Search Search . Very rare cases of myocarditis and/or pericarditis following vaccination with COMIRNATY have been reported during post-authorization use. Participants 5 Years Through12 Years of Age. Each dose must contain 0.2mL of vaccine. The participant was treated and recovered. After your first vaccine, you should have been given a card titled 'My Personal COVID-19 Vaccine Record Card' with your name, date of birth, the vaccine name and the date you received the vaccine . Prior to mixing, the thawed vaccine may contain white to off-white opaque amorphous particles. 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 18-month shelf-life. COMIRNATY Original & Omicron BA.4/BA.5 is indicated only for booster doses. The products discussed herein may have different labeling in different countries. Vaccine Manufacturer Lot Number Expiration Date Name of Vaccine Administrator COVID-19 _____ml 1st _____ml 2nd IM - L Arm IM - It is unknown whether COMIRNATY is excreted in human milk. Administer immediately and no later than 12 hours after first puncture. Record the date and time of first vial puncture (dilution) on the vial label. For 12 Years and Older: DO NOT DILUTE (Vials with Gray Cap and Gray Label Border). 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: CDC's COVID-19 Vaccine Expiration Date Tracking Tool can help providers keep track of the expiration date by lot number. or . Contents of the pack and other information. 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. Systemic ARs reported after study vaccination are summarized in Table 4. 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. By. Unleashing the next wave of scientific innovations. Acarton of10vials may take up to6hours to thaw at this temperature. Do not mix COMIRNATY Original & Omicron BA.4/BA.5 with other vaccines/products in the same syringe. Serious adverse events from Dose 1 through 1 month after Dose 3, with an overall median of 1.3 months follow up after Dose 3, were reported by 1.4% of COMIRNATY recipients and by 2.3% of placebo recipients. There were no reports of myocarditis/pericarditis or anaphylaxis by the study cut-off date. 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 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%). Files will be updated on a daily basis Monday through Friday as new lots are released by each manufacturer or as updates are made to the lot expiration dates. This informationincluding product informationis intended only for residents of the United States. As the weather cools, viruses have a tendency to spread with more ease. Hospitals were filling, and no one was sure how best to treat the people who were sick. Study 2 also included 200 participants with confirmed stable human immunodeficiency virus (HIV) infection. If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents. 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. Pain at injection site was the most frequently reported local AR within 7 days after study vaccination, with swelling and redness at the injection site reported much less frequently. How will hospitals and pharmacies keep vaccines cold? 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. Participants 12 Years of Age After a Dose of COMIRNATY Original/Omicron BA.4/BA.5 as a Second Booster (4th Dose). Thank you for taking the time to confirm your preferences. Inspect vials to confirm there are no particulates and no discolouration is observed. Dear Colleagues, For a complete listing see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. Vials may be stored at room temperature [up to 25C (77F)] for up to 12 hours prior to use. Individuals may not be optimally protected until at least 7 days after their second dose of vaccine (see 14CLINICAL TRIALS). Many of the AEs were consistent with reactogenicity events (e.g., fever and fatigue). Children 5 Years Through 12 Years of Age After Booster Dose. Cartons of COMIRNATY Original & Omicron BA.4/BA.5 (for age 5 years to <12 years) may also arrive at 2C to 8C (35F to 46F). HIV-positive participants are included in safety population disposition but are summarized separately in safety analyses. After first puncture, the vial should be stored at 2C to 25C (35F to 77F). Pfizer and Moderna are two-dose vaccines,. 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. In order to prevent, treat, and identify diseases that disproportionately impact underserved and minority populations, Pfizer believes that research must be directed to the root causes of healthcare disparities. with Angela Hwang, Group President, Pfizer Biopharmaceuticals Group, with Mike McDermott, President, Pfizer Global Supply. If refrigerated, allow the diluted vaccine to come to room temperature prior to use. On March 11, 2020 the World Health Organization declared COVID-19 a pandemic1. Lymphadenopathy was reported in 87 (0.4%) participants in the vaccine group compared to 8 (<0.1%) participants in the placebo group, which is plausibly related to vaccination. 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. 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. In clinical studies with a data cut-off of March 13, 2021, and where 2 doses were administered 3 weeks apart, the most common adverse reactions in the reactogenicity subset (n=4,924) of participants 16 years of age and older after any dose included injection site pain (84.3%), fatigue (64.7%), headache (57.1%), muscle pain (40.2%), chills (34.7%), joint pain (25.0%), fever (15.2%), injection site swelling (11.1%), and injection site redness (9.9%). 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 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. f. Severity was not collected for use of antipyretic or pain medication. On Monday, August 23, 2021, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. It is supplied as a frozen suspension that does not contain preservative. 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. Individuals who have received one dose of COMIRNATY should receive a second dose of COMIRNATY to complete the primary vaccination series and for any additional doses. 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. On April 7, 2022, FDA authorized an extension (PDF, 136 KB) for the shelf life of the refrigerated Janssen COVID-19 Vaccine, allowing the product to be stored at 2-8 degrees . Table 15: Study 3 Frequency of Solicited Local Reactions Within 7 Days After Each Dose Children 5 Years Through <12Years of Age Safety Population*. Please choose the category that best describes you. If received at 2C to 8C, they should be stored at 2C to 8C. Verify that the vial has a gray plastic cap and gray label border. Adolescents 12 to 15 Years of Age Primary Series (Two Doses). Table 17: Study 3 Frequency and Percentages of Participants With Solicited Local Reactions, By Maximum Severity, Within 7 Days After the Booster Dose of COMIRNATY Children 5 Years through 12 Years of Age Safety Population*. This site is intended . 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. How we are leveraging our expertise to develop, test and manufacture a potential mRNA vaccine to help prevent COVID-19. COMIRNATY Original & Omicron BA.4/BA.5 is a suspension for intramuscular injection which must be diluted prior to administration. A few vaccines are packaged with two component vaccines. Equalize vial pressure before removing the needle from the vial by withdrawing 2.2 mL air into the empty diluent syringe. In the analyses of Study 3 in participants 6 months through 2 years of age (386 COMIRNATY; 184 placebo), 83.7% of participants had at least 30 days of follow-up after Dose 3. Add 2.2 mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial. 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). 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. Additional AEs reported in the safety population (n=21,926) of participants 16 years of age and older from dose 1 to 1 month after dose 2 included nausea (1.2%), malaise (0.6%), lymphadenopathy (0.4%), asthenia (0.3%), decreased appetite (0.2%), hyperhidrosis (0.1%), lethargy (0.1%), and night sweats (0.1%). The COMIRNATY Original & Omicron BA.4/BA.5 multiple dose vial with a gray cap and a gray label border contains a volume of 2.25 mL, and is supplied as a frozen suspension that does not contain preservative. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to product exposure. 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%). 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. Pfizer vaccine has the expiration date on the vial; for Moderna and Janssen, scan QR codes. DILUTE PRIOR TO USE (Vials with Orange Cap and Orange Label Border). A booster dose of COMIRNATY Original & Omicron BA.4/BA.5 may be administered intramuscularly at least 6 months after completing the primary course of COMIRNATY in children 5 years through <12 years of age. Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. 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. 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%). "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 store vials at 25C to 15C (-13F to 5F). 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. Each vial must be thawed and diluted prior to administration. One dose (0.2 mL) contains 10 micrograms of COVID-19 mRNA vaccine Vials with a maroon cap and maroon label border contain 10 doses of 0.2 mL after dilution. COMIRNATY Original & Omicron BA.4/BA.5 is a suspension for intramuscular injection. Adolescents 12 to 15 Years of Age Primary Series (Two Doses). During the visual inspection: After dilution, vials of COMIRNATY (for age 5 years to <12 years) contain 10 doses of 0.2 mL of vaccine. Each 0.2 mL dose of COMIRNATY contains 10 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. 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: The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. b. The vial stoppers are not made with natural rubber latex. Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw. Using aseptic technique, withdraw 1.3mL of diluent into a transfer syringe (using 21gauge or narrower needle). The median age of these 401 participants was 8.0 years (range 5 years through 12 years of age), 52.4% were male and 47.6% were female, 70.1% were White, 7.2% were Black or African American, 22.9% were Hispanic/Latino, 7.7% were Asian, and 2.0% were American Indian/Alaska Native. dose. Each dose must contain 0.2 mL of vaccine. Two formulations of COMIRNATY are available for individuals 12 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. COMIRNATY is supplied as a frozen suspension in multiple dose vials. Additional analyses of AEs from post-dose to the data cut-off did not suggest any meaningful differences in the safety profile. Confirm there are no particulates and that no discolouration is observed. 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. COMIRNATY (COVID-19 Vaccine, mRNA) is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) in individuals 6 months of age and older. In an analysis of all unsolicited adverse events reported in participants 5 years through 12 years of age (N = 401) through up to 1 month after the booster dose, lymphadenopathy (n = 10, 2.5%) was an adverse reaction not already captured by solicited local and systemic reactions. Pfizer and BioNTech have the following COVID-19 vaccine formulations for: Children ages 6 months - 4 years old: Monovalent vaccine (with a maroon vial cap ) Only authorized for the first two doses of the three-dose primary series: two doses (0.2 mL), at least three to eight weeks apart. We have developed packaging and storage innovations to be fit for purpose to meet the needs of our global network. COMIRNATY does not contain preservative. Contact your regional poison control centre. Allowing vial(s) to thaw in the refrigerator [2C to 8C (35F to 46F)]. Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. 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