(after dilution, each vial contains 10* doses of 0.2 mL). 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. After dilution, the vial should be held between 2C to 25C (35F to 77F). How will the Pfizer-BioNTech COVID-19 vaccine be distributed? The vaccine will be a white to off-white suspension. If vials are received at 2C to 8C, they should be stored at 2C to 8C. Published December 11, 2020. We have developed detailed logistical plans and tools to support effective vaccine transport, storage and continuous temperature monitoring. Pfizer COVID-19 Vaccine: 5 through 11 years formulation (orange cap) Formulation does NOT have expiration printed on vial Instead, each vial has the lot number and date of manufacture printed on the label 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%). 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. Vaccine recipients should be kept under observation for at least 15 minutes after immunization; 30 minutes is a preferred interval when there is a specific concern about a possible vaccine reaction. Study 3 (Phase 2/3) also enrolled 1,776 participants 6 months through <2 years of age (1,178 COMIRNATY 3 mcg; 598 placebo). Participants 12 Years of Age After a Dose of COMIRNATY Original/Omicron BA.4/BA.5 as a Second Booster (4th Dose). Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the vaccine. After dilution, vials of COMIRNATY Original & Omicron BA.4/BA.5 (for age 5 years to <12 years) contain 10 doses of 0.2 mL of vaccine. 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). No interaction studies have been performed. Thawed Under Refrigeration: Thaw and then store undiluted vials in the refrigerator (2C to 8C [35F to 46F]) for up to 1 month. Do not dilute. The date printed on the vial and carton reflects the date of manufacture. Currently available information is insufficient to determine a causal relationship with the 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. 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. 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. Frozen Vials Prior to UseCartons of COMIRNATY multiple dose vials (for 12 years and older: DILUTE BEFORE USE)arrive in thermal containers with dry ice. Of the total number of COMIRNATY recipients in the study, 20.7% were 65 years of age and older. As SARS-CoV-2 spreads around the globe, it is mutating, in other words it is acquiring genetic changes. The most frequent adverse reactions in participants 5 years through <12 years of age following the booster dose (data cut-off date of March 22, 2022; median follow-up time of 1.3 months) were injection site pain (73.9%), fatigue (45.6%), headache (34.0%), myalgia (18.3%), chills (10.5%), injection site redness (15.6%), and swelling (16.4%). These cookies may also be used for advertising purposes by these third parties. Each vial must be thawed prior to administration. Visually inspect each dose in the dosing syringe prior to administration. Do not use if liquid is discoloured or if particles are observed after mixing. 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. There are no data available on the interchangeability of COMIRNATY with other COVID-19 vaccines to complete the primary vaccination series or for a booster dose. Equalize vial pressure before removing the needle from the vial by withdrawing 2.2 mL air into the empty diluent syringe. Additional analyses of AEs from post-dose to the data cut-off did not suggest any meaningful differences in the safety profile. The recent announcement that the United States Trade Representative will discuss options to waive some COVID-19 vaccine intellectual property (IP) rights has created some confusion to the world. Do not inject the vaccine intravascularly, subcutaneously or intradermally. Check that the carton has been updated to reflect the 10-week refrigerated expiry date. Once thawed and stored under 2-8C conditions, the vials cannot be re-frozen or stored under frozen conditions. Note: Reactions were collected in the e-diary and unscheduled clinical assessments from Day 1 through Day 7 after vaccination. The information in this Product Monograph supersedes the number of hours printed on vial labels and cartons. Vials should be discarded 12hours after first puncture. Cartons of COMIRNATY multiple dose vials (for 12 years and older: DO NOT DILUTE) may arrive frozen at ultra cold conditions in thermal containers with dry ice. In individuals 1 year of age and older, the recommended injection site is the anterolateral aspect of the thigh or the deltoid muscle. Procedures should be in place to avoid injury from fainting. DILUTE PRIOR TO USE (Vial with Maroon Cap and Maroon Label Border). After dilution the vials should be stored at 2C to 25C (35F to 77F). Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. 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 . Record the date and time of first vial puncture (dilution) on the COMIRNATY (for age 6 months to <5 years) vial label. COMIRNATY Original & Omicron BA.4/BA.5 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. The 10 week refrigerated expiry date should be recorded on the carton at the time of transfer. Fatigue was the most frequently reported systemic AR reported within 7 days after study vaccination, followed by headache, and less frequently chills, muscle and joint pain. 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). 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. 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. These cookies perform functions like remembering presentation options or choices and, in some cases, delivery of web content that based on self-identified area of interests. Each dose contains 30 mcg modRNA in total and also includes the non-medicinal ingredients listed in Table 1. "Her father and paternal grandmother both died . 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. We have specially designed, temperature-controlled shippers utilizing dry ice to maintain recommended temperature conditions up to 10 days unopened. Allowing vial(s) to sit at room temperature [up to 25C (77F)] for 30minutes. Vials should be discarded 12 hours after dilution. From study vaccination to the data cut-off date (16 May 2022), the proportions of participants with any AEs were generally similar. Vials should be discarded 12 hours after dilution (i.e., the first puncture). Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. No serious adverse events were reported that were considered related to vaccination. Discard any unused vaccine 12 hours after first puncture. A booster dose of COMIRNATY Original & Omicron BA.4/BA.5 may be administered intramuscularly at least 3 to 6 months after completing the primary course of COMIRNATY and/or a previous booster dose of COMIRNATY in individuals 12 years of age or older. Information about our efforts to drive equitable global access to the Pfizer-BioNTech COVID-19 vaccine, including scaling up of manufacturing. A number of studies have proved that COVID-19 vaccines are effective at preventing people from getting severe COVID-19 disease. However, some of the effects mentioned under 8 ADVERSE REACTIONS may temporarily affect the ability to drive or use machines. Dr Gina Reghetti Do Pc Inc is a Medical Group that has only one practice medical office located in Warren OH. ONLY use 0.9% Sodium Chloride Injection, USP as the diluent. 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. Table 15 and Table 16 present the frequency of solicited local and systemic reactions, respectively, within 7 days following each dose of COMIRNATY and placebo in children 2 through <5 years of age who were monitored for reactogenicity with an electronic diary. The extension is also applicable to batches that might have expired prior to this amendment. Children 5 Years Through <12 Years of Age Primary Series (Two Doses). Cartons of COMIRNATY (for age 5 years to <12 years) and COMIRNATY (for age 6 months to <5 years) may also arrive at 2C to 8C (35F to 46F). COMIRNATY does not contain preservative. No Grade 4 local reactions were reported. 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 World Health Organization recently declared a pandemic in the wake of a global outbreak of the novel coronavirus disease (COVID-19). Appendicitis was reported as a serious adverse event for 27 participants, 15 vaccine participants and 12 placebo participants. Adverse Events (AEs) from Study Vaccination to Data Cut-off Date. After dilution, the vaccine will be an off-white suspension. The initial 2 doses are administered 3 weeks apart followed by a third dose administered at least 8 weeks after the second dose. The safety and efficacy of COMIRNATY in children under 6 months of age have not yet been established. Table 15: Study 3 Frequency of Solicited Local Reactions Within 7 Days After Each Dose Children 5 Years Through <12Years of Age Safety Population*. The efficacy and safety of the vaccine has not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. Cookies used to make website functionality more relevant to you. Thawed vials may be stored at room temperature [up to 25C (77F)] for up to 12 hours prior to dilution. 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). Children 6 Months Through <2 Years of Age Primary Series (Three Doses). One year. 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 . Additionally, 306 existing Phase 3 participants 18 through 55 years of age received a booster dose of COMIRNATY approximately 6 months (range of 4.8 to 8.0 months) after completing the second dose in the nonplacebocontrolled booster dose portion of Study 2. It is unknown whether COMIRNATY has an impact on fertility. Katherine Ellen Foley. Very rare cases of myocarditis and/or pericarditis following vaccination with COMIRNATY have been reported during post-authorization use. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. Of these, 2,171 (95.7%) (1,456 COMIRNATY 10 mcg and 715 placebo) participants have been followed for at least 3 months after Dose 2. Pfizer-BioNTech COVID-19 Vaccine is a monovalent COVID-19 vaccine that is authorized for emergency use to prevent COVID-19 as a: Three-dose primary series for individuals 6 months through 4. These are reference CPT codes for vaccine categorization and are not intended to represent billable codes. Equalize vial pressure before removing the needle from the vial by withdrawing 1.8 mL air into the empty diluent syringe. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, thrombotic events, myocarditis or anaphylactic reaction to the vaccine) reported during the blinded placebo-controlled follow-up period of the study. 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. The median onset for all local reactions was 1 to 2.5 days, and all events resolved within a median duration of 1 to 3 days after onset. Bells palsy (facial paralysis and facial paresis) was reported by four participants in the vaccine group and two in the placebo group. StudyC4591001 (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. Safety data from studies in individuals 12 years of age using bivalent formulations of COMIRNATY at 30 mcg are considered supportive. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. Access to this report is strictly managed by registration only. VAERS data is accessible by downloading raw data in comma-separated value (CSV) files for import into a database, spreadsheet, or text editing program, or by using the CDC WONDER online search tool. 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