The efficacy information in adolescents 12 through 15 years of age is presented in Table 9. 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? PDF Pfizer-BioNTech COVID-19 Vaccine, BIVALENT - niaid.nih.gov COVID-19 Vaccine Emergency Use Instructions (EUI) Resources 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. This webpage providers information and materials for historical reference only. (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 FDA has authorized Pfizer-BioNTech COVID-19 Vaccine, Bivalent to provide better protection against COVID-19 caused by the Omicron variant of SARS-CoV-2. Pfizer-biontech Covid-19 Vaccine, Bivalent Polysorbate allergy is a precaution to Pfizer-BIONTech COVID-19 vaccine (due to No. Vials must reach room temperature before dilution. V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. For primary vaccination, another choice for preventing COVID-19 is SPIKEVAX (COVID-19 Vaccine, mRNA), an FDA-approved COVID-19 vaccine. What's in Pfizer's vaccine? A look at the ingredients All of these criteria must be met to allow for the product to be used during the COVID-19 pandemic. COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine, when prepared according to their respective instructions for use, can be used interchangeably. These NDC will not be manufactured. All pregnancies have a risk of birth defect, loss, or other adverse outcomes. Individuals 12 years of age and older may receive a booster dose with Pfizer-BioNTech COVID-19 Vaccine, Bivalent. From an independent report (Kamar N, Abravanel F, Marion O, et al. The lab reports showed the prolongation of activated partial thromboplastin time and the presence of a factor VIII inhibitor. Procedures should be in place to avoid injury from fainting. Note: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination. 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. 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. Pfizer-BioNTech COVID-19 Vaccines | CDC Covid-19 Vaccine Pfizer, Monovalent, 6 mo-4 yr - Drugs.com Next COVID-19 Vaccine Details Next. There is no information on the co-administration of the Pfizer-BioNTech COVID-19 Vaccine with other vaccines. The safety evaluation in Study 2 is ongoing. View Comirnaty information, press release and frequently asked questions. 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). The information in this section applies to the Pfizer-BioNTech COVID-19 Vaccine that is supplied in multiple dose vials with a purple cap. 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. The vaccine elicits an immune response to the S antigen, which protects against COVID-19. The mean duration of pain at the injection site after Dose 1 was 2.4 days (range 1 to 10 days), for redness 2.4 days (range 1 to 16 days), and for swelling 1.9 days (range 1 to 5 days) for adolescents in the Pfizer-BioNTech COVID-19 Vaccine group. 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. ___ 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]. Getting rid of any unwanted vaccine A doctor, nurse or pharmacist will dispose of any unused vaccine. 2:22 U.K . Wyeth/Pfizer: Nov 2021: Bexsero: Meningococcal Group B: GlaxoSmithKline: Jan 2022: Pneumovax 23: Pneumococcal (polysaccharide) Merck: Apr 2021: Prevnar 13: . 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? Across both age groups, 18 through 55 years of age and 56 years of age and older, the mean duration of pain at the injection site after Dose 2 was 2.5 days (range 1 to 36 days), for redness 2.6 days (range 1 to 34 days), and for swelling 2.3 days (range 1 to 34 days) for participants in the Pfizer-BioNTech COVID-19 Vaccine group. In Study 2, all participants 12 through 15 years of age, and 16 years of age and older in the reactogenicity subset, were monitored for solicited local and systemic reactions and use of antipyretic medication after each vaccination in an electronic diary. If you are considering receiving COMIRNATY (COVID-19 Vaccine, mRNA), the Pfizer-BioNTech COVID-19 Vaccine, or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent with other vaccines, discuss your options with your healthcare provider. Call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away. PFIZER-BIONTECH COVID-19 VACCINE- bnt162b2injection, suspensionPfizer Manufacturing Belgium NV, FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE (VACCINATION PROVIDERS), EMERGENCY USE AUTHORIZATION (EUA) OF THE PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19), PRIMARY SERIES FOR 12 YEARS OF AGE AND OLDER DILUTE BEFORE USE. It . N Engl J Med), Table 5: Study 2 Frequency and Percentages of Adolescents With Solicited Local Reactions, by Maximum Severity, Within 7 Days After Each Dose Adolescents 12 Through 15 Years of Age Safety Population, Table 6: Study 2 Frequency and Percentages of Adolescents with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose Adolescents 12 Through 15 Years of Age Safety Population, Table 7: Demographics (population for the primary efficacy endpoint), Table 8: Vaccine Efficacy First COVID-19 Occurrence From 7 Days After Dose 2, by Age Subgroup Participants Without Evidence of Infection and Participants With or Without Evidence of Infection Prior to 7 Days After Dose 2 Evaluable Efficacy (7 Days) Population, First COVID-19 occurrence from 7 days after Dose 2 in participants without evidence of prior SARS-CoV-2 infection, Table 9: Vaccine Efficacy First COVID-19 Occurrence From 7 Days After Dose 2: Without Evidence of Infection and With or Without Evidence of Infection Prior to 7 Days After Dose 2 Blinded Placebo-Controlled Follow-up Period, Adolescents 12 Through 15 Years of Age Evaluable Efficacy (7 Days) Population, First COVID-19 occurrence from 7 days after Dose 2 in adolescents 12 through 15 years of age without evidence of prior SARS-CoV-2 infection, Table 10: Summary of Geometric Mean Ratio for 50% Neutralizing Titer Comparison of Adolescents 12 Through 15 Years of Age to Participants 16 Through 25 Years of Age (Immunogenicity Subset) Participants Without Evidence of Infection up to 1 Month After Dose 2 Dose 2 Evaluable Immunogenicity Population, 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 older. 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. FDA Product Approval: View All - immunize.org Novavax [package insert]. 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. If you are immunocompromised, you may receive a third primary series dose of Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY (COVID-19 Vaccine, mRNA). PACLITAXEL | Pfizer The possible side effects of these vaccines are still being studied. Information to include: The following steps are highlighted to provide the necessary information for safety tracking: There are no data to assess the concomitant administration of the Pfizer-BioNTech COVID-19 Vaccine with other vaccines. Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients. The vaccination provider enrolled in the federal COVID-19 Vaccination Program is responsible for MANDATORY reporting of the listed events following Pfizer-BioNTech COVID-19 Vaccine to the Vaccine Adverse Event Reporting System (VAERS): The vaccination provider enrolled in the federal COVID-19 Vaccination Program should complete and submit a VAERS form to FDA using 1 of the following methods: IMPORTANT: When reporting adverse events or vaccine administration errors to VAERS, please complete the entire form with detailed information. The formulation supplied in a multiple dose vial with a gray cap and label with a gray border IS NOT DILUTED PRIOR TO USE. 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. See Overall Safety Summary (Section 6) for additional information. It is predominantly a respiratory illness that can affect other organs. See "MANDATORY REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINE ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION" for reporting requirements. Individuals using assistive technology may not be able to fully please 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. Verify that the vial of Pfizer-BioNTech COVID-19 Vaccine has a purple plastic cap. A separate fact sheet is provided for J&J COVID-19 vaccine recipients and their caregivers. This Full EUA Prescribing Information may have been updated. No cases of Bell's palsy were reported in the placebo group. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. 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. COMIRNATY [package insert]. a 2-dose primary series to individuals 12 years of age and older; and. What is an Emergency Use Authorization (EUA)? 30 mcg of a nucleosidemodified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2. N Engl J Med), safety and effectiveness of a third dose of the Pfizer-BioNTech COVID-19 vaccine have been evaluated in persons that received solid organ transplants. Observe patient for 30 minutes following vaccination iii. 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. Moderna COVID-19 Vaccine: Package Insert - Drugs.com Janssen's website has detailed descriptions and images of its COVID-19 vaccine labeling and packaging. https://www.cdc.gov/coronavirus/2019-ncov/index.html. 1. Please see the REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS section for details on reporting to VAERS and Pfizer Inc. This diluent is not packaged with the vaccine and must be sourced separately. Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients. A doctor, nurse or pharmacist will prepare the injection for you before you are given it. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. INFORMATION TO PROVIDE TO VACCINE RECIPIENTS/CAREGIVERS. RED ALERT: American Babies Could Be Given Pfizer's COVID Vaccine By Currently available information is insufficient to determine a causal relationship with the vaccine. 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 Gently invert the vaccine vial 10 times iv. Administer the Pfizer-BioNTech COVID-19 Vaccine intramuscularly. People with COVID-19 have had a wide range of symptoms reported, ranging from mild symptoms to severe illness leading to death. Amtrak Announces It's Stopping Vaccine Mandate For Staffers For more information about IISs visit: https://www.cdc.gov/vaccines/programs/iis/about.html. 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 . Symptoms may appear 2 to 14 days after exposure to the virus. Patients should still be counselled to maintain physical precautions to help prevent COVID-19. Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. 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). Oxford-AstraZeneca COVID-19 vaccines have shown a few cases of blood clotting disorders . Manufactured forBioNTech Manufacturing GmbH An der Goldgrube 1255131 Mainz, Germany. Undiluted vials may be stored at room temperature for no more than 2 hours. Lead Stories contacted Janssen and Johnson & Johnson to ask about the video and why the insert panels are blank. 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. It is approved for use as a 2-dose primary series for the prevention of COVID-19 in individuals 12 years of age and older. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. Fact check: Blank packaging insert in J&J vaccine is on purpose From Dose 1 through 30 days after Dose 2, reports of lymphadenopathy plausibly related to the study intervention were imbalanced, with notably more cases in the Pfizer-BioNTech COVID-19 Vaccine group (7) vs. the placebo group (1). The emergency use . 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. These vaccines do not contain SARS-CoV-2 and cannot give you COVID-19. 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. This is the Product Information that was approved with the submission described in this AusPAR. If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital. 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. The safety evaluation in Study 2 is ongoing. The chance of having this occur is very low. Vials must reach room temperature before dilution. a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. Pfizer-BioNTech COVID-19 Vaccine is authorized for use in individuals 6 months through 17 years of age. 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. When you get your first COVID-19 vaccine, you will get a vaccination card. After dilution, 1 vial contains 6 doses of 0.3 mL. 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. It clearly states: 1 product insert per carton. Adverse Reactions Identified in Post Authorization Experience. An EUA is in effect for the duration of the COVID-19 EUA declaration justifying emergency use of this product, unless terminated or revoked (after which the product may no longer be used). 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). Symptoms may appear 2 to 14 days after exposure to the virus. For more information on EUA, see the "What is an Emergency Use Authorization (EUA)?" Pull back plunger to 1.8 mL to remove air from vial. Pfizer-biontech Covid-19 Vaccine For additional information about Emergency Use Authorization visit FDA at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization. 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). . The Pfizer-BioNTech COVID-19 Vaccine does not contain preservative. 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. Solicited reactogenicity data in 16 and 17 year-old participants are limited. The Pfizer-BioNTech COVID-19 Vaccine is administered intramuscularly as a primary series of 2 doses (0.3 mL each) 3 weeks apart to individuals 12 years of age and older. 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. COVID-19 - immunize.org Source: National Center for Immunization and Respiratory Diseases. At the time of the analysis of Study 2 for the EUA, 37,586 [18,801 Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA) and 18,785 placebo] participants 16 years of age or older had been followed for a median of 2 months after the second dose.