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. Each vial must be thawed and diluted prior to administration. Refer to thawing instructions in the panels below. Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. Pfizer is activating its extensive U.S. and European manufacturing network, including thousands of highly skilled U.S. workers in multiple states and localities, to prepare to produce the COVID-19 vaccine. January 31, 2023. Please be mindful of when your COVID-19 vaccine expires! Inspect vials to confirm there are no particulates and no discolouration is observed. The various storage options at the POU allow for equitable access to the Pfizer vaccine to areas with differing infrastructure. 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. 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. The safety evaluation in Study 3 is ongoing. Where is the Pfizer-BioNTech COVID-19 vaccine made? Please confirm pricing with your Pfizer Distributor. b. Adverse events detailed below for participants 16 years of age and older are for the placebo-controlled blinded follow-up period up to the participants unblinding dates. HIV-positive participants are included in safety population disposition but are summarized separately in safety analyses. 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. Vials may be stored at room temperature [up to 25C (77F)] for up to 12 hours prior to use. Strict adherence to aseptic techniques must be followed. Each vial must be diluted with 1.3 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. Please review the Comirnaty or the Comirnaty Original & Omicron BA.4/BA.5, Bivalent Product Monograph for more complete information. Many of the AEs were consistent with reactogenicity events (e.g., fever and fatigue). Submit a medical question for Pfizer prescription products. The safety and efficacy of COMIRNATY in children under 6 months of age have not yet been established. Do not store vials at 25C to 15C (-13F to 5F). Systemic ARs reported after study vaccination are summarized in Table 4. The most frequent adverse reactions in these participants 18 - 55 years of age were pain at the injection site (77.9%), fatigue (64.3%), headache (47.6%), myalgia (33.7%), chills (31.6%) and arthralgia (23.5%). Each Product Monograph is available below, at www.pfizer.ca/products, or www.cvdvaccine.ca. Do not use if vaccine is discoloured or contains particulate matter. Procedures should be in place to avoid injury from fainting. Do not dilute. Record the date and time of first vial puncture on the vial label. Vials of COMIRNATY Original & Omicron BA.4/BA.5 intended for individuals aged 5 years to <12 years (orange cap/orange label border) cannot be used to prepare doses for individuals 12 years of age and older. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. You may also contact the Canada Vigilance Program directly to report adverse events or product quality concerns at 1-866-234-2345 or www.healthcanada.gc.ca/medeffect. 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 . or . Note: Events and use of antipyretic or pain medication were collected in an electronic diary (e-diary) from Day 1 to Day 7 after each dose. Unleashing the next wave of scientific innovations. Cleanse the vaccine vial stopper with a single-use antiseptic swab. Individuals receiving anticoagulant therapy or those with a bleeding disorder that would contraindicate intramuscular injection should not be given the vaccine unless the potential benefit clearly outweighs the risk of administration. If standard syringes and needles are used, there may not be sufficient volume to extract a 6th dose from a single vial. 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). Local ARs are summarized in Table 3. No withdrawals due to AEs were reported in any of the groups beyond 1-month post-dose. COMIRNATY Original & Omicron BA.4/BA.5 has no or negligible influence on the ability to drive and use machines. The vaccine elicits both neutralizing antibody and cellular immune responses to the spike (S) antigen, which may contribute to protection against COVID-19 disease. 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. Fever >38.9 C to 40.0 C was reported by 4 participants in the COMIRNATY Original/BA.1 30 mcg group and 0 participants in the COMIRNATY 30 mcg group. 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. Ultra-low-temperature freezers, which are commercially available and can extend shelf life for up to six months. 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. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/ fetal development, parturition, or post-natal development (see 16 NON-CLINICAL TOXICOLOGY). g. Severity was not collected for use of antipyretic or pain medication. Each vial must be thawed prior to administration. Overall, frequencies of any AEs reported after study vaccination up to the data cut-off date were generally similar between both vaccine groups. 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. Each dose contains 30 mcg modRNA in total and also includes the non-medicinal ingredients listed in Table 1. Cumulative safety follow-up to at least 6 months after Dose 2 for approximately 12,000 participants who received COMIRNATY showed no other safety signals arising from longer-term follow-up of the study. Once vials are thawed they should not be refrozen. How will Pfizer maintain vaccine integrity during distribution? Inspect the liquid in the vial prior to dilution. This diluent is not packaged with the vaccine and must be sourced separately. From study vaccination to the data cut-off date (16 May 2022), the proportions of participants with any AEs were generally similar. There are no data available on the interchangeability of COMIRNATY with other COVID-19 vaccines to complete the vaccination series. Each vial contains 6 doses of 0.3 mL. An Open Letter from Albert Bourla to Pfizer Employees Pfizer and Moderna are two-dose vaccines,. 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. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. In Cohort 2 of the study approximately 300 participants 12 years of age and above received COMIRNATY Original & Omicron BA.4/BA.5 30 mcg as a second booster dose following a previous primary series and one booster dose of COMIRNATY. It is unknown whether COMIRNATY Original & Omicron BA.4/BA.5 is excreted in human milk. A subsetfrom Study C4591001 (Study 2) Phase 2/3 participants, of 306 adults 18 through 55 years of age who completed the original COMIRNATY 2-dose series, received a booster dose of COMIRNATY approximately 6 months (range of 4.8 to 8.0 months) after receiving Dose 2. 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. The safety and efficacy of COMIRNATY Original & Omicron BA.4./BA.5 in children under 5years of age have not yet been established. 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%). No serious adverse events were reported that were considered related to vaccination. Each vial must be thawed and diluted prior to administration. Table 1: Dosage Forms, Strengths, Composition and Packaging (For 12 Years of Age and Older), Tozinameran (mRNA) encodes for the viral spike (S) protein of SARS-CoV-2 Original strain and famtozinameran (mRNA) encodes for the viral spike (S) protein of SARS-CoV-2 Omicron BA.4/BA.5 strain. Allowing vial(s) to thaw in the refrigerator [2C to 8C (35F to 46F)]. 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]. Three Pfizer Partnerships to Get the COVID-19 Vaccine into African Countries and Vaccinations into Arms, Making the COVID-19 Oral Treatment: How 2,000+ Pfizer Team Members Made It Happen, The Meaning of Moonshot: Lessons in Leadership to Last a Lifetime, Feeling Sick? Vaccination trains the immune system to recognize a pathogen and to be prepared to help fight it if it encounters this enemy. 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. Refrigeration units that are commonly available in hospitals. The administration of COMIRNATY Original & Omicron BA.4/BA.5 should be postponed in individuals suffering from acute severe febrile illness. The overall safety profile for the booster dose was similar to that seen after 2 doses. Allowing vial(s) to sit at room temperature [up to 25C (77F)] for 30minutes. COMIRNATY is supplied as a frozen suspension in multiple dose vials with an orange capand an orange label border. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. CDC twenty four seven. 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. I went on to identify several additional ranges of toxicity, each one identified by similar sequences of batch codes. The thermal container maintains a temperature range of -90C to -60C (130F to -76F). 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. No withdrawals due to AEs or deaths were reported. Shortly after, the novel virus was identified as SARS-CoV-2. DILUTE PRIOR TO USE (Vial with Maroon Cap and Maroon Label Border). Cardiology consultation for management and follow up should be considered. 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. Careful attention should be paid to the vial cap colour and label border and the appropriate corresponding instructions must be followed. 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). Study 2 also included 200 participants with confirmed stable human immunodeficiency virus(HIV) infection. Vaccine Lot Release Certificates. Vials must reach room temperature before dilution. Add 2.2 mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial. The safety profile of the participants with stable HIV infection receiving COMIRNATY (n=100) was similar to that seen in the general population. If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume. The safety of a booster dose of COMIRNATY Original & Omicron BA.4/BA.5 for individuals 12 years of age and older is inferred from safety data from studies of a booster dose of COMIRNATY Original/Omicron BA.1 in individuals >55 years of age and also safety data from studies of a booster dose of monovalent Omicron BA.1 in individuals 18 to 55 years of age. Regardless of storage condition, vaccines should not be used after 12 months from the date of manufacture printed on the vial and cartons. We have developed packaging and storage innovations to be fit for purpose to meet the needs of our global network. Adverse reactions were usually mild or moderate in intensity and resolved within a few days after vaccination. The initial 2 doses are administered 3 weeks apart followed by a third dose administered at least 8 weeks after the second dose. If received at 2C to 8C, they should be stored at 2C to 8C. Very rare cases of myocarditis and/or pericarditis following vaccination with COMIRNATY have been reported during post-authorization use. 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 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). 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. Using aseptic technique, withdraw 1.3mL of diluent into a transfer syringe (using 21gauge or narrower needle). Published December 11, 2020. Serious adverse events from Dose 1 through 1 month after Dose 3, with an overall median of 1.4 months follow-up after Dose 3, were reported by 0.7% of COMIRNATY recipients and by 0.9% of placebo recipients. How Do Viruses Mutate and What it Means for a Vaccine? A total of 12,006 (54.5%) participants originally randomized to the vaccine group in Study 2 had been followed up for at least 6 months after the second dose including the blinded and open-label periods. Equalize vial pressure before removing the needle from the vial by withdrawing 1.8 mL air into the empty diluent syringe. Once vials are thawed they should not be refrozen. One dose (0.3 mL) contains 30 micrograms of COVID-19 mRNA vaccine Vials with an orange cap and orange label border contain 10 doses of 0.2 mL after dilution. COMIRNATY has no or negligible influence on the ability to drive and use machines. Store between 2C to 25C (35F to 77F). 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. Lymphadenopathy was reported in 13 (0.9%) participants in the COMIRNATY 10 mcg group vs. 1 (0.1%) in the placebo group. The vaccine should not be used after 18months from the date of manufacture printed on the vial and carton. Vials should be discarded 12 hours after dilution (i.e., the first puncture). The vial stoppers are not made with natural rubber latex. In the analysis of unblinded follow-up, there were no notable patterns of specific categories of non-serious adverse events that would suggest a causal relationship to COMIRNATY. fully loaded. We have specially designed, temperature-controlled shippers utilizing dry ice to maintain recommended temperature conditions up to 10 days unopened. When at room temperature, mix by inverting vaccine vial gently 10 times. The safety evaluation of participants in Study 2 and Study 4 is ongoing. Not all pack sizes may be available. On March 11, 2020 the World Health Organization declared COVID-19 a pandemic1. Vials may be thawed in the refrigerator at 2C to 8C [35F to 46F] or at room temperature (up to 25C [77F]) (see. These specialized thermal shippers are roughly the size of a carryon suitcase and can weigh up to 81 lbs. These cases occurred more commonly after the second dose and in adolescents and young adults. Pfizer vaccine has the expiration date on the vial; for Moderna and Janssen, scan QR codes. 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. The safety and efficacy of COMIRNATY in pregnant women have not yet been established. A subset from Study C4591001 (Study 2) Phase 2/3 participants, of 306 adults 18 through 55 years of age who completed the original COMIRNATY 2-dose series, received a booster dose of COMIRNATY approximately 6 months (range of 4.8 to 8.0 months) after receiving Dose 2. New Search . During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. Liquid in the general population purpose to meet the needs of our site date on the vial for... A single vial Monograph is available below, at www.pfizer.ca/products, or www.cvdvaccine.ca for use antipyretic. 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