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. Very rare cases of myocarditis and/or pericarditis following vaccination with COMIRNATY have been reported during post-authorization use. Verify the final dosing volume of 0.2 mL. Note: Events and use of antipyretic or pain medication were collected in an electronic diary (e-diary) from Day 1 to Day 7 after each dose. Check that the carton has been updated to reflect the 10-week refrigerated expiry date. No study participants died. Vials may also be stored at -25C to -15C (13F to 5F) for up to 2 weeks. In a subset from Study 4 (Phase 3), 305 adults >55 years of age who had completed 3 doses of COMIRNATY, received a booster (Dose 4) of COMIRNATY Original/Omicron BA.1, 4.7 to 11.5 months after receiving Dose 3. Here's how to find the expiration date of the different COVID-19 Vaccine Brands. 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). 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. The participant was treated and recovered. In Study C4591031 (Study 4), a placebo-controlled booster study, 5,081 participants 16 years of age and older were recruited from Study 2 to receive a booster dose of COMIRNATY at least 6 months after the second dose. It is supplied as a frozen suspension that does not contain preservative. Each dose must contain 0.2mL of vaccine. ONLY use 0.9% Sodium Chloride Injection, USP as the diluent. Document the current date, the vaccine lot number, and the updated expiration date. 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. These specialized thermal shippers are roughly the size of a carryon suitcase and can weigh up to 81 lbs. Each vial contains 6 doses of 0.3 mL. Vaccine Manufacturer Lot Number Expiration Date Name of Vaccine Administrator COVID-19 _____ml 1st _____ml 2nd IM - L Arm IM - Gently invert the vial containing COMIRNATY Original & Omicron BA.4/BA.5 10 times to mix. 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. (after dilution, each vial contains 10* doses of 0.2 mL). Verify the final dosing volume of 0.3 mL. c. Mild: does not interfere with activity; moderate: some interference with activity; severe: prevents daily activity. Each vial must be diluted with 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine, and contains 6 doses of 0.3 mL after dilution. In the four vaccinated participants, events began from 3 to 48 days after their last dose, were mild to moderate in severity, and duration ranged from 3 to 68 days. Table 13: Study 2 Frequency of Solicited Local Reactions Within 7 Days After Each Dose of COMIRNATY Adolescents 12 to 15 Years of Age Safety Population*, Table 14: Study 2 Frequency of Solicited Systemic Reactions Within 7 Days After Each Dose of COMIRNATY Adolescents 12 to 15 Years of Age Safety Population*. Hospitals were filling, and no one was sure how best to treat the people who were sick. b. n = Number of participants with the specified reaction. In a clinical study of approximately 10,000 participants 16 years of age and older, unsolicited adverse reactions following administration of a booster dose included headache (5%), fever (4.8%), lymphadenopathy (2.8%), pain in extremity (1.1%), nausea (0.9%), malaise (0.7%), and decreased appetite (0.2%). Most of the events began from 3-11 days after the second dose and were characterized as mild and self-limited. The World Health Organization recently declared a pandemic in the wake of a global outbreak of the novel coronavirus disease (COVID-19). Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the vaccine. When prepared according to their respective instructions, COMIRNATY for 12 years of age and older (DILUTE BEFORE USE: purple cap and purple label border) and COMIRNATY for 12 years of age and older (DO NOT DILUTE: gray cap and gray label border) can be used interchangeably to provide the COVID-19 vaccination series.COMIRNATY and the Interim Order authorized Pfizer-BioNTech COVID-19 Vaccine, for use in individuals 12 years of age and older, have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series.Vials of COMIRNATY intended for individuals 12 years of age and older (purple cap/purple label border or gray cap/gray label border) cannot be used to prepare doses for individuals aged 6 monthsto <12 years. Do not add more than 1.8 mL of diluent. Procedures should be in place to avoid injury from fainting. COVID-19 vaccine codes and crosswalks are provided in anticipation of potential vaccine availability under an approved Biologics License Application (BLA), Emergency Use Authorization (EUA), or as a potential vaccine submission for EUA (Pre-EUA). 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. Using either thawing method, vials must reach room temperature before dilution and must be diluted within 2 hours of exposure to room temperature. Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. b. n = Number of participants with the specified characteristic. Total cumulative time the vials are stored at -25C to -15C (-13F to 5F) should be tracked and should not exceed 2 weeks. If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents. The efficacy and safety of the vaccine has not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. We operate one of the most sophisticated supply chain systems in the industry, with over 40 Pfizer-owned sites and over 200 suppliers globally, which provides capacity and redundancy as needed. Add 2.2 mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial. As SARS-CoV-2 spreads around the globe, it is mutating, in other words it is acquiring genetic changes. The median duration was 3.5 days (ranged from 1 to 14 days) in the vaccine group. a. N = number of participants reporting at least 1 yes or no response for the specified event after the specified dose. The information in this Product Monograph supersedes the number of hours printed on vial labels and cartons. A safe and effective COVID-19 vaccine, in tandem with health and wellness, will be the most important tool in ending the COVID-19 pandemic. 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. 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. To ensure proper storage and handling, please see cvdvaccine.com. 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. Overall, among participants who received a booster dose in a subset from Study C4591001 (Study 2), the median age was 42 years (range 19 through 55 years of age), 45.8% were male and 54.2% were female, 81.4% were White, 27.8% were Hispanic/Latino, 9.2% were Black or African American, 5.2% were Asian, and 0.7% were American Indian/Alaska Native. 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. 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. Table 16: Study 3 Frequency of Solicited Systemic Reactions Within 7Days After Each Dose Children 5Years Through <12Years of Age Safety Population*. Thawed vials can be handled in room light conditions. Verify that the vial has a gray plastic cap and gray label border. Once vials are thawed they should not be refrozen. Children who will turn from 4 to 5 years of age between their doses in the vaccination series should receive their age-appropriate dose at the time of the vaccination and the interval between doses is determined by the childs age at the start of the vaccination series. 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. The safety and efficacy of COMIRNATY in pregnant women have not yet been established. Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. 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. Children 5 Years Through12 Years of Age Primary Series (Two Doses). Each vial must be thawed and diluted prior to administration. Multiple Dose Vial (for 12 years of age and older: DILUTE BEFORE USE), Dilute with 1.8 mL sterile 0.9% Sodium Chloride Injection, USP prior to use, Multiple Dose Vial (for 12 years of age and older: DO NOT DILUTE), COMIRNATY* Multiple Dose Vial (for age 5 years to <12 years: DILUTE PRIOR TO USE), Dilute with 1.3 mL sterile 0.9% Sodium Chloride Injection, USP prior to use, 4.2.1 Vaccination Schedule for Individuals 12 Years of Age and Older. 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. Thawed vials can be stored in the refrigerator [2C to 8C (35F to 46F)] for up to 10 weeks prior to use within the expiry date. No withdrawals due to AEs or deaths were reported. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the vaccine. Once thawed and stored under 2-8C conditions, the vials cannot be re-frozen or stored under frozen conditions. Of the total number of COMIRNATY recipients in the study, 20.7% were 65 years of age and older. Each vial must be thawed prior to administration. Contact your regional poison control centre. Record the date and time of first vial puncture on the vial label. Equalize vial pressure before removing the needle from the vial by withdrawing 1.8 mL air into the empty diluent syringe. Lymphadenopathy was reported in 13 (0.9%) participants in the COMIRNATY 10 mcg group vs. 1 (0.1%) in the placebo group. Available short-term follow-up data suggest that the symptoms resolve in most individuals, but information on long-term sequelae is lacking. The safety evaluation of participants in Study 2 and Study 4 is ongoing. Administer immediately, and no later than 12 hours after dilution. Centers for Disease Control and Prevention. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. Check that the carton has been updated to reflect the 10-week refrigerated expiry date. Purple Cap: Monovalent Pfizer-BioNTech COVID-19 Vaccines This product (for ages 12 years and older) is no longer being distributed. Bivalent vaccine (with a maroon vial cap and different label. In a clinical study of participants 18 through 55 years of age (N=306), 289 participants (94%) completed the e-diary recording adverse reactions. 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