pfizer covid vaccine package insert

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). V-safe is a 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. 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. The Advisory Committee on Immunization Practices (ACIP) met on April 19, 2023, to review FDA's April 18 amendments to the emergency use authorizations (EUAs) for use of bivalent mRNA COVID-19 vaccines.The amendments further simplify U.S. COVID-19 vaccine recommendations and provide additional flexibility for people at higher risk of COVID-19 complications. Any vaccine remaining in vials must be discarded after 6 hours. The safety evaluation in Study 2 is ongoing. COMIRNATY (COVID-19 Vaccine, mRNA) and SPIKEVAX (COVID-19 Vaccine, mRNA) are FDA-approved vaccines to prevent COVID-19 caused by SARS-CoV-2. 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. HOW ARE COMIRNATY (COVID-19 VACCINE, mRNA), THE PFIZER-BIONTECH COVID-19 VACCINE, AND THE PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT RELATED? In a clinical trial, approximately 300 individuals greater than 55 years of age received one dose of a bivalent vaccine that differs from the Pfizer-BioNTech COVID-19 Vaccine, Bivalent in that it contains a different Omicron component. No. a 2-dose primary series to individuals 12 years of age and older; and. Gently invert the vaccine vial 10 times iv. No more than 2 hours at room temperature (up to 25C/77F). This week, Frank D'Amelio, chief financial officer at . 1 . The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older when prepared according to their respective instructions for use can be used interchangeably.2, COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine intended for individuals 12 years of age and older should not be used for individuals 6 months through 11 years of age because of the potential for vaccine administration errors, including dosing errors.3, SUMMARY OF INSTRUCTIONS FOR COVID-19 VACCINATION PROVIDERS. 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. MANDATORY REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINE ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION4. The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients. COMIRNATY (COVID-19 Vaccine, mRNA), Pfizer-BioNTech COVID-19 Vaccine, and Pfizer-BioNTech COVID-19 Vaccine, Bivalent include the following ingredients: Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older contains 1 of the following sets of additional ingredients; ask the vaccination provider which version is being administered: Pfizer-BioNTech COVID-19 Vaccine, Bivalent for individuals 12 years of age and older contains the following additional ingredients: COMIRNATY (COVID-19 Vaccine, mRNA) contains 1 of the following sets of additional ingredients; ask the vaccination provider which version is being administered: In clinical trials, approximately 23,000 individuals 12 years of age and older have received at least 1 dose of Pfizer-BioNTech COVID-19 Vaccine. CDC does not have a specific recommendation for brands of containers or bins for storage of vaccine. 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). Visually inspect each dose in the dosing syringe prior to administration. Overall in a similar analysis in which 7960 participants 56 years of age and older received Pfizer-BioNTech COVID-19 Vaccine, non-serious adverse events within 30 days were reported in 23.8% of participants who received Pfizer-BioNTech COVID-19 Vaccine and 11.7% of participants in the placebo group, for participants who received at least 1 dose. Symptoms may appear 2 to 14 days after exposure to the virus. Participants are planned to be followed for up to 24 months, for assessments of safety and efficacy against COVID-19. PDF COMIRNATY COVID-19 VACCINE - Therapeutic Goods Administration There is a remote chance that these vaccines could cause a severe allergic reaction. COVID-19 - immunize.org The formulation supplied in a multiple dose vial with a gray cap and label with a gray border IS NOT DILUTED PRIOR TO USE. It includes vaccine ingredients, a list of side effects and information about who should and should not receive the shot. It is MANDATORY for vaccination providers to report to the Vaccine Adverse Event Reporting System (VAERS) all vaccine administration errors, all serious adverse events, cases of myocarditis, cases of pericarditis, cases of Multisystem Inflammatory Syndrome (MIS) in adults and children, and hospitalized or fatal cases of COVID-19 following vaccination with the Pfizer-BioNTech COVID-19 Vaccine.7 To the extent feasible, provide a copy of the VAERS form to Pfizer Inc. 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. Purple plastic cap and purple label border. The Countermeasures Injury Compensation Program. 5 Cartons and vials of Pfizer-BioNTech COVID-19 Vaccine with an expiry date of May 2021 through February 2022 printed on the label may remain in use for 3months beyond the printed date, as long as The modRNA in the Pfizer-BioNTech COVID-19 Vaccine is formulated in lipid particles, which enable delivery of the RNA into host cells to allow expression of the SARS-CoV-2 S antigen. Study 2 is a multicenter, multinational, Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in participants 12 years of age and older. Getting rid of any unwanted vaccine A doctor, nurse or pharmacist will dispose of any unused vaccine. However, vaccination providers may seek appropriate reimbursement from a program or plan that covers COVID-19 vaccine administration fees for the vaccine recipient (private insurance, Medicare, Medicaid, Health Resources & Services Administration [HRSA] COVID-19 Uninsured Program for non-insured recipients). It is also authorized for emergency use to provide a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. If not stored between -90C to -60C (-130F to -76F), vials may be stored at -25C to -15C (-13F to 5F) for up to 2 weeks. If you are pregnant or breastfeeding, discuss your options with your healthcare provider. The safety evaluation in Study 2 is ongoing. 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. 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. Pfizer-BioNTech COVID-19 Vaccine is authorized for use in individuals 6 months through 17 years of age. https://fda.gov/media/167211/download " No data are available regarding the use of Pfizer-BioNTech COVID-19 Vaccine, Bivalent during pregnancy." WHAT IS AN EMERGENCY USE AUTHORIZATION (EUA)? 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. The administration of a third dose of vaccine appears to be only moderately effective in increasing potentially protective antibody titers. Pfizer-BioNTech COVID-19 Vaccines (CDC) Moderna COVID-19 vaccine (mRNA) Moderna COVID-19 Vaccines (CDC) Novavax COVID-19 vaccine, Adjuvanted (protein subunit) Each 0.3 mL dose of the Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with purple caps also includes the following ingredients: lipids (0.43 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.2 mg cholesterol), 0.01 mg potassium chloride, 0.01 mg monobasic potassium phosphate, 0.36 mg sodium chloride, 0.07 mg dibasic sodium phosphate dihydrate, and 6 mg sucrose. Under the EUA, it is your choice to receive or not receive any of these vaccines. On This Page. Appendicitis was reported as a serious adverse event for 12 participants, and numerically higher in the vaccine group, 8 vaccine participants and 4 placebo participants. This product (for ages 12 years and older) is no longer being distributed. ___ Severe allergic reaction*** (e.g., anaphylaxis) to a previous dose of any vaccine (not including Pfizer-BioNTech COVID-19 Vaccine) Action a. Assess the risk of vaccination b. 2022 . During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. MANDATORY REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINE ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION, REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS, CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA. 2022 Nov10 [cited 2023 Jan 17]. Tip: Read Package Inserts - Twitter After dilution, 1 vial contains 6 doses of 0.3 mL. or a Pfizer-BioNTech COVID-19 Vaccine 2-dose series (N=151) at least 12 weeks (range 12 to 20 weeks) prior to enrollment and who reported no history of SARS-CoV-2 infection were randomized 1:1:1 to receive a booster dose of one of . IZ Express # 1,690: Immunize.org summarizes ACIP's April 19, 2023 Covid-19 Vaccine Pfizer, Monovalent, 6 mo-4 yr - Drugs.com The Secretary of Health and Human Services (HHS) has declared a public health emergency that justifies the emergency use of drugs and biological products during the COVID-19 pandemic. Amtrak issued a memo to employees saying that it would allow those who have not been vaccinated against COVID-19 to opt for regular testing. Participants 18 through 55 years of age and 56 years of age and older began enrollment from July 27, 2020, 16 through 17 years of age began enrollment from September 16, 2020, and 12 through 15 years of age began enrollment from October 15, 2020. 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. FDA Product Approval: View All - immunize.org Procedures should be in place to avoid injury from fainting. Version 3 Page 1 / 13 - Pfizer To the extent feasible, report adverse events to Pfizer Inc. using the contact information below or by providing a copy of the VAERS form to Pfizer Inc. For general questions, visit the website or call the telephone number provided below. COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) Daily Mail reported that the timeline of this rollout would depend on the findings of in-house trials that will look into whether vaccines are safe and effective in children aged six months to five years. Equalize vial pressure before removing the needle from the vial by withdrawing 1.8 mL air into the empty diluent syringe. No cases of Bell's palsy were reported in the placebo group. Study BNT162-01 (Study 1) was a Phase 1/2, 2-part, dose-escalation trial that enrolled 60 participants, 18 through 55 years of age. Purple plastic cap and purple label border. Lead Stories contacted Janssen and Johnson & Johnson to ask about the video and why the insert panels are blank. Amtrak Announces It's Stopping Vaccine Mandate For Staffers Record the date and time of dilution.Use within 6 hours after dilution. The vaccine will be an off-white suspension. Document date and time the vaccine was diluted on the Pfizer vaccine vial v. Clean top of Pfizer vaccine vial with alcohol prep pad and with draw 0.2ml of . Pfizer-BioNTech COVID-19 Vaccine Vial with Purple Cap VIAL VERIFICATION. NAME OF THE MEDICINE BNT162b2 [mRNA] 2. 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. Apr 25, 2023. See below the CDC-issued EUI fact sheets for healthcare providers and recipients/caregivers regarding Pfizer-BioNTech COVID-19 vaccine . PDF Pfizer-BioNTech COVID-19 Vaccine - CDC Janssen's website has detailed descriptions and images of its COVID-19 vaccine labeling and packaging. Storage in boxes or bins can help maintain temperature longer, especially if power is lost. It is approved as a 2-dose series for prevention of COVID-19 in individuals 12 years of age and older. Pfizer-biontech Covid-19 Vaccine, Bivalent COVID-19 Vaccine Emergency Use Instructions (EUI) Resources 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 storage, preparation, and administration information in this Fact Sheet 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. 1. Information is not yet available about potential long-term sequelae. Refer to the re-icing guidelines packed in the original thermal container for instructions regarding the use of the thermal container for temporary storage. Generally, a claim must be submitted to the CICP within one (1) year from the date of receiving the vaccine. After dilution, 1 vial contains 6 doses of 0.3 mL. 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). Some vials also may have a purple label border on the label. For immediate use, thaw undiluted vials at room temperature [up to 25C (77F)] for 30 minutes. New York, NY: Pfizer Inc.; 2022. After preparation, each dose of the Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with orange caps and labels with orange borders is 0.2 mL for individuals 5 through 11 years of age [see Dosage and Administration (2.1)]. However, vaccination providers may seek appropriate reimbursement from a program or plan that covers COVID-19 vaccine administration fees for the vaccine recipient (private insurance, Medicare, Medicaid, Health Resources & Services Administration [HRSA] COVID-19 Uninsured Program for non-insured recipients). Note: Events and use of antipyretic or pain medication were collected in the electronic diary (e-diary) from Day 1 to Day 7 after each dose. PDF INGREDIENTS INCLUDED IN COVID-19 VACCINES - Alabama Department of A 69-year-old man complained of reddish bruises on his wrist after the first dose of the Pfizer-BioNTech COVID-19 vaccine. Pfizer-BioNTech COVID-19 Vaccines | CDC 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. The observed risk is highest in males 12 through 17 years of age. The safety of a Pfizer-BioNTech COVID-19 Vaccine booster dose in individuals who completed primary vaccination with another authorized or approved COVID-19 Vaccine . Purple Cap: Monovalent Pfizer-BioNTech COVID-19 Vaccines. The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html). After dilution, store vials between 2C to 25C (35F to 77F) and use within 6 hours from the time of dilution. See Overall Safety Summary (Section 6) for additional information. The Pfizer-BioNTech COVID-19 Vaccine does not contain preservative. Dosage and Administration; . Pfizer-BioNTech COVID-19 Vaccine is a suspension for injection. To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information: 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. For more information on how to sign up, visit: www.cdc.gov/vsafe. INFORMATION TO PROVIDE TO VACCINE RECIPIENTS/CAREGIVERS. Verify that the vial of Pfizer-BioNTech COVID-19 Vaccine has a purple plastic cap. It clearly states: 1 product insert per carton. The duration of protection against COVID-19 is currently unknown. 1. The vaccine efficacy information is presented in Table 8. A separate fact sheet is provided for J&J COVID-19 vaccine recipients and their caregivers. . The full list of ingredients are included in the vaccine package inserts: View the Pfizer package insert for ages 12+ View the Pfizer package insert for ages 5 to 11; View the Moderna package insert; View the Johnson & Johnson package insert From an independent report (Kamar N, Abravanel F, Marion O, et al. Please include either "COMIRNATY (COVID-19 Vaccine, mRNA)", "Pfizer-BioNTech COVID-19 Vaccine EUA", or "Pfizer-BioNTech COVID-19 Vaccine, Bivalent EUA" as appropriate, in the first line of box #18 of the report form. The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine authorized under Emergency Use Authorization (EUA) for individuals 12 years of age and older, when prepared according to their respective instructions for use, can be used interchangeably.10. CAN I RECEIVE COMIRNATY (COVID-19 VACCINE, mRNA), PFIZER-BIONTECH COVID-19 VACCINE, OR THE PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT AT THE SAME TIME AS OTHER VACCINES? WHAT SHOULD YOU MENTION TO YOUR VACCINATION PROVIDER BEFORE YOU GET ANY OF THESE VACCINES? VACCINE FORMULATION AND DESCRIPTION . Data have not yet been submitted to FDA on administration of COMIRNATY (COVID-19 Vaccine, mRNA), the Pfizer-BioNTech COVID-19 Vaccine, or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent at the same time with other vaccines. No vaccine-related adverse effects on female fertility, fetal development, or postnatal development were reported in the study. Symptoms may include: fever or chills; cough; shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea. Symptoms may appear 2 to 14 days after exposure to the virus. 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. In an analysis of Study 2, based on data up to the cutoff date of March 13, 2021, 2,260 adolescents (1,131 Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA); 1,129 placebo) were 12 through 15 years of age. Demographic characteristics in Study 2 were generally similar with regard to age, gender, race, and ethnicity among participants who received Pfizer-BioNTech COVID-19 Vaccine and those who received placebo. Please see the REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS section for details on reporting to VAERS and Pfizer Inc. I. Administer a dose of Pfizer or Moderna bivalent COVID-19 vaccine according to ACIP recommendations and the vaccine package insert. The chance of having this occur is very low. Active ingredient. Millions of individuals have received the Pfizer-BioNTech COVID-19 Vaccine under EUA since December 11, 2020. 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 . Source: National Center for Immunization and Respiratory Diseases. In the Phase 2/3 portion of Study 2, based on data accrued through November 14, 2020, approximately 44,000 participants 12 years of age and older were randomized equally and received 2 doses of Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA) or placebo separated by 21 days. Serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow-up were reported by 0.4% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 0.1% of placebo recipients. Scan to capture that this Fact Sheet was provided to vaccine recipient for the electronic medical records/immunization information systems. PDF 1, MD FACOG FACS; C. Daniel Mullins 2 1, MSc; COVID-19 Vaccination The following adverse reactions have been identified during post authorization use of Pfizer-BioNTech COVID-19 Vaccine. Syncope (fainting) may occur in association with administration of injectable vaccines, in particular in adolescents. 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. Dilute with 1.8 mL sterile 0.9% Sodium Chloride Injection, USP prior to use. The Pfizer-BioNTech COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent for individuals 6 months through 4 years of age are supplied in multiple dose vials with maroon caps and labels with maroon borders and after dilution are administered intramuscularly. Of the total number of Pfizer-BioNTech COVID-19 Vaccine recipients in Study 2 (N=20,033), 21.4% (n=4,294) were 65 years of age and older and 4.3% (n=860) were 75 years of age and older. PDF Immunization Pharmacy Protocol - Oregon PDF Missouri Department of Health and Senior Services For immediate use, thaw undiluted vials at room temperature [up to 25C (77F)] for 30 minutes. Official Vaccine Product Information from FDA: vaccine product approval The Pfizer-BioNTech COVID-19 Vaccine is a suspension for intramuscular injection. Adverse Events following Immunization with COVID-19 Vaccines: A

Education Mind Quotes, Articles P

pfizer covid vaccine package insert

pfizer covid vaccine package insert