pfizer covid vaccine package insert

There were no other notable patterns or numerical imbalances between treatment groups for specific categories of non-serious adverse events that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine. Although some cases required intensive care support, available data from short-term follow-up suggest that most individuals have had resolution of symptoms with conservative management. Any vaccine remaining in vials must be discarded after 6 hours. COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech. It must be kept in the original package in order to protect from light. After preparation, each dose of the Pfizer-BioNTech COVID-19 Vaccine supplied in vials with purple caps is 0.3 mL for individuals 12 years of age and older [see Dosage and Administration (2.1)]. For more information about IISs visit: https://www.cdc.gov/vaccines/programs/iis/about.html. The storage, preparation, and administration information in this Prescribing Information apply to the Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older, which is supplied in a multiple dose vial with a purple cap and MUST BE DILUTED before use. In a similar analysis, in participants 56 years of age and older (Pfizer-BioNTech COVID-19 Vaccine = 7,960, placebo = 7,934), serious adverse events were reported by 0.8% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 0.6% of placebo recipients who received at least 1 dose of Pfizer-BioNTech COVID-19 Vaccine or placebo, respectively. COMIRNATY (BNT162b2 [mRNA]) COVID-19 VACCINE. Note: the front and back panels of this insert were intentionally left blank. Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. Covid-19 Vaccine Pfizer, Bivalent package insert / prescribing information for healthcare professionals. Vaccinations may not provide full immunity to COVID-19 in people who are immunocompromised, and you should continue to maintain physical precautions to help prevent COVID-19. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Some vials also may have a purple label border on the label. 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 Pfizer-BioNTech COVID-19 Vaccine. At that time, FDA published a BLA package insert that included the approved new COVID-19 vaccine trade name Comirnaty and listed two new NDCs and images of labels with the new trade name. 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). WHAT IS THE COUNTERMEASURES INJURY COMPENSATION PROGRAM? Each dose is 0.2 mL. Verify that the vial of Pfizer-BioNTech COVID-19 Vaccine has a purple plastic cap. Any hours used for transport at -25C to -15C (-13F to 5F) count against the 2-week limit for storage at -25C to -15C (-13F to 5F). Getting rid of any unwanted vaccine A doctor, nurse or pharmacist will dispose of any unused vaccine. A carton of 25 vials or 195 vials may take up to 2 or 3 hours, respectively, to thaw in the refrigerator, whereas a fewer number of vials will thaw in less time. Available data support transportation of one or more thawed vials at 2C to 8C (35F to 46F) for up to 48 hours. Heavy menstrual bleeding in product information Pfizer and Moderna vaccines [Internet]. The safety population includes participants 16 years of age and older enrolled by October 9, 2020, and includes safety data accrued through November 14, 2020. Manufactured forBioNTech Manufacturing GmbH An der Goldgrube 1255131 Mainz, Germany. Polysorbate allergy is a precaution to Pfizer-BIONTech COVID-19 vaccine (due to The Pfizer-BioNTech COVID-19 Vaccine is a suspension for intramuscular injection. COMIRNATY (COVID-19 Vaccine, mRNA) and SPIKEVAX (COVID-19 Vaccine, mRNA) are FDA-approved vaccines to prevent COVID-19 caused by SARS-CoV-2. MANDATORY REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINE ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION4. Provide the v-safe information sheet to vaccine recipients/caregivers and encourage vaccine recipients to participate in v-safe. The population in the primary efficacy analysis included all participants 12 years of age and older who had been enrolled from July 27, 2020, and followed for the development of COVID-19 through November 14, 2020. All of these criteria must be met to allow for the product to be used during the COVID-19 pandemic. After dilution, store vials between 2C to 25C (35F to 77F) and use within 6 hours from the time of dilution. Participants are being monitored for unsolicited adverse events, including serious adverse events, throughout the study [from Dose 1 through 1 month (all unsolicited adverse events) or 6 months (serious adverse events) after the last vaccination]. Pfizer-BioNTech COVID-19 Vaccine is not authorized for use in individuals younger than 6 months of age. Background Clinical trials for both the Moderna and Pfizer -BioNTech The vaccination provider must include vaccination information in the state/local jurisdiction's Immunization Information System (IIS) or other designated system. Syncope (fainting) may occur in association with administration of injectable vaccines, in particular in adolescents. COMIRNATY [package insert]. For information on clinical trials that are testing the use of the Pfizer-BioNTech COVID-19 Vaccine for active immunization to prevent COVID-19, please see www.clinicaltrials.gov. Procedures should be in place to avoid injury from fainting. Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients. Should you decide not to receive any of these vaccines, it will not change your standard medical care. V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. The administration of a third dose of vaccine appears to be only moderately effective in increasing potentially protective antibody titers. FDA approves Priorix (GSK) (Measles, Mumps and Rubella Vaccine, Live) vaccine for the prevention of measles, mumps and rubella in individuals 12 months of age and older. Association and the American Nurses Association also released a statement applauding the FDA's full approval of the Pfizer COVID-19 vaccine. Tables 1 through 6 present the frequency and severity of solicited local and systemic reactions, respectively, within 7 days following each dose of Pfizer-BioNTech COVID 19 Vaccine and placebo. A separate fact sheet is provided for J&J COVID-19 vaccine recipients and their caregivers. Of these, approximately 43,448 participants [21,720 Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2; 21,728 placebo] in Phase 2/3 are 16 years of age or older (including 138 and 145 adolescents 16 and 17 years of age in the vaccine and placebo groups, respectively) and 2,260 adolescents are 12 through 15 years of age (1,131 and 1,129 in the vaccine and placebo groups, respectively). The Pfizer-BioNTech COVID-19 Vaccine is administered intramuscularly as a primary series of 2 doses (0.3 mL each) 3 weeks apart in individuals 12 years of age and older. 1. The VAERS toll-free number is 1-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html. In order to mitigate the risks of using this unapproved product under EUA and to optimize the potential benefit of Pfizer-BioNTech COVID-19 Vaccine, the following items are required. No. For immediate use, thaw undiluted vials at room temperature [up to 25C (77F)] for 30 minutes. The Pfizer-BioNTech COVID-19 Vaccine is administered as a primary series of 2 doses (0.3 mL each) 3 weeks apart in individuals 12 years of age or older. Observe patient for 30 minutes following vaccination iii. Provide a vaccination card to the recipient or their caregiver with the date when the recipient needs to return for the second dose of Pfizer-BioNTech COVID-19 Vaccine. Purple plastic cap and purple label border. Randomization was stratified by age: 12 through 15 years of age, 16 through 55 years of age, or 56 years of age and older, with a minimum of 40% of participants in the 56-year stratum. Note: Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom consistent with COVID-19 (symptoms included: fever; new or increased cough; new or increased shortness of breath; chills; new or increased muscle pain; new loss of taste or smell; sore throat; diarrhea; vomiting). Demographic characteristics in Study 2 were generally similar with regard to age, gender, race, and ethnicity among adolescents who received Pfizer-BioNTech COVID-19 Vaccine and those who received placebo. Gently invert the vaccine vial 10 times iv. If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital. Physician Prescribing Information There is no information on the co-administration of the Pfizer-BioNTech COVID-19 Vaccine with other vaccines. N Engl J Med), a single arm study has been conducted in 101 individuals who had undergone various solid organ transplant procedures (heart, kidney, liver, lung, pancreas) 978 months previously. The safety evaluation in Study 2 is ongoing. V-safe is a new voluntary smartphone-based tool that uses text messaging and web surveys to check in with people who have been vaccinated to identify potential side effects after COVID-19 vaccination. This is what's important. a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. PACLITAXEL (paclitaxel) This product information is intended only for residents of the United States. Overall, among the total participants who received either the Pfizer-BioNTech COVID-19 Vaccine or placebo, 50.6% were male and 49.4% were female, 83.1% were White, 9.1% were Black or African American, 28.0% were Hispanic/Latino, 4.3% were Asian, and 0.5% were American Indian/Alaska Native. If local redistribution is needed and full cartons containing vials cannot be transported at -90C to -60C (-130F to -76F), vials may be transported at -25C to -15C (-13F to 5F). It includes vaccine ingredients, a list of side effects and information about who should and should not receive the shot. Once thawed remove the cap of the Pfizer vaccine and inject 1.3ml of 0.9% sodium chloride that comes in the ancillary kit of the vaccine iii. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, and available alternatives. A product authorized for emergency use has not undergone the same type of review by FDA as an FDA-approved product. 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). Of these, 1,308 (660 Pfizer-BioNTech COVID-19 Vaccine and 648 placebo) adolescents have been followed for at least 2 months after the second dose. Scan to capture that this Fact Sheet was provided to vaccine recipient for the electronic medical records/immunization information systems. Cardiac Disorders: myocarditis, pericarditis, Gastrointestinal Disorders: diarrhea, vomiting, Immune System Disorders: severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (e.g., rash, pruritus, urticaria, angioedema), Musculoskeletal and Connective Tissue Disorders: pain in extremity (arm), Nervous System Disorders: syncope, dizziness. For more information, visit: www.cdc.gov/vsafe. In Study 2, an analysis of SARS-CoV-2 50% neutralizing titers (NT50) 1 month after Dose 2 in a randomly selected subset of participants demonstrated non-inferior immune responses (within 1.5-fold) comparing adolescents 12 through 15 years of age to participants 16 through 25 years of age who had no serological or virological evidence of past SARS-CoV-2 infection up to 1 month after Dose 2 (Table 10). (Primary series completed) CoV-2 infection, including recommendations after receiving If the recipient has received 3 or more doses of any monovalent COVID-19 vaccine, administer a booster dose of People with COVID-19 have had a wide range of symptoms reported, ranging from mild symptoms to severe illness leading to death. Table 7 presents the specific demographic characteristics in the studied population. The Countermeasures Injury Compensation Program. A descriptive efficacy analysis of Study 2 has been performed in approximately 2,200 adolescents 12 through 15 years of age evaluating confirmed COVID-19 cases accrued up to a data cutoff date of March 13, 2021.

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