There is no information on the co-administration of COMIRNATY Original & Omicron BA.4/BA.5 with other vaccines. How will hospitals and pharmacies keep vaccines cold? Clinical studies of COMIRNATY 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). This content is intended for Canadian Healthcare Professionals. What is the path of a vaccine from Pfizers facilities to where its distributed to patients? In 2020, as Pfizer and BioNTech were still developing the COVID-19 vaccine, Julie Jenson was thinking about how to distribute that vaccine to every country around the world, regardless of that countrys means. Once vials are thawed they should not be refrozen. 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. Pfizer is a proven, reliable multinational vaccine producer, supplying vaccines to more than 165 countries. 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. Verify that the vial has a maroon plastic cap and a maroon 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*. If received at 2C to 8C, they should be stored at 2C to 8C. Fainting may occur in association with administration of injectable vaccines. expiration date tracking tool (PDF) to record updated expiration dates for COVID-19 vaccine. Fatigue was the most frequently reported systemic event within 7 days after booster dose, followed by headache, muscle pain and less frequently by chills, joint pain, diarrhea, or fever. 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. COMIRNATY does not contain preservative. As with any vaccine, vaccination with COMIRNATY may not protect all recipients. Administer a single 0.3 mL dose of COMIRNATY Original & Omicron BA.4/BA.5 intramuscularly, preferably in the deltoid muscle. 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. The median age of these 401 participants was 8.0 years (range 5 years through 12 years of age), 52.4% were male and 47.6% were female, 70.1% were White, 7.2% were Black or African American, 22.9% were Hispanic/Latino, 7.7% were Asian, and 2.0% were American Indian/Alaska Native. Table 13: Study 2 Frequency of Solicited Local Reactions Within 7 Days After Each Dose of COMIRNATY Adolescents 12 to 15 Years of Age Safety Population*, Table 14: Study 2 Frequency of Solicited Systemic Reactions Within 7 Days After Each Dose of COMIRNATY Adolescents 12 to 15 Years of Age Safety Population*. Gently invert the vial containing COMIRNATY Original & Omicron BA.4/BA.5 10 times to mix. Of these,1,559 (786 COMIRNATY and 773 placebo) adolescents have been followed for 4 months after the second dose of COMIRNATY. . You can review and change the way we collect information below. Most of the events began from 3-11 days after the second dose and were characterized as mild and self-limited. Access to this report is strictly managed by registration only. 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). One serious adverse event of fever (maximum temperature 40.3C) on Day 3 after Dose 2 in a 4-year-old was considered possibly related to vaccination. Once vials are thawed they should not be refrozen. Here's how to find the expiration date of the different COVID-19 Vaccine Brands. 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. 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. Severe local reactions were reported by 1 (1.0%) participant in the 12 to 17 years of age group who received a booster dose of COMIRNATY Original & Omicron BA.4/BA.5 30 mcg. After storage for 15 days in the Pfizer thermal shipper, vaccination centers can transfer the vials to 2-8C storage conditions for an additional five days, for a total of 20 days. If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2mL, discard the vial and any excess volume. 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. COMIRNATY Original & Omicron BA.4/BA.5 does not contain preservative. We have experience working with customers in all markets to ensure success. Do not use if liquid is discoloured or if other particles are observed. No data are available yet regarding the use of COMIRNATY Original & Omicron BA.4/BA.5 during breast- feeding. Each vial contains 6 doses of 0.3 mL. In study 2, a 16-year-old male was diagnosed with myopericarditis 3 days after his 2nd dose. It is unknown whether this vaccine has an impact on fertility. Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. Children 5 Years Through <12 Years of Age Primary Series (Two Doses). Total cumulative time the vials are stored at -25C to -15C (-13F to 5F) should be tracked and should not exceed 2 weeks. Using aseptic technique, withdraw 1.3mL of diluent into a transfer syringe (using 21gauge or narrower needle). 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). Do not inject the vaccine intravascularly, subcutaneously or intradermally. The safety profile of the participants with stable HIV infection receiving COMIRNATY (n = 100) was similar to that seen in the general population. A carton of 10 vials may take up to 6 hours to thaw at this temperature. If received at 2C to 8C, they should be stored at 2C to 8C. (HIV) infection. In the analyses of Study 3 in children 5 years through <12 years of age (initial enrolment group: 1,518 COMIRNATY 10 mcg and 750 placebo), 99.5% of participants had at least 30 days and 95.7% of participants had at least 3 months follow-up after Dose 2. Do not add more than 1.8 mL of diluent. 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%). 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. A carton of 10 vials may take up to 4 hours to thaw at this temperature. Severe systemic events were reported infrequently in both vaccine groups. Table 13and Table 14present the frequency and severity of solicited local and systemic reactions, respectively, within 7 days following each dose of COMIRNATY and placebo in adolescents 12 to 15 years of age included in the safety population who were monitored for reactogenicity with an electronic diary. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to product exposure. There were no reports of myocarditis/pericarditis or anaphylaxis by the study cut-off date. Additional analyses of AEs from post-dose to the data cut-off did not suggest any meaningful differences in the safety profile. Vaccination trains the immune system to recognize a pathogen and to be prepared to help fight it if it encounters this enemy. Do not freeze or shake the diluted vaccine. 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)]. The median duration was 3.5 days (ranged from 1 to 14 days) in the vaccine group. Do not store vials at 25C to 15C (-13F to 5F). Vaccines are one of the greatest health interventions ever developed. Study C4591001 (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. 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. Overall, frequencies of any AEs reported after study vaccination up to the data cut-off date were generally similar between both vaccine groups. 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%). An additional 562 million Moderna, Pfizer, and Johnson & Johnson vaccines are . The vaccine can be stored for five days at refrigerated 2-8C conditions. As SARS-CoV-2 spreads around the globe, it is mutating, in other words it is acquiring genetic changes. 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. How Do Viruses Mutate and What it Means for a Vaccine? 2 DOSAGE AND ADMINISTRATION For intramuscular injection only. Do not mix COMIRNATY Original & Omicron BA.4/BA.5 with other vaccines/products in the same syringe. It was December 15, 2020 when Melissa French got the message: Pfizer needed large quantities of something called a cationic lipid that was critical to the COVID-19 vaccine. 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. Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. For 12 Years and Older: DILUTE BEFORE USE (Vials with Purple Cap and Purple Label Border). After dilution, vials of COMIRNATY (for age 6 months to <5 years) contain 10 doses of 0.2 mL of vaccine. Moderna COVID-19 Vaccine: The expiration date is NOT printed on the vaccine vial or carton. After first puncture, the vial should be stored at 2C to 25C (35F to 77F). Search for terms Find Studies. Record the date and time of first vial puncture(dilution) on the COMIRNATY (for age 5 years to <12 years) vial label. 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. with Angela Hwang, Group President, Pfizer Biopharmaceuticals Group, with Mike McDermott, President, Pfizer Global Supply. Table 16: Study 3 Frequency of Solicited Systemic Reactions Within 7Days After Each Dose Children 2Through <5 Years of Age Safety Population*. Lymphadenopathy was reported in 13 (0.9%) participants in the COMIRNATY 10 mcg group vs. 1 (0.1%) in the placebo group. * Randomized participants who received at least 1 dose of the study intervention. If standard syringes and needles are used, there may not be sufficient volume to extract a 6th dose from a single vial. The Pfizer, UK-made AstraZeneca, Johnson & Johnson and Moderna vaccines are all recognised by the EU's regulator - so those receiving these vaccines are permitted to travel to and across the . If the vial has a gray plastic cap and gray label border, refer to the preparation instructions for 12 Years of Age and Older: DO NOT DILUTE (Vials with Gray Cap and Gray Label Border). Cartons of COMIRNATY multiple dose vials (for 12 years and older: DO NOT DILUTE) may also arrive at 2C to 8C. 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. Information about our efforts to drive equitable global access to the Pfizer-BioNTech COVID-19 vaccine, including scaling up of manufacturing. Equalize vial pressure before removing the needle from the vial by withdrawing 1.8 mL air into the empty diluent syringe. 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 . Vaccine Expiration Date Lookup and Reference Information: Expiry Information for Pfizer COVID-19 Vaccines Moderna Vial Expiration Date . d. Severe: disabling; not interested in usual daily activity. Each vial must be thawed prior to administration. Each vial must be thawed and diluted prior to administration. To prevent vaccine from inadvertently being discarded, providers . 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. Adolescents 12 to 15 Years of Age Primary Series (Two Doses). 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. Is Pfizer working with Operation Warp Speed? 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 Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. Transportation of Frozen VialsIf local redistribution is needed and full cartons containing vials cannot be transported at 90C to 60C (130F to 76F), vials may be transported at -25C to 15C (-13F to 5F). Check that the carton has been updated to reflect the 10-week refrigerated expiry date. 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. Regardless of storage condition, vaccine should not be used after 18 months from the date of manufacture printed on the vial and cartons. 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. Third Dose Vaccination With AstraZeneca or Pfizer COVID-19 Vaccine Among Adults Received Sinovac COVID-19 Vaccine. 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. 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. Irrespective of the type of syringe and needle: Administer a single 0.2 mL dose of COMIRNATY intramuscularly. Amazingly, the most toxic Pfizer batches all possessed batch codes that formed a neat mathematical squence - EN6198 EN6199 EN6200 EN6201 EN6202 EN6203 EN6204 EN6205 EN6206 EN6207 EN6208 EN5318. Thats because people tend to spend more time indoors, where germs can circulate from one person to another through the air or close contact. HIV-positive participants are included in safety population disposition but are summarized separately in safety analyses. 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. The participant was treated and recovered. After dilution the vials should be stored at 2C to 25C (35F to 77F). Do not store vials at 25C to 15C (-13F to 5F). 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. 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. Please be mindful of when your COVID-19 vaccine expires! for a specific lot number: Pfizer COVID-19 Vaccine: The expiration date is located on the vaccine vial and packaging. If local redistribution is needed, full cartons containing undiluted vials may be transported at 90C to 60C (130F to 76F); full cartons or individual undiluted vials may also be transported at 2C to 8C (35F to 46F). We take your privacy seriously. 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. Obtain sterile 0.9% Sodium Chloride Injection, USP. After dilution, the vial should be held between 2C to 25C (35F to 77F). 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. Table 16: Study 3 Frequency of Solicited Systemic Reactions Within 7Days After Each Dose Children 5Years Through <12Years of Age Safety Population*. 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