How Do Viruses Mutate and What it Means for a Vaccine? To ensure proper storage and handling, please see cvdvaccine.com. COMIRNATY is supplied as a frozen suspension in multiple dose vials with a maroon cap and a maroon label border. Refer to thawing and dose preparation instructions in the panels below. 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. An additional 562 million Moderna, Pfizer, and Johnson & Johnson vaccines are . Download the Seasonal Influenza Crosswalk table. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2mL, discard the vial and any excess volume. In participants who received a booster dose the mean duration of pain at the injection site after the booster dose was 2.6 days (range 1 to 8 days), for redness 2.2 days (range 1 to 15 days), and for swelling 2.2 days (range 1 to 8 days). The information in this Product Monograph supersedes the number of hours printed on vial labels and cartons. Clinical trials are conducted under very specific conditions. A carton of 10 vials may take up to 4 hours to thaw at this temperature. Using a combination of surveys and qualitative . The safety profile of the participants with stable HIV infection receiving COMIRNATY (n = 100) was similar to that seen in the general population. Not all pack sizes may be available. 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. Please be mindful of when your COVID-19 vaccine expires! In individuals 1 year of age and older, the recommended injection site is the anterolateral aspect of the thigh or the deltoid muscle. COMIRNATY has no or negligible influence on the ability to drive and use machines. We have crossed another milestone in the fight against COVID-19. The safety evaluation of participants in Study 2 and Study 4 is ongoing. As SARS-CoV-2 spreads around the globe, it is mutating, in other words it is acquiring genetic changes. 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. Of these, approximately 44,047 participants (22,026 COMIRNATY; 22,021 placebo) in Phase 2/3 are 16 years of age or older (including 378 and 376 adolescents 16 and 17 years of age in the vaccine and placebo groups, respectively) and 2,260 adolescents are 12 to 15 years of age (1,131 and 1,129 in the vaccine and placebo groups, respectively). Each vial must be thawed and diluted prior to administration. 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). Frozen vials transported at -25C to -15C (13F to 5F) may be returned one time to the recommended storage condition of -90C to -60C (-130F to -76F). COMIRNATY (for age 6 months to <5 years): A carton of 10 vials may take up to 2 hours to thaw at this temperature. 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%). 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). Diagnostic testing is a critical tool in helping to understand and control the spread of the virus. Note: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination. Confirm there are no particulates and that no discolouration is observed. Appendicitis was reported as a serious adverse event for 27 participants, 15 vaccine participants and 12 placebo participants. Bells palsy (facial paralysis and facial paresis) was reported by four participants in the vaccine group and two in the placebo group. Vials should be discarded 12 hours after dilution (i.e., the first puncture). 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. Add 2.2 mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial. Currently available information is insufficient to determine a causal relationship with the vaccine. Irrespective of the type of syringe and needle: COMIRNATY Original & Omicron BA.4/BA.5 is supplied as a frozen suspension in multiple dose vials with gray caps and labels with gray borders. How can you prevent a cold chain failure? The date printed on the vial and carton reflects the date of manufacture. Dispatches from the Backyard Chicken Movement. You can review and change the way we collect information below. ONLY use 0.9% Sodium Chloride Injection, USP as the diluent. In analyses of all unsolicited adverse events in Study 2 from Dose 1 up to the participant unblinding date, 69.0% of study participants 12 through 15 years of age had at least 4 months of follow-up after Dose 2. Sorry, you need to enable JavaScript to visit this website. In a video that has been shared massively on social media, Joseph Fraiman, who was a lead author of the peer-reviewed research that re-analyzed Pfizer & Moderna trials for mRNA COVID-19 vaccine . The COMIRNATY Original & Omicron BA.4/BA.5 multiple dose vial (for ages 5 years to <12 years) has an orange cap and an orange label border and contains a volume of 1.3 mL. Pfizer is working very closely with the U.S. government on several fronts as we strategize and plan for our future COVID-19 vaccine distribution effort, keeping in mind that our vaccine candidate needs to clear a number of efficacy, safety and manufacturing hurdles before we submit for any FDA consideration. 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. Adverse reactions following administration of any dose included irritability (68.4%), decreased appetite (38.6%), tenderness at the injection site (26.4%), injection site redness (17.8%), fever (14.4%), injection site swelling (7.3%), and lymphadenopathy (0.2%). Together, they worked to better understand the novel virus. Dilute the vial contents using 2.2 mL of sterile 0.9% Sodium Chloride Injection, USP to form COMIRNATY. The safety and effectiveness of a booster dose of Comirnaty Original & Omicron BA.4/BA.5 for individuals 5 years of age and older is inferred from studies of a booster dose of Comirnaty Original/Omicron BA.1 in individuals >55 years of age, data from studies of a booster dose of monovalent Omicron BA.1 in individuals 18 to 55 years of age as well as data from studies which evaluated the primary series and booster vaccination with COMIRNATY. As the weather cools, viruses have a tendency to spread with more ease. Before use, mix by inverting vaccine vial gently 10 times. Once vials are thawed they should not be refrozen. Local ARs are summarized in Table 3. 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. COMIRNATY Original & Omicron BA.4/BA.5 is a suspension for intramuscular injection. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. 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 various storage options at the POU allow for equitable access to the Pfizer vaccine to areas with differing infrastructure. The FDA approved a request from Pfizer, Inc. to extend the shelf-life of the Pfizer COVID-19 vaccine for an additional three months - from six months to nine months when the vaccine is stored at a temperature of -90 to -60 degrees Celsius. 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. 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. Verify the final dosing volume of 0.3 mL. Most of the events began from 3-11 days after the second dose and were characterized as mild and self-limited. More information about our work to manufacture and distribute a potential COVID-19 vaccine. 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. The most frequently reported unsolicited adverse event was lymphadenopathy (2.5%). 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 . The 10 week refrigerated expiry date should be recorded on the carton at the time of transfer. Study 2 also included 200 participants with confirmed stable human immunodeficiency virus (HIV) infection. Regardless of storage condition, vaccines should not be used after 12 months from the date of manufacture printed on the vial and cartons. Strict adherence to aseptic techniques must be followed. Two additional severe AEs, also reported as SAEs (pneumonia, ischaemic stroke) were reported in the COMIRNATY 30 mcg group. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. COMIRNATY is supplied as a frozen suspension in multiple dose vials. 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. Vials should be discarded 12 hours after first puncture. COMIRNATY is supplied as a frozen suspension in multiple dose vials. Severe systemic events were reported infrequently in both vaccine groups. 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. No interaction studies have been performed. No deaths related to the vaccine were reported in 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 (dilution) on the vial label. Allowing vial(s) to thaw in the refrigerator [2C to 8C (35F to 46F)]. A few vaccines are packaged with two component vaccines. The vaccine will be an off white suspension. Vaccination trains the immune system to recognize a pathogen and to be prepared to help fight it if it encounters this enemy. 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. 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 . first. 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. Reports are accepted from anyone and can be submitted electronically at www.vaers.hhs.gov. 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%). 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. View public records and voter registration of Gina Warren born 1964, includes court and personal records. From the Maryland online immunization portal, Immunet, it looks like this (note that some vaccine information has not been reported to Immunet): 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. 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. Do not mix COMIRNATY with other vaccines/products in the same syringe. Visually inspect each dose in the dosing syringe prior to administration. 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. The analysis of the Study 3 Phase 2/3 subset is based on data up to the cut-off date of March 22, 2022 (median follow-up time of 1.3 months). After first puncture, the vial should be stored at 2C to 25C (35F to 77F). 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. Study C4591044 is an ongoing study to evaluate the safety, tolerability, and immunogenicity of new bivalent vaccines including COMIRNATY Original & Omicron BA.4/BA.5. This technology is designed primarily to help immunization providers record information about the VIS as is required by the National Childhood Vaccine Injury Act (NCVIA). However, we will also be using our existing distribution centers for the COVID-19 distribution in Pleasant Prairie, WI and in Karlsruhe, Germany. 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. There were no reports of myocarditis/pericarditis or anaphylaxis by the study cut-off date. 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. COMIRNATY Original & Omicron BA.4/BA.5 does not contain preservative. Currently available information is insufficient to determine a causal relationship with the vaccine. COMIRNATY is contraindicated in individuals who are hypersensitive to the active substance or to any ingredient in the formulation. 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. 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. Refrigeration units that are commonly available in hospitals. These GPS-enabled devices will allow Pfizer to proactively prevent unwanted deviations and act before they happen. Instructions on the handling and dose preparation of the vaccine prior to administration are provided below. A 17-year-old male in Study 2 was diagnosed with myocarditis three days after receiving the booster dose (Dose 3). Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. 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. Participants 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]. Those participants vaccinated prior to February 22, 2022 provided the safety database (n=401), and had a median safety follow-up of 1.3 months from vaccination through the data cut-off date of March 22, 2022. 4.2.2Vaccination Schedule for Individuals Aged 5 Years to <12 Years. Pfizer-BioNTech COVID-19 Vaccine multiple dose vials with orange caps and labels with orange borders may be stored at room temperature [8C to 25C (46F to 77F)] for a total of 12 hours prior to 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). 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). There is no information on the co-administration of COMIRNATY with other vaccines. COVID-19 vaccine, receive an additional dose of hat same mRNA . Of the total number of COMIRNATY recipients in the study, 20.7 % were 65 years of age and older. What Makes an RNA Vaccine Different From a Conventional Vaccine? The median duration was 3.5 days (ranged from 1 to 14 days) in the vaccine group. Adverse reactions were usually mild or moderate in intensity and resolved within a few days after vaccination. Vials should be discarded 12 hours after dilution. Refer to the re-icing guidelines packed in the original thermal container for instructions regarding the use of the thermal container for temporary storage. Currently available information is insufficient to determine a causal relationship with the vaccine. Document the current date, the vaccine lot number, and the updated expiration date. One year. 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. In study 2, a 16-year-old male was diagnosed with myopericarditis 3 days after his 2nd dose. The vial stoppers are not made with natural rubber latex. . The vial stoppers are not made with natural rubber latex. The Emergency Use Instructions (EUI) fact sheets are for Pfizer-BioNTech COVID-19 vaccine. Add 1.8 mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial. It is unknown whether this vaccine has an impact on fertility. When you are uploading your vaccine information (primary vaccine or booster), you will see a new field for lot number. 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. 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. COMIRNATY multiple dose vials (with gray cap and gray label border) are supplied in a carton containing 10 multiple dose vials or 195 multiple dose vials. Equalize vial pressure before removing the needle from the vial by withdrawing 1.3mL air into the empty diluent syringe. 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. A free web-based tool to manage vaccine administration and registration Information Immunization Systems (IIS) IIS consolidate immunization information into one reliable source VTrckS CDC's vaccine order management system and platform for all COVID-19 vaccine ordering IZ Gateway A cloud-based message routing service intended to enable data exchange All cases were considered to be mild, with a median onset of 3 days after Dose 1, and 2 days after Dose 2 in the vaccine group. f. Severity was not collected for use of antipyretic or pain medication. expiration date tracking tool (PDF) to record updated expiration dates for COVID-19 vaccine. 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. They are included because: a) they represent reactions that are known to occur following immunizations generally; b) they are potentially serious; or c) on the basis of their frequency of reporting. The COMIRNATY multiple dose vial (for ages 5 years to <12 years) has an orange cap and an orange label border and contains a volume of 1.3 mL. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. f. Severe: 6 or more loose stools in 24 hours. 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. Shortly after, the novel virus was identified as SARS-CoV-2. Pfizer consistently and diligently monitors the supply of our medicines. If standard syringes and needles are used, there may not be sufficient volume to extract a 6th dose from a single vial. 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. The thawed suspension may contain white to off-white opaque amorphous particles. The liquid is a white to off-white suspension and may contain white to off-white opaque amorphous particles. In an analysis of all unsolicited adverse events reported following the booster dose of COMIRNATY, through 1 month after the booster dose, in participants 16 through 87 years of age (N = 5,055), adverse reactions included headache (5%), fever (4.8%), lymphadenopathy (2.8%), decreased appetite (0.2%), malaise (0.7%), nausea (0.9%), and pain in extremity (1.1%).
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