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]. We have years of proven experience in supply chain and cold chain management, and we are accelerating the development of innovative technologies to further advance our capabilities as a supply chain leader. dose. Table 5: Solicited Local Adverse Reactions Reported for Vaccine Groups Within 7 Days After Study Vaccination. 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) . 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%). expiration date tracking tool (PDF) to record updated expiration dates for COVID-19 vaccine. We have also developed packaging and storage innovations to be fit for purpose to meet the needs of our global network. Transportation of Thawed VialsAvailable data support transportation of one or more thawed,undiluted vials at 2C to 8C (35F to 46F) for up to 12 hours. Administer immediately, and no later than 6 hours after dilution. Add 2.2 mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial. 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. COMIRNATY Original & Omicron BA.4/BA.5 is a suspension for intramuscular injection. Here's how to find the expiration date of the different COVID-19 Vaccine Brands. Local ARs are summarized in Table 5. 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. Cartons of COMIRNATY multiple dose vials (for 12 years and older: DO NOT DILUTE) may also arrive at 2C to 8C. 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. The median duration was 3.5 days (ranged from 1 to 14 days) in the vaccine group. 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. 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. The new files include COVID-19 vaccine National Drug Codes (NDCs), lot numbers, and lot expiration dates. Each vial contains 6 doses of 0.3 mL. The vaccine will be a white to off-white suspension. 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 Home Data Catalog Developers Video Guides 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. Sorry, you need to enable JavaScript to visit this website. ALC-0315 = ((4-hydroxybutyl) azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), ALC-0159 = 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-distearoyl-sn-glycero-3-phosphocholine, ALC-0315 = ((4-hydroxybutyl) azanediyl)bis (hexane-6,1-diyl)bis(2-hexyldecanoate). 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. The safety evaluation in Study 3 is ongoing. COMIRNATY Original & Omicron BA.4/BA.5 For Age 5 Years to <12 Years: DILUTE PRIOR TO USE, (Vials with Orange Cap and Orange Label Border), Orange plastic cap and label with orange border. Search Search . Typically, the onset of symptoms has been within a few days following receipt of COMIRNATY. 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. Verify that the vial has a maroon plastic cap and a maroon label border. (See Add 1.8 mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial. 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. Would you like to proceed? The denominators (N) used in the percentage calculations for redness and swelling were 749 after Dose 1 and 741 after Dose 2 in the placebo group, due to an e-diary error. Storage of the vials between -96C to -60C (-141F to -76F) is not considered an excursion from the recommended storage condition. The most frequently reported unsolicited adverse event was lymphadenopathy (2.5%). The vaccine should not be used after 12 months from the date of manufacture printed on the vial and carton. a. N = Number of participants reporting at least 1 yes or no response for the specified event after the specified dose. Each vial must be thawed prior to administration. Do not add more than 2.2 mL of diluent. The vial stoppers are not made with natural rubber latex. How will the Pfizer-BioNTech COVID-19 vaccine be distributed? The mRNAs are formulated in lipid nanoparticles, which enable delivery of the RNA into host cells to allow expression of the SARS-CoV-2 S antigen. 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 . Participants 16 Years of Age and Older After Booster Dose. The COMIRNATY 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. To ensure proper storage and handling, please see cvdvaccine.com. These EUIs provide information about emergency use of FDA-approved medical products that may not be included in or differ in some way from the information provided in the FDA-approved labeling. We have crossed another milestone in the fight against COVID-19. Any hours used for transport at 2C to 8C (35F to 46F) count against the 1-month limit for storage at 2C to 8C (35F to 46F). Published December 11, 2020. Table 17 and Table 18 present the frequency and severity of reported solicited local and systemic reactions, respectively, within 7 days of a booster dose of COMIRNATY for Phase 2/3 participants 5 years through 12 years of age. Do not dilute. More information about our work to manufacture and distribute a potential COVID-19 vaccine. 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 allow us to count visits and traffic sources so we can measure and improve the performance of our site. The overall safety profile for the COMIRNATY Original/Omicron BA.1 booster (Dose 4) was similar to that seen after the COMIRNATY booster (Dose 3). 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. Adverse reactions following administration of any dose included pain at the injection site (47.0%), fatigue (44.8%), injection site redness (18.9%), fever (10.5%), headache (8.7%), injection site swelling (8.4%), chills (5.7%), muscle pain (5.0%), joint pain (2.4%), and lymphadenopathy (0.1%). 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. 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. 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]. Table 9 and Table 10 present the frequency and severity of solicited local and systemic reactions, respectively, within 7days following each dose of COMIRNATY and placebo in adolescents 12to15years of age included in the safety population who were monitored for reactogenicity with an electronic diary. If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2 mL, discard the vial and any excess volume. Cardiology consultation for management and follow up should be considered. Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. 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. COMIRNATY Original & Omicron BA.4/BA.5 does not contain preservative. COMIRNATY (for age 6 months to <5 years): A carton of 10 vials may take up to 2 hours to thaw at this temperature. A carton of 10 vials may take up to 4hours to thaw, and thawed vials can be stored in the refrigerator for up to 10weeks. ONLY use 0.9% Sodium Chloride Injection, USP as the diluent. Dispatches from the Backyard Chicken Movement. Vials should be discarded 12 hours after dilution. Verify that the vial has an orange plastic cap and an orange label border. 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. A 17-year-old male in Study 2 was diagnosed with myocarditis three days after receiving the booster dose (Dose 3). Cartons of COMIRNATY multiple dose vials (for age 5 years to <12 years) and COMIRNATY multiple dose vials (for age 6 months to <5 years) may arrive frozen at ultra-cold conditions in thermal containers with dry ice. "Her father and paternal grandmother both died . A carton of 10 vials may take up to 4 hours to thaw at this temperature. Currently available information is insufficient to determine a causal relationship with the vaccine. 2 DOSAGE AND ADMINISTRATION For intramuscular injection only. Adolescents 12 to 15 Years of Age Primary Series (Two Doses). 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. Study 2 also included 200 participants with confirmed stable human immunodeficiency virus (HIV) infection. fully loaded. Tables 3 through 6 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. Lymphadenopathy was reported in 87 (0.4%) participants in the vaccine group compared to 8 (<0.1%) participants in the placebo group, which is plausibly related to vaccination. COMIRNATY Original & Omicron BA.4/BA.5 multiple dose vials (with orange cap and orange label border) are supplied in a carton containing 10 multiple dose vials. Children who will turn from 4 to 5 years of age between their doses in the vaccination series should receive their age-appropriate dose at the time of the vaccination and the interval between doses is determined by the childs age at the start of the vaccination series. Healthcare professionals are advised to consider the possibility of myocarditis and/or pericarditis in their differential diagnosis if individuals present with chest pain, shortness of breath, palpitations or other signs and symptoms of myocarditis and/or pericarditis following immunization with a COVID-19 vaccine. 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. For important information on handling and preparation for administration, please refer to 11 STORAGE, STABILITY AND DISPOSAL and 4 DOSAGE AND ADMINISTRATION. Most of the events began from 3-11 days after the second dose and were characterized as mild and self-limited. Route Site Code Dosage mL MFG Code Lot Number IM 0.3 cc 301308A Expiration 11PFR -30 2021 MFG Codes: PFR=Pfizer, MOD=Moderna, ASZ=AstraZeneca, JSN=Janssen, NVX=Novavax, MSD=Merck When the current expiration date gets close, contact the manufacturer before discarding vaccine. The participants were unblinded to offer placebo participants COMIRNATY when they became locally eligible under regulatory approval in December 2020. Regardless of storage condition, vaccines should not be used after 12 months from the date of manufacture printed on the vial and cartons. 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. Unleashing the next wave of scientific innovations. Inspect vials to confirm there are no particulates and no discolouration is observed. Overall, among participants who received a booster dose in a subset from Study C4591001 (Study 2), the median age was 42 years (range 19 through 55 years of age), 45.8% were male and 54.2% were female, 81.4% were White, 27.8% were Hispanic/Latino, 9.2% were Black or African American, 5.2% were Asian, and 0.7% were American Indian/Alaska Native. If the vaccine is frozen, it must be discarded. Vials must reach room temperature before dilution. The vaccine elicits both neutralizing antibody and cellular immune responses to the spike (S) antigen, which may contribute to protection against COVID-19 disease. Each dose contains 30 mcg modRNA in total and also includes the non-medicinal ingredients listed in Table 1. 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. On March 11, 2020 the World Health Organization declared COVID-19 a pandemic1. It is supplied as a frozen suspension that does not contain preservative. 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. 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. 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. COMIRNATY multiple dose vial contain a frozen suspension that does not contain preservative and must be thawed and may require dilution prior to administration. The efficacy and safety of the vaccine has not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. 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. COVID-19 Vaccine Lot Number and Expiration Date Tool. The administration of COMIRNATY should be postponed in individuals suffering from acute severe febrile illness. Check that the carton has been updated to reflect the 10-week refrigerated expiry date. 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. Appendicitis was reported as a serious adverse event for 27 participants, 15 vaccine participants and 12 placebo participants. A booster dose of COMIRNATY (0.2 mL) may be administered intramuscularly at least 6 months after completion of the primary series in individuals 5 years through 12 years of age. 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. Please choose the category that best describes you. Our scientific content is evidence-based, scientifically balanced and non-promotional. On Dec. 11, the US Food and Drug Administration issued its first emergency use authorization for a Covid-19 vaccine, shortly after the UK . 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. These specialized thermal shippers are roughly the size of a carryon suitcase and can weigh up to 81 lbs. The overall safety profile for the booster dose was similar to that seen after 2 doses. It is supplied as a frozen suspension that does not contain preservative. Instructions on the handling and dose preparation of the vaccine prior to administration are provided below. Submit a medical question for Pfizer prescription products. Table 17: Study 3 Frequency of Solicited Local Reactions Within 7 Days After Each Dose Children 6Months Through <2 Years of Age Safety Population*. 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). 4.2.2Vaccination Schedule for Individuals Aged 5 Years to <12 Years. 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). Before ordering, please check the Vaccine Advertisement page in the WAIIS to see if other providers in your area have vaccine available. (*) 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. 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. 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 . 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. * Randomized participants who received at least 1 dose of the study intervention. Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw 0.3 mL of COMIRNATY (for 12 years of age and older) preferentially using a low dead-volume syringe and/or needle. The participant was treated and recovered. Do not inject the vaccine intravascularly, subcutaneously or intradermally. Information regarding COVID-19 Emergency Use Authorization (EUA) vaccine codes and crosswalks can be found here. After dilution the vials should be stored at 2C to 25C (35F to 77F). General Gustave Perna and the Operation Warp Speed team have offered any and all support and we are grateful for that as what we are tasked with is no simple feat. The 10 week refrigerated expiry date should be recorded on the carton at the time of transfer. Table 13 and Table 14 present the frequency and severity of reported solicited local and systemic reactions, respectively, within 7 days of a booster dose of COMIRNATY for Phase 2/3 participants 5 years through 12 years of age. Confirm there are no particulates and that no discolouration is observed. Table 11 and Table 12 present the frequency and severity of solicited local and systemic reactions, respectively, within 7days following each dose of COMIRNATY and placebo in children 5 years through 12years of age included in the initial enrolment safety population who were monitored for reactogenicity with an electronic diary. c. n = Number of participants with the specified reaction. For Age 5 Years to <12 YearsCOMIRNATY is a suspension for intramuscular injection which must be diluted prior to administration. 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. Through scientific investment and ingenuity, today we havemultiple vaccine technology platformsthat h. When it comes to healthcare, the terms equitable and "access" often go hand-in-hand. Study 3 also enrolled 1,776 participants 6 months through <2 years of age (1,178 COMIRNATY 3 mcg; 598 placebo), and 2,750 participants 2 through <5 years of age (1,835 COMIRNATY 3 mcg; 915 placebo) in Phase 2/3. 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. We have developed packaging and storage innovations to be fit for purpose to meet the needs of our global network. Very rare cases of myocarditis and/or pericarditis following vaccination with COMIRNATY have been reported during post-authorization use. Katherine Ellen Foley. An additional 562 million Moderna, Pfizer, and Johnson & Johnson vaccines are . To help ensure the traceability of vaccines for patient immunization record-keeping as well as safety monitoring, health professionals should record the time and date of administration, quantity of administered dose (if applicable), anatomical site and route of administration, brand name and generic name of the vaccine, the product lot number and expiry date (or manufacture date). 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%). Adverse Events (AEs) from Study Vaccination to Data Cut-off Date. Read . The most commonly reported adverse reactions (10%) following administration of a booster dose were pain at the injection site (83.0%), fatigue (63.7%), headache (48.4%), muscle pain (39.1%), chills (29.1%), and joint pain (25.3%). Safety data from studies in individuals 12 years of age using bivalent formulations of COMIRNATY at 30 mcg are considered supportive. d. Severe: requires intravenous hydration. 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. Do not freeze or shake the diluted vaccine. 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. After dilution, the vial contains 6 doses, of 0.3 mL with 30 . 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. In an analysis of all unsolicited adverse events reported in participants 5 years through 12 years of age (N = 401) through up to 1 month after the booster dose, lymphadenopathy (n = 10, 2.5%) was an adverse reaction not already captured by solicited local and systemic reactions. 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. You can order COVID-19 vaccines through the Washington State Immunization Information System (WAIIS). We have developed detailed logistical plans and tools to support effective vaccine transport, storage and continuous temperature monitoring. Inspect the liquid in the vial prior to dilution. 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)]. Pdf ) to record updated expiration dates condition, vaccines should not be used after 12 from... Fit for purpose to meet the needs of our global network dose 3 ) the handling and preparation for,... Storage of the vaccine is frozen, it must be discarded vial a. 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