You can order COVID-19 vaccines through the Washington State Immunization Information System (WAIIS). Each 0.2 mL dose of COMIRNATY contains 3 mcg of a nucleoside modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 (original strain) and the non-medicinal ingredients listed in Table 2. It is unknown whether COMIRNATY is excreted in human milk. Storage of the vials between -96C to -60C (-141F to -76F) is not considered an excursion from the recommended storage condition. She recognized the number immediately and excused herself from her young daughters and her husband to take the work call. Vials may be stored at room temperature [up to 25C (77F)] for up to 12 hours prior to dilution. For important information on handling and preparation for administration, please refer to 11 STORAGE, STABILITY AND DISPOSAL and 4 DOSAGE AND ADMINISTRATION. 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. Animal studies do not indicate direct or indirect harmful effects with respect to female fertility or reproductive toxicity (see 16 NON-CLINICAL TOXICOLOGY). 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. Our distribution approach will be to largely ship from our Kalamazoo and Puurs sites direct to the point of use (POU). For Canadian Healthcare Professionals 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. If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents. Two additional severe AEs, also reported as SAEs (pneumonia, ischaemic stroke) were reported in the COMIRNATY 30 mcg group. 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. Do not add more than 1.8 mL of diluent. When the current expiration date gets close, contact the manufacturer before discarding vaccine. The COMIRNATY multiple dose vial (for age 6 months to <5 years) has a maroon cap and a maroon label border and contains a volume of 0.4 mL. Pfizers Institute of Translational Equitable Medicine Addresses Equity in Health Research, Shot of a Lifetime: How Two Pfizer Manufacturing Plants Upscaled to Produce the COVID-19 Vaccine in Record Time, Retrospect and Context: One Scientist's Thoughts on Comparing COVID-19 to the 1918 Flu Pandemic, Shot of a Lifetime: How Pfizer Developed its Own Raw Materials to Ensure a Steady Supply for the COVID-19 Vaccine, Shot of a Lifetime: How Pfizer is Partnering with CMOs to Increase COVID-19 Vaccine Production and Reach More People, Shot of a Lifetime: How Pfizer and BioNTech Developed and Manufactured a COVID-19 Vaccine in Record Time, The Truth About COVID-19 and Black Fungus, Continuing to Follow the Science: An Open Letter from Pfizer Chairman and CEO Dr. Albert Bourla, An Open Letter from Pfizer Chairman and CEO to Colleagues, Albert Bourla Reflects on the One Year Anniversary of the COVID-19 Pandemic, Managing Your Mental Health During a Pandemic, Albert Bourla On Ensuring Equitable Access to COVID-19 Vaccines. COMIRNATY has no or negligible influence on the ability to drive and use machines. No serious adverse events were reported after the booster dose of COMIRNATY through the cut-off date. Study C4591007 (Study 3) is a Phase 1/2/3 study comprised of an open-label vaccine dose finding portion (Phase 1) and a multicenter, multinational, randomized, saline placebo-controlled, observer-blind immunogenicity and efficacy portion (Phase 2/3) that has enrolled approximately 4,600 participants 5 years through <12 years of age. No data are available yet regarding the use of COMIRNATY Original & Omicron BA.4/BA.5 during pregnancy. COMIRNATY is supplied as a frozen suspension in multiple dose vials with an orange capand an orange label border. Allowing vial(s) to sit at room temperature [up to 25C (77F)] for 30minutes. There is no information on the co-administration of COMIRNATY Original & Omicron BA.4/BA.5 with other vaccines. 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. Each 0.2 mL dose of COMIRNATY Original & Omicron BA.4/BA.5 contains 5 mcg of a nucleoside modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 original strain and 5 mcg of modRNA encoding the S glycoprotein of SARS-CoV-2 Omicron variant lineages BA.4 and BA.5 (Omicron BA.4/BA.5) and the non-medicinal ingredients listed in Table 2. d. Mild: 1 to 2 times in 24 hours; moderate: >2 times in 24 hours; severe: requires intravenous hydration. 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. Instructions on the handling and dose preparation of the vaccine prior to administration are provided below. Dispatches from the Backyard Chicken Movement. The safety of the primary seriesof COMIRNATY was evaluated in participants 6 months of age and older in three clinical studies conducted in the United States, Europe, Turkey, South Africa, and South America. Unleashing the next wave of scientific innovations. Severe systemic events were reported infrequently in both vaccine groups. Alternatively, frozen vials may be stored in an ultra-low temperature freezer at 90C to 60C ( 130F to 76F) for up to 18months from the date of manufacture. To ensure proper storage and handling, please see cvdvaccine.com. The safety of a COMIRNATY Original/Omicron BA.1 booster dose in individuals 18 - 55 years of age is extrapolated from safety data from a subset of 315 adults 18 - 55 years of age who received a booster (Dose 4) of Omicron BA.1 30 mcg (monovalent) after completing 3 doses of COMIRNATY. Children 5 Years Through12 Years of Age Primary Series (Two Doses). Information provided to VAERS which identifies a person who received the vaccine or vaccines will not be made available to the public. Study 2 also included 200 participants with confirmed stable human immunodeficiency virus (HIV) infection. Once opened, and if being used as temporary storage by a vaccination center, then it can be used for a total of 15 days with re-icing every five days. 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) . Using aseptic technique, withdraw 1.8 mL of 0.9% Sodium Chloride Injection, USP into a transfer syringe (using 21-gauge or narrower needle). Based on accumulating data, the reporting rates of myocarditis and pericarditis after COMIRNATY primary series in children ages 5 through <12 years are lower than in ages 12 through 17 years. Orders may be placed either online at www.primevaccines.pfizer.com or through Pfizer Customer Service at 1-800-666-7248. Vials must reach room temperature before dilution. Thaw vial(s) of COMIRNATY before use either by: Allowing vial(s) to thaw in the refrigerator (2C to 8C [35F to 46F]). Each Product Monograph is available below, at www.pfizer.ca/products, or www.cvdvaccine.ca. After dilution, the vial should be held between 2C to 25C (35F to 77F). 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). Today, the COVID-19 pandemic is frequently compared with the influenza pandemic of 1918-1919. Before ordering, please check the Vaccine Advertisement page in the WAIIS to see if other providers in your area have vaccine available. Record the date and time of first vial puncture (dilution) on the vial label. Inspect vials to confirm there are no particulates and no discolouration is observed. The vaccine will be an off white suspension. In Study C4591031 (Study 4), a placebo-controlled booster study, participants 16 years of age and older recruited from Study C4591001 (Study 2) received a booster dose of COMIRNATY (5,081 participants), or placebo (5,044 participants) at least 6 months after the second dose of COMIRNATY. Our distribution is built on a flexible just-in-time system which will ship the frozen vials to the point of vaccination. Vaccines are one of the greatest health interventions ever developed. Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw 0.2 mL of COMIRNATY (for age 6 months to <5 years) preferentially using a low dead-volume syringe and/or needle. Appendicitis was reported as a serious adverse event for 27 participants, 15 vaccine participants and 12 placebo participants. 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. COMIRNATY multiple dose vial contain a frozen suspension that does not contain preservative and must be thawed and may require dilution prior to administration. Record the date and time of first vial puncture on the vial label. Here are some examples of where to find the lot number, depending on your data source. 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 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. January 31, 2023. After preparation, a single dose is 0.3 mL. 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. Pfizer COVID-19 vaccine: This vaccine product has an expiration date located on the vaccine vial. Check that the carton has been updated to reflect the 10-week refrigerated expiry date. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. In the analysis of blinded, placebocontrolled 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. No Grade 4 systemic events were reported in any vaccine groups evaluated. Where is the Pfizer-BioNTech COVID-19 vaccine made? After Pfizer and BioNtech signed a letter of intent in March 2020 to work together on a vaccine, two Pfizer facilities were swiftly selected for developing the processes and manufacturing the product at an industrial scale. In Study 2, all participants 12 to 15 years of age and 16 years of age and older in the reactogenicity subset, and a subset of 306 participants 18 through 55 years of age who received a booster dose in Study 2, were monitored for solicited local and systemic reactions and use of antipyretic medication after each vaccination with an electronic diary during the 7 days following any dose of vaccination. 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. Using aseptic technique, withdraw 1.3mL of diluent into a transfer syringe (using 21gauge or narrower needle). a. N = number of participants reporting at least 1 yes or no response for the specified event after the specified dose. As SARS-CoV-2 spreads around the globe, it is mutating, in other words it is acquiring genetic changes. It is unknown whether this vaccine has an impact on fertility. Serious adverse events from Dose 1 through 1 month after Dose 3, with an overall median of 1.3 months follow up after Dose 3, were reported by 1.4% of COMIRNATY recipients and by 2.3% of placebo recipients. Do not store vials at 25C to 15C (-13F to 5F). On April 7, 2022, FDA authorized an extension (PDF, 136 KB) for the shelf life of the refrigerated Janssen COVID-19 Vaccine, allowing the product to be stored at 2-8 degrees . (after dilution, each vial contains 10* doses of 0.2 mL). The decision to administer COMIRNATY to an individual with a history of myocarditis or pericarditis should take into account the individuals clinical circumstances. a. N = Number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose. The Limited Time Discount may also be available to customers through Pfizer Distributors from Sunday, January 1, 2023 to Wednesday, February 22, 2023. 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. Do not store vials at 25C to 15C (-13F to 5F). Each vial must be diluted with 2.2 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine, and contains 10* doses of 0.2 mL after dilution. 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%). Table 15: Study 3 Frequency of Solicited Local Reactions Within 7 Days After Each Dose Children 2 Through <5 Years of Age Safety Population*. Note: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination. Table 18: Study 3 Frequency of Solicited Systemic Reactions Within 7Days After Each Dose Children 6Months Through <2 Years of Age Safety Population*. We have developed detailed logistical plans and tools to support effective vaccine transport, storage and continuous temperature monitoring. COMIRNATY Original & Omicron BA.4/BA.5 is a suspension for intramuscular injection which must be diluted prior to administration. Pfizer and Moderna are two-dose vaccines,. Each vial must be thawed and diluted prior to administration. DILUTE PRIOR TO USE (Vials with Orange Cap and Orange Label Border). 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. 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 1 participant (0.1%) in each group after receiving the vaccine or placebo through the data cut-off date. Search Search . The bivalent vaccine is available in vials with gray cap and gray label border (for individuals 12 years of age and older) and in vials with an orange cap and orange label border (for individuals 5 to <12 years of age). Currently available information is insufficient to determine a causal relationship with the vaccine. In an analysis of Study 2, based on data up to the cut-off date of March 13, 2021, a total of 2,260 adolescents (1,131COMIRNATY; 1,129 placebo) were 12 to 15years of age. Study BNT16201 (Study 1) was a Phase 1/2, two-part dose-escalation trial that enrolled 60 participants 18 through 55 years of age and 36 participants 56 through 85 years of age. The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for immunization against COVID-19. Safety data from studies in individuals 12 years of age using bivalent formulations of COMIRNATY at 30 mcg are considered supportive. Administer immediately, and no later than 6 hours after dilution. Enfermedad por coronavirus (COVID-19) Situacin. Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. These cases occurred more commonly after the second dose and in adolescents and young adults. In Study C4591031 (Study 4), a placebo-controlled booster study, 5,081 participants 16 years of age and older were recruited from Study 2 to receive a booster dose of COMIRNATY at least 6 months after the second dose. Bells palsy (facial paralysis and facial paresis) was reported by four participants in the vaccine group and two in the placebo group. Read . Prior to dilution, the thawed suspension may contain white to off-white opaque amorphous particles. Add 1.3mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial. 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. The various storage options at the POU allow for equitable access to the Pfizer vaccine to areas with differing infrastructure. Once received, remove the vial cartons immediately from the thermal container and preferably store in an ultra-low temperature freezer between 90C to -60C (-130F to -76F) until the expiry date printed on the label. 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. 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%). Any vaccine remaining in vials must be discarded after 6 hours. 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. In Study 2 and Study 3, all participants 6 months through <5 years of age, 5 through <12 years of age, 12 to 15 years of age and 16 years of age and older in the reactogenicity subset, and a subset of 306 participants 18 through 55 years of age who received a booster dose in Study 2, were monitored for solicited local and systemic reactions and use of antipyretic medication after each vaccination with an electronic diary during the 7 days following any dose of vaccination. From Dose 1 through 30 days after Dose 3, lymphadenopathy was reported in 2 (0.2%) of COMIRNATY recipients vs. 0 (0%) of placebo recipients. Search for Vaccine Lot Release For information on COVID-19 Vaccine, please refer to 'Lot Release of COVID-19' IMOJEV Powder and diluent* for suspension for injection Japanese encephalitis vaccine (live, attenuated) * 0.4 % Sterile Sodium chloride solution 08A2003EA . 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. 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. Individuals should be advised to bring symptoms (e.g., dizziness, increases in heart rate, feeling short of breath, tingling sensations or sweating) to the attention of the vaccination provider for evaluation. As the potential threat of COVID-19 became clear by early 2020, teams across Pfizer sprang into action. Adverse reactions were usually mild or moderate in intensity and resolved within a few days after vaccination. How will Pfizer maintain vaccine integrity during distribution? Participants 5 Years Through <12 Years of Age. 4.2.3Vaccination Schedule for Individuals Aged 6 Months to <5 Years. Store between 2C to 25C (35F to 77F). A Life-Saving Education: The Bodys Response to a Vaccine, Research and Business Development Partnerships, COVID-19 Vaccine U.S. Distribution Fact Sheet, Scaling-Up to Manufacture a Potential COVID-19 Vaccine, COVID-19 Vaccines Access, Manufacturing, and Trade. With differing infrastructure ischaemic stroke ) were reported infrequently in both vaccine.... And time of first vial puncture ( dilution ) on the vaccine group and two in the diary. Paralysis and facial paresis ) was reported by four participants in the Phase 2/3 part of the vials between to! After vaccination co-administration of COMIRNATY through the cut-off date to extract 10 doses from single. To areas with differing infrastructure also reported as SAEs ( pneumonia, ischaemic stroke ) reported! Have developed detailed logistical plans and tools to support effective vaccine transport, storage and continuous monitoring! 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