DOCSLIB.ORG

CSW Presentation 041721.Pptx

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
CSW Presentation 041721.Pptx 4/15/21 COVID 19 Vaccines 101: Outline – Hour 1 Vaccine Development and Regulatory Landscape n Part 1 – COVID-19 Vaccine Development Landscape (10:00 – April 17, 2021 11:00 AM) • Human Immune System Basics • Overview and Typology of Vaccines Vicky Pebsworth, PhD, RN • COVID-19 Vaccines Director of Research and Patient Safety • Vaccine Components National Vaccine Information Center Outline – Hour 2 n Part 2- COVID-19 Vaccine Regulatory Landscape (11:00 – 12:00 AM) • Policymaking - Federal Agencies and Advisory Committees, State Legislatures and Departments of Health • Research, Approval and Licensure Part 1. COVID-19 Vaccine Development Landscape Processes • Post-marketing Surveillance HUMAN IMMUNE SYSTEM • Current and Emerging COVID-19 BASICS Vaccine Issues Immune System Basics Innate Immune System n Innate (non-specific) immune system n Three main parts • Primary line of defense • Barrier part • Rapid response n Skin, mucosal and epithelial lining of the n Adaptive (specific, acquired) immune respiratory and gastrointestinal system system • Cells • Secondary line of defense n Mast cells, macrophages, granulocytes, • Slow response (the first exposure) dendritic cells • Specific, recognizes and targets specific • Lymphocytes (not specific to an antigens antigen) • Has memory to attack known antigens n Natural killer(NK) cells, gamma delta cells 1 4/15/21 Adaptive Immune System n Two separate, overlapping arms • Humoral (anti-body mediated) immunity n B lymphocytes/B cells • Antibodies (Ab) n Binding antibody (BAb) n Neutralizing (NAb) • Cellular (cell-mediated) immunity n T lymphocytes / T cells • Helper T cells/ CD4+ (Th1 and Th2) • Killer (cytotoxic) T cells/ CD8+ Infection and Immunity Part 1. COVID-19 Vaccine Development Landscape OVERVIEW AND TYPOLOGY OF VACCINES NIH Vaccine Classification Vaccine Overview Antigen Categories n Goals of vaccination 1. Whole Pathogen Vaccines n Categories by antigen type 2. Subunit Vaccines n Non-antigen vaccine components 3. Nucleic Acid Vaccines 2 4/15/21 Whole Pathogen Vaccines Subunit Vaccines 1. Live, attenuated 1. Component n Acellular pertussis n Measles, mumps, rubella, varicella 2. Polysaccharide (chickenpox), influenza (nasal spray), polio n Haemophilus influenzae type B (oral), smallpox, yellow fever, zoster 3. Conjugate (shingles) n Pneumococcal, meningococcal, Hib 2. Inactivated 4. Toxoid n Hepatitis A (Havrix), influenza, polio n Tetanus, diphtheria (injectable), rabies, whole cell pertussis 5. Recombinant protein n Hepatitis B, influenza 6. Virus-like particles n Human papillomavirus Nucleic Acid Vaccines Nucleic Acid Vaccines n Nucleic acid • DNA • RNA • Recombinant viral vector n Replicating n Non-replicating Nature 580, 576-577, 2020 Viral Vector and Protein Whole Pathogen Vaccines Vaccines 3 4/15/21 Milken Institute Part 1. COVID-19 Vaccine Development Landscape COVID-19 VACCINES New York Times World Health Organization Global Vaccines in Clinical US Operation Warp Speed Trials Type Developer Name Phase Total n 272 (total) = 184 (pre-clinical) + 88 (clinical trials) Whole 0 • Whole Pathogen – 16% Subunit Protein Novavax NVX-CoV2373 3 2 n Live – 2% Protein Sanofi/GSK VAT00002 3 n Inactivated – 14% Nucleic RNA Moderna/NIH mRNA-1273/1283 4 5 • Subunit – 37% n Protein subunit – 32% RNA BioNTech/Pfizer BNT162b2/ 4 n Virus-like particle – 5% Comirnaty • Nucleic Acid – 48% DNA Inovio INO-4800 2/3 n Viral vector – 23% Vector, NR Oxford/AstraZeneca AZD 1222/ 4 Covishield n RNA – 14% Vector, NR Janssen/J&J Ad26.COV2.5 4 n DNA – 11% Vector, R Merck/IAVI PC 4 4/15/21 COVID-19 Vaccine Types Vaccine Approaches n Whole Pathogen Vaccines • Live/attenuated • Inactivated n Subunit Vaccines • Recombinant viral protein • Virus like particles n Nucleic Acid Vaccines • RNA • DNA • Recombinant viral vector (replicating, non- replicating) US Funded COVID-19 Vaccines Pfizer/BioNTech n EUA n RNA: 3 LNP-mRNA (BNT162b) • Moderna n Emergency Use 12/11/20 • BioNTech/Pfizer n US, Canada, UK, Argentina, Mexico, • Janssen/J&J Saudi Arabia, Bahrain, European n Non-EUA/Phase 3 or 2/3 Commission • AstraZeneca/Oxford n Pediatric trials, 12-15, 11 to 6 mos. • Novavax • Sanofi Pasteur Moderna/NIAID Janssen/Johnson & Johnson n RNA: LNP-encapsulated mRNA n Non-Replicating Viral (mRNA-1273) Vector:Ad26.COV2-2 n Emergency Use 12/18/20 n Emergency Use 2/27/21 (US only) n US, Canada, Israel, Switzerland, EU, n Single dose UK n Trials expanded to 12-17 y/o n Pediatric trials, 12-18, <12 n Modified vaccine – mRNA 1283 – trial 3/15/21 5 4/15/21 Univ of Oxford/AstraZeneca Novavax/Emergent Biosolutions n Non-Replicating Viral Vector: AZD n Subunit:Recombinant Adjuvanted 1222 (ChAdOx1) Glycoprotein: NVX-CoV2373 n Not authorized in US n Phase 3 n Used in UK, Argentina, Brazil, n Potential for EUA May 2021 Dominican Republic, El Salvador, India, Mexico, Morocco, Pakistan Sanofi Pasteur/GSK n Subunit: Recombinant Protein, Baculovirus n Phase 2 n Potential for EUA late fall 2021 Part 1. COVID-19 Vaccine Development Landscape VACCINE COMPONENTS Vaccine Excipients Preservatives Non-antigen Components n Preservatives n Benzethonium chloride n Adjuvants n EDTA n Inactivating chemicals n Formaldehyde n Cell and growth culture materials, nutrients n Phenol n Antimicrobials n Thimerosal n Stabilizers, buffers, protein purifiers n 2-Phenoxyethanol n Surfactants n Other 6 4/15/21 Adjuvants Inactivating Chemicals n Aluminum - Amorphous aluminum n Formaldehyde hydroxyphosphate sulfate, aluminum n Glutaraldehyde hydroxide, aluminum phosphate, potassium aluminum sulfate (alum) n Beta-propiolactone n AS04 - Monophosphoryl lipid A (MPL) + aluminum salt n AS01 - MPL + QS-21 (soap bark) n MF59 – squalene n CpG 1018 – synthetic DNA Cell and Growth Cultures Medium Nutrients n Cell cultures and manufacturing n Medium nutrients residue • Amino acids, casein and extract (cow), • Aborted fetal cell strain – MRC-5, WI-38, calcium chloride, carbohydrates, • Animal - Vero cells – African green dextrose, dimethyl-beta-cyclodexrin, monkey kidney cells DMEM, ferric nitrate, galactose, glutamate, histidine, hydrocortisone, L- n Residual mediums cystine, L-histadine, L-tyrosine, • Albumin (egg), chick embryo lactalbumin hydrolysate, magnesium • DNA – human, porcine, insect, sulfate, peptone (soy),salts, sodium pyruvate, vitamins, yeast Antimicrobials Stabilizers n Antibiotics n Stabilizers • Amphotericin B, Chlortetracycline, • 2-phenoxyethanol, albumin (human, Gentamicin sulfate, Kanamycin, bovine, bovine serum, calf serum, calf Neomycin, Neomycin sulfate, Polymyxin, serum protein, fetal bovine serum), Polymyxin B, Polymyxin B sulfate, bovine extract, bovine casamino acid, Streptomycin gelatin (hydrolyzed and porcine hydrolyzed), lactose, monosodium n Phenol glutamate, monosodium l-glutamate, n Thimerosal potassium glutamate, sodium borate, sodium metabisulphite, succinate buffer, sucrose, sorbitol 7 4/15/21 Buffers Protein Purifiers n Calcium carbonate n Ammonium sulfate n Phosphates – monobasic potassium, n Chick fibroblasts monobasic sodium, diabasic sodium, n CTAB potassium dihydrogen, unspecified n Hexadecyltrimethylammonium n Potassium chloride bromide, n Sodium bicarbonate n Protamine sulfate n Sodium Borate n Sodium taurodeoxycholate n Vitamins Surfactants Other excipients n Polysorbate 20 n Latex n Gelatin n Polysorbate 80 n Xanthum (thickening agent) n Nonylphenol ethoxylate n Mineral salts (tone adjuster) n Octoxynol-10 (Tritan X-100) n Ascorbic acid (antioxidant) n Magnesium stearate (lubricant) n Octylphenol ethoxylate n Unspecified function – barium, citric n Sodium deoxycholate acid monohydrate, sodium citrate dihydrate, sorbitan trioleate, sodium hydroxide Aborted Fetal Cell Strains Aborted Fetal Cell Strains Non-COVID-19 Vaccines COVID-19 Vaccines n Human DNA and cell protein n HEK293 cells – kidney cells, female • MRC-5 – lung fibroblast, 14 week old male fetus • WI-38 – lung fibroblast, 12 week old female • Viral Vector n Vaccines n University of Oxford/AstraZeneca (UK/USA) • Hepatitis A (Hepatitis A and B formulas) • mRNA • Chickenpox (varicella) n ? • Rubella (included in MMR and MMRV) • Zoster n PER.C6 – retinal cells, 18 w fetus • Adenovirus • Viral Vector • Rabies n Janssen/ J&J (USA) 8 4/15/21 COVID-19 Vaccine Ingredients n Polyethylene glycol (PEG2000) n Matrix M – saponin (Chilean soapbark) n HEK293 cells n PER.C6 cells Part 2. COVID-19 Vaccine Regulatory Landscape n sf9 insect cells POLICYMAKING – FEDERAL AGENCIES AND ADVISORY COMMITTEES, STATE LEGISLATURES AND DEPARTMENTS OF HEALTH Federal Vaccine Advisory Vaccine Policymaking Committees n HHS – National Vaccine Program n Federal recommendations • NVAC (National Vaccine Advisory Committee) n FDA – Center for Biologics Evaluation and n State laws Research • Vaccine mandates/exemptions • VRBPAC (Vaccines and Related Biologic Products Advisory Committee) n Three exemption types n CDC – Immunization Services Division • NVIC Advocacy Portal • ACIP (Advisory Committee on Immunization (nvicadvocacy.org) Practices) n HRSA – • ACCV (Advisory Commission on Childhood Vaccines) Research and Approval Process n Preclinical – animals, immune response, 6 mo. n Phase I – small, dosing, safety, immune, 6 mo. n Phase II – larger, immune, safety, 1 yr. n Phase III – largest, placebo-controlled, effectiveness, safety, 3+ yrs. Part 2. COVID-19 Vaccine Regulatory Landscape n Approval/Licensure review, VRBPAC, ACIP RESEARCH, APPROVAL AND • Licensure vs EUA n Phase IV – post-marketing surveillance, LICENSURE PROCESSES safety 9 4/15/21 WHO / Cochrane Collaboration Ongoing COVID-19 Trials Published
Load more

Recommended publications
  • Adjuvants and Additives in Human and Animal Vaccines
    Medical Research Archives Volume 2 Issue 5 July 2016. Adjuvants and Additives in Human and Animal Vaccines ADJUVANTS AND ADDITIVES IN HUMAN AND ANIMAL VACCINES *Author W. Jean Dodds, DVM Hemopet, 938 Stanford Street, Santa Monica, California, United States of America Email: [email protected] Abstract : Vaccines typically contain immunologic adjuvants and other additives which act to accelerate, prolong, or enhance antigen-specific immune responses when used together with specific vaccine antigens. Nevertheless, despite ongoing questions about their efficacy and safety, millions of individuals have received these vaccines with relatively few documented adverse events. Vaccine pharmacovigilance is the term used to remind all of us that vaccines carry an inherent, albeit small, risk ( CIOMS/WHO 2012) . Key words: vaccine, adjuvants, additives Copyright 2016 KEI Journals. All rights reserved. 1 Medical Research Archives Volume 2 Issue 5 July 2016. Adjuvants and Additives in Human and Animal Vaccines Introduction: Tomljenovic L 2013, Shaw CA, Li D and Countless individuals have been vaccinated Tomljenovic L 2014, Spickler AR and Roth routinely and repeatedly for the common, JA 2003, Stejskal V 2013, Tomljenovic L and Shaw CA 2012, 2016, Vogel FR 2000, serious infectious viral and bacterial diseases without obvious untoward effects Wilson-Welder JH et al. 2009). (Dodds WJ 1997, 1999, Tizard I 1990, While current vaccine adjuvants can Wellborn LV et al. 2011). But, medical successfully generate humoral antibody- professionals still need to be aware of the mediated protection, other diseases such as potential for adverse events (AE) and tuberculosis and malaria require a cell- determine what constitutes "acceptable" mediated immune response for adequate harm (Dodds WJ 1997,1999, Tizard I 1990).
    [Show full text]
  • 1 Complaint 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22
    Case 1:20-cv-00364 Document 1 Filed 08/19/20 Page 1 of 82 PageID #: 1 1 IN THE UNITED STATES DISTRICT COURT 2 FOR THE DISTRICT OF RHODE ISLAND 3 JULIA BALASCO, Case No. 4 Plaintiff, 5 v. COMPLAINT FOR 6 MERCK & CO., INC., a New Jersey Corporation; (1) Negligence and MERCK SHARP & DOHME CORP., a New (2) Strict Liability (Failure to Warn) 7 Jersey Corporation, (3) Strict Liability (Manufacturing Defect) 8 Defendants. (4) Breach of Warranty 9 (5) Common Law Fraud 10 (6) Violation of Rhode Island’s Deceptive Trade Practices Act 11 12 DEMAND FOR JURY TRIAL 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 1 COMPLAINT Case 1:20-cv-00364 Document 1 Filed 08/19/20 Page 2 of 82 PageID #: 2 TABLE OF CONTENTS 1 2 INTRODUCTION ................................................................................................................................... 5 3 PARTIES AND VENUE ........................................................................................................................ 5 4 GENERAL ALLEGATIONS ................................................................................................................. 7 5 I. “History Doesn’t Repeat Itself, But It Often Rhymes” – Mark Twain ........................................ 7 6 II. In Bringing Its Holy Grail, Gardasil, to Market, Merck Engaged in the Same Fraudulent 7 Research and Marketing It Had Engaged in Vis-à-vis Vioxx Resulting In Patients Being 8 Exposed to a Vaccine That is Of Questionable Efficacy and Which Can Cause Serious and Debilitating Adverse Events ........................................................................................................
    [Show full text]
  • Systematic Scoping Review on Social Media Monitoring Methods and Interventions Relating to Vaccine Hesitancy
    TECHNICAL REPORT Systematic scoping review on social media monitoring methods and interventions relating to vaccine hesitancy www.ecdc.europa.eu ECDC TECHNICAL REPORT Systematic scoping review on social media monitoring methods and interventions relating to vaccine hesitancy This report was commissioned by the European Centre for Disease Prevention and Control (ECDC) and coordinated by Kate Olsson with the support of Judit Takács. The scoping review was performed by researchers from the Vaccine Confidence Project, at the London School of Hygiene & Tropical Medicine (contract number ECD8894). Authors: Emilie Karafillakis, Clarissa Simas, Sam Martin, Sara Dada, Heidi Larson. Acknowledgements ECDC would like to acknowledge contributions to the project from the expert reviewers: Dan Arthus, University College London; Maged N Kamel Boulos, University of the Highlands and Islands, Sandra Alexiu, GP Association Bucharest and Franklin Apfel and Sabrina Cecconi, World Health Communication Associates. ECDC would also like to acknowledge ECDC colleagues who reviewed and contributed to the document: John Kinsman, Andrea Würz and Marybelle Stryk. Suggested citation: European Centre for Disease Prevention and Control. Systematic scoping review on social media monitoring methods and interventions relating to vaccine hesitancy. Stockholm: ECDC; 2020. Stockholm, February 2020 ISBN 978-92-9498-452-4 doi: 10.2900/260624 Catalogue number TQ-04-20-076-EN-N © European Centre for Disease Prevention and Control, 2020 Reproduction is authorised, provided the
    [Show full text]
  • Responding to Parents' Questions Regarding Polysorbate 80, Aluminum, and Thimerosal in Vaccines
    Brigham Young University BYU ScholarsArchive Student Works 2021-08-09 Responding to Parents' Questions Regarding Polysorbate 80, Aluminum, and Thimerosal in Vaccines Elli Hugh [email protected] Beth Luthy Brigham Young University - Provo Follow this and additional works at: https://scholarsarchive.byu.edu/studentpub Part of the Nursing Commons BYU ScholarsArchive Citation Hugh, Elli and Luthy, Beth, "Responding to Parents' Questions Regarding Polysorbate 80, Aluminum, and Thimerosal in Vaccines" (2021). Student Works. 323. https://scholarsarchive.byu.edu/studentpub/323 This Peer-Reviewed Article is brought to you for free and open access by BYU ScholarsArchive. It has been accepted for inclusion in Student Works by an authorized administrator of BYU ScholarsArchive. For more information, please contact [email protected]. Responding to Parents’ Questions Regarding Polysorbate 80, Aluminum, and Thimerosal in Vaccines Elli Hugh A scholarly paper submitted to the faculty of Brigham Young University in partial fulfillment of the requirements for the degree of Master of Science Karlen E. (Beth) Luthy, Chair College of Nursing Brigham Young University Copyright © 2021 Elli Hugh All Rights Reserved ABSTRACT Responding to Parents’ Questions Regarding Polysorbate 80, Aluminum, and Thimerosal in Vaccines Elli Hugh College of Nursing, BYU Master of Science Vaccines save millions of lives worldwide every year. Nevertheless, misinformation regarding vaccine ingredients circulates on various media platforms and may negatively influence parental decisions regarding childhood vaccinations. Three vaccine ingredients commonly associated with parental vaccine concerns include polysorbate 80, aluminum, and thimerosal. Common misconceptions about polysorbate 80 and neurological sequela exist within the vaccine hesitant community. Additionally, aluminum has been incorrectly connected to chronic disease in children.
    [Show full text]
  • COVID-19 Vaccines: Safety Surveillance Manual
    COVID-19 Vaccines: Safety Surveillance Manual Module: COVID-19 vaccine safety communication Contents Abbreviations..................................................................................................................... ii Glossary ............................................................................................................................ iii 1. COVID-19 vaccine safety communication.....................................................................6 2. Factors influencing vaccine safety perceptions .............................................................6 2.1. Individual intentions towards COVID-19 vaccination ....................................................7 2.2. Negative messages ..................................................................................................9 2.3. Environmental influences ....................................................................................... 10 3. Recommendations for a vaccine safety communications approach ............................ 11 3.1. Plan and prepare prior to vaccine introduction.......................................................... 12 3.2. Set up lines of communication ................................................................................ 13 3.3. Identify potential threats to confidence in vaccine safety ........................................... 14 3.4. Listen proactively .................................................................................................. 15 3.5. Communicate in ways that build understanding
    [Show full text]
  • September 2018 Meeting Minutes
    Advisory Commission on Childhood Vaccines (ACCV) Adobe Connect Webinar and Telephone Conference meeting September 6, 2018 Members Present Karlen E. (Beth) Luthy, D.N.P., (’18), Chair Kathleen F. Gaffney, PhD, RN (’19) John Howie, J.D., (’19) Tina Tan, MD, (’19) Alexandra Stewart, J.D., (’18) Division of Injury Compensation Programs (DICP), Health Resources and Services Administration (HRSA), U.S. Department of Health and Human Services (HHS) Narayan Nair, M.D., Director, DICP Andrea Herzog, Principal Staff Liaison, ACCV Welcome and Report of the Chair, Beth Luthy, ACCV Ms. Luthy called the meeting to order, welcomed the commission members, DICP staff, ex officio members, and guests on the teleconference call. A role call confirmed the presence of a quorum. Public Comment on Agenda Items, Ms. Beth Luthy, Chair The invitation to submit comments on agenda items was announced by the conference operator and there was one request to speak: (1) Theresa Wrangham, Executive Director of the National Vaccine Information Center (NVIC) requested that the Process Work Group look at ways to enhance the program’s interaction with the public. Ms. Wrangham discussed petitions to add injuries to the Vaccine Injury Table (the Table) and noted that they may be submitted to the ACCV by anyone. Currently HRSA responds to petitions with a PowerPoint presentation of about 20 minutes, and then responds to questions from the ACCV commissioners. However, the parties who submit petitions have no opportunity for a similar response. The NVIC recommends that members of the public who submit petitions be allowed that opportunity to make a presentation to the Commission.
    [Show full text]
  • COVID-19 Vaccine Information / FAQ – January 2021 Both the Pfizer
    COVID-19 Vaccine Information / FAQ – January 2021 Both the Pfizer/BioNTech vaccine and the Moderna vaccine for COVID-19 have been fully approved for emergency use by the Food and Drug Administration (FDA). Both require two doses—Pfizer 21 days apart; Moderna 28 days apart. It is recommended that you take both doses from the same company. What are the COVID vaccines and are they effective? The COVID vaccines are the world’s first mRNA (messenger ribonucleic acid) vaccines, but the technology used to create them is not new. The mRNA vaccine tricks the body into making the COVID-19 protein itself, which in turn triggers an immune response and antibodies. The mRNA does not enter a cell’s nucleus, so it does not alter the recipient’s own DNA. The Pfizer vaccine has proven to be 95% effective in clinical trials; Moderna 94.1% effective. By comparison, the CDC says recent studies show that the flu vaccine reduces the risk of flu illness by between 40% and 60% among the overall population. Are the new COVID vaccines safe? The U.S. vaccine safety system ensures that all vaccines are as safe as possible, according to the CDC. In the case of the COVID vaccines from Pfizer and Moderna, no scientific steps were skipped. The approval process was sped up, but no corners were cut. One of the biggest differences was that Phase 2 was begun while Phase I was still happening. Steps like funding and permission applications were accelerated. It should also be noted that mRNA is manufactured by chemical rather than biological synthesis, so it is much quicker than conventional vaccines to be redesigned, scaled up and mass-produced.
    [Show full text]
  • Childhood Immunizations (PDF)
    Childhood Immunizations Maria Dycoco, MD Division of General Academic Pediatrics Director of Medical Student Programs Children’s Mercy Hospital Kansas City, Missouri Disclosures • I have nothing to disclose. Objectives • By the end of this discussion, participants should: • Become familiar with the history of the development of vaccines • Have a better understanding of the impact of vaccines in the health of children • Have more awareness of the misconceptions about the safety of vaccines • Be aware of discussion strategies for a parent/caregiver with vaccine hesitancy Birth of Vaccines • Discovery that exposure to cowpox conferred protection to smallpox • Evidence of practices hundreds of years ago • 1774: Benjamin Jesty – inoculated his family with cowpox to prevent smallpox • 1796: Edward Jenner developed and promoted the first smallpox vaccine using cowpox material Source: The 1901 Atlas of Clinical Medicine, Surgery, and Pathology, photographs by Dr. Allan Warner Types of Vaccines • Live-attenuated vaccines • Use weakened version of virus • Conveys longer immunity/protection similar to that protection as having had infection • Lifelong immunity after just 1-2 doses • Not given to those with immunocompromise • Vaccines: MMR, Varicella, Rotavirus • Inactivated vaccines and subunit or conjugate vaccines • Use killed versions or parts of virus or bacteria • Cannot cause illness • Need boosters more often • Vaccines: Polio (IPV), Influenza, Hepatitis B Impact of Vaccines • Eradication or dramatic decrease in the prevalence of many infections causing significant morbidity and mortality • Decrease in medical costs for treatments and hospitalizations • Decrease in time away from work for family members • Decrease in time away from school for children Global Impact of Vaccines 1988-2015 2000-2014 Graphic from CDC; The Global AFGHANISTAN Annual estimated meas/es deaths declined 79%, Impact of Vaccines in Reducing PAKISTAN From 546,800 lo 114,900.
    [Show full text]
  • The Expanding Cocktail of Harmful Ingredients in Human
    Frontiers in Women’s Health Commentary ISSN: 2398-2799 The expanding cocktail of harmful ingredients in human papillomavirus vaccines Arthur E Brawer* and Deborah H Sullivan Monmouth Medical Center, Long Branch, New Jersey 07740, USA Vaccination-induced disorders are a genuine reality that continue to (commonly known as silica), and sorbitol. All three have recently generate intense controversy. Although the majority of immunization been implicated as participants causing systemic toxicity in Gardasil recipients have little or no safety issues, that does not detract from the recipients. Any autoimmune features in these scenarios have been occurrences of multiple systemic diseases initiated by a wide variety of relegated to secondary amplification loops that circuitously enhance parenteral vaccine exposures. Over the past four decades case reports of the disorder once it is already underway [4,5]. As the list of known chronic vaccination-induced disorders have generally segregated into harmful substances present in Gardasil expands, multiple overlapping two main categories: (a) autoimmune and autoinflammatory diseases; pathophysiologic disruptions of the body’s biochemistry become and (b) neuro-psychiatric diseases, characterized by overlapping clinical more and more plausible. Perhaps the most glaring new revelation is the features of the various neurologic fatiguing syndromes [1-5]. Afflicted Identification of volatile organic compounds in the toluene and benzene individuals in category “b” are typically Gardasil vaccine recipients. families that persist in the finished Gardasil products [22]. Official They manifest widespread generalized pain, fatigue, muscle weakness, chemical designations are phenylmethylsulfonyl fluoride (PMSF) and and small fiber neuropathy, along with mood and sleep disturbances, aminoethylbenzenesulfonyl fluoride (AEBSF) respectively. A synonym lethargy, headaches, dizziness, vertigo, reduced alertness, tinnitus, for PMSF is toluenesulfonyl fluoride.
    [Show full text]
  • Common Questions About Vaccine Ingredients
    Common Questions about Vaccine Ingredients Do vaccines contain harmful toxic substances? Every vaccine undergoes safety testing before it is released, and manufacturers are required to list the contents of the vaccine for the Food and Drug Administration (FDA). G In addition to the dead or weakened germ (or other purified components that are included in vaccines because they stimulate the immune system), vaccines usually contain sterile water or saline. G Some vaccines are prepared with a preservative or antibiotic (to prevent bacterial growth). G Some vaccines also are prepared with substances known as stabilizers (to help the vaccine maintain its effectiveness during storage). G Another component of some vaccines is an adjuvant, such as aluminum (to help stimulate the production of antibodies against the vaccine and make it more effective). Under strict supervision of the FDA, vaccines are tested by pharmaceutical companies throughout the development and manufacturing process and after the vaccine is licensed and made available for use. The FDA inspects the factory where the vaccine is produced to be sure that the vaccine is made in a safe and consistent manner. Each batch of vaccine is tested for purity, potency, and safety before it is given to children. A sample from each lot is sent to the FDA. In addition, the FDA sets limits on how much of a component, such as aluminum or thimerosal, may be included in a vaccine. In 1999, a preservative known as thimerosal received attention because it contains mercury. As a part of a larger effort to examine environmental exposure to mercury, an FDA audit determined that while no individual vaccine contains more mercury (as part of the preservative thimerosal) than recommended, when considered together, some children might receive an amount of mercury that exceeds the guidelines of one federal agency Environmental Protection Agency (EPA) but not others (FDA and CDC).
    [Show full text]
  • Vaccines: Religio-Cultural Arguments from an Islamic Perspective
    Ethics Vol 6 - No. 2 | December 2020 | www.jbima.com Vaccines: Religio-cultural arguments from an Islamic perspective Mufti Usman Maravia, ESRC Centre for Corpus Approaches to Social Science (CASS) Bailrigg House, Lancaster University Correspondence: [email protected] Keywords: fatwas, gelatine, ingredients, Muslims, Pfizer-BioNTech COVID-19 vaccine, vaccination, vaccines Abstract As of December 29, 2020, more than 70,750 deaths had been reported in the UK to have been caused by COVID-19. Although efforts are being made worldwide to develop a vaccine, the question British Muslims face is regarding the Islamic ruling on the Pfizer-BioNTech COVID-19 vaccine. For this purpose, this article provides an analysis of the research into the main arguments made from an Islamic perspective concerning vaccines. These arguments are extrapolated from the discourse on vaccination by examining key fatwas and events since the late 1980s. My research finds that the 57 member states of the Organisation of Islamic Cooperation (OIC) have been and continue to be strongly in favour of eradicating infectious diseases through the use of vaccines. The arguments made against vaccines are based on a) an interpretation of the Qur’an that the human immune system is not designed to be vaccinated through intramuscular (IM) or oral vaccines and b) that vaccines contain dangerous ingredients. Moreover, in war-ravaged Muslim countries, notions have emerged that vaccines are adulterated to sterilise Muslim women. This article is aimed to help British muftis, Muslim faith leaders, healthcare professionals in the UK, the NHS and PHE to help contextualise the arguments put forward against vaccines in the effort to overcome challenges in introducing the new Pfizer-BioNTech COVID- 19 vaccine.
    [Show full text]
  • Sharing Medicine
    !" # $ bit.ly/Sharing-Medicine #SharingMedicine Nations Unite. Respect the Virus. MAAD’OOKIING MSHKIKI SHARING MEDICINE First Nations, Inuit & Métis Perspectives & Knowledge Sharing on C VID-19 Vaccines What’s in the Messenger RNA (mRNA) vaccines approved by Health Canada: Pfizer-BioNTech & Moderna & how do they work? 1 !" # $ bit.ly/Sharing-Medicine #SharingMedicine Nations Unite. Respect the Virus. AS OF JANUARY 2021, THERE ARE TWO VACCINES APPROVED BY HEALTH CANADA: PFIZER-BIONTECH & MODERNA Other vaccines (AstraZeneca/Oxford and Johnson & Johnson/Janssen) are being reviewed by Health Canada. In general, common ingredients that make up a vaccine include: VACCINE COMPONENT SAMPLE INGREDIENTS WHAT THE COMPONENT DOES FATS 1,2-distearoyl-sn-glycero-3- A little fat molecule that carries the phosphocholine; lipid SM-102; mRNA into your body so that your body cholesterol knows to get to work SALTS Sodium acetate; potassium chloride; Keeps the pH or acidity of the vaccine basic sodium phosphate dihydrate stable, protects the fat molecule, and helps the body absorb the solution SUGAR Sucrose Helps keep the vaccine’s components stable and safe while the vaccine is being stored. SALINE SOLUTION H20 + sodium chloride Makes sure that the vaccine’s salt content roughly matches the salt content of the blood. A SNIPPET OF GENETIC mRNA Tells your body to make the COVID-19 CODE mRNA-1273 SARS-CoV-2 (moderna) spike protein but, without the rest of the (not the actual virus) BNT162b2 (Pfizer) virus, the spike is harmless. Your body’s immune system then starts creating antibodies to target the new protein. The mRNA does not stay in your body and does not enter your cells.
    [Show full text]