After preparation, a single dose is 0.2 mL. 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. The vaccine should not be used after 12 months from the date of manufacture printed on the vial and carton. No study participants died. Vials stored at -25C to 15C (-13F to 5F) for up to 2 weeks may be returned one time to the recommended storage condition of -90C to -60C (-130F to -76F). Is Pfizer working with Operation Warp Speed? 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. 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 . Katherine Ellen Foley. However, the vaccines do not only reduce the chance . Theyve been cited as being as important to keeping communities healthy as having access to clean water and safe sanitation.1 Appendicitis was reported as a serious adverse event for 27 participants, 15 vaccine participants and 12 placebo participants. 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. If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2mL, discard the vial and any excess volume. 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). A 17-year-old male in Study 2 was diagnosed with myocarditis three days after receiving the booster dose (Dose 3). No serious adverse events were reported that were considered related to vaccination. The COMIRNATY 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. After preparation, a single dose is 0.3 mL. The safety profile in 545 participants receiving COMIRNATY that were seropositive for SARS-CoV-2 at baseline was similar to that seen in the general population. Verify the final dosing volume of 0.3 mL. Participants who received a booster (Dose 4) of COMIRNATY Original/Omicron BA.1 had a median follow-up time of at least 1.7 months up to a data cut-off date of 16 May 2022. Reconcile COVID-19 Vaccine Inventory II Enter your On-hand Inventory for each COVID-19 lot at your site by . Frozen vials transported at -25C to -15C (13F to 5F) may be returned one time to the recommended storage condition of -90C to -60C (-130F to -76F). Study 2 also included 200 participants with confirmed stable human immunodeficiency virus (HIV) infection. Children 6 Months Through <2 Years of Age Primary Series (Three Doses). Study C4591044 is an ongoing study to evaluate the safety, tolerability, and immunogenicity of new bivalent vaccines including COMIRNATY Original & Omicron BA.4/BA.5. When the current expiration date gets close, contact the manufacturer before discarding vaccine. Once vials are thawed they should not be refrozen. Visually inspect each dose in the dosing syringe prior to administration. Currently available information is insufficient to determine a causal relationship with the vaccine. 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. COMIRNATY is administered intramuscularly as a primary series of two doses (0.3 mL each) 3 weeks apart in individuals 12 years of age and older. COVID-19 Vaccine Lot Number and Expiration Date Tool. 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%). Contents of the pack and other information. Vials may be stored at room temperature [up to 25C (77F)] for up to 12 hours prior to dilution. 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. The safety of a COMIRNATY Original/Omicron BA.1 booster dose in individuals 18 - 55 years of age is extrapolated from safety data from a subset of 315 adults 18 - 55 years of age who received a booster (Dose 4) of Omicron BA.1 30 mcg (monovalent) after completing 3 doses of COMIRNATY. How will Pfizer maintain vaccine integrity during distribution? The median duration was 3.5 days (ranged from 1 to 14 days) in the vaccine group. Thank you for taking the time to confirm your preferences. fully loaded. Thawed vials may be stored at room temperature [up to 25C (77F)] for up to 12 hours prior to use. Equalize vial pressure before removing the needle from the vial by withdrawing 1.8 mL air into the empty diluent syringe. BUD Case Scenarios: Pfizer-BioNTech COVID-19 Vaccine Expiration Extension With the Pfizer-BioNTech COVID-19 Vaccine expiration date extension, there have been a number of questions about how this might impact beyond-use date. Any hours used for transport at -25C to -15C (-13F to 5F) count against the 2week limit for storage at -25C to -15C (-13F to 5F). Using aseptic technique, withdraw 1.3mL of diluent into a transfer syringe (using 21gauge or narrower needle). d. Severe: requires intravenous hydration. 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. Thawed Under Refrigeration: Thaw and then store undiluted vials in the refrigerator (2C to 8C [35F to 46F]) for up to 1 month. 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. Adverse Events (AEs) from Study Vaccination to Data Cut-off Date. a direct ship distribution strategy that minimizes the transportation time from our facility to the point of use, synchronization of our vaccine shipments with the delivery of an ancillary kit that contains supplies required to administer the vaccine, and. After storage for 15 days in the Pfizer thermal shipper, vaccination centers can transfer the vials to 2-8C storage conditions for an additional five days, for a total of 20 days. 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*. 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 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. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. Individuals should be advised to bring symptoms (e.g., dizziness, increases in heart rate, feeling short of breath, tingling sensations or sweating) to the attention of the vaccination provider for evaluation. 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. In order to ensure consistent withdrawal of 6 doses of 0.3 mL, it is important to adhere to minimizing volume loss during dose extraction. The vial stoppers are not made with natural rubber latex. ONLY use 0.9% Sodium Chloride Injection, USP as the diluent. Adverse reactions were usually mild or moderate in intensity and resolved within a few days after vaccination. Each vial must be thawed and diluted prior to administration. 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. Study 3 also enrolled 1,776 participants 6 months through <2 years of age (1,178 COMIRNATY 3 mcg; 598 placebo), and 2,750 participants 2 through <5 years of age (1,835 COMIRNATY 3 mcg; 915 placebo) in Phase 2/3. DILUTE PRIOR TO USE (Vial with Orange Cap and Orange Label Border). After dilution, the vial should be held between 2C to 25C (35F to 77F). The decision to administer COMIRNATY to an individual with a history of myocarditis or pericarditis should take into account the individuals clinical circumstances. 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. Cardiology consultation for management and follow up should be considered. 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. Of these, approximately 44,047 participants (22,026 COMIRNATY; 22,021 placebo) in Phase 2/3 are 16 years of age or older (including 378 and 376 adolescents 16 and 17 years of age in the vaccine and placebo groups, respectively) and 2,260 adolescents are 12 to 15 years of age (1,131 and 1,129 in the vaccine and placebo groups, respectively). 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. 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. 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 vial stoppers are not made with natural rubber latex. Administer a single 0.3 mL dose of COMIRNATY intramuscularly, preferably in the deltoid muscle. Drug and vaccine authorizations for COVID-19: List of authorized drugs, vaccines and expanded indications Overview List of applications received List of authorized products Date published: 2022-12-09 Drugs and vaccines that have been authorized by Health Canada for use in relation to the COVID-19 pandemic are listed here. Administer immediately and no later than 12 hours after first puncture. Lymphadenopathy was reported in 13 (0.9%) participants in the COMIRNATY 10mcg group vs. 1 (0.1%) in the placebo group. Information provided to VAERS which identifies a person who received the vaccine or vaccines will not be made available to the public. (*) Please note that the CPT codes shown for each vaccine crosswalk are not mapped to the NDC codes, but are mapped to the CVX codes shown. Each vial contains 6 doses of 0.3 mL. It is supplied as a frozen suspension that does not contain preservative. 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. Clinical studies of COMIRNATY 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). Please confirm pricing with your Pfizer Distributor. A risk to the newborns/infants cannot be excluded. Overall, participants who received a booster dose, had a median follow-up time of 2.5 months after the booster dose to the cut-off date (5 October 2021). Pfizer-BioNTech COVID-19 Vaccine (also known as BNT162b2) This product information is intended only for residents of the United States. 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%). How is Pfizer utilizing a cold chain process to distribute its vaccine? 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). 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