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. Thats because people tend to spend more time indoors, where germs can circulate from one person to another through the air or close contact. The vaccine can be stored for five days at refrigerated 2-8C conditions. Vials may be thawed in the refrigerator at 2C to 8C [35F to 46F] or at room temperature (up to 25C [77F]) (see. To report and adverse reaction, or concern about the quality of a Pfizer product, please call Pfizer 1 866 723-7111 or visit www.healthcanada.gc.ca/medeffect or call Canada Vigilance Program at 1-866-234-2345. 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. All information these cookies collect is aggregated and therefore anonymous. The participant was treated and recovered. 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. The vial stoppers are not made with natural rubber latex. 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. There are currently no data available from Pfizer and BioNTech clinical trials on the interchangeability of COMIRNATY with other COVID-19 vaccines to complete the primary vaccination series or for a booster dose. 09.24.22. It is supplied as a frozen suspension that does not contain preservative. a. N = Number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose. DO NOT administer COMIRNATY Original & Omicron BA.4/BA.5 with Gray Cap and Gray Label Border to children 5 years to <12 years. Currently available information is insufficient to determine a causal relationship with the vaccine. 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. 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. Administer a single 0.3 mL dose of COMIRNATY intramuscularly, preferably in the deltoid muscle. For a complete listing, see 6DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. Inspect the liquid in the vial prior to dilution. Any hours used for transport at 2C to 8C (35F to 46F) count against the 1-month limit for storage at 2C to 8C (35F to 46F). The efficacy and safety of the vaccine has not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. Serious adverse events from Dose1 through up to 30 days after Dose2 in ongoing followup 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. Bivalent vaccine (with a maroon vial cap and different label. The safety of a booster dose of COMIRNATY Original & Omicron BA.4/BA.5 at 10 mcg in children 5 to < 12 years of age is inferred primarily from the safety profile of COMIRNATY at 10 mcg administered as a booster dose in this age bracket. c. Mild: does not interfere with activity; moderate: some interference with activity; severe: prevents daily activity. Of the total number of COMIRNATY recipients in the study, 20.7% were 65 years of age and older. Among participants with confirmed stable HIV infection serious adverse events from Dose 1 up to the participant unblinding date in ongoing follow-up were reported by 2 (2%) COMIRNATY recipients and 2 (2%) placebo recipients.Pericarditis was reported for one participant in the vaccine group, and no case was reported in the placebo group. There are two formulations of COMIRNATY authorized for use in individuals 12 years of age and older. Participants, including those who received a booster in Study 4, 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]. Administer a single 0.3 mL dose of COMIRNATY Original & Omicron BA.4/BA.5 intramuscularly, preferably in the deltoid muscle. Clinical trials are conducted under very specific conditions. 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. d. Severe: disabling; not interested in usual daily activity. Vials must reach room temperature before dilution. 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. As of the data cut-off date, any related or any severe AEs were reported across the vaccine groups by 5.1% or 0.9% of participants, respectively. Once thawed and stored under 2-8C conditions, the vials cannot be re-frozen or stored under frozen conditions. If the vaccine is frozen, it must be discarded. Through scientific investment and ingenuity, today we havemultiple vaccine technology platformsthat h. When it comes to healthcare, the terms equitable and "access" often go hand-in-hand. Thawed at Room Temperature: For immediate use, thaw undiluted vials at room temperature (up to 25C (77F)] for 30 minutes. Enter a '0' if you have no vaccine doses to enter Your . Do not store vials at 25C to 15C (-13F to 5F). Vials of COMIRNATY intended for individuals 12 years of age or older with a purple cap/purple label border or gray cap/gray label border and vials of COMIRNATY intended for individuals aged 5 years to <12 years with an orange cap/orange label border cannot be used to prepare doses for individuals aged 6 months to <5 years. g. Severity was not collected for use of antipyretic or pain medication. 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. Of the participants who received a booster dose of COMIRNATY or placebo (COMIRNATY = 5,055; placebo = 5,020) to the cut-off date (October 5, 2021), serious adverse events were reported by 0.3% of COMIRNATY recipients and 0.5% by placebo recipients. The administration of COMIRNATY Original & Omicron BA.4/BA.5 should be postponed in individuals suffering from acute severe febrile illness. Pfizer: Vials stored in an utlracold storage unit can be used until the last day of the month printed on the tray and each vial. Any vaccine remaining in vials must be discarded after 6 hours. expiration date tracking tool (PDF) to record updated expiration dates for COVID-19 vaccine. At the time of the analysis of Study 2 (data accrued through March 13, 2021), a total of 25,651 (58.2%) participants (13,031 in vaccine group and 12,620 in placebo group) 16 years of age and older had been followed up for at least 4 months, with 3,082 (7.0%) participants (1,778 in vaccine group and 1,304 in placebo group) followed up for at least 6 months after the second dose during the blinded placebo-controlled follow-up period. Reconcile COVID-19 Vaccine Inventory II Enter your On-hand Inventory for each COVID-19 lot at your site by . If refrigerated, allow the diluted vaccine to come to room temperature prior to use. Clinical studies of COMIRNATY Original/Omicron BA.1 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). Download the Seasonal Influenza Crosswalk table. COMIRNATY Original & Omicron BA.4/BA.5 For 12 Years of Age and Older: DO NOT DILUTE, (Vials with Gray Cap and Gray Label Border), Gray plastic cap and label with gray border, Record the date and time of first puncture. Check that the carton has been updated to reflect the 10-week refrigerated expiry date. Instructions on the handling and dose preparation of the vaccine prior to administration are provided below. Verify that the vial has a gray plastic cap and gray label border. 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. Emergency uses of the vaccines have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID 19) in: individuals 6 months of age and older (Pfizer-BioNTech COVID-19 Vaccine) No serious adverse events were reported that were considered related to vaccination. In individuals from 6 to less than 12 months of age, the recommended injection site is the anterolateral aspect of the thigh. 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. 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). 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. 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. 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. 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. Vials may be thawed in the refrigerator (2C to 8C [35F to 46F]) or at room temperature (up to 25C [77F]) (see. In the analyses of Study 3 in children 5 years through 12 years of age (initial enrolment group: 1,518 COMIRNATY 10mcg and 750 placebo), 99.5% of participants had at least 30days and 95.7% of participants had at least 3 months follow-up after Dose 2. The vaccine elicits both neutralizing antibody and cellular immune responses to the spike (S) antigen, which may contribute to protection against COVID-19 disease. how to clean a manrose bathroom extractor fan, soorarai pottru real characters, king soopers copper mountain lift tickets, Daily activity to less than 12 pfizer covid 19 vaccine lot number lookup of age and older or pain medication approximately 1,500 participants received 10... Supplied as a frozen suspension that does not contain preservative & # x27 ; 0 & x27! 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