Advisory Committee on Immunization Practices (Acip)
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Maternal Vaccines - Safety in Pregnancy
Journal Pre-proof Maternal Vaccines - Safety in pregnancy Dr Mala Arora, FRCOG (UK), FICOG, DObst (Ire), Chairperson, Vice President, Director, Consultant, Dr Rama Lakshmi, MBBS, MD PII: S1521-6934(21)00017-1 DOI: https://doi.org/10.1016/j.bpobgyn.2021.02.002 Reference: YBEOG 2112 To appear in: Best Practice & Research Clinical Obstetrics & Gynaecology Received Date: 14 August 2020 Revised Date: 18 November 2020 Accepted Date: 6 February 2021 Please cite this article as: Arora M, Lakshmi R, Maternal Vaccines - Safety in pregnancy, Best Practice & Research Clinical Obstetrics & Gynaecology, https://doi.org/10.1016/j.bpobgyn.2021.02.002. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2021 Published by Elsevier Ltd. Maternal Vaccines - Safety in pregnancy Dr Mala Arora FRCOG (UK),FICOG, DObst (Ire) Chairperson ICOG 2017 Vice President FOGSI 2011 Director Noble IVF Centre, sector 14, Faridabad Consultant Fortis La Femme, GK2 New Delhi India Dr Rama Lakshmi MBBS,MD Fellowship (IVF &Reproductive Medicine) Milann Fertility Centre Bengaluru India Corresponding author: Dr Mala Arora E-mail: [email protected];Journal [email protected] Pre-proof Abstract Vaccination during pregnancy is important for active immunity of the mother against serious infectious diseases, and also for passive immunity of the neonate to infectious diseases with high morbidity and mortality. -
Program Evaluation Key Outcomes and Addressing Remaining
Vaccine 31S (2013) J73–J78 Contents lists available at ScienceDirect Vaccine jou rnal homepage: www.elsevier.com/locate/vaccine Key outcomes and addressing remaining challenges—Perspectives from a final ଝ evaluation of the China GAVI project a,1 a,1 a,1 a,1 b c Weizhong Yang , Xiaofeng Liang , Fuqiang Cui , Li Li , Stephen C. Hadler , Yvan J. Hutin , d a,∗ Mark Kane , Yu Wang a Chinese Center for Disease Control and Prevention, Beijing, China b Centers for Disease Control and Prevention, Atlanta, USA c Europe Center for Disease Control and Prevention, Stockholm, Sweden d Mercer Island, Washington, USA a r t a b i c s t l r e i n f o a c t Article history: During the China GAVI project, implemented between 2002 and 2010, more than 25 million children Received 6 June 2012 received hepatitis B vaccine with the support of project, and the vaccine proved to be safe and effective. Received in revised form 24 July 2012 With careful consideration for project savings, China and GAVI continually adjusted the budget, addi- Accepted 24 September 2012 tionally allowing the project to spend operational funds to support demonstration projects to improve timely birth dose (TBD), conduct training of EPI staff, and to monitor the project impact. Results from the final evaluation indicated the achievement of key outcomes. As a result of government co-investment, Keywords: human resources at county level engaged in hepatitis B vaccination increased from 29 per county on GAVI Project average in 2002 to 66 in 2009. All project counties funded by the GAVI project use auto-disable syringes Outcomes for hepatitis B vaccination and other vaccines. -
(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. -
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 -
Version Gdsv27/Ipiv21
Version GDSv27/IPIv21 Interactions Use with Other Vaccines CERVARIX can be given concomitantly with any of the following vaccines: reduced antigen diphtheria-tetanus- acellular pertussis vaccine (dTpa), inactivated poliovirus vaccine (IPV) and the combined dTpa-IPV vaccine; meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine (MenACWY-TT); hepatitis A (inactivated) vaccine (HepA), hepatitis B (rDNA) vaccine (HepB) and the combined HepA-HepB vaccine. Administration of CERVARIX at the same time as Twinrix (combined HepA-HepB vaccine) has shown no clinically relevant interference in the antibody response to the HPV and hepatitis A antigens. Anti-HBs geometric mean Human Papillomavirus Vaccine Types 16 and 18 antibody titres were lower on co-administration, but the clinical significance of this observation is not known since the seroprotection rates remain unaffected. The proportion of subjects reaching anti-HBs 10mIU/ml was 98.3% (Recombinant, AS04 adjuvanted) for concomitant vaccination and 100% for Twinrix alone. If CERVARIX is to be given at the same time as another injectable vaccine, the vaccines should always be Qualitative and Quantitative Composition administered at different injection sites. Suspension for injection. Use with Hormonal Contraceptive In clinical efficacy studies, approximately 60% of women who received CERVARIX used hormonal contraceptives. 1 dose (0.5 ml) contains: There is no evidence that the use of hormonal contraceptives has an impact on the efficacy of CERVARIX. Human Papillomavirus type 16 L1 protein1 20 micrograms Human Papillomavirus type 18 L1 protein1 20 micrograms Use with Systemic Immunosuppressive Medications 3-O-desacyl-4’- monophosphoryl lipid A (MPL)2 50 micrograms Aluminium hydroxide, hydrated2 0.5 milligrams Al3+ As with other vaccines it may be expected that in patients receiving immunosuppressive treatment an adequate 1 L1 protein in the form of non-infectious virus-like particles (VLPs) produced by recombinant DNA technology response may not be elicited. -
Intramuscular and Intradermal Electroporation of HIV-1 PENNVAX-GP® DNA Vaccine and IL-12 Is Safe, Tolerable, Acceptable in Healthy Adults
Article Intramuscular and Intradermal Electroporation of HIV-1 PENNVAX-GP® DNA Vaccine and IL-12 Is Safe, Tolerable, Acceptable in Healthy Adults Srilatha Edupuganti 1,*, Stephen C. De Rosa 2,3, Marnie Elizaga 2 , Yiwen Lu 2, Xue Han 2, Yunda Huang 2,4, Edith Swann 5, Laura Polakowski 5, Spyros A. Kalams 6, Michael Keefer 7, 2,8 9, 9 9 9, Janine Maenza , Megan C. Wise y, Jian Yan , Matthew P. Morrow , Amir S. Khan y, 9 9 9 9, 9,§ Jean D. Boyer , Laurent Humeau , Scott White , Niranjan Y. Sardesai z, Mark L. Bagarazzi , Peter B. Gilbert 2, James G. Kublin 2, Lawrence Corey 2, David B. Weiner 10, on behalf of the HVTN 098 Study Team k and the NIAID-Funded HIV Vaccine Trials Network 1 Division of Infectious Disease, Department of Medicine, Emory University, Atlanta, GA 30322, USA 2 Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA; [email protected] (S.C.D.R.); [email protected] (M.E.); [email protected] (Y.L.); [email protected] (X.H.); [email protected] (Y.H.); [email protected] (J.M.); [email protected] (P.B.G.); [email protected] (J.G.K.); [email protected] (L.C.) 3 Department of Laboratory Medicine, University of Washington, Seattle, WA 98195, USA 4 Department of Global Health, University of Washington, Seattle, WA 98195, USA 5 Division of AIDS, NIH, Bethesda, MD 20892, USA; [email protected] (E.S.); [email protected] (L.P.) 6 Vanderbilt University Medical Center, Nashville, TN 37232, USA; [email protected] 7 Department of Medicine, University of Rochester School of Medicine & Dentistry, Rochester, NY 14642, USA; [email protected] 8 Division of Allergy and Infectious Diseases, Department of Medicine, University of Washington, Seattle, WA 98195, USA 9 Inovio Pharmaceuticals Inc. -
Self-Reported Real-World Safety and Reactogenicity of COVID-19 Vaccines: a Vaccine Recipient Survey
life Brief Report Self-Reported Real-World Safety and Reactogenicity of COVID-19 Vaccines: A Vaccine Recipient Survey Alexander G. Mathioudakis 1,2 , Murad Ghrew 3,4,5, Andrew Ustianowski 5,6, Shazaad Ahmad 7, Ray Borrow 8, Lida Pieretta Papavasileiou 9, Dimitrios Petrakis 10 and Nawar Diar Bakerly 3,11,* 1 Division of Infection, Immunity and Respiratory Medicine, School of Biological Sciences, The University of Manchester, Manchester M23 9LT, UK; [email protected] 2 North West Lung Centre, Wythenshawe Hospital, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester M23 9LT, UK 3 Department of Respiratory Medicine, Salford Royal Hospital NHS Foundation Trust, Manchester M6 8HD, UK; [email protected] 4 Department of Intensive Care Medicine, Salford Royal Hospital NHS Foundation Trust, Manchester M6 8HD, UK 5 Faculty of Biology, Medicine & Health, School of Biological Sciences, The University of Manchester, Manchester M13 9PL, UK; [email protected] 6 Regional Infectious Diseases Unit, North Manchester General Hospital, Manchester M8 5RB, UK 7 Department of Virology, Manchester Medical Microbiology Partnership, Manchester University NHS Foundation Trust, Manchester M13 9WL, UK; [email protected] 8 Vaccine Evaluation Unit, Public Health England, Manchester Royal Infirmary, Manchester University NHS Citation: Mathioudakis, A.G.; Foundation Trust, Manchester Academic Health Science Centre, Manchester M13 9WL, UK; Ghrew, M.; Ustianowski, A.; Ahmad, [email protected] 9 Department of Cardiology, Hygeia Hospital, 15123 Athens, Greece; [email protected] S.; Borrow, R.; Papavasileiou, L.P.; 10 Allergy Clinic, Petrakis Allergy Care, 55133 Thessaloniki, Greece; [email protected] Petrakis, D.; Bakerly, N.D. -
Summary of Supportive Science Regarding Thimerosal Removal
Summary of Supportive Science Regarding Thimerosal Removal Updated December 2012 www.safeminds.org Science Summary on Mercury in Vaccines (Thimerosal Only) SafeMinds Update – December 2012 Contents ENVIRONMENTAL IMPACT ................................................................................................................................. 4 A PILOT SCALE EVALUATION OF REMOVAL OF MERCURY FROM PHARMACEUTICAL WASTEWATER USING GRANULAR ACTIVATED CARBON (CYR 2002) ................................................................................................................................................................. 4 BIODEGRADATION OF THIOMERSAL CONTAINING EFFLUENTS BY A MERCURY RESISTANT PSEUDOMONAS PUTIDA STRAIN (FORTUNATO 2005) ......................................................................................................................................................................... 4 USE OF ADSORPTION PROCESS TO REMOVE ORGANIC MERCURY THIMEROSAL FROM INDUSTRIAL PROCESS WASTEWATER (VELICU 2007)5 HUMAN & INFANT RESEARCH ............................................................................................................................ 5 IATROGENIC EXPOSURE TO MERCURY AFTER HEPATITIS B VACCINATION IN PRETERM INFANTS (STAJICH 2000) .................................. 5 MERCURY CONCENTRATIONS AND METABOLISM IN INFANTS RECEIVING VACCINES CONTAINING THIMEROSAL: A DESCRIPTIVE STUDY (PICHICHERO 2002) ...................................................................................................................................................... -
Supplemental Information and Guidance for Vaccination Providers Regarding Use of 9-Valent HPV Vaccine
Supplemental information and guidance for vaccination providers regarding use of 9-valent HPV A 9-valent human papillomavirus (HPV) vaccine (9vHPV, Gardasil 9, Merck & Co.) was licensed for use in females and males in December 2014.1,2,3,4 The 9vHPV was the third HPV vaccine licensed in the United States by the Food and Drug Administration (FDA); the other vaccines are bivalent HPV vaccine (2vHPV, Cervarix, GlaxoSmithKline), licensed for use in females, and quadrivalent HPV vaccine (4vHPV, Gardasil, Merck & Co.), licensed for use in females and males.5 In February 2015, the Advisory Committee on Immunization Practices (ACIP) recommended 9vHPV as one of three HPV vaccines that can be used for routine vaccination of females and one of two HPV vaccines for routine vaccination of males.6 After the end of 2016, only 9vHPV will be distributed in the United States. In October 2016, ACIP updated HPV vaccination recommendations regarding dosing schedules.7 CDC now recommends two doses of HPV vaccine (0, 6–12 month schedule) for persons starting the vaccination series before the 15th birthday. Three doses of HPV vaccine (0, 1–2, 6 month schedule) continue to be recommended for persons starting the vaccination series on or after the 15th birthday and for persons with certain immunocompromising conditions. Guidance is needed for persons who started the series with 2vHPV or 4vHPV and may be completing the series with 9vHPV. The information below summarizes some of the recommendations included in ACIP Policy Notes and provides additional guidance.5-7 Information about the vaccines What are some of the similarities and differences between the three HPV vaccines? y Each of the three HPV vaccines is a noninfectious, virus-like particle (VLP) vaccine. -
UNHCR COVID-19 Global Emergency Response
GLOBAL COVID-19 EMERGENCY RESPONSE 17 February 2021 UNHCR COVID-19 Preparedness and Response Highlights COVID-19 update ■ UNHCR and Gavi, the Vaccine Alliance, signed a Memorandum of Over 46,000 Understanding (MoU) on 03 February 2020, with the overall goal of ensuring reported cases refugees and other forcibly displaced can access vaccines on par with of COVID-19 nationals. The MoU also looks at expanding coverage and quality of among forcibly displaced people immunization services, promoting equity in access and uptake of vaccines, and strengthening health systems at community and primary care level. across 103 countries ■ Jordan has become one of the world’s first countries to start COVID-19 vaccinations for refugees, including vaccinations in Za’atari refugee camp on 15 February. UNHCR has been working with the Jordanian government to increase of vaccinate refugees and provide critical health, sanitation, hygiene and logistical some 7,500 cases compared support. UNHCR appeals to all countries to follow suit and include refugees in to the previous their national vaccination drives in line with COVAX allocation principles. reporting period ■ In 2020, 39.4 million persons of concern received COVID-19 assistance (numbers as of 08 February including access to protection services, shelter, health, and education. This 2021) includes over 8.5 million individuals who received cash assistance. ■ Despite an estimated 1.44 million refugees in urgent need of resettlement globally, less than 23,000 were resettled through UNHCR last year. These are the lowest refugee resettlement numbers UNHCR has witnessed in almost two decades. The drop stems from low quotas put forward by states, as well as the impact of COVID-19, which delayed departures and programmes. -
Vaccine Hesitancy
WHY CHILDREN WORKSHOP ON IMMUNIZATIONS ARE NOT VACCINATED? VACCINE HESITANCY José Esparza MD, PhD - Adjunct Professor, Institute of Human Virology, University of Maryland School of Medicine, Baltimore, MD, USA - Robert Koch Fellow, Robert Koch Institute, Berlin, Germany - Senior Advisor, Global Virus Network, Baltimore, MD, USA. Formerly: - Bill & Melinda Gates Foundation, Seattle, WA, USA - World Health Organization, Geneva, Switzerland The value of vaccination “The impact of vaccination on the health of the world’s people is hard to exaggerate. With the exception of safe water, no other modality has had such a major effect on mortality reduction and population growth” Stanley Plotkin (2013) VACCINES VAILABLE TO PROTECT AGAINST MORE DISEASES (US) BASIC VACCINES RECOMMENDED BY WHO For all: BCG, hepatitis B, polio, DTP, Hib, Pneumococcal (conjugated), rotavirus, measles, rubella, HPV. For certain regions: Japanese encephalitis, yellow fever, tick-borne encephalitis. For some high-risk populations: typhoid, cholera, meningococcal, hepatitis A, rabies. For certain immunization programs: mumps, influenza Vaccines save millions of lives annually, worldwide WHAT THE WORLD HAS ACHIEVED: 40 YEARS OF INCREASING REACH OF BASIC VACCINES “Bill Gates Chart” 17 M GAVI 5.6 M 4.2 M Today (ca 2015): <5% of children in GAVI countries fully immunised with the 11 WHO- recommended vaccines Seth Berkley (GAVI) The goal: 50% of children in GAVI countries fully immunised by 2020 Seth Berkley (GAVI) The current world immunization efforts are achieving: • Equity between high and low-income countries • Bringing the power of vaccines to even the world’s poorest countries • Reducing morbidity and mortality in developing countries • Eliminating and eradicating disease WHY CHILDREN ARE NOT VACCINATED? •Vaccines are not available •Deficient health care systems •Poverty •Vaccine hesitancy (reticencia a la vacunacion) VACCINE HESITANCE: WHO DEFINITION “Vaccine hesitancy refers to delay in acceptance or refusal of vaccines despite availability of vaccination services. -
Prospecting for an HIV Vaccine D
Brett-Major et al. Tropical Diseases, Travel Medicine and Vaccines (2017) 3:6 DOI 10.1186/s40794-017-0050-4 REVIEW Open Access Prospecting for an HIV vaccine D. M. Brett-Major1,2*, T. A. Crowell1,2 and N. L. Michael1 Abstract Human immunodeficiency virus (HIV) sets several challenges for the development of a preventative HIV vaccine. Predictable, protective natural immunity against HIV does not occur and so unlike most other diseases for which vaccines exist, there are few guideposts from natural infection. Nonetheless, six vaccine efficacy trials have occurred. One in particular, the Thai trial called RV144, showed partial protective efficacy and potential ways ahead to a better vaccine approach. This coupled with other lessons from studies of acute infections as well as an increasingly complex knowledge of HIV-related vaccine immunology bring hope that a vaccine solution might be reached for this pervasive and deadly pandemic. Keywords: Human immunodeficiency virus vaccine protective efficacy immunology review Background Why not already Human immunodeficiency virus (HIV) disease remains A reasonable person new to the global conversation one of the greatest threats to global public health. about HIV might ask, if an HIV vaccine is so critical and According to the World Health Organization (WHO), in the pandemic known for three decades, why do we not 2014 over one million people died from HIV, nearly already have an HIV vaccine? There is no simple answer thirty-seven million people had chronic infection and to this question, though an easy one is that people do two million people newly acquired infections [1]. Of not develop natural, protective immunity to HIV infec- those persons known to be HIV infected, only 35% tion and disease.