People with a history of a non-severe, immediate (onset less than 4 hours) allergic reaction after a dose of, Moderate or severe acute illness, with or without fever. Learn about SARS-CoV-2, the coronavirus that causes COVID-19, what you can do to stay safe and prevent the spread, and our scientific efforts to help bring an end to the current global health crisis. Pfizer The vaccination provider may include your vaccination information in your state/local jurisdiction's Immunization Information System (IIS) or other designated system. For the primary series, the first and second doses are separated by 3 weeks and the second and third doses are separated by at least 4 weeks. These forward-looking statements may include, but may not be limited to, statements concerning: BioNTechs efforts to combat COVID-19; the collaboration between BioNTech and Pfizer including the program to develop a COVID-19 vaccine and COMIRNATY (COVID-19 vaccine, mRNA) (BNT162b2) (including updated data regarding BNT162b2 and its potential in children 6 months to under 5 years of age and planned regulatory submissions, qualitative assessments of available data, potential benefits, expectations for clinical trials, the anticipated timing of regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply); our expectations regarding the potential characteristics of BNT162b2 in our clinical trials, real world data studies, and/or in commercial use based on data observations to date; preclinical and clinical data (including Phase 1/2/3 or Phase 4 data), including the descriptive data discussed in this release, for BNT162b2 or any other vaccine candidate in the BNT162 program, including any monovalent, bivalent, or variant-adapted vaccine candidates in any of our studies in pediatrics, adolescents or adults or real world evidence, including the possibility of unfavorable new preclinical, clinical or safety data, including the risk that final or formal results from the clinical trial could differ from the topline data; the ability of BNT162b2 or a future vaccine to prevent COVID-19 caused by emerging virus variants; the expected time point for additional readouts on efficacy data of BNT162b2 in our clinical trials; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; widespread use of BNT162b2 will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; the timing for submission of data for BNT162, or any future vaccine, in additional populations (including in children 6 months to under 5 years of age, including any monovalent, bivalent or variant-adapted vaccine and potential future annual boosters or re-vaccinations), or receipt of, any marketing approval or emergency use authorization or equivalent, including or amendments or variations to such authorizations, including making a determination as to whether the vaccines benefits outweigh its known risks and determination of the vaccines efficacy and, if approved, whether it will be commercially successful; the development of other vaccine formulations, booster doses or potential future annual boosters or re-vaccinations or new variant based vaccines; our contemplated shipping and storage plan, including our estimated product shelf life at various temperatures; the ability of BioNTech to supply the quantities of BNT162 to support clinical development and market demand, including our production estimates for 2022; challenges related to public vaccine confidence or awareness; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; disruptions in the relationships between us and our collaboration partners, clinical trial sites or third-party suppliers; the risk that demand for any products may be reduced or no longer exist; the availability of raw material to manufacture BNT162 or other vaccine formulation, which may lead to reduced revenues or excess inventory; challenges related to our vaccines formulation, dosing schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery; and uncertainties regarding the impact of COVID-19 on BioNTechs trials, business and general operations. For patients who receive B-cell-depleting therapies on a continuing basis, COVID-19 vaccines should be administered approximately 4 weeks before the next scheduled therapy. People ages 12 years and older: A 2-dose primary series and 1 bivalent mRNA booster dose (Moderna or Pfizer-BioNTech) is recommended. MANDATORY REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION3. cap To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X. INFORMATION TO PROVIDE TO VACCINE RECIPIENTS/CAREGIVERS. Abbreviations: rS = recombinant spike protein *Illustrations of the different vaccine vial cap and label border colors are available for Moderna and Pfizer-BioNTech COVID-19 vaccines. Revaccination should start at least 3 months (12 weeks) after transplant or CAR-T-cell therapy. In Box 13, provide the name and contact information of the prescribing healthcare provider or institutional designee who is responsible for the report. Effectiveness of a booster dose of Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA) was based on an assessment of 50% neutralizing antibody titers (NT50) against SARS-CoV-2 (USA_WA1/2020). Verify that the vial of Pfizer-BioNTech COVID-19 Vaccine, Bivalent: has a gray cap and a label with a gray border. endobj COVID-19 vaccination is recommended for everyone ages 6 months and older in the United States for the prevention of COVID-19. Use of unapproved Pfizer-BioNTech COVID-19 Vaccine, Bivalent for active immunization to prevent COVID-19 under this EUA is limited to the following (all requirements must be met): OTHER ADVERSE EVENT REPORTING TO VAERS AND PFIZER INC. Vaccination providers may report to VAERS other adverse events that are not required to be reported using the contact information above. Effectiveness of a Pfizer-BioNTech COVID-19 Vaccine booster dose (30 mcg modRNA) in individuals who completed primary vaccination with another authorized or approved COVID-19 Vaccine (heterologous booster dose) is inferred from immunogenicity data supporting effectiveness of a Pfizer-BioNTech COVID-19 Vaccine booster dose administered following completion of Pfizer-BioNTech COVID-19 Vaccine primary series and from immunogenicity data from an independent NIH study Phase 1/2 open-label clinical trial (NCT04889209) conducted in the United States that evaluated a heterologous booster dose of the Pfizer-BioNTech COVID-19 Vaccine. In an analysis of Study 3 Phase 2/3, based on data up to the cutoff date of September 06, 2021, 2,268 participants [1,518 Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA); 750 placebo] were 5 through 11 years of age. For the Pfizer-BioNTech COVID-19 Vaccine, the observed risk is higher among adolescent males and adult males under 40 years of age than among females and older males, and the observed risk is highest in males 12 through 17 years of age. Blue Cap Ages. For more information on how to sign up, visit: www.cdc.gov/vsafe. For people who have a history of myocarditis associated with MIS-C or MIS-A, see COVID-19 vaccination and MIS-C and MIS-A. 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 older5. Interact with the Medical Information Digital Assistant, Comirnaty Full Prescribing Information (12 years of age and older) - DILUTE BEFORE USE, Purple Cap, Comirnaty Full Prescribing Information (12 years of age and older) DO NOT DILUTE, Gray Cap, Medical Updates & Immunization Site Training for Healthcare Providers, Pfizer-BioNTech COVID-19 Global Vaccine Site. Primary Series. Procedures should be in place to prevent falling injuries and manage syncopal reactions. People who develop signs and symptoms that could be from either COVID-19 vaccination or SARS-CoV-2 infection (e.g., fever, fatigue, headache, myalgia) without typical COVID-19 symptoms described above, and are clinically stable, should, Clinical recovery has been achieved, including return to baseline cardiac function; and, It has been at least 90 days after the diagnosis of MIS-C/A. The higher frequency of reported unsolicited non-serious adverse events among Pfizer-BioNTech COVID-19 Vaccine recipients compared to placebo recipients was primarily attributed to local and systemic adverse events reported during the first 7 days following vaccination that are consistent with adverse reactions solicited among participants in the reactogenicity subset. Additionally, providers should consider observing people with the following medical histories for 30 minutes after COVID-19 vaccination to monitor for allergic reactions: See also Contraindications and precautions. punctured vial . Abbreviations: GMR = geometric mean ratio; GMT = geometric mean titer; LLOQ = lower limit of quantitation; N-binding = SARS-CoV-2 nucleoproteinbinding; NAAT = nucleic acid amplification test; NT50 = 50% neutralizing titer; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2. Learn about specific ways our research is leading to medicines and vaccines that will benefit patients around the world. They help us to know which pages are the most and least popular and see how visitors move around the site. The safety evaluation in Study 3 is ongoing. 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? In these analyses, 91.6% of study participants had at least 30 days of follow-up after Dose 2. Files, Presentations 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. Prior receipt of a COVID-19 vaccine will not affect the results of SARS-CoV-2 viral tests (nucleic acid amplification or antigen tests). There is no revaccination for monovalent booster doses received prior to or during treatment. This press release features multimedia. See COVID-19 vaccination and myocarditis and pericarditisfor additional information. COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine have been shown to prevent COVID-19. 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. Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels. The safety of the primary series Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA) was evaluated in participants 12 years of age and older in 2 clinical studies conducted in the United States, Europe, Turkey, South Africa, and South America. Children age 5 years: A 3-dose primary series and 1 bivalent Pfizer-BioNTech booster dose is recommended. Provide a detailed report of vaccine administration error and/or adverse event. People who have a history of other heart disease, including congenital heart disease and Kawasaki disease, may receive any currently FDA-approved or FDA-authorized COVID-19 vaccine. 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. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose. SARS-CoV-2 antibody tests currently authorized under an EUAhave variable performance characteristics and limitations. Following a bumpy launch week that saw frequent server trouble and bloated player queues, Blizzard has announced that over 25 million Overwatch 2 players have logged on in its first 10 days. Key findings include: Proposition 30 on reducing greenhouse gas emissions has lost ground in the past month, with support among likely voters now falling short of a majority. Children ages 6 months4 years: A 2-dose primary series separated by 48 weeks is recommended. family houses - wcybr.karolinas.shop Individuals using assistive technology may not be able to fully Thank you for taking the time to confirm your preferences. 5 Menzies Close, Lara. On July 8, Pfizer and BioNTech submitted safety and immunogenicity data to the European Medicines Agency (EMA) requesting an update to the Conditional Marketing Authorization (CMA) in the European Union (EU) to include children ages 6 months through 4 years. Obtaining a serum sample before any intravenous immune globulin (IVIG) is administered is highly recommended so that the sample can be tested for SARS-CoV-2 anti-nucleocapsid antibody, which may require a reference laboratory. The same vaccine product should be used for all doses of the primary series (see Interchangeability of COVID-19 vaccine products). The Pfizer-BioNTech COVID-19 Vaccine, Bivalent is a suspension for intramuscular injection. The risk of recurrence of a dysregulated immune response following reinfection with SARS-CoV-2 or an MIS-like illness following COVID-19 vaccination is unknown. Three 3-g doses of the Pfizer-BioNTech COVID-19 Vaccine continue to be well-tolerated in this age group. Links to sites outside of Pfizer Medical Information are provided as a resource to the viewer. If cartons of Pfizer-BioNTech COVID-19 Vaccine, Bivalent are received at 2C to 8C (35F to 46F), they should be stored at 2C to 8C (35F to 46F). Administration of antihistamines before COVID-19 vaccination to prevent allergic reactions is not generally recommended. In addition, you can report side effects to Pfizer Inc. at the contact information provided below. Abbreviations: LLOQ = lower limit of quantitation; N-binding = SARS-CoV-2 nucleoproteinbinding; NAAT = nucleic acid amplification test; NT50 = 50% neutralizing titer; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2. People with known current SARS-CoV-2 infection should defer any COVID-19 vaccination, including booster vaccination, at least until recovery from the acute illness (if symptoms were present) and criteriato discontinue isolation have been met. MSAC - Medical Services Advisory Committee Model Standing Order In younger children, symptoms of myocarditis may also include non-specific symptoms such as irritability, vomiting, poor feeding, tachypnea, or lethargy. 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). Vaccination providers should ensure the correct age-appropriate product is administered based on the recipients age on the day of vaccination (Table 1). Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. Acetaminophen can be offered as an option for pregnant people experiencing fever (fever has been associated with adverse pregnancy outcomes) or other post-vaccination symptoms. The vaccine is administered as a 2-dose series, 3 weeks apart. 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: *If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site. The bivalent booster dose is administered at least 2 months after completion of the primary series (for people who have not received any booster doses), or at least 2 months after the last monovalent booster dose. In participants who received the bivalent vaccine (Original and Omicron BA.1), the mean duration of injection site pain, redness, and swelling was 2.2 days (range 1 to 12 days), 2.9 days (range 1 to 10 days), and 1.9 days (range 1 to 4 days), respectively. About Our Coalition. Participants were monitored for solicited local and systemic reactions and use of antipyretic medication after each vaccination in an electronic diary. In an analysis of a subset from Study 4, a total of 610 participants greater than 55 years of age who had previously received a 2-dose primary series and 1 booster dose with Pfizer-BioNTech COVID-19 Vaccine received 1 of the following as a second booster dose: Pfizer-BioNTech COVID-19 Vaccine or bivalent vaccine (Original and Omicron BA.1). Pfizer If antibody testing was done, vaccination with the primary series or a booster dose should be completed as recommended regardless of the antibody test result. cases of COVID-19 that result in hospitalization or death. Overall, among the participants who received the Pfizer-BioNTech COVID-19 Vaccine, 50.1% were male and 49.9% were female, 85.9% were White, 4.6% were Black or African American, 11.7% were Hispanic/Latino, 6.4% were Asian, and 0.4% were American Indian/Alaska Native. For a discussion of these and other risks and uncertainties, see BioNTechs quarterly report on Form 6-K for the quarter ended June 30, 2022 and in subsequent filings made by BioNTech with the SEC, which are available on the SECs website at www.sec.gov. G. For Pfizer vaccine only: thaw, if needed. safety data from a clinical study which evaluated a booster dose of Pfizer-BioNTech's bivalent COVID-19 vaccine (Original and Omicron BA.1), not authorized or approved, hereafter referred to as bivalent vaccine (Original and Omicron BA.1), safety data from clinical trials which evaluated primary and booster vaccination with Pfizer-BioNTech COVID-19 Vaccine, and. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. A positive anti-nucleocapsid antibody test result indicates prior SARS-CoV-2 infection. 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. Thawed vials may be stored at room temperature [up to 25C (77F)] for up to 12 hours prior to use. states Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5). Inpatient hospitalization or prolongation of existing hospitalization; A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; An important medical event that based on appropriate medical judgement may jeopardize the individual and may require medical or surgical intervention to prevent 1 of the outcomes listed above.