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. 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). No. 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 experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital. You may also be given an option to enroll in v-safe. 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. See Overall Safety Summary (Section 6) for additional information. Gently invert the vaccine vial 10 times iv. ONLY use sterile 0.9% Sodium Chloride Injection, USP as the diluent. Only NDCs for the subsequently BLA approved tri sucrose formulation will be produced." Do not refreeze. Storage of the vials between -96C to -60C (-141F to -76F) is not considered an excursion from the recommended storage condition. What's in Pfizer's vaccine? A look at the ingredients See section 3 for vaccine volume and spacing based on age and vaccine formulation. This Vaccine Information Fact Sheet for Recipients and Caregivers comprises the Fact Sheet for the authorized Pfizer-BioNTech COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, and also includes information about the U.S. Food and Drug Administration (FDA)-licensed vaccine, COMIRNATY (COVID-19 Vaccine, mRNA) for use in individuals 12 years of age and older9. On This Page. There is a remote chance that these vaccines could cause a severe allergic reaction. PDF Missouri Department of Health and Senior Services P.O. Box 570 https://www.cdc.gov/coronavirus/2019-ncov/index.html. In addition, close contacts of immunocompromised persons should be vaccinated as appropriate for their health status. The Countermeasures Injury Compensation Program. Booster Dose: Pfizer-BioNTech COVID-19 Vaccine, Bivalent is administered as a single booster dose at least 2 months after: WHO SHOULD NOT GET COMIRNATY (COVID-19 VACCINE, mRNA), THE PFIZER-BIONTECH COVID-19 VACCINE, OR THE PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT? Visually inspect each dose in the dosing syringe prior to administration. RT @HopeRising19: Canada has just updated its package insert for Comirnaty #pfizer #CovidVaccines Updated in March 2023 it's interesting to see what they are STILL saying about the use of their covid injection in PREGNANT and BREAST FEEDING women It's certainly NOT what their Mininstry of Show more . Procedures should be in place to avoid injury from fainting. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose. No vaccine-related adverse effects on female fertility, fetal development, or postnatal development were reported in the study. 1 . WHERE WILL MY VACCINATION INFORMATION BE RECORDED? Background Clinical trials for both the Moderna and Pfizer -BioNTech Postmarketing data with Pfizer-BioNTech COVID-19 Vaccine demonstrate increased risks of myocarditis and pericarditis, particularly within the period 0 through 7 days following the second dose of the primary series. After dilution, store vials between 2C to 25C (35F to 77F) and use within 6 hours from the time of dilution. Note: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination. 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. V-safe also provides dose reminders if needed and live telephone follow-up by CDC if participants report a significant health impact following COVID-19 vaccination. COVID-19 Vaccines (Pfizer/BioNTech) Quick Finder Please see the, Table 1:Study 2 Frequency and Percentages of Participants with Solicited Local Reactions, by Maximum Severity, Within 7 Days After Each Dose Participants 18 Through 55 Years of Age, Table 2: Study 2 Frequency and Percentages of Participants with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose Participants 18 Through 55 Years of Age, Table 3: Study 2 Frequency and Percentages of Participants with Solicited Local Reactions, by Maximum Severity, Within 7 Days After Each Dose Participants 56 Years of Age and Older Reactogenicity Subset of the Safety Population, Table 4: Study 2 Frequency and Percentages of Participants with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose Participants 56 Years of Age and Older Reactogenicity Subset of the Safety Population, (Kamar N, Abravanel F, Marion O, et al. From an independent report (Kamar N, Abravanel F, Marion O, et al. Comirnaty Vaccine: Risk of Heavy Menstrual Bleeding Moderna COVID-19 Vaccine: Package Insert - Drugs.com CDC's vaccine excipient summary and the National Institutes of Health DailyMed database can also be used as a resource. When you get your first COVID-19 vaccine, you will get a vaccination card. The vaccine must be thawed prior to preparation and . All 40 patients who had been seropositive before the third dose were still seropositive 4 weeks later. This is the Product Information that was approved with the submission described in this AusPAR. A product authorized for emergency use has not undergone the same type of review by FDA as an FDA-approved product. The safety evaluation in Study 2 is ongoing. Pfizer-BioNTech COVID-19 Vaccine at least 4 weeks (28 days) after the second dose. Solicited Local and Systemic Adverse Reactions. Medical countermeasures are specific vaccines, medications, devices, or other items used to prevent, diagnose, or treat the public during a public health emergency or a security threat. The formulation supplied in a multiple dose vial with a gray cap and label with a gray border IS NOT DILUTED PRIOR TO USE. Special hazards arising from the substance or mixture Specific hazards arising from the chemical Fine particles (such as mists) may fuel fires/explosions. (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 ARE OTHER CHOICES AVAILABLE FOR PREVENTING COVID-19 BESIDES COMIRNATY (COVID-19 VACCINE, mRNA), THE PFIZER-BIONTECH COVID-19 VACCINE, OR THE PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT? PDF Package leaflet: Information for the user Pfizer-BioNTech/Comirnaty Getting rid of any unwanted vaccine A doctor, nurse or pharmacist will dispose of any unused vaccine. Your close contacts should be vaccinated as appropriate. Pfizer-BioNTech COVID-19 Vaccine, Multiple Dose Vial with Purple Cap, Refer to the re-icing guidelines packed in the original thermal container for instructions regarding the use of the thermal container for temporary storage, Do not use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent, Pfizer-BioNTech COVID-19 Vaccine Vial with Purple Cap . (package insert). 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. The vaccines also contain various salts, fats and other ingredients to help your body use the mRNA. PACLITAXEL (paclitaxel) This product information is intended only for residents of the United States. This vaccine is being made available for emergency use exclusively through the CDC COVID-19 Vaccination Program (the Vaccination Program). The Countermeasures Injury Compensation Program (CICP) is a federal program that may help pay for costs of medical care and other specific expenses of certain people who have been seriously injured by certain medicines or vaccines, including these vaccines. Novavax [package insert]. 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. COMIRNATY (COVID-19 Vaccine, mRNA) and SPIKEVAX (COVID-19 Vaccine, mRNA) are FDA-approved vaccines to prevent COVID-19 caused by SARS-CoV-2. Do not use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent. Currently available information is insufficient to determine a causal relationship with the vaccine. V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. Adverse Events following Immunization with COVID-19 Vaccines: A An EUA is a mechanism to facilitate the availability and use of medical products, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. Information is not yet available about potential long-term sequelae. 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. 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. Talk to your vaccination provider if you have questions. FDA Approval - 6/3/22. FDA Product Approval: View All - immunize.org The Pfizer-BioNTech COVID-19 Vaccine does not contain preservative. Pfizer-BioNTech COVID-19 Vaccine(N=18,242)n (%), Native Hawaiian or other Pacific Islander, Human Immunodeficiency Virus (HIV) infection (not included in the efficacy evaluation). SARS-CoV-2 neutralization assay - NT50 (titer). 2. and MMWR published EUA fact sheets revised with warning added, June 25 FDA approval of Pfizer BioNTech COVID -19 vaccine on August 23, 2021 You asked, we answered: Do the COVID-19 vaccines contain tromethamine Therefore, the EMA recommended the updating of package insert for the Comirnaty vaccine to include heavy menstrual bleeding as a side effect of unknown frequency. Pfizer-BioNTech Bivalent COVID-19 Vaccine with gray cap and gray label border is supplied as a frozen suspension for intramuscular injection in single dose vials (containing 0.48 mL per vial) and multiple dose vials (containing 2.25 mL per vial). The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Pfizer-BioNTech COVID-19 Vaccine, for active immunization to prevent COVID-19 in individuals 6 months of age and older. This is the only active ingredient in the vaccine. Package Inserts : Additional Immunization Resources : Photos: Adult Vaccination: Screening Checklists: Ask the Experts: Shop IAC: CDC Schedules . This Fact Sheet may have been updated. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent, when administered as a booster dose, is authorized for use as: a single booster dose in children 6 months through 4 years of age at least 2 months . The safety evaluation in Study 2 is ongoing. This product (for ages 12 years and older) is no longer being distributed. 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)]. Polysorbate allergy is a precaution to Pfizer-BIONTech COVID-19 vaccine (due to Vaccination providers may not charge any fee for the vaccine and may not charge the vaccine recipient any out-of-pocket charge for administration. Horsham, PA: Janssen Biotech, Inc.; 2023. HOW ARE COMIRNATY (COVID-19 VACCINE, mRNA), THE PFIZER-BIONTECH COVID-19 VACCINE, AND THE PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT RELATED? Vials must reach room temperature before dilution. For information regarding provider requirements and enrollment in the CDC COVID-19 Vaccination Program, see https://www.cdc.gov/vaccines/covid-19/provider-enrollment.html. It must be kept in the original package in order to protect from light. Pfizer-BioNTech COVID-19 Vaccine is a suspension for injection. Adverse Reactions Identified in Post Authorization Experience.