DOCSLIB.ORG

COVID-19 Vaccines

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
COVID-19 Vaccines 1/28/2021 COVID-19 Vaccines & Nurse-to-Nurse Chat 1 Take Note RECORDING THIS SESSION 2 1 1/28/2021 Interactivity • Chat box • Question & answers • Polls 3 Connecticut Nurses Association COVID-19 Web Page ASSOCIATION PHILOSOPHY Americans have rated nurses as the #1 most ethical and honest profession, according to the most recent Gallup poll (2020). https://nurse.org/articles/nursing-ranked-most-honest-profession/ 4 2 1/28/2021 A little Bit About Yourself • Hospital (inpatient) • Hospital (outpatient) • Home Care • Medical Office • Long-Term Care • School System • University/Faculty • Student In what setting do • Not Currently Working you currently work? • Retired • Other (submit in text box) 5 A little Bit About Yourself • Yes, currently work • Not now, plan to work in the future • Still undecided • Have no plan to work in future • Other Do you have a plan to work in a COVID-19 Vaccination Clinic? 6 3 1/28/2021 Welcome Dr. Jennifer Girotto, PharmD, BCPPS, BCIDP Associate Clinical Professor of Pharmacy Practice and Pediatrics University of Connecticut Member Governor Lamont’s COVID-19 Vaccine Advisory Group 7 COVID-19 Vaccines Jennifer Girotto, PharmD, BCPPS, BCIDP Clinical Associate Professor University of Connecticut 8 4 1/28/2021 OBJECTIVES • Identify COVID-19 vaccines currently or likely soon to be authorized in the US as part of Emergency Use Authorization • Explain current mechanisms of action for COVID-19 vaccines • Answer common questions regarding COVID-19 vaccines 9 Phases of Vaccine Development and Approval Emergency use authorization Phase I Phase II Phase III • Dose finding/escalation • Evaluation of dose • Comparison to placebo (tens of people) clinically (hundreds of or current standard of FDA approval people) care (thousands to tens of thousands of people) 10 5 1/28/2021 Year Total patients in Vaccine Approved Phase II & III Prevnar 2000 42,723 Boostrix 2005 6,192 Adacel 2005 11,758 Vaccine Trials Menactra 2005 10,942 & Participants RotaTeq 2006 67,469 Gardasil 2006 26,985 Zostavax 2006 41,943 Rotarix 2008 86,801 Prevnar 13 2010 50,774 Moderna COVID 2020 14,673 Pfizer-BioNTechCOVID 2020 18,198 Weinberg SH, et al. Human Vaccines & Immunotherapeutics 2012; Polack FP, et al. NEJM 2020; Baden LR, et al NEJM 2020; Modernatx.com 11 14 Vaccines in at least Phase III Development Current Vaccine Dosing Technology Phase Pfizer-BioNTech 2 doses 21 days apart mRNA EUA Moderna 2 doses 28 days apart mRNA EUA Ad26.COV2.S Johnson & Initial trial 1 dose now Adenovirus Phase III Johnson evaluating 2 doses vector AZD1222(Covishield) 2 doses 28 days apart Chimp Phase III Astrazeneca/UofOxford adenovirus vector 12 6 1/28/2021 How does the COVID-19 Vaccine Work & How were they made so fast? 13 Traditional Approaches: • Requires growing the virus • Weakened - live attenuated • Killed - inactivated Newer Approaches • Does not require full virus at any point • Viral vector vaccines • Genetic vaccines (including Classification of Vaccines mRNA) • Virus-like particle 14 7 1/28/2021 Vaccine Process Unique Characteristics • History of prior SARs infections SARs CoV1 & MERS • Spike Protein • RNA sequence known • Combining experts from government and pharmaceutical industry with sufficient funds 15 Mechanism of Action of COVID-19 Vaccines: mRNA Moderna slides to ACIP Dec 2020 16 8 1/28/2021 17 Mechanism of Action of COVID-19 Vaccines: Adenovirus Vectors • Adenovirus usually causes mild cold disease • Virus infects host cell • The DNA will then have the host cell make spike protein • Non-replicating virus vectors so no additional virus created/produced • Currently in development with this mechanism https://edhub.ama-assn.org/jn-learning/video-player/18547208 • Johnson & Johnson is human adenovirus vector • AZ – Univ of Oxford is chimp adenovirus vector 18 9 1/28/2021 Do the COVID-19 Vaccines with the Emergency Use Authorization Work? Do patient’s need both doses? Do they prevent infection or just symptomatic disease? 19 Example: Efficacy • Currently uncertain with likely large range of possibility After Dose 1 Pfizer- • Explains why CDC recommends 2 doses for full BioNTech protection FDA Briefing Document: https://www.fda.gov/media/144245/download 20 10 1/28/2021 Moderna Vaccine Efficacy After 2 Doses Baden LR, et al NEJM 2020 21 PfizerNBiotech Vaccine Efficacy after 2 Doses Polack FP, et al. NEJM 2020 22 11 1/28/2021 Do they prevent infection or symptomatic disease? https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020-12/slides-12-19/02- COVID-Miller.pdf 23 Scheduling Doses 24 12 1/28/2021 Characteristic Pfizer – BIoNTech Moderna Minimum age 16 years 18 years authorized CDC Current Number of Doses 2 2 Clinical Dose 30 mcg 100 mcg Overview of 2 0.3 ml/dose 0.5 ml/dose EUA Available Interval between 21 days 28 days doses Vaccines: Number of doses ~ 6 doses per vial ~ 11 doses per vial per vial Moderna and How comes Powder requires Comes as solution Pfizer- reconstitution with 1.8 ml preservative BioNTech free normal saline 25 • Interchangeability of mRNA vaccines. • Vaccines are NOT interchangeable no safety or efficacy data. • In rare situations when the first-dose vaccine product cannot be determined or is no longer available, any available mRNA COVID-19 vaccine may be Should patients administered at a minimum interval of 28 days between doses to complete the mRNA COVID-19 receive the vaccination series. • If two doses of different mRNA COVID-19 vaccine same vaccine products are administered in these situations (or inadvertently), no additional doses of either product for both doses? are recommended at this time. • CDC provides ways to help ensure patients receive same vaccine For Vaxtext – pt will be asked question regarding if they want just • Having pts sign up for second appointment at same vaccine reminder or symptoms, site before they leave. when they received the vaccine and • Remind pts to bring vaccine cards to second visit which they received. (Let them (picture on phone), know it does not sign them up for • Record vaccine administration in MAR appointments • Sign up for VaxText (1-800-vaxtext) if tech savvy 26 13 1/28/2021 • Pfizer-BioNTech COVID-19 vaccine 21 days apart COVID-19 • Moderna COVID-19 vaccine 28 days apart Vaccine Scheduling per • New information (1/21/2021) – can be st CDC, Updated scheduled as late as 6 weeks after 1 dose • Although not recommended to be scheduled Jan 21,2021 earlier, doses can be given up to 4 days before schedule • If inadvertently given earlier – okay to count dose • If patient does not receive vaccine within 6- week period, not need to restart series https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html 27 • Spacing between OTHER vaccines – minimum interval of 14 days before Ask about or after administration with ANY other vaccine due to lack of data. other • If there is a situation where 2 vaccines are being considered vaccinations closer, risk vs benefit must be too… assessed. If administered closer no need to redose, vaccine is counted. https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html 28 14 1/28/2021 What if a Patient Had COVID-19 Illness? • Vaccination should be delayed until the patient has recovered from the acute illness and no longer requires quarantine/isolation. • First and/or second dose • No testing or assessing for prior COVID-19 is recommended • Due to limited vaccine supply patients with recent infection may temporarily delay vaccination with the understanding as time goes on their risk for reinfection will increase. • Importantly, those who have been vaccinated should be treated(e.g. antiviral therapy, monoclonal antibodies, convalescent plasma, and/or corticosteroids) similarly to those who have no prior history of vaccine if they do become ill with COVID-19. https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html 29 Are These Vaccines Safe? 30 15 1/28/2021 • Most adverse effects occur soon after vaccines are administered • The mRNA vaccines had a median of ~ 2 months when they applied for authorization. CDC and pharmaceutical companies following adverse Vaccines and effects continually. • Highlights the importance of reporting any Side-Effects severe adverse effects to VAERS • Over 23 million doses COVID-19 vaccine doses administered in US • Long-term adverse effects not apparent by 1-2 months is extremely unlikely but still unknown. 31 mRNA Vaccine Safety – Summary of what is known • Moderna • Injection site reactions D1 84%; D2 89% vs ~ 20% placebo • Systemic reactions D1 55%; D2 79% vs ~ 40% placebo • Pfizer BioNTech • Systemic reactions ~ 75%; more common D2 than D1 and more common in younger patients (18 – 55 y vs > 55y) • Most in both groups grade 1 or 2 in severity; severe adverse reactions rare. • Anaphylaxis rate • Data for Pfizer-BioNTech from VAERS 12/14 – 12/23 from VAERS • 21 cases of anaphylaxis after 1,893,360 first doses (rate of 11.1 cases per million doses or 0.001%) • 71% and 86% occurred within 15 and 30 minutes of vaccination Polack FP, et al. NEJM 2020; Baden LR, et al NEJM 2020; MMWR Jan 2021 32 16 1/28/2021 How long to monitor patients for adverse effects? 33 Additional information on risk assessment: https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html 34 17 1/28/2021 Type of reaction and Immediate allergic reaction Vasovagal Reaction Vaccine Adverse Reaction timing after vaccination Most occur within 15-30 minutes of Most occur within 15 minutes Median of 1 to 3 days after vaccination vaccination (with most occurring
Load more

Recommended publications
  • HPV Vaccine Safety - Vaccine Safety
    CDC - HPV Vaccine Safety - Vaccine Safety Skip directly to search Skip directly to A to Z list Skip directly to navigation Skip directly to site content Skip directly to page options CDC Home CDC 24/7: Saving Lives. Protecting People.™ Search The CDC Vaccine Safety Vaccine Safety Vaccines Safety Basics Diphtheria, Tetanus, and Pertussis Vaccines: DTaP, Td, and Tdap Haemophilus Influenzae Type B (Hib) Hib Summary Human Papillomavirus (HPV) FAQs about HPV Vaccine Safety FAQ: Gardasil Vaccine recall JAMA Report Summary Information from FDA and CDC on Gardasil and its Safety (Archived) Measles, Mumps, Rubella (MMR) MMR Vaccine Safety Studies Measles, Mumps, Rubella, Varicella (MMRV) Information on the VSD MMRV Vaccine Safety Study MMRV Vaccine Safety Studies MMRV and Febrile Seizures Rotavirus Varicella Addressing Common Concerns Adjuvants Autism Vaccine not associated with autism CDC Statement: 2004 Pediatrics Paper CDC Statement on Pandemrix Fainting (Syncope) FAQs about Fainting (Syncope) After Vaccination Childhood Vaccines and Febrile Seizures Influenza Season 2012-2013 Influenza Season 2010-2011 GBS GBS and Menactra Meningococcal Vaccine FAQs about GBS and Menactra Meningococcal Vaccine IOM Assessment of Studies on Childhood Immunization Schedule IOM Report on Adverse Effects of Vaccines Pregnancy and Influenza Vaccine Safety Sudden Infant Death Syndrome (SIDS) Thimerosal http://www.cdc.gov/vaccinesafety/vaccines/HPV/index.html[10/13/2014 5:59:00 PM] CDC - HPV Vaccine Safety - Vaccine Safety CDC Study on Thimerosal and Risk of Autism
    [Show full text]
  • COVID-19 and Cancer: from Basic Mechanisms to Vaccine Development Using Nanotechnology
    International Immunopharmacology 90 (2021) 107247 Contents lists available at ScienceDirect International Immunopharmacology journal homepage: www.elsevier.com/locate/intimp Review COVID-19 and cancer: From basic mechanisms to vaccine development using nanotechnology Hyun Jee Han a,*, Chinekwu Nwagwu b, Obumneme Anyim c, Chinedu Ekweremadu d, San Kim e a University College London, Department of Neonatology, United Kingdom b Department of Pharmaceutics, University of Nigeria Nsukka, Nigeria c Department of Internal Medicine, University of Nigeria Teaching Hospital Ituku-Ozalla, Enugu, Nigeria d Department of Pharmaceutics and Pharmaceutical Technology Enugu State University of Science and Technology, Nigeria e Basildon and Thurrock University Hospital, United Kingdom ARTICLE INFO ABSTRACT Keywords: Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV- COVID-19 2), is a global pandemic which has induced unprecedented ramifications,severely affecting our society due to the Cancer long incubation time, unpredictably high prevalence and lack of effective vaccines. One of the interesting notions Vaccine development is that there is an association between COVID-19 and cancer. Cancer patients seem to exhibit exacerbated Pharmaceutics conditions and a higher mortality rate when exposed to the virus. Therefore, vaccines are the promising solution Nanotechnology to minimise the problem amongst cancer patients threatened by the new viral strains. However, there are still limitations to be considered, including the efficacy of COVID vaccines for immunocompromised individuals, possible interactions between the vaccine and cancer, and personalised medicine. Not only to eradicate the pandemic, but also to make it more effective for immunocompromised patients who are suffering from cancer, a successful vaccine platform is required through the implementation of nanotechnology which can also enable scalable manufacturing and worldwide distribution along with its faster and precise delivery.
    [Show full text]
  • Vaccines for Preteens
    | DISEASES and the VACCINES THAT PREVENT THEM | INFORMATION FOR PARENTS Vaccines for Preteens: What Parents Should Know Last updated JANUARY 2017 Why does my child need vaccines now? to get vaccinated. The best time to get the flu vaccine is as soon as it’s available in your community, ideally by October. Vaccines aren’t just for babies. Some of the vaccines that While it’s best to be vaccinated before flu begins causing babies get can wear off as kids get older. And as kids grow up illness in your community, flu vaccination can be beneficial as they may come in contact with different diseases than when long as flu viruses are circulating, even in January or later. they were babies. There are vaccines that can help protect your preteen or teen from these other illnesses. When should my child be vaccinated? What vaccines does my child need? A good time to get these vaccines is during a yearly health Tdap Vaccine checkup. Your preteen or teen can also get these vaccines at This vaccine helps protect against three serious diseases: a physical exam required for sports, school, or camp. It’s a tetanus, diphtheria, and pertussis (whooping cough). good idea to ask the doctor or nurse every year if there are any Preteens should get Tdap at age 11 or 12. If your teen didn’t vaccines that your child may need. get a Tdap shot as a preteen, ask their doctor or nurse about getting the shot now. What else should I know about these vaccines? These vaccines have all been studied very carefully and are Meningococcal Vaccine safe.
    [Show full text]
  • 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.
    [Show full text]
  • Recommended Adult Immunization Schedule
    Recommended Adult Immunization Schedule UNITED STATES for ages 19 years or older 2021 Recommended by the Advisory Committee on Immunization Practices How to use the adult immunization schedule (www.cdc.gov/vaccines/acip) and approved by the Centers for Disease Determine recommended Assess need for additional Review vaccine types, Control and Prevention (www.cdc.gov), American College of Physicians 1 vaccinations by age 2 recommended vaccinations 3 frequencies, and intervals (www.acponline.org), American Academy of Family Physicians (www.aafp. (Table 1) by medical condition and and considerations for org), American College of Obstetricians and Gynecologists (www.acog.org), other indications (Table 2) special situations (Notes) American College of Nurse-Midwives (www.midwife.org), and American Academy of Physician Assistants (www.aapa.org). Vaccines in the Adult Immunization Schedule* Report y Vaccines Abbreviations Trade names Suspected cases of reportable vaccine-preventable diseases or outbreaks to the local or state health department Haemophilus influenzae type b vaccine Hib ActHIB® y Clinically significant postvaccination reactions to the Vaccine Adverse Event Hiberix® Reporting System at www.vaers.hhs.gov or 800-822-7967 PedvaxHIB® Hepatitis A vaccine HepA Havrix® Injury claims Vaqta® All vaccines included in the adult immunization schedule except pneumococcal 23-valent polysaccharide (PPSV23) and zoster (RZV) vaccines are covered by the Hepatitis A and hepatitis B vaccine HepA-HepB Twinrix® Vaccine Injury Compensation Program. Information on how to file a vaccine injury Hepatitis B vaccine HepB Engerix-B® claim is available at www.hrsa.gov/vaccinecompensation. Recombivax HB® Heplisav-B® Questions or comments Contact www.cdc.gov/cdc-info or 800-CDC-INFO (800-232-4636), in English or Human papillomavirus vaccine HPV Gardasil 9® Spanish, 8 a.m.–8 p.m.
    [Show full text]
  • 3.2.3 Gardasil and Autoimmune Diseases
    HPV vaccination and autoimmune disease CONFIDENTIAL Medicines Adverse Reactions Committee Meeting date 10 September 2015 Agenda item 3.2.3 Title Gardasil and autoimmune diseases Medsafe For advice/ Submitted by Paper type Pharmacovigilance Team For information Active constituent Medicines Sponsors Human papillomavirus type 6 L1 protein, type 11 Gardasil Bio CSL for MSD L1 protein, type 16 L1 protein and type 18 L1 protein Funding Fully funded for girls aged under 18 years or patients aged under 25 years old with confirmed HIV infection or in transplant patients. Previous MARC Gardasil has only been discussed previously in relation to CARM case meetings reports. International action The EMA have announced an investigation into HPV vaccine and complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS). This review will complete at the end of the year. Prescriber Update None Schedule Prescription medicine Usage data Over 200,000 girls and women have received at least one dose in NZ Worldwide cumulative exposure post-marketing, to the end of May 2015 was 63.6 million. Cumulative exposure in clinical trials was 29,932 Advice sought The Committee is asked to advise whether: − There is a safety concern relating to development of autoimmune conditions after HPV vaccination Medicines Adverse Reactions Committee: 10 September 2015 Page 1 of 46 HPV vaccination and autoimmune disease CONFIDENTIAL Table of Contents 1.0 PURPOSE .................................................................................................................................
    [Show full text]
  • COVID-19 Vaccine-Associated Anaphylaxis and Allergic Reactions: Consensus Statements of the KAAACI Urticaria/Angioedema/Anaphylaxis Working Group
    Allergy Asthma Immunol Res. 2021 Jul;13(4):526-544 https://doi.org/10.4168/aair.2021.13.4.526 pISSN 2092-7355·eISSN 2092-7363 Review COVID-19 Vaccine-associated Anaphylaxis and Allergic Reactions: Consensus Statements of the KAAACI Urticaria/Angioedema/Anaphylaxis Working Group Mi-Ae Kim ,1† Yong Won Lee ,2† So Ri Kim ,3 Joo-Hee Kim ,4 Taek ki Min ,5 6 7 6 8 Received: May 10, 2021 Hae-Sim Park , Meeyong Shin , Young-Min Ye , Sooyoung Lee , 9 10,11 12* Accepted: Jun 2, 2021 Jeongmin Lee , Jeong-Hee Choi , Gwang Cheon Jang , Yoon-Seok Chang 13* Correspondence to Gwang Cheon Jang, MD, PhD 1Department of Pulmonology, Allergy and Critical Care Medicine, CHA Bundang Medical Center, CHA Department of Pediatrics, National Health University, Seongnam, Korea Insurance Service Ilsan Hospital, 100 Ilsan-ro, 2Division of Allergy and Clinical Immunology, Department of Internal Medicine, International St. Mary's Ilsandong-gu, Goyang 10444, Korea. Hospital, Catholic Kwandong University College of Medicine, Incheon, Korea 3 Tel: +82-31-900-0520 Division of Respiratory Medicine and Allergy, Department of Internal Medicine, Research Center for Fax: +82-31-900-0343 Pulmonary Disorders, Jeonbuk National University Medical School, Jeonju, Korea 4Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine Hallym University E-mail: [email protected] Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Korea 5 Yoon-Seok Chang, MD, PhD Department of Pediatrics, Soonchunhyang University Seoul Hospital, Soonchunhyang University
    [Show full text]
  • Gsk Vaccines in 2010
    GSK VACCINES IN 2010 Thomas Breuer, MD, MSc Senior Vice President Head of Global Vaccines Development GSK Biologicals Vaccines business characteristics Few global players and high barriers to entry – Complex manufacturing – Large scale investment Long product life cycles – Complex intellectual property High probability of R&D success – 70% post-POC New technology/novel products Better pricing for newer vaccines – HPV vaccines (Cervarix, Gardasil) – Pneumococcal vaccines (Synflorix, Prevnar-13) Operating margin comparable to pharmaceutical products Heightened awareness New markets 2 Research & development timelines Identify Produce Pre-Clinical Proof of Registration/ Phase I Phase II Phase III File Antigens Antigens Testing Concept Post Marketing Research (inc. Immunology) Pre-Clinical Development (inc. Formulation Science) Clinical Development (inc. Post Marketing Surveillance) Transfer Process to Manufacturing Build Facility x x Up to $10-20M Up to $50-100M $500M - $1B x x x 1-10 yrs 2-3 yrs 2-4 yrs > 1 yr GSK vaccines business 2009 sales £3.7 billion (+30%) +19% CAGR excl. H1N1 Vaccines represent 13% since 2005 of total GSK sales Sale s (£m) 4000 3500 Recent approvals: 3000 US: Cervarix 2500 EU: Synflorix 2000 Pandemic: Pandemrix; Arepanrix 1500 1000 500 0 2005 2006 2007 2008 2009 Increased Emerging Market presence Growth rate is CER 5 GSK vaccines: fastest growing part of GSK in 2009 2009 Sales Share Growth (CER) Respiratory £ 6,977m 25% +5% Consumer £ 4,654m 16% +7% Anti-virals £ 4,150m 15% +12% Vaccines £ 3,706m 13% +30% CV & Urogenital
    [Show full text]
  • Global Advisory Committee on Vaccine Safety (GACVS)
    Global Advisory Committee on Vaccine Safety (GACVS) Report on GACVS meeting June 2013 1 | GACVS June 2013 report Topics Discussed ! Pentavalent vaccine in 4 Asian Countries ! Zoster vaccine safety and varicella vaccine safety in immunocompromised populations ! Immunization during pregnancy ! Yellow fever vaccine safety during mass immunization campaigns in sub-Saharan Africa ! Safety profile: Japanese encephalitis vaccines ! Update: human papillomavirus vaccines ! Update: pandemic influenza vaccine (Pandemrix®) and narcolepsy 2 | GACVS June 2013 report Progressive pentavalent vaccine introduction in 4 Asian Countries ! Sri Lanka (Crucell, Jan 2008): – Within 3 months, 4 deaths and 24 suspected HHE: precautionary suspension of initial lot. – 1 death following immunization April 2009: vaccine suspended, DTwP and Hep B resumed. ! Bhutan (Panacea, Sep 2009) – 5 cases of encephalopathy and/or meningoencephalitis lead to suspended vaccination 23 Oct 2009. (Subsequently, 4 serious AEFI were identified and investigated). ! India (Serum Institute of India, Tamil Nadu and Kerala, Dec 2011; Goa, Pondicherry, Karnataka, Haryana, Jammu and Kashmir, Gujarat and Delhi from Q3 2012 – Q1 2013) – To date, 83 AEFI cases reported, some associated with mortality. ! Vietnam (Crucell, Jun 2010 - May 2013) – 43 serious AEFI investigated, including 27 with fatal outcome. – Following 9 deaths following vaccination reported Dec 2012 - March 2013: vaccine suspended. 3 | GACVS June 2013 report GACVS analysis of common features among countries experiencing significant vaccine safety concerns ! Vaccination programmes are well established and achieves high coverage ! Vaccine introduction was accompanied by thorough training of health-care staff on benefits and risks of vaccine ! Sri Lanka and Bhutan: discontinuation and resumption of pentavalent vaccine did not significantly modify pattern of serious AEFI with previously utilized vaccines ! Limitations in all 4 countries: – Incomplete clinical information complicated causality assessment.
    [Show full text]
  • Gardasil, INN-Human Papillomavirus Vaccine [Types 6, 11, 16
    SCIENTIFIC DISCUSSION 1. Introduction Human papillomavirus (HPV) infection is currently the most common sexually transmitted disease worldwide. By 5 years after sexual debut, ~50% of young women will have been infected with at least one of the 40 HPV types that preferentially infect the genitals. Thirteen of these HPV types are highly carcinogenic. Although a consistent picture of the epidemiology and pathogenesis of genital infections in women has developed during the past two decades, less is known about these infections in men. However, studies suggest a similar infection pattern in men, who are the most important vectors for transmission of HPV disease to women. The peak incidence of HPV infection occurs in young adults between the ages 16 and 23 years. Human papillomaviruses are double-stranded DNA viruses that infect epithelial cells and are significantly associated with low-grade cervical intraepithelial neoplasia (CIN), genital condyloma and cervical cancer. HPVs are judged to be the primary cause of cervical cancer, which is the second most common type of cancer causing deaths in women worldwide. Other HPV-related cancers in young women include vulvar and vaginal cancers, which are preceded by dysplastic lesions (vulvar intraepithelial neoplasia (VIN) and vaginal intraepithelial neoplasia (VaIN). In men anal cancer is the most common HPV-related cancer. The virus is also related to penile and certain oropharyngeal cancers. Other benign HPV-associated conditions include condyloma acuminata (genital warts) located in the genital or perianal region and juvenile recurrent respiratory papillomatosis (JRRP) primarily located in the larynx. JRRP is thought to occur by transmission of the virus from an infected mother to her child.
    [Show full text]
  • Gardasil, INN-Human Papillomavirus Vaccine [Types 6, 11, 16, 18
    PACKAGE LEAFLET: INFORMATION FOR THE USER Gardasil® suspension for injection in a pre-filled syringe Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed) Read all of this leaflet carefully before you or your child are vaccinated. - Keep this leaflet. You may need to read it again. - If you have any further questions, please ask your doctor or pharmacist. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4. What is in this leaflet 1. What Gardasil is and what it is used for 2. What you need to know before you receive Gardasil 3. How Gardasil is given 4. Possible side effects 5. How to store Gardasil 6. Contents of the pack and other information 1. What Gardasil is and what it is used for Gardasil is a vaccine. Vaccination with Gardasil is intended to protect against diseases caused by Human Papillomavirus (HPV) types 6, 11, 16, and 18. These diseases include pre-cancerous lesions of the female genitals (cervix, vulva, and vagina); pre- cancerous lesions of the anus and genital warts in males and females; cervical and anal cancers. HPV types 16 and 18 are responsible for approximately 70 % of cervical cancer cases, 75-80 % of anal cancer cases; 70 % of HPV-related pre-cancerous lesions of the vulva and vagina, 75 % of HPV related pre-cancerous lesions of the anus. HPV types 6 and 11 are responsible for approximately 90 % of genital wart cases. Gardasil is intended to prevent these diseases.
    [Show full text]
  • Vaccine Development Throughout History
    Open Access Review Article DOI: 10.7759/cureus.16635 Vaccine Development Throughout History Amr Saleh 1 , Shahraz Qamar 2 , Aysun Tekin 3 , Romil Singh 3 , Rahul Kashyap 3 1. Faculty of Medicine, Mansoura University, Mansoura, EGY 2. Post-baccalaureate Research Education Program, Mayo Clinic, Rochester, USA 3. Critical Care, Mayo Clinic, Rochester, USA Corresponding author: Aysun Tekin, [email protected] Abstract The emergence of the coronavirus disease 2019 (COVID-19) pandemic has made us appreciate how important it is to quickly develop treatments and save lives. The race to develop a vaccine for this novel coronavirus began as soon as the pandemic emerged. Time was the only limiting factor. From the first vaccine developed in 1796 against smallpox to the latest COVID-19 vaccine, there have been several vaccines that have reduced the burden of disease, with the associated mortality and morbidity. Over the years we have seen many new advancements in organism isolation, cell culture, whole-genome sequencing, and recombinant nuclear techniques. These techniques have greatly facilitated the development of vaccines. Each vaccine has its own development story and there is much wisdom to be gained from learning about breakthroughs in vaccine development. Categories: Internal Medicine, Infectious Disease, Epidemiology/Public Health Keywords: vaccine development, infectious and parasitic diseases, smallpox, polio, rabies, cholera, covid-19 Introduction And Background Although inoculation practices were started more than 500 years ago, the term vaccine was first described in the 18th century by Edward Jenner. It is derived from Vacca, a Latin word for cow. Jenner inoculated an eight- year-old boy with cowpox lesions from the hands of milkmaids in 1796.
    [Show full text]