MyHVP Newsletter | Vol. 5 No. 2 (December 2020)

MyHVP Newsletter Volume 05 | Issue 02 | December 2020

The 14th Malaysia International Genetics Congress 15-17 March 2021| A Virtual Conference

M

IGC14 is a joint project between the Genetic Society of Malaysia (PGM) and the Malaysian Human Variation Project Node (MyHVP). MIGC14 is an annual seminar organized by the Malaysian Genetic Association aimed to create knowledge sharing about advances in the field of genetics. In November 2019, the MIGC14 was held at Bangi Resort Hotel, Selangor with the theme “Exploring Innovation In Genetics”.

benefits and exposure to the latest information and invaluable knowledge regarding genetics; basics, diagnostics, evolution and innovation. In addition, this conference will promote Malaysia as a leader in the latest technology in the field of genetics, and as a research hub in the field of plant, animal and human genetics.

In conjunction with the Annual General Meeting of the Genetic Society of Malaysia, Universiti Sains Malaysia, Health Campus, Kelantan with the cooperation of PGM and MyHVP, will host the 2021 virtual MIGC14, themed “Translating Genes for A Better Future” - via Cisco WebEx platform.

With a target of 150 to 250 participants, the objectives of the conference is to develop and promote knowledge of the genetic field, create awareness of the importance of involvement and contribution of scientists in this field and discussing problems and related issues. It is hoped that this conference will also provide encouragement and latest information on genetic diseases.

A total of ten (10) international speakers from Europe and Southeast Asia will be invited to participate in the conference to discuss the genetic issues of humans, animals and plants.

Among the speakers who have confirmed their involvement in this virtual conference are Dr Nik Serena Nik Zainal of the University of Cambridge, United Kingdom, Prof. Dr. Wendy Harwood and Dr. Brande Wulff of John Innes Center, United Kingdom, and Prof. Dr. Johan den Dunnen of Leiden University Medical Center, The Netherland and Professor Dr. Wang Linfa of DUKE-National University of Singapore (NUS) Medical School, Singapore. MIGC14 will also be attended by local speakers including Dr. Hishamshah Bin Mohd Ibrahim who is the Deputy Director General of Health, YBhg. Tan Sri Dr. Jemilah Mahmood the Special Advisor to the YAB Prime Minister and many more.

The conference will be open to participants in Malaysia and from other countries who will represent various fields of expertise such as clinical genetics, genetics lecturers, research officers, science officers, undergraduate and graduate students related to genetics. It is hoped that participants gain

Contact us: | Secretariat Office: Human Variome Project Malaysian Node & South-east Asian Node School of Medical Sciences, Universiti Sains Malaysia, Health Campus, 16150 Kubang Kerian, Kota Bharu, Kelantan, Malaysia | Phone :(60) 097676543 / 6531 | Fax: (60) 097676543 | Email : myhvp@usm.my | Website: hvpmalaysia.kk.usm.my

MyHVP Newsletter Board of Editors 2020

ISSN: 2550-1747 | Volume 05 | Issue 02| Year 2020

Editor in Chief

Journal | Call for papers

Malaysian Journal of Human Genetics The Malaysian Journal of Human Genetics (MJHG) (eISSN: 2716-649X) is an official journal of Malaysian Node of Human Variome Project and Malaysian Society of Human Genetics, publishing high quality peer reviewed original research, case report, short report and review articles that covers all aspect of human genetics including molecular, clinical, pharmacogenetics, population genetics and functional genomics. MJHG is now indexed in MyJurnal and Google Scholar.

Professor Dr. Zilfalil Alwi

Managing Editor

Dr. Nik Norliza Nik Hassan

Editorial Board Members

Prof. Ida Madieha binti Azmi Assoc. Prof. Dr. Muhammad Farid Johan Assoc. Prof. Dr. Rosnah Bahar Mr. Abdul Halim Fikri Bin Hashim

English Editor Amyzar Alwi

Contents

2 Board of Editors

2020

2 Journal

3-4 Report

5-6 Article

Š 2020. All rights reserved. The information in this newsletter is provided by the Malaysian Node of the Human Variome Project (MyHVP) members including South-east Asian Node (HVPSEA Node) for educational / information purpose only. It is not a substitute for professional medical care and medical advice.

The contents express the opinions of the authors who alone are responsible for their view expressed. MyHVP does not accept any legal responsibility for their contents.

Writers, Invited!

MyHVP Newsletter is issued biannually. For the coming issue, the public from various fields and specialties are invited to their lived experience in dealing with the issues of medicine or biomedicine. Writers can contribute their writing based on these following criteria: 1. Length (Max. 1page A4 size, and it may be edited for our use) 2. The committee has the right to share your writing for further issues.

3. To suit the needs of the publication, and your writing won’t be returned 4. Emailed the article to myhvp@usm.my

Published by

Malaysian Node of the Human Variome Project (MyHVP) School of Medical Sciences Universiti Sains Malaysia Health Campus 16150, Kubang Kerian, Kelantan, Malaysia Tel: +6097676531 /6543 | Email: myhvp@usm.my

MyHVP Newsletter | December 2020| page 2

Report The EduVariome Program in Sarawak Prepared by M. Hamdi M., Faculty of Medicine & Health Science, UNIMAS.

Background of the Project Since its inception in 2015 by the Malaysian Node of Human Variome Project (MyHVP), the Eduvariome has established its reputation in the peninsular region of the country. This program is committed to raising awareness on genetic disease focussing on Thalassaemia and the importance of pre-marital genetic screening at several schools and higher learning institutions.

With its tagline “Educating people towards a healthier nation”, this one of its kind community knowledge transfer project in Malaysia aims at inculcating awareness amongst students and the younger generations.

Conclusion This program prepared the students and participants which would one day settle down and have their own family. Sharing session with the thalassemia patient gave the audience a sense of empathy towards fellow community members who faced the challenge. Positive values gained perhaps may be extended by organising of future similar program at other localities in Sarawak. Selected pictures of the event, elective poster on awareness pre- & post- of the Eduvariome program and local newspaper cutting were enclosed as appendices.

In 2019, the program was extended to the Borneo region of this country in the state of Sarawak. Located in the district of Kuching, Sekolah Menengah Kebangsaan Batu Lintang which was located in the district of Kuching was chosen as the host for the ‘Decent Nuptial Agreement’: should or shouldn’t we consider a pre-martial DNA screening talk. The invited speakers were three panelists from The Institute of Islamic skills Sarawak (IKMAS), led by Ust Abd Rahim Othman, Pastor Ambrose Liap from the Association of Churches (ACS), Kuching Sarawak and Dr Ainul Nadiah Salam from the Blood Bank service Department, Kuching General Hospital. The program was also supported by Kuching Thalassemia Society and Kuching Specialist Hospital.

Impact of this conducted Program i. As organiser of the program, the working committee from the Universiti Malaysia Sarawak (UNIMAS) medical residential college (Kolej Kasturi), the program has given future medical doctors opportunities and experience in conducting local community outreach events, particularly through involvement of the media. ii. In recognition of the multi-racial, multi-religion population of Sarawak, the forum was the first interfaith discourse by Muslim IKMAS and non-Muslim ACS panelists. iii. A thought provoking sharing of experience through the perspectives of a thalassemia patient and a medical specialist provided forum participants insightful knowledge beyond the classroom. iv. Participants were educated on the danger, risks and the lifetime burden faced by thalassemia patients, as well as the present treatment approach and management offered by the local health-care professionals.

These impacts were well aligned to the initiative of the Human Variome Project (HVP) which is the Global Globin 2020 (GG2020) Challenge for a better and healthy community.

MyHVP Newsletter | December 2020 | page 3

Report

Elective project poster on awareness pre- & post- of the Eduvariome program

Published article and news report in local newspaper MyHVP Newsletter | December 2020 | page 4

Article VACCINE DEVELOPMENT, TESTING & REGULATION: WHAT WE SHOULD KNOW Nik Norliza Nik Hassan School of Health Sciences Health Campus, Universiti Sains Malaysia 16150 Kelantan Vaccination is a simple, safe and effective way of protecting human against harmful diseases, before human come into contact with them. To date, there are vaccines available to protect against at least 20 diseases, such as diphtheria, tetanus, pertussis, influenza and measles. Together, these vaccines save the lives of up to 3 million people every year [1,2].

Vaccination uses human body’s natural defenses to build resistance to specific infections and makes the immune system stronger. However, because vaccines contain only killed or weakened forms of germs like viruses or bacteria, they do not cause the disease or put us at risk of its complications.

Vaccination is not just about protecting ourselves, but also those around us. However, seriously ill people are advised against getting certain vaccines - so they depend on the rest of us to get vaccinated and help reduce the spread of disease.

Our immune systems are designed to remember. Once exposed to one or more doses of a vaccine, we typically remain protected against a disease for years, decades or even a lifetime. This is what makes vaccines so effective. As more people in a community get vaccinated, fewer people remain vulnerable, and there is less possibility for passing the pathogen on from person to person. Lowering the possibility for a pathogen to circulate in the community protects those who cannot be vaccinated due to other serious health conditions are known as “herd immunity.”

However, Herd immunity does not protect against all vaccinepreventable diseases. For example, tetanus that is caught from bacteria in the environment, not from other people [1,2].

During the COVID-19 pandemic, vaccination continues to be critically important. WHO has urged countries to ensure that essential immunization and health services continue, despite the challenges posed by COVID-19. WHO is one of the leaders of a global effort known as COVAX, which is speeding up the search for safe and effective COVID-19 vaccines by pooling resources from many different countries. This includes the COVAX Facility, a global risk-sharing mechanism for pooled procurement and equitable distribution of eventual COVID-19 vaccines. In addition to the investment for vaccine R & D, COVAX also helps in scale up vaccine manufacturing capabilities and commiting to buy vaccine doses if vaccines are shown to be safe and effective, with the goal of distributing 2 billion doses where they’re needed most, worldwide, by the end of 2021.

Thus, COVAX is the vaccine pillar of the Access to COVID-19 tools (ACT) accelerator, a global collaboration to accelerate development, production, and equitable access to COVID-19 tests, treatments, and vaccines. A Solidarity clinical trials setup by WHO helps in the evaluation of the potential COVID-19 vaccines at sites across the globe.

In general, the vaccine development is a long, complex process, often lasting 10-15 years and involving a combination of public and private involvement. The current system for developing, testing, and regulating vaccines developed during the 20th century as the groups involved standardized their procedures and regulations. At the end of the 19th century, several vaccines for humans had been developed. They were smallpox, rabies, plague, cholera, and typhoid vaccines. However, no regulation of vaccine production existed.

In general, stages of vaccine development and testing involved few steps. a) LABORATORY AND ANIMAL STUDIES Exploratory Stage This stage involves basic laboratory research and often lasts 2-4 years. At this phase, federally funded academic and governmental scientists identify natural or synthetic antigens that might help prevent or treat a disease. These antigens could include virus-like particles, weakened viruses, bacteria, bacterial toxins, or other substances derived from pathogens.

Pre-Clinical Stage A stage that give researchers an idea of the cellular responses they might expect in humans. A tissue-culture or cell-culture systems and animal testing involved in the assessing the safety of the candidate vaccine and its immunogenicity, or ability to provoke an immune response. Animal subjects may include mice and monkeys. A safe starting dose and method for administering the vaccine in the next phase of research also will be suggested. The pre-clinical stages often lasts 1-2 years and usually involves researchers in private industry. Before the vaccine is subject to three phases of testing, an approval from the U.S. Food and Drug Administration (FDA) are needed. b) CLINICAL STDIES WITH HUMAN SUBJECTS Phase I Vaccine Trials It involves a small group of subjects, usually between 20-80 subjects. If the vaccine is intended for children, researchers will first test adults, and then gradually step down the age of the test subjects until they reach their target. Phase I trials may be nonblinded (researchers and subjects know whether a vaccine or placebo is used). The goals of the phase are to assess the safety of the candidate vaccine and to determine the type and extent of immune response that the vaccine provokes. Researchers may use the challenge model, attempting to infect participants with the pathogen after the experimental group has been vaccinated.

The participants in these studies are carefully monitored and conditions are carefully controlled. The promising results will ensure the next stage of trials.

Phase II Vaccine Trials This phase involved larger group of subjects in Phase II testing.

Some of the individuals may belong to groups at risk of acquiring the disease. These trials are randomized and well controlled and include a placebo group. The goals of Phase II testing are to study the candidate vaccine’s safety, immunogenicity, proposed doses, schedule of immunizations, and method of delivery.

MyHVP Newsletter | December 2020 | page 5

Article Phase III Vaccine Trials Successful Phase II candidate vaccines move on to larger trials, involving thousands to tens of thousands of subjects. They are randomized and double blind and involve the experimental vaccine being tested against a placebo (the placebo may be a saline solution, a vaccine for another disease, or some other substance). Major goal of the phase is to assess vaccine safety in a large group of people. Certain rare side effects might not be seen in the smaller groups of subjects tested in earlier phases. For example, suppose that an adverse event related to a candidate vaccine might occur in 1 of every 10,000 people. To detect a significant difference for a low-frequency event, the trial would have to include 60,000 subjects, half of them in the control, or no vaccine.

Vaccine efficacy is tested as well. These factors might include 1) Does the candidate vaccine prevent disease?

2) Does it prevent infection with the pathogen?

3) Does it lead to production of antibodies or other types of immune responses related to the pathogen? c) Approval and Licensure Data from a successful Phase III trial will be submit to the Biologics License Application. FDA later will perform factory inspection where the vaccine will be made before approving the labeling of the vaccine. After licensure, the FDA will continue to monitor the production of the vaccine, including inspecting facilities and reviewing the manufacturer’s tests of lots of vaccines for potency, safety and purity. At this stage, the FDA has the right to conduct its own testing of manufacturers’ vaccines [2, 4].

Post-Licensure Monitoring of Vaccines A variety of systems such as Phase IV trials, the Vaccine Adverse Event Reporting System (VAERS), and the Vaccine Safety Datalink (VSD) used in the monitoring the vaccines after they have been approved.

Phase IV Trials Phase IV trial are optional studies that drug companies may conduct after a vaccine is released. The manufacturer may continue to test the vaccine for safety, efficacy, and other potential uses.

vaccination among the populations served by the medical groups. Researchers can access the data by proposing studies to the CDC and having them approved.

Rapid Cycle Analysis (RCA), a program under VSD was launched in 2005 with the objective to monitoring a real-time data to compare rates of adverse events in recently vaccinated people with rates among unvaccinated people. RCA has been used mainly to monitor new vaccines such as the conjugated meningococcal vaccine, rotavirus vaccine, MMR vaccine and the HPV vaccine. Data obtained allows more detail investigation that might possibly associated with adverse events and vaccination studied further [3].

In Conclusion Vaccines are developed, tested, and regulated in a very similar manner to other drugs. In general, vaccines are even more thoroughly tested than non-vaccine drugs because the number of human subjects in vaccine clinical trials is usually greater.

In addition, post-licensure monitoring of vaccines is closely examined by the Centers for Disease Control and the FDA. References 1.

VAX. Understanding vaccine trials: How are AIDS vaccines tested? IAVI Report. Volume 1, no. 1. August 2003.

Accessed 01/17/2018.Plotkin, S.A., Orenstein, W.A., Offit, P.A., eds. Vaccines, 5th ed. Philadelphia: Saunders, 2008. Chapters 3 and 73.

2.

U.S Department of Health and Human Services. Vaccine product approval process. U.S. Food and Drug Administration.

Updated 01/09/2018. Accessed 01/17/2018.

3.

U.S. Department of Health and Human Services.

Investigational New Drug (IND) Application. U.S. Food and Drug Administration. Updated 10/05/2017. Accessed 01/17/2018.

4.

Lilienfeld, D.E. The first pharmacoepidemiologic investigations: national drug safety policy in the United States, 1901-1902. Perspectives in Biology and Medicine. 51.2 (2008): 192-96.

VAERS It is a voluntary reporting system, established in 1990 by CDC and FDA. The main objective of VAERS were “to detect possible signals of adverse events associated with vaccines.” Adverse vaccine effects are a major health problem when approximately about 30,000 cases were reported each year to VAERS. Between 10% and 15% of these reports describe serious medical events that result in hospitalization, life-threatening illness, disability, or death. For example, VAERS has successfully identified several rare adverse events related to vaccination. Among them are an intestinal problem after the first vaccine for rotavirus was introduced in 1999 and neurologic and gastrointestinal diseases related to yellow fever vaccine [2, 4].

VSD VSD was established by CDC in 1990. It is a collection of linked databases containing information from large medical groups.

The linked databases allow officials to gather data about MyHVP Newsletter | December 2020 | page 6