No serious adverse events were reported that were considered related to vaccination. 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. Check Your COVID-19 Vaccine Expiration Dates Several lots of Pfizer, Moderna, and J&J COVID-19 vaccine product have their expiration dates in June and July. In the analysis of blinded, placebo-controlled follow-up, there were no notable patterns between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to COMIRNATY. c. Mild: 0.5 to 2.0 cm; moderate: >2.0 to 7.0 cm; severe: >7.0 cm. Inspect vials to confirm there are no particulates and no discolouration is observed. expiration date tracking tool (PDF) to record updated expiration dates for COVID-19 vaccine. If an ultra-low temperature freezer is not available, the thermal container in which COMIRNATY arrives may be used as temporary storage when consistently re-filled to the top of the container with dry ice. 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). Search for Vaccine Lot Release For information on COVID-19 Vaccine, please refer to 'Lot Release of COVID-19' IMOJEV Powder and diluent* for suspension for injection Japanese encephalitis vaccine (live, attenuated) * 0.4 % Sterile Sodium chloride solution 08A2003EA . 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. 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 . For 12 Years and Older: DO NOT DILUTE (Vials with Gray Cap and Gray Label Border). Record the date and time of first vial puncture (dilution) on theCOMIRNATY vial label. 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). Discard any unused vaccine 12 hours after dilution. This diluent is not packaged with the vaccine and must be sourced separately. second. The novel coronavirus has recently been linked to two serious fungal infections: COVID-19 associated pulmonary aspergillosis (CAPA) and COVID-19 associated mucormycosis (CAM).1 The resurgence of these rare fungal infections has medical personnel concerned. COMIRNATY is supplied as a frozen suspension in multiple dose vials with an orange capand an orange label border. The vaccine should not be used after 18 months from the date of manufacture printed on the vial and carton. 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. 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. 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. This diluent is not packaged with the vaccine and must be sourced separately. We take your privacy seriously. Preparation for AdministrationDO NOT DILUTE, For 12 Years of Age and Older: DO NOT DILUTE (Vials with Gray Cap and Gray Label Border), 4.3.2 For Age 5 Years to <12 Years: DILUTE PRIOR TO USE (Vials with Orange Cap and Orange Label Border), For Age 5 Years to <12 Years: DILUTE PRIOR TO USE (Vials with Orange Cap and Orange Label Border), 4.3.3For Age 6 Months to <5 Years: DILUTE PRIOR TO USE (Vials with Maroon Cap and Maroon Label Border), For Age 6 Months to <5 Years: DILUTE PRIOR TO USE (Vials with Maroon Cap and Maroon Label Border). Appendicitis was reported as a serious adverse event for 27 participants, 15 vaccine participants and 12 placebo participants. Do not add more than 2.2 mL of diluent. 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%). Do not use if vaccine is discoloured or contains particulate matter. 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. COMIRNATY Original & Omicron BA.4/BA.5 is contraindicated in individuals who are hypersensitive to the active substance or to any ingredient in the formulation. 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. Participants 16 Years of Age and Older Primary Series (Two Doses). 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. 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. 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). Before dilution, allow the thawed vial to come to room temperature. 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. HIV-positive participants are included in safety population disposition but are summarized separately in safety analyses. 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. 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. 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. After dilution, the vial contains 6 doses, of 0.3 mL with 30 . 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: Home Data Catalog Developers Video Guides By. Do not store vials at 25C to 15C (-13F to 5F). "Filter Update: if you insinuate Lisa Marie Presley went into cardiac arrest because of the COVID-19 vaccine, that's an #instablock," they commented. Do not add more than 1.8 mL of diluent. For example, if a provider was getting 975 doses, it will now be 1,170 doses. Submit Please enter a valid lot number Special characters (commas, /, *, &) are not allowed in the Lot numbers OR Scan bar / 2D code From Dose 1 through 30 days after Dose 3, lymphadenopathy was reported in 1 (0.1%) of COMIRNATY recipients vs. 0 (0.0%) of placebo recipients. Refer to thawing instructions in the panels below. Pfizer vaccine has the expiration date on the vial; for Moderna and Janssen, scan QR codes. Visually inspect each dose in the dosing syringe prior to administration. Table 3: Solicited Local Adverse Reactions Reported for Vaccine Groups Within 7 Days After Study Vaccination, COMIRNATY Original & Omicron BA.4/BA.5 (15 mcg/15 mcg), Solicited Systemic Adverse Reactions (ARs). 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). The Pfizer thermal shippers, in which doses will arrive, that can be used as temporary storage units by refilling with dry ice for up to 15 days of storage. The products discussed herein may have different labeling in different countries. Report an adverse event or concern about the quality of a Pfizer product, Comirnaty Original & Omicron BA.4/BA.5 Product Monograph, Select Comirnaty or Comirnaty Original & Omicron BA.4/BA.5 Medical Information Documents, Dilute with 2.2 mL sterile 0.9% Sodium Chloride Injection, USP prior to use, DILUTE PRIOR TO USE (Vials with Orange Cap and Orange Label Border), DILUTE PRIOR TO USE (Vials with Maroon Cap and Maroon Label Border). Children 5 Years Through <12 Years of Age Primary Series (Two Doses). Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw. 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. Search for terms Find Studies. Before use, mix by inverting vaccine vial gently 10 times. Table 15 and Table 16 present the frequency and severity of solicited local and systemic reactions, respectively, within 7 days following each dose of COMIRNATY and placebo in children 5 years through <12 years of age included in the initial enrolment safety population who were monitored for reactogenicity with an electronic diary. Participants 5 Years Through12 Years of Age. Verify the final dosing volume of 0.3 mL. 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. Vials must reach room temperature before dilution. Data.CDC.gov. Vials of COMIRNATY (for age 5 years to <12 years) and COMIRNATY (for age 6 months to <5 years) may be stored at temperatures up to 25C (77F) for a total of 12 hours prior to dilution. Is Pfizer working with Operation Warp Speed? 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. 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. In Study 2, among participants 16 through 55 years of age who had received at least 1 dose of vaccine or placebo (COMIRNATY = 12,995; placebo = 13,026), serious adverse events from Dose 1 up to the participant unblinding date in ongoing follow-up were reported by 103 (0.8%) COMIRNATY recipients and 117 (0.9%) placebo recipients. 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. The KFF COVID-19 Vaccine Monitor is an ongoing research project tracking the public's attitudes and experiences with COVID-19 vaccinations. This content is intended for Canadian Healthcare Professionals. Theyve been cited as being as important to keeping communities healthy as having access to clean water and safe sanitation.1 COMIRNATY does not contain preservative. or . This report includes COVID-19 vaccine lot numbers . Vial labels and cartons may state that a vial should be discarded 6hours after dilution. COMIRNATY is supplied as a frozen suspension in multiple dose vials. Table 17 and Table 18 present the frequency and severity of reported solicited local and systemic reactions, respectively, within 7 days of a booster dose of COMIRNATY for Phase 2/3 participants 5 years through 12 years of age. 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 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). Verify that the vial has a purple plastic cap and purple label border. Vials should be discarded 12 hours after dilution (i.e., the first puncture). No withdrawals due to AEs or deaths were reported. d. Mild: does not interfere with activity; moderate: interferes with activity; severe: prevents daily activity. 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. A booster dose of COMIRNATY (0.3 mL) may be administered intramuscularly at least 6 months after completion of the primary series in individuals 16 years of age or older. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. No data are available yet regarding the use of COMIRNATY Original & Omicron BA.4/BA.5 during pregnancy. DILUTE PRIOR TO USE (Vials with Orange Cap and Orange Label Border). 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 . Ultra-low-temperature freezers, which are commercially available and can extend shelf life for up to six months. 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) 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. Do not use if liquid is discoloured or if particles are observed after mixing. . We have developed packaging and storage innovations to be fit for purpose to meet the needs of our global network. The diluted vaccine will be a white to off white suspension. Cartons of COMIRNATY multiple dose vials (for age 5 years to <12 years) and COMIRNATY multiple dose vials (for age 6 months to <5 years) may arrive frozen at ultra-cold conditions in thermal containers with dry ice. After first puncture, the vial should be stored at 2C to 25C (35F to 77F). Table 13 and Table 14 present the frequency and severity of reported solicited local and systemic reactions, respectively, within 7 days of a booster dose of COMIRNATY for Phase 2/3 participants 5 years through 12 years of age. Storage of the vials between -96C to -60C (-141F to -76F) is not considered an excursion from the recommended storage condition. After dilution, the vial should be held between 2C to 25C (35F to 77F). Equalize vial pressure before removing the needle from the vial by withdrawing 1.3mL air into the empty diluent syringe. Obtain sterile 0.9% Sodium Chloride Injection, USP. Among the participants, the median age was 53.0 years (range 16 through 87 years of age), including 1,175 booster dose recipients (23.1%) who were 65 years of age, 49.1% were male and 50.9% were female, 79.0% were White, 14.9% were Hispanic/Latino, 9.2% were Black or African American, 5.5% were Asian, and 1.7% were American Indian/Alaska Native. However, we will also be using our existing distribution centers for the COVID-19 distribution in Pleasant Prairie, WI and in Karlsruhe, Germany. As the potential threat of COVID-19 became clear by early 2020, teams across Pfizer sprang into action. Add 1.3mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial. Very rare cases of myocarditis and/or pericarditis following vaccination with COMIRNATY have been reported during post-authorization use. After dilution, the vaccine will be an off-white suspension. 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. 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%). 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. To ensure proper storage and handling, please see cvdvaccine.com. 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. Third Dose Vaccination With AstraZeneca or Pfizer COVID-19 Vaccine Among Adults Received Sinovac COVID-19 Vaccine. 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