Adverse Effects of Vaccines Evidence and Causality
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Adverse Effects of Vaccines: Evidence and Causality
REPORT BRIEF AUGUST 2011 .For more information visit www.iom.edu/vaccineadverseeffects Adverse Effects of Vaccines Evidence and Causality Immunizations are a cornerstone of the nation’s efforts to protect people from a host of infectious diseases. As required by the Food and Drug Admin- istration, vaccines are tested for safety before they enter the market, and their performance is continually evaluated to identify any risks that might appear over time. Vaccines are not free from side effects, or “adverse effects,” but most are very rare or very mild. Importantly, some adverse health problems following a vaccine may be due to coincidence and are not caused by the vaccine. As part of the evaluation of vaccines over time, researchers assess evidence to deter- As part of the evaluation of mine if adverse events following vaccination are causally linked to a specific vaccines over time, researchers vaccine, and if so, they are referred to as adverse effects. Under the National assess evidence to determine if Childhood Vaccine Injury Act of 1986, Congress established the National Vac- adverse events following cine Injury Compensation Program (VICP) to provide compensation to peo- vaccination are causally linked to ple injured by vaccines. Anyone who thinks they or a family member—often a a specific vaccine, and if so, they are referred to as adverse effects. child—has been injured can file a claim. The Health Resources and Services Administration (HRSA), the agency within the Department of Health and Human Services that administers VICP, can use evidence that demonstrates a causal link between an adverse event and a vaccine to streamline the claim process. -
(ACIP) General Best Guidance for Immunization
9. Special Situations Updates Major revisions to this section of the best practices guidance include the timing of intramuscular administration and the timing of clotting factor deficiency replacement. Concurrent Administration of Antimicrobial Agents and Vaccines With a few exceptions, use of an antimicrobial agent does not interfere with the effectiveness of vaccination. Antibacterial agents have no effect on inactivated, recombinant subunit, or polysaccharide vaccines or toxoids. They also have no effect on response to live, attenuated vaccines, except BCG vaccines. Antimicrobial or immunosuppressive agents may interfere with the immune response to BCG and should only be used under medical supervision (for additional information, see www.merck.com/product/usa/pi_circulars/b/bcg/bcg_pi.pdf). Antiviral drugs used for treatment or prophylaxis of influenza virus infections have no effect on the response to inactivated influenza vaccine (2). However, live, attenuated influenza vaccine should not be administered until 48 hours after cessation of therapy with antiviral influenza drugs. If feasible, to avoid possible reduction in vaccine effectiveness, antiviral medication should not be administered for 14 days after LAIV administration (2). If influenza antiviral medications are administered within 2 weeks after receipt of LAIV, the LAIV dose should be repeated 48 or more hours after the last dose of zanamavir or oseltamivir. The LAIV dose should be repeated 5 days after peramivir and 17 days after baloxavir. Alternatively, persons receiving antiviral drugs within the period 2 days before to 14 days after vaccination with LAIV may be revaccinated with another approved vaccine formulation (e.g., IIV or recombinant influenza vaccine). Antiviral drugs active against herpesviruses (e.g., acyclovir or valacyclovir) might reduce the efficacy of vaccines containing live, attenuated varicella zoster virus (i.e., Varivax and ProQuad) (3,4). -
Safety of Immunization During Pregnancy a Review of the Evidence
Safety of Immunization during Pregnancy A review of the evidence Global Advisory Committee on Vaccine Safety © World Health Organization 2014 All rights reserved. Publications of the World Health Organization are available on the WHO website (www.who.int) or can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). Requests for permission to reproduce or translate WHO publications –whether for sale or for non-commercial distribution– should be addressed to WHO Press through the WHO website (www.who.int/about/licensing/copyright_form/en/index.html). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. -
Adult Vaccines
What do flu, whooping cough, measles, shingles and pneumonia have in common? 1 They’re viruses that can make you very sick. 2 Vaccines can help prevent them. Protect yourself and those you care about. Get vaccinated at a network pharmacy near you. • Ask your pharmacist which vaccines are right for you. • Find out if your pharmacist can administer the recommended vaccinations. • Many vaccinations are covered by your plan at participating retail pharmacies. • Don’t forget to present your member ID card to the pharmacist at the time of service! The following vaccines are available and can be administered by pharmacists at participating network pharmacies: • Flu (seasonal influenza) • Meningitis • Travel Vaccines (typhoid, yellow • Tetanus/Diphtheria/Pertussis • Pneumonia fever, etc.) • Hepatitis • Rabies • Childhood Vaccines (MMR, etc.) • Human Papillomavirus (HPV) • Shingles/Zoster See other side for recommended adult vaccinations. The vaccinations you need ALL adults should get vaccinated for1: • Flu, every year. It’s especially important for pregnant women, older adults and people with chronic health conditions. • Tetanus, diphtheria and pertussis (whooping cough). Adults should get a one-time dose of the Tdap vaccine. It’s different from the tetanus vaccine (Td), which is given every 10 years. You may need additional vaccinations depending on your age1: Young adults not yet vaccinated need: Human papillomavirus (HPV) vaccine series (3 doses) if you are: • Female age 26 or younger • Male age 21 or younger • Male age 26 or younger who has sex with men, who is immunocompromised or who has HIV Adults born in the U.S. in 1957 or after need: Measles, mumps, rubella (MMR) vaccine2 Adults should get at least one dose of MMR vaccine, unless they’ve already gotten this vaccine or have immunity to measles, mumps and rubella Adults born in the U.S. -
Hearing Before the Committee on Government Reform
DOCUMENT RESUME ED 466 915 EC 309 063 TITLE Autism: Present Challenges, Future Needs--Why the Increased Rates? Hearing before the Committee on Government Reform. House of Representatives, One Hundred Sixth Congress, Second Session (April 6,2000). INSTITUTION Congress of the U.S., Washington, DC. House Committee on Government Reform. REPORT NO House-Hrg-106-180 PUB DATE 2001-00-00 NOTE 483p. AVAILABLE FROM Government Printing Office, Superintendent of Documents, Congressional Sales Office, Washington, DC 20402-9328. Tel: 202-512-1800. For full text: http://www.house.gov/reform. PUB TYPE Legal/Legislative/Regulatory Materials (090) EDRS PRICE EDRS Price MF02/PC20 Plus Postage. DESCRIPTORS *Autism; *Child Health; Children; *Disease Control; *Etiology; Family Problems; Hearings; *Immunization Programs; Incidence; Influences; Parent Attitudes; *Preventive Medicine; Research Needs; Symptoms (Individual Disorders) IDENTIFIERS Congress 106th; Vaccination ABSTRACT This document contains the proceedings of a hearing on April 6, 2000, before the U.S. House of Representatives Committee on Government Reform. The hearing addressed the increasing rate of children diagnosed with autism, possible links between autism and childhood vaccinations, and future needs of these children. After opening statements by congressmen on the Committee, the statements and testimony of Kenneth Curtis, James Smythe, Shelley Reynolds, Jeana Smith, Scott Bono, and Dr. Wayne M. Danker, all parents of children with autism, are included. Their statements discuss symptoms of autism, vaccination concerns, family problems, financial concerns, and how parents can be helped. The statements and testimony of the second panel are then provided, including that of Andrew Wakefield, John O'Leary, Vijendra K. Singh, Coleen A. Boyle, Ben Schwartz, Paul A. -
COVID-19 Vaccines: Update on Allergic Reactions, Contraindications, and Precautions
Centers for Disease Control and Prevention Center for Preparedness and Response COVID-19 Vaccines: Update on Allergic Reactions, Contraindications, and Precautions Clinician Outreach and Communication Activity (COCA) Webinar Wednesday, December 30, 2020 Continuing Education Continuing education will not be offered for this COCA Call. To Ask a Question ▪ All participants joining us today are in listen-only mode. ▪ Using the Webinar System – Click the “Q&A” button. – Type your question in the “Q&A” box. – Submit your question. ▪ The video recording of this COCA Call will be posted at https://emergency.cdc.gov/coca/calls/2020/callinfo_123020.asp and available to view on-demand a few hours after the call ends. ▪ If you are a patient, please refer your questions to your healthcare provider. ▪ For media questions, please contact CDC Media Relations at 404-639-3286, or send an email to [email protected]. Centers for Disease Control and Prevention Center for Preparedness and Response Today’s First Presenter Tom Shimabukuro, MD, MPH, MBA CAPT, U.S. Public Health Service Vaccine Safety Team Lead COVID-19 Response Centers for Disease Control and Prevention Centers for Disease Control and Prevention Center for Preparedness and Response Today’s Second Presenter Sarah Mbaeyi, MD, MPH CDR, U.S. Public Health Service Clinical Guidelines Team COVID-19 Response Centers for Disease Control and Prevention National Center for Immunization & Respiratory Diseases Anaphylaxis following mRNA COVID-19 vaccination Tom Shimabukuro, MD, MPH, MBA CDC COVID-19 Vaccine -
Addressing the Justifications for Vaccine Denial and Applying The
University of Northern Iowa UNI ScholarWorks Honors Program Theses Honors Program 2016 A healthy herd: addressing the justifications for accinev denial and applying the health belief model to the current anti- vaccination movement Sarah L. McHugh University of Northern Iowa Let us know how access to this document benefits ouy Copyright ©2016 Sarah L. McHugh Follow this and additional works at: https://scholarworks.uni.edu/hpt Part of the Infectious Disease Commons, and the Preventive Medicine Commons Recommended Citation McHugh, Sarah L., "A healthy herd: addressing the justifications for accinev denial and applying the health belief model to the current anti-vaccination movement" (2016). Honors Program Theses. 225. https://scholarworks.uni.edu/hpt/225 This Open Access Honors Program Thesis is brought to you for free and open access by the Honors Program at UNI ScholarWorks. It has been accepted for inclusion in Honors Program Theses by an authorized administrator of UNI ScholarWorks. For more information, please contact [email protected]. A HEALTHY HERD: ADDRESSING THE JUSTIFICATIONS FOR VACCINE DENIAL AND APPLYING THE HEALTH BELIEF MODEL TO THE CURRENT ANTI- VACCINATION MOVEMENT A Thesis Submitted in Partial Fulfillment of the Requirements for the Designation University Honors with Distinction Sarah L. McHugh University of Northern Iowa May 2016 This Study by: Sarah L. McHugh Entitled: A Healthy Herd: Addressing the Justifications for Vaccine Denial and Applying the Health Belief Model to the Current Anti-vaccination Movement has been approved as meeting the thesis or project requirement for the Designation University Honors with Distinction __________ ______________________________________________________ Date Dr. Thomas Davis, Honors Thesis Advisor, Division of Health Promotion and Education, School of Health, Physical Education and Leisure Services __________ ______________________________________________________ Date Dr. -
Vaccines You Might Need?
Do You Know Which Adult Vaccines You Might Need? Vaccines are recommended for all adults based on factors such as age, travel, occupation, medical history, and vaccines they have had in the past. Below are the main vaccines you might need. But, this list may not include every vaccine that you need. Find out which vaccines you need by taking the quiz at: www.cdc.gov/vaccines/AdultQuiz/ ALL adults 19 and older, including pregnant women, need: Influenza vaccine every year • A flu vaccine is especially important for people with chronic health conditions, pregnant women, and older adults Tetanus, diphtheria, and pertussis (whooping cough) vaccine (Tdap) • Adults should get a one-time dose of Tdap. Adults can get Tdap no matter when they got their last tetanus vaccine (Td), which is given every 10 years • Pregnant women should get Tdap to protect themselves and their newborn babies from whooping cough In addition to influenza and Tdap vaccines, you may also need other vaccines depending on your age or other factors. Flip the page to learn more. Talk to your healthcare provider about which vaccines are right for you. National Center for Immunization and Respiratory Diseases Immunization Services Division CS235267 In addition to influenza and Tdap vaccines, you may also need other vaccines depending on your age… Young adults not yet vaccinated need: Adults born in the US in 1980 or after need: Human papillomavirus (HPV) vaccine series Varicella “chickenpox” vaccine* (3 doses) if you are: • Adults should get 2 doses of chickenpox vaccine • -
Considerations for Causality Assessment of Neurological And
Occasional essay J Neurol Neurosurg Psychiatry: first published as 10.1136/jnnp-2021-326924 on 6 August 2021. Downloaded from Considerations for causality assessment of neurological and neuropsychiatric complications of SARS- CoV-2 vaccines: from cerebral venous sinus thrombosis to functional neurological disorder Matt Butler ,1 Arina Tamborska,2,3 Greta K Wood,2,3 Mark Ellul,4 Rhys H Thomas,5,6 Ian Galea ,7 Sarah Pett,8 Bhagteshwar Singh,3 Tom Solomon,4 Thomas Arthur Pollak,9 Benedict D Michael,2,3 Timothy R Nicholson10 For numbered affiliations see INTRODUCTION More severe potential adverse effects in the open- end of article. The scientific community rapidly responded to label phase of vaccine roll- outs are being collected the COVID-19 pandemic by developing novel through national surveillance systems. In the USA, Correspondence to SARS- CoV-2 vaccines (table 1). As of early June Dr Timothy R Nicholson, King’s roughly 372 adverse events have been reported per College London, London WC2R 2021, an estimated 2 billion doses have been million doses, which is a lower rate than expected 1 2LS, UK; timothy. nicholson@ administered worldwide. Neurological adverse based on the clinical trials.6 kcl. ac. uk events following immunisation (AEFI), such as In the UK, adverse events are reported via the cerebral venous sinus thrombosis and demyelin- MB and AT are joint first Coronavirus Yellow Card reporting website. As of ating episodes, have been reported. In some coun- authors. early June 2021, approximately 250 000 Yellow tries, these have led to the temporary halting of BDM and TRN are joint senior Cards have been submitted, equating to around authors. -
Medicine Safety “Pharmacovigilance” Fact Sheet
MINISTRY OF MEDICAL SERVICES MINISTRY OF PUBLIC HEALTH AND SANITATION PHARMACY AND POISONS BOARD MEDICINE SAFETY “PHARMACOVIGILANCE” FACT SHEET What is medicine safety? Medicine safety, also referred to as Pharmacovigilance refers to the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medicines, biological products, herbals and traditional medicines. It aims at identifying new information about hazards, and preventing harm to patients. What is an Adverse Drug Reaction? The World Health Organization defines an adverse drug reaction (ADR) as "A response to a drug which is noxious and unintended, and which occurs at doses normally used or tested in man for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function". Simply put, when the doctor prescribes you medicines, he expects the desirable effects of them. The undesired effects of the medicines is the ADR or, commonly known as “side effects”. An adverse drug reaction is considered to be serious when it is suspected of causing death, poses danger to life, results in admission to hospital, prolongs hospitalization, leads to absence from productive activity, increased investigational or treatment costs, or birth defects. Age, gender, previous history of allergy or reaction, race and genetic factors, multiple medicine therapy and presence of concomitant disease processes may predispose one to adverse effects. Why monitor adverse drug reactions? Before registration and marketing of a medicine, its safety and efficacy experience is based primarily on clinical trials. Some important adverse reactions may not be detected early or may even be rare. -
SCIENCE and HEALTH MISINFORMATION in the DIGITAL AGE: How Does It Spread? Who Is Vulnerable? How Do We Fight It?
SCIENCE AND HEALTH MISINFORMATION IN THE DIGITAL AGE: How does it spread? Who is vulnerable? How do we fight it? ERIC MERKLEY & PETER LOEWEN J U LY, 2021 ABOUT PPF Good Policy. Better Canada. The Public Policy Forum builds bridges among diverse participants in the policy-making process and gives them a platform to examine issues, offer new perspectives and feed fresh ideas into critical policy discussions. We believe good policy is critical to making a better Canada—a country that’s cohesive, prosperous and secure. We contribute by: . Conducting research on critical issues . Convening candid dialogues on research subjects . Recognizing exceptional leaders Our approach—called Inclusion to Conclusion—brings emerging and established voices to policy conversations, which informs conclusions that identify obstacles to success and pathways forward. PPF is an independent, non-partisan charity whose members are a diverse group of private, public and non-profit organizations. ppforum.ca @ppforumca © 2021, Public Policy Forum 1400 - 130 Albert Street Ottawa, ON, Canada, K1P 5G4 613.238.7858 ISBN: 978-1-77452-085-7 WITH THANKS TO OUR PARTNERS ABOUT THE AUTHORS ERIC MERKLEY Eric Merkley (PhD, UBC) is an Assistant Professor in the Department of Political Science at the University of Toronto. He was the lead survey analyst of the Media Ecosystem Observatory, which studied the Canadian information ecosystem and public opinion during the COVID-19 pandemic, and the Digital Democracy Project, which studied misinformation and public attitudes during the 2019 Canadian federal election. His research focuses on the link between political elite behaviour, the news media, and public opinion. -
Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP:VAERS)
Grant Final Report Grant ID: R18 HS 017045 Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP:VAERS) Inclusive dates: 12/01/07 - 09/30/10 Principal Investigator: Lazarus, Ross, MBBS, MPH, MMed, GDCompSci Team members: Michael Klompas, MD, MPH Performing Organization: Harvard Pilgrim Health Care, Inc. Project Officer: Steve Bernstein Submitted to: The Agency for Healthcare Research and Quality (AHRQ) U.S. Department of Health and Human Services 540 Gaither Road Rockville, MD 20850 www.ahrq.gov Abstract Purpose: To develop and disseminate HIT evidence and evidence-based tools to improve healthcare decision making through the use of integrated data and knowledge management. Scope: To create a generalizable system to facilitate detection and clinician reporting of vaccine adverse events, in order to improve the safety of national vaccination programs. Methods: Electronic medical records available from all ambulatory care encounters in a large multi-specialty practice were used. Every patient receiving a vaccine was automatically identified, and for the next 30 days, their health care diagnostic codes, laboratory tests, and medication prescriptions were evaluated for values suggestive of an adverse event. Results: Restructuring at CDC and consequent delays in terms of decision making have made it challenging despite best efforts to move forward with discussions regarding the evaluation of ESP:VAERS performance in a randomized trial and comparison of ESP:VAERS performance to existing VAERS and Vaccine Safety Datalink data. However, Preliminary data were collected and analyzed and this initiative has been presented at a number of national symposia. Key Words: electronic health records, vaccinations, adverse event reporting The authors of this report are responsible for its content.