COVID-19 Vaccine Frequently Asked Questions
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Perspectives for Therapeutic HPV Vaccine Development Andrew Yang1†, Emily Farmer1†,T.C.Wu1,2,3,4 and Chien-Fu Hung1,4,5*
Yang et al. Journal of Biomedical Science (2016) 23:75 DOI 10.1186/s12929-016-0293-9 REVIEW Open Access Perspectives for therapeutic HPV vaccine development Andrew Yang1†, Emily Farmer1†,T.C.Wu1,2,3,4 and Chien-Fu Hung1,4,5* Abstract Background: Human papillomavirus (HPV) infections and associated diseases remain a serious burden worldwide. It is now clear that HPV serves as the etiological factor and biologic carcinogen for HPV-associated lesions and cancers. Although preventative HPV vaccines are available, these vaccines do not induce strong therapeutic effects against established HPV infections and lesions. These concerns create a critical need for the development of therapeutic strategies, such as vaccines, to treat these existing infections and diseases. Main Body: Unlike preventative vaccines, therapeutic vaccines aim to generate cell-mediated immunity. HPV oncoproteins E6 and E7 are responsible for the malignant progression of HPV-associated diseases and are consistently expressed in HPV-associated diseases and cancer lesions; therefore, they serve as ideal targets for the development of therapeutic HPV vaccines. In this review we revisit therapeutic HPV vaccines that utilize this knowledge to treat HPV-associated lesions and cancers, with a focus on the findings of recent therapeutic HPV vaccine clinical trials. Conclusion: Great progress has been made to develop and improve novel therapeutic HPV vaccines to treat existing HPV infections and diseases; however, there is still much work to be done. We believe that therapeutic HPV vaccines have the potential to become a widely available and successful therapy to treat HPV and HPV-associated diseases in the near future. -
Gavi's Vaccine Investment Strategy
Gavi’s Vaccine Investment Strategy Deepali Patel THIRD WHO CONSULTATION ON GLOBAL ACTION PLAN FOR INFLUENZA VACCINES (GAP III) Geneva, Switzerland, 15-16 November 2016 www.gavi.org Vaccine Investment Strategy (VIS) Evidence-based approach to identifying new vaccine priorities for Gavi support Strategic investment Conducted every 5 years decision-making (rather than first-come- first-serve) Transparent methodology Consultations and Predictability of Gavi independent expert advice programmes for long- term planning by Analytical review of governments, industry evidence and modelling and donors 2 VIS is aligned with Gavi’s strategic cycle and replenishment 2011-2015 Strategic 2016-2020 Strategic 2021-2025 period period 2008 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 RTS,S pilot funding decision VIS #1 VIS #2 VIS #3 MenA, YF mass campaigns, JE, HPV Cholera stockpile, Mid 2017 : vaccine ‘long list’ Rubella, Rabies/cholera studies, Oct 2017 : methodology Typhoid Malaria – deferred Jun 2018 : vaccine shortlist conjugate Dec 2018 : investment decisions 3 VIS process Develop Collect data Develop in-depth methodology and Apply decision investment decision framework for cases for framework with comparative shortlisted evaluation analysis vaccines criteria Phase I Narrow long list Phase II Recommend for Identify long list to higher priority Gavi Board of vaccines vaccines approval of selected vaccines Stakeholder consultations and independent expert review 4 Evaluation criteria (VIS #2 – 2013) Additional Health Implementation -
Gamma-Irradiated SARS-Cov-2 Vaccine Candidate, OZG-38.61.3, Confers Protection from SARS-Cov-2 Challenge in Human ACEII-Transgen
www.nature.com/scientificreports OPEN Gamma‑irradiated SARS‑CoV‑2 vaccine candidate, OZG‑38.61.3, confers protection from SARS‑CoV‑2 challenge in human ACEII‑transgenic mice Raife Dilek Turan1,2,19, Cihan Tastan1,3,4,19*, Derya Dilek Kancagi1,19, Bulut Yurtsever1,19, Gozde Sir Karakus1,19, Samed Ozer5, Selen Abanuz1,6, Didem Cakirsoy1,8, Gamze Tumentemur7, Sevda Demir2, Utku Seyis1, Recai Kuzay1, Muhammer Elek1,2, Miyase Ezgi Kocaoglu1, Gurcan Ertop7, Serap Arbak9, Merve Acikel Elmas9, Cansu Hemsinlioglu1, Ozden Hatirnaz Ng10, Sezer Akyoney10,11, Ilayda Sahin8,12, Cavit Kerem Kayhan13, Fatma Tokat14, Gurler Akpinar15, Murat Kasap15, Ayse Sesin Kocagoz16, Ugur Ozbek12, Dilek Telci2, Fikrettin Sahin2, Koray Yalcin1,17, Siret Ratip18, Umit Ince14 & Ercument Ovali1 The SARS‑CoV‑2 virus caused the most severe pandemic around the world, and vaccine development for urgent use became a crucial issue. Inactivated virus formulated vaccines such as Hepatitis A and smallpox proved to be reliable approaches for immunization for prolonged periods. In this study, a gamma‑irradiated inactivated virus vaccine does not require an extra purifcation process, unlike the chemically inactivated vaccines. Hence, the novelty of our vaccine candidate (OZG‑38.61.3) is that it is a non‑adjuvant added, gamma‑irradiated, and intradermally applied inactive viral vaccine. Efciency and safety dose (either 1013 or 1014 viral RNA copy per dose) of OZG‑38.61.3 was initially determined in BALB/c mice. This was followed by testing the immunogenicity and protective efcacy of the vaccine. Human ACE2‑encoding transgenic mice were immunized and then infected with the SARS‑CoV‑2 virus for the challenge test. -
Main Outcomes of Discussion of WHO Consultation on Nucleic Acid
MAIN OUTCOMES OF DISCUSSION FROM WHO CONSULTATION ON NUCLEIC ACID VACCINES I. Knezevic, R. Sheets 21-23 Feb, 2018 Geneva, Switzerland CONTEXT OF DISCUSSION • WHO Consultation held to determine whether the existing DNA guidelines were due for revision or if they remained relevant with today’s status of nucleic acid vaccine development and maturity towards licensure (marketing authorization) • Presentation will cover alignment to existing guidelines • Current status of development of DNA and RNA vaccines, both prophylactic & therapeutic • Main outcomes of discussion • Next steps already underway & planned STATUS OF DEVELOPMENT OF NUCLEIC ACID VACCINES • First likely candidate to licensure could be a therapeutic DNA vaccine against Human Papilloma Viruses • Anticipated to be submitted for licensure in 3-5 years • Other DNA vaccines are likely to follow shortly thereafter, e.g., Zika prophylaxis • RNA vaccines – less clinical experience, but therapeutic RNAs anticipated in 2021/22 timeframe to be submitted for licensure • For priority pathogens in context of public health emergencies, several candidates under development (e.g., MERS-CoV, Marburg, Ebola) MAIN OUTCOMES - GENERAL • Regulators expressed need for updated DNA guideline for prophylaxis and therapy • Less need at present for RNA vaccines in guideline but need some basic PTC • Flexibility needed now until more experience gained for RNA vaccines that will come in next few years • Revisit need for a more specific guideline at appropriate time for RNA vaccines • Institutional Biosafety Committees are regulated by national jurisdictions & vary considerably • How can WHO assist to streamline or converge these review processes? Particularly, during Public Health Emergency – can anything be done beforehand? MAIN OUTCOMES - DEFINITIONS • Clear Definitions are needed • Proposed definition of DNA vaccine: • A DNA plasmid(s) into which the desired immunogen(s) is (are) encoded and prepared as purified plasmid preparations to be administered in vivo. -
COVID-19: How Hateful Extremists Are Exploiting the Pandemic
COVID-19 How hateful extremists are exploiting the pandemic July 2020 Contents 3 Introduction 5 Summary 6 Findings and recommendations 7 Beliefs and attitudes 12 Behaviours and activities 14 Harms 16 Conclusion and recommendations Commission for Countering Extremism Introduction that COVID-19 is punishment on China for their treatment of Uighurs Muslims.3 Other conspiracy theories suggest the virus is part of a Jewish plot4 or that 5G is to blame.5 The latter has led to attacks on 5G masts and telecoms engineers.6 We are seeing many of these same narratives reoccur across a wide range of different ideologies. Fake news about minority communities has circulated on social media in an attempt to whip up hatred. These include false claims that mosques have remained open during 7 Since the outbreak of the coronavirus (COVID-19) lockdown. Evidence has also shown that pandemic, the Commission for Countering ‘Far Right politicians and news agencies [...] Extremism has heard increasing reports of capitalis[ed] on the virus to push forward their 8 extremists exploiting the crisis to sow division anti-immigrant and populist message’. Content and undermine the social fabric of our country. such as this normalises Far Right attitudes and helps to reinforce intolerant and hateful views We have heard reports of British Far Right towards ethnic, racial or religious communities. activists and Neo-Nazi groups promoting anti-minority narratives by encouraging users Practitioners have told us how some Islamist to deliberately infect groups, including Jewish activists may be exploiting legitimate concerns communities1 and of Islamists propagating regarding securitisation to deliberately drive a anti-democratic and anti-Western narratives, wedge between communities and the British 9 claiming that COVID-19 is divine punishment state. -
(ACIP) General Best Guidance for Immunization
8. Altered Immunocompetence Updates This section incorporates general content from the Infectious Diseases Society of America policy statement, 2013 IDSA Clinical Practice Guideline for Vaccination of the Immunocompromised Host (1), to which CDC provided input in November 2011. The evidence supporting this guidance is based on expert opinion and arrived at by consensus. General Principles Altered immunocompetence, a term often used synonymously with immunosuppression, immunodeficiency, and immunocompromise, can be classified as primary or secondary. Primary immunodeficiencies generally are inherited and include conditions defined by an inherent absence or quantitative deficiency of cellular, humoral, or both components that provide immunity. Examples include congenital immunodeficiency diseases such as X- linked agammaglobulinemia, SCID, and chronic granulomatous disease. Secondary immunodeficiency is acquired and is defined by loss or qualitative deficiency in cellular or humoral immune components that occurs as a result of a disease process or its therapy. Examples of secondary immunodeficiency include HIV infection, hematopoietic malignancies, treatment with radiation, and treatment with immunosuppressive drugs. The degree to which immunosuppressive drugs cause clinically significant immunodeficiency generally is dose related and varies by drug. Primary and secondary immunodeficiencies might include a combination of deficits in both cellular and humoral immunity. Certain conditions like asplenia and chronic renal disease also can cause altered immunocompetence. Determination of altered immunocompetence is important to the vaccine provider because incidence or severity of some vaccine-preventable diseases is higher in persons with altered immunocompetence; therefore, certain vaccines (e.g., inactivated influenza vaccine, pneumococcal vaccines) are recommended specifically for persons with these diseases (2,3). Administration of live vaccines might need to be deferred until immune function has improved. -
Treating Rare and Neglected Pediatric Diseases: Promoting the Development of New Treatments and Cures
S. HRG. 111–1147 TREATING RARE AND NEGLECTED PEDIATRIC DISEASES: PROMOTING THE DEVELOPMENT OF NEW TREATMENTS AND CURES HEARING OF THE COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS UNITED STATES SENATE ONE HUNDRED ELEVENTH CONGRESS SECOND SESSION ON EXAMINING TREATING RARE AND NEGLECTED PEDIATRIC DISEASES, FOCUSING ON PROMOTING THE DEVELOPMENT OF NEW TREAT- MENTS AND CURES JULY 21, 2010 Printed for the use of the Committee on Health, Education, Labor, and Pensions ( Available via the World Wide Web: http://www.gpo.gov/fdsys/ U.S. GOVERNMENT PRINTING OFFICE 76–592 PDF WASHINGTON : 2012 For sale by the Superintendent of Documents, U.S. Government Printing Office Internet: bookstore.gpo.gov Phone: toll free (866) 512–1800; DC area (202) 512–1800 Fax: (202) 512–2104 Mail: Stop IDCC, Washington, DC 20402–0001 COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS TOM HARKIN, Iowa, Chairman CHRISTOPHER J. DODD, Connecticut MICHAEL B. ENZI, Wyoming BARBARA A. MIKULSKI, Maryland JUDD GREGG, New Hampshire JEFF BINGAMAN, New Mexico LAMAR ALEXANDER, Tennessee PATTY MURRAY, Washington RICHARD BURR, North Carolina JACK REED, Rhode Island JOHNNY ISAKSON, Georgia BERNARD SANDERS (I), Vermont JOHN MCCAIN, Arizona SHERROD BROWN, Ohio ORRIN G. HATCH, Utah ROBERT P. CASEY, JR., Pennsylvania LISA MURKOWSKI, Alaska KAY R. HAGAN, North Carolina TOM COBURN, M.D., Oklahoma JEFF MERKLEY, Oregon PAT ROBERTS, Kansas AL FRANKEN, Minnesota MICHAEL F. BENNET, Colorado DANIEL SMITH, Staff Director PAMELA SMITH, Deputy Staff Director FRANK MACCHIAROLA, Republican Staff Director and Chief Counsel (II) CONTENTS STATEMENTS WEDNESDAY, JULY 21, 2010 Page Harkin, Hon. Tom, Chairman, Committee on Health, Education, Labor, and Pensions, opening statement .............................................................................. -
Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP)
Morbidity and Mortality Weekly Report Recommendations and Reports February 8, 2002 / Vol. 51 / No. RR-2 General Recommendations on Immunization Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP) INSIDE: Continuing Education Examination Centers for Disease Control and Prevention SAFER • HEALTHIER • PEOPLETM MMWR CONTENTS The MMWR series of publications is published by the Introduction ......................................................................... 1 Epidemiology Program Office, Centers for Disease Timing and Spacing of Immunobiologics .............................. 2 General Principles for Vaccine Scheduling ......................... 2 Control and Prevention (CDC), U.S. Department of Spacing of Multiple Doses of the Same Antigen ................ 2 Health and Human Services, Atlanta, GA 30333. Simultaneous Administration ............................................ 4 Nonsimultaneous Administration ...................................... 5 Spacing of Antibody-Containing Products and Vaccines ..... 6 SUGGESTED CITATION Interchangeability of Vaccines from Different Manufacturers 8 Centers for Disease Control and Prevention. General Lapsed Vaccination Schedule ............................................ 8 recommendations on immunization: recom- Unknown or Uncertain Vaccination Status ......................... 8 mendations of the Advisory Committee on Contraindications and Precautions ....................................... 8 Immunization Practices and the -
Poliomyelitis and Polio-Encephalitis
POLIOMYELITIS AND POLIO-ENCEPHALITIS. 151 Postgrad Med J: first published as 10.1136/pgmj.2.22.151 on 1 July 1927. Downloaded from coryza, or gastro-intestinal symptoms such as vomiting and diarrhoea. The lymphatic glands are POLIOMYELITIS enlarged. The temperature rises, often ranging AND POLIO-ENCEPHALITIS.* between 101° and 103°F., and there is general malaise often accompanied by profuse sweating. BY In some cases both local and general symptoms are E. A. COCKAYNE, M.D. OXF., F.R.C.P. LOND., so slight that they may be overlooked and the PHYSICIAN TO THE MIDDLESEX HOSPITAL; PHYSICIAN rise of temperature may be very small. After TO OUT-PATIENTS, HOSPITAL FOR SICK CHILDREN, lasting from one to four days the illness may end GREAT ORMOND-STREET. at this stage. If it continues headache, drowsiness POLIOMYELITIS, like other specific fevers, has its and irritability, pain and stiffness in the back, special age and seasonal incidence; it is commonest accompanied sometimes by twitching of the in the late summer and early autumn, and the limbs or retraction of the head, may develop, and majority of its victims are children between the these indicate involvement of the meninges. ages of 1 and 5 years. The earliest symptoms are Hyperssthesia of skin and muscles may also be constitutional, malaise and fever, and in some prominent. Then if the grey matter of the central cases the involvement of the nervous system, to nervous system becomes infected, weakness, paresis, which it owes its name, never occurs. Such and paralysis of muscles develops. Paralyses cases are usually regarded as abortive, but in may appear to be dramatically sudden, but my opinion this view is not the correct one. -
Common COVID-19 Myths and Misinformation
Common COVID-19 Myths and Misinformation Myth: The side effects of Myth: The COVID-19 Myth: If I’ve already had the COVID-19 vaccine are vaccine can affect COVID-19, I don’t need a dangerous. women’s fertility. vaccine. Myth: Researchers rushed the development of the Myth: Getting the COVID- Myth: The COVID-19 COVID-19 vaccine, so its 19 vaccine gives you vaccine can affect effectiveness and safety COVID-19. women’s fertility. cannot be trusted. Myth: The COVID-19 vaccine enters your cells and changes your DNA. Information gathered from the following website: https://www.hopkinsmedicine.org/health/conditions-and-diseases/coronavirus/covid-19-vaccines-myth-versus-fact https://www.muhealth.org/our-stories/covid-19-vaccine-myths-vs-facts FACT: People who have gotten sick with COVID-19 may still benefit from getting vaccinated. Due to the severe health risks associated with COVID-19 and the fact that re-infection with COVID-19 is possible, people may be advised to get a COVID-19 vaccine If I’ve already had even if they have been sick with COVID-19 before. There is not enough information currently available to COVID-19, I don’t say if or for how long people are protected from getting COVID-19 after they have had it (natural need a vaccine. immunity). Early evidence suggests natural immunity from COVID-19 may not last very long, but more studies are needed to better understand this. Several subjects in the Pfizer trial who were previously infected got vaccinated without ill effects. Some scientists believe the vaccine offers better protection for coronavirus than natural infection. -
Package Insert
HIGHLIGHTS OF PRESCRIBING INFORMATION ----------------------------- CONTRAINDICATIONS ------------------------------------- These highlights do not include all the information needed to use ® • History of severe allergic reactions (e.g., anaphylaxis) to egg proteins, or any FLUVIRIN (Influenza Virus Vaccine) safely and effectively. See full ® ® component of FLUVIRIN , or life-threatening reactions to previous influenza prescribing information for FLUVIRIN . vaccinations. (4.1, 11) FLUVIRIN® (Influenza Virus Vaccine) Suspension for Intramuscular Injection ---------------------- WARNINGS AND PRECAUTIONS ------------------------------ 2017-2018 Formula • If Guillain-Barré syndrome has occurred within 6 weeks of receipt of prior Initial US Approval: 1988 influenza vaccine, the decision to give FLUVIRIN® should be based on -------------------------- INDICATIONS AND USAGE ---------------------------------- careful consideration of the potential benefits and risks. (5.1) ® • FLUVIRIN is an inactivated influenza virus vaccine indicated for active • Immunocompromised persons may have a reduced immune response to immunization of persons 4 years of age and older against influenza disease FLUVIRIN®. (5.2) caused by influenza virus subtypes A and type B contained in the vaccine (1). • The tip caps of the FLUVIRIN® prefilled syringes may contain natural rubber • FLUVIRIN® is not indicated for children less than 4 years of age because latex which may cause allergic reactions in latex sensitive individuals. there is evidence of diminished immune response -
SOS – Save Our Shoulders: a Guide for Polio Survivors
1 • Save Our Shoulders: A Guide for Polio Survivors A Guide for Polio Survivors S.O.S. Save Our Shoulders: A Guide for Polio Survivors by Jennifer Kuehl, MPT Roberta Costello, MSN, RN Janet Wechsler, PT Funding for the production of this manual was made possible by: The National Institute for Disability and Rehabilitation Research Grant #H133A000101 and The U.S. Department of the Army Grant #DAMD17-00-1-0533 Investigators: Mary Klein, PhD Mary Ann Keenan, MD Alberto Esquenazi, MD Acknowledgements We gratefully acknowledge the contributions and input provided from all of those who participated in our research. The time and effort of our participants was instrumental in the creation of this manual. Jennifer Kuehl, MPT Moss Rehabilitation Research Institute, Philadelphia Roberta Costello, MSN, RN Moss Rehabilitation Research Institute, Philadelphia Janet Wechsler, PT Moss Rehabilitation Research Institute, Philadelphia Mary Klein, PhD Moss Rehabilitation Research Institute, Philadelphia Mary Ann Keenan, MD University of Pennsylvania, Philadelphia Alberto Esquenazi, MD MossRehab Hospital, Philadelphia Cover and manual design by Ron Kalstein, MEd Albert Einstein Medical Center, Philadelphia Table of Contents 1. Introduction . .5 2. General Information About the Shoulder . .6 3. Facts About Shoulder Problems . .8 4. Treatment Options . .13 5. About Exercise . .16 6. Stretching Exercises . .19 7. Cane Stretches . .22 8. Strengthening Exercises . .25 9. Tips to Avoid Shoulder Problems . .29 10. Conclusion . .31 11. Resources . .31 The information contained within this manual is for reference only and is not a substitute for professional medical advice. Before beginning any exercise program consult your physician. Save Our Shoulders: A Guide for Polio Survivors • 4 Introduction Many polio survivors report new symptoms as they age.