited Local Reactions Within 7 Days After Each Dose of COMIRNATY Participants 56 Years of Age and Older (Reactogenicity Subset of the Safety Population*), Table 10: Study 2 Frequency of Solicited Systemic Reactions Within 7 Days After Each Dose of COMIRNATY Participants 56 Years of Age and Older (Reactogenicity Subset of the Safety Population*), Study 2 also included 200 participants with confirmed stable human immunodeficiency virus. Most of the events began from 3-11 days after the second dose and were characterized as mild and self-limited. Adolescents 12 to 15 Years of Age Primary Series (Two Doses). Vials must reach room temperature before dilution. 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 safety evaluation of participants in Study 2 and Study 4 is ongoing. the vial has an orange plastic cap and a label with an orange border. After dilution, the vaccine vials can be handled in room light conditions. Regardless of storage condition, vaccine should not be used after 12 months from the date of manufacture printed on the vial and cartons. 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. After dilution, the vaccine will be an off-white suspension. 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. Lymphadenopathy was reported in 87 (0.4%) participants in the vaccine group compared to 8 (<0.1%) participants in the placebo group. Each vial contains 6 doses of 0.3 mL. 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. Careful attention should be paid to the vial cap colour and label border and the appropriate corresponding instructions must be followed. The participant was treated and recovered. Do not use if vaccine is discoloured or contains particulate matter. Fainting may occur in association with administration of injectable vaccines. The participant was treated and recovered. 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. By. 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 have developed packaging and storage innovations to be fit for purpose to meet the needs of our global network. 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). In total, 5.9% and 6.2% of participants reported any AE (with 0% and 0.3% reporting any serious AE) from study vaccination through 1 month post-dose in the COMIRNATY (30 mcg) and COMIRNATY Original/Omicron BA.1 (30 mcg), respectively. 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. Pericarditis was reported for one participant in the vaccine group, and no case was reported in the placebo group. This webpage is designed as a lookup table where the Unit of Use and Unit of Sale NDC are mapped to each other. COMIRNATY Original & Omicron BA.4/BA.5 does not contain preservative. 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]. Participants 6 Months Through <2 Years of Age. 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. COMIRNATY Original & Omicron BA.4/BA.5 has no or negligible influence on the ability to drive and use machines. The safety evaluation in Study 3 is ongoing. Dilute the vial contents using 1.3 mL of sterile 0.9% Sodium Chloride Injection, USP to form COMIRNATY. Participants 16 Years of Age and Older Primary Series (Two Doses). Refer to thawing and dose preparation instructions in the panels below. Vials may be stored at room temperature [up to 25C (77F)] for up to 12 hours prior to dilution. Please choose the category that best describes you. An additional 562 million Moderna, Pfizer, and Johnson & Johnson vaccines are . 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. Unleashing the next wave of scientific innovations. 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%)). 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. . After your first vaccine, you should have been given a card titled 'My Personal COVID-19 Vaccine Record Card' with your name, date of birth, the vaccine name and the date you received the vaccine . In a clinical study of approximately 10,000 participants 16 years of age and older, unsolicited adverse reactions following administration of a booster dose included headache (5%), fever (4.8%), lymphadenopathy (2.8%), pain in extremity (1.1%), nausea (0.9%), malaise (0.7%), and decreased appetite (0.2%). A carton of 25 vials or 195 vials may take up to 2 or 3 hours, respectively, to thaw in the refrigerator, whereas a fewer number of vials will thaw in less time. Allowing vial(s) to thaw in the refrigerator [2C to 8C (35F to 46F)]. The vaccine should not be used after 12 months from the date of manufacture printed on the vial and carton. 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. It is supplied as a frozen suspension that does not contain preservative. 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 Where is the Pfizer-BioNTech COVID-19 vaccine made? On Monday, August 23, 2021, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. 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