Signs of a severe allergic reaction can include: Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received COMIRNATY (COVID-19 Vaccine, mRNA) or Pfizer-BioNTech COVID-19 Vaccine, more commonly in adolescent males and adult males under 40 years of age than among females and older males. The duration of protection against COVID-19 is currently unknown. No more than 2 hours at room temperature (up to 25C/77F). Administer the Pfizer-BioNTech COVID-19 Vaccine intramuscularly. Participants with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, were included as were participants with known stable infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV). 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. 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. There is no information on the co-administration of the Pfizer-BioNTech COVID-19 Vaccine with other vaccines. Meet the honorees The Crossword Where they . At this time, the provider cannot charge you for a vaccine dose and you cannot be charged an out-of-pocket vaccine administration fee or any other fee if only receiving a COVID-19 vaccination. This product information is intended only for residents of the United States. Storage in boxes or bins can help maintain temperature longer, especially if power is lost. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent is made in the same way as COMIRNATY and Pfizer-BioNTech COVID-19 Vaccine but it also contains an Omicron component to help prevent COVID-19 caused by the Omicron variant of SARS-CoV-2. 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. Pfizer-BioNTech COVID-19 Vaccine at least 4 weeks (28 days) after the second dose. Only NDCs for the subsequently BLA approved tri sucrose formulation will be produced." Official Vaccine Product Information from FDA: vaccine product approval For immediate use, thaw undiluted vials at room temperature [up to 25C (77F)] for 30 minutes. It clearly states: 1 product insert per carton. No. For the most recent Fact Sheet, please see www.cvdvaccine.com. Lead Stories contacted Janssen and Johnson & Johnson to ask about the video and why the insert panels are blank. The vaccines also contain various salts, fats and other ingredients to help your body use the mRNA. Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients. Pfizer-BioNTech COVID-19 Vaccine Vial with Purple Cap THAWING PRIOR TO DILUTION. Vial labels and cartons may state that after dilution, a vial contains 5 doses of 0.3 mL. J. Novavax monovalent vaccine may be used as a first booster in an adult patient Special hazards arising from the substance or mixture Specific hazards arising from the chemical Fine particles (such as mists) may fuel fires/explosions. The population for the analysis of the primary efficacy endpoint included, 36,621 participants 12 years of age and older (18,242 in the Pfizer-BioNTech COVID-19 Vaccine group and 18,379 in the placebo group) who did not have evidence of prior infection with SARS-CoV-2 through 7 days after the second dose. 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: 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. Note: the front and back panels of this insert were intentionally left blank. Talk to your vaccination provider if you have questions. This diluent is not packaged with the vaccine and must be sourced separately. 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. 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. 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. a single booster dose to individuals 12 years of age and older at least 2 months after completion of primary vaccination with any authorized or approved COVID-19 vaccine; or, a single booster dose to individuals 12 years of age and older at least 2 months after receipt of the most recent booster dose with any authorized or approved monovalent, https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html, https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html, https://www.cdc.gov/vaccines/covid-19/provider-enrollment.html, https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization, Clinical Trial Results and Supporting Data for EUA (18.1), https://www.cdc.gov/vaccines/programs/iis/about.html. As the vaccination provider, you must communicate to the recipient or their caregiver, information consistent with the "Vaccine Information Fact Sheet for Recipients and Caregivers" (and provide a copy or direct the individual to the website www.cvdvaccine.com to obtain the Vaccine Information Fact Sheet for Recipients and Caregivers) prior to the individual receiving each dose of the Pfizer-BioNTech COVID-19 Vaccine, including: For information on clinical trials that are testing the use of the Pfizer-BioNTech COVID-19 Vaccine to prevent COVID-19, please see www.clinicaltrials.gov. Package Inserts and Manufacturers for some US Licensed Vaccines and 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]. COVID-19 disease is caused by a coronavirus called SARS-CoV-2. Severe allergic reactions, including anaphylaxis, have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine. 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. CDC's vaccine excipient summary and the National Institutes of Health DailyMed database can also be used as a resource. . The possible side effects of these vaccines are still being studied. PDF INGREDIENTS INCLUDED IN COVID-19 VACCINES - Alabama Department of You should not get any of these vaccines if you: WHAT ARE THE INGREDIENTS IN THESE VACCINES? Purple plastic cap and purple label border. Manufactured forBioNTech Manufacturing GmbHAn der Goldgrube 1255131 Mainz, Germany, Manufactured byPfizer Inc., New York, NY 10017, VACCINE INFORMATION FACT SHEET FOR RECIPIENTS AND CAREGIVERS ABOUT COMIRNATY (COVID-19 VACCINE, mRNA), THE PFIZER-BIONTECH COVID-19 VACCINE, AND THE PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19) FOR USE IN INDIVIDUALS 12 YEARS OF AGE AND OLDER. INFORMATION TO PROVIDE TO VACCINE RECIPIENTS/CAREGIVERS. First COVID-19 occurrence from 7 days after Dose 2 in participants without evidence of prior SARS-CoV-2 infection*, Pfizer-BioNTech COVID-19 VaccineN=18,198 Casesn1Surveillance Time (n2#), Placebo N=18,325 Casesn1Surveillance Time (n2#), First COVID-19 occurrence from 7 days after Dose 2 in participants with or without evidence of prior SARS-CoV-2 infection, Pfizer-BioNTech COVID-19 VaccineN=19,965Casesn1Surveillance Time (n2#), PlaceboN=20,172Casesn1Surveillance Time (n2#). The following adverse reactions have been identified during post authorization use of Pfizer-BioNTech COVID-19 Vaccine. The emergency use . The formulation supplied in a multiple dose vial with a gray cap and label with a gray border IS NOT DILUTED PRIOR TO USE. Vaccination providers enrolled in the federal COVID-19 Vaccination Program must report 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 cases of COVID-19 that result in hospitalization or death following administration of Pfizer-BioNTech COVID-19 Vaccine. (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 In clinical studies of participants 16 years of age and older who received Pfizer-BioNTech COVID-19 Vaccine containing 30 mcg of a nucleoside-modified messenger RNA encoding the viral spike (S) glycoprotein of SARS-CoV-2 (30 mcg modRNA), adverse reactions following administration of the primary series included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%). You are being offered either COMIRNATY (COVID-19 Vaccine, mRNA), the Pfizer-BioNTech COVID-19 Vaccine, or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), hereafter referred to as the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, to prevent Coronavirus Disease 2019 (COVID-19) caused by SARS-CoV-2. Tootypetodrunk on Twitter: "RT @HopeRising19: Canada has just updated 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. This authorization is based on safety and effectiveness data in this age group and adults. 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. Purple plastic cap and purple label border. Patients should still be counselled to maintain physical precautions to help prevent COVID-19. All 40 patients who had been seropositive before the third dose were still seropositive 4 weeks later. No vaccine-related adverse effects on female fertility, fetal development, or postnatal development were reported in the study. The information in this section applies to the Pfizer-BioNTech COVID-19 Vaccine that is supplied in multiple dose vials with a purple cap. A third primary series dose of the Pfizer-BioNTech COVID-19 Vaccine (0.3 mL) at least 28 days following the second dose is authorized for administration to individuals at least 12 years of age with certain kinds of immunocompromise. Verify that the vial of Pfizer-BioNTech COVID-19 Vaccine has a purple plastic cap. Gently invert the vaccine vial 10 times iv. For more information on EUA, see the "What is an Emergency Use Authorization (EUA)?" PDF Missouri Department of Health and Senior Services Pfizer-biontech Covid-19 Vaccine Covid-19 Vaccine Pfizer, Monovalent,5 yr to 11 yr - Drugs.com CDC issued initial Emergency Use Instructions (EUI) for the Pfizer-BioNTech COVID-19 vaccine on November 17, 2021, and another EUI for the Moderna COVID-19 vaccine on February 11, 2022. . Study C4591001 (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. Call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away. ii. This is what's important. The Countermeasures Injury Compensation Program. Pfizer-BioNTech COVID-19 Vaccine, Bivalent has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals aged 6 months of age and older. Storage of the vials between -96C to -60C (-141F to -76F) is not considered an excursion from the recommended storage condition. Other vaccines to prevent COVID-19 may be available under EUA, including bivalent vaccines that contain an Omicron component of SARS-CoV-2. Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. Individuals 12 years of age and older may receive a booster dose with Pfizer-BioNTech COVID-19 Vaccine, Bivalent. The vaccine must be thawed prior to preparation and . . WHAT IS AN EMERGENCY USE AUTHORIZATION (EUA)? PDF Model Standing Order and Immunization Protocol Template - Oregon 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 . You should seek medical attention right away if you have any of the following symptoms after receiving the vaccine: Side effects that have been reported with these vaccines include: These may not be all the possible side effects of these vaccines. Dilute the vial contents using 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP (not provided) to form the Pfizer-BioNTech COVID-19 Vaccine. . Each 0.3 mL dose of the Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with purple caps contains 30 mcg of a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of the SARS-CoV-2 Wuhan-Hu-1 strain. 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. Millions of individuals have received the Pfizer-BioNTech COVID-19 Vaccine under EUA since December 11, 2020. People with COVID-19 have reported a wide range of symptoms, ranging from mild symptoms to severe illness. Visually inspect each dose in the dosing syringe prior to administration. IZ Express # 1,690: Immunize.org summarizes ACIP's April 19, 2023 Includes: indications, dosage, adverse reactions and pharmacology. After dilution, vials of Pfizer-BioNTech COVID-19 Vaccine with purple caps contain 6 doses of 0.3 mL of vaccine. It includes vaccine ingredients, a list of side effects and information about who should and should not receive the shot. 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 . 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. 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). FDA Grants Full Approval, Changes Name of Pfizer Vaccine - Nurse.org . This is the Product Information that was approved with the submission described in this AusPAR. Novavax [package insert]. Pfizer-BioNTech COVID-19 Vaccine | Pfizer Data are not available to assess the effects of Pfizer-BioNTech COVID-19 Vaccine on the breastfed infant or on milk production/excretion. In a clinical study in adolescents 12 through 15 years of age who received Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA), adverse reactions following administration of the primary series included pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever (24.3%), joint pain (20.2%), injection site swelling (9.2%), injection site redness (8.6%), lymphadenopathy (0.8%), and nausea (0.4%). 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 . Pfizer-BioNTech COVID-19 Vaccine Vial with Purple Cap VIAL VERIFICATION. Michael Patmas, MD. The information in this Full EUA Prescribing Information regarding the number of doses per vial after dilution supersedes the number of doses stated on vial labels and cartons. 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. Provide the v-safe information sheet to vaccine recipients/caregivers and encourage vaccine recipients to participate in v-safe. Next COVID-19 Vaccine Details Next. Note: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination. See Overall Safety Summary (Section 6) for additional information. COVID-19 Vaccines (Pfizer/BioNTech) Quick Finder Physician Prescribing Information The diluent (sterile 0.9% Sodium Chloride Injection, USP) contributes an additional 2.16 mg sodium chloride per dose. The safety of the primary series Pfizer-BioNTech COVID-19 Vaccine was evaluated in participants 12 years of age and older in two clinical studies conducted in the United States, Europe, Turkey, South Africa, and South America. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, and available alternatives. V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. 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). Please see the REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS section for details on reporting to VAERS and Pfizer Inc. Healthcare providers must enroll as providers in the Vaccination Program and comply with the provider requirements.

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