Malaysia will be conducting its first phase 3 clinical trial for COVID-19 vaccine and the Ministry of Health is looking for 3,000 healthy adults for the study. The trial which is to be conducted at selected hospitals throughout the country is aimed at studying the effectiveness and safety of the COVID-19 vaccine.
To answer some of the questions and concerns, the Institute for Clinical Research (ICR) has released an FAQ for the vaccine trial and here’s what you need to know.
Trial only for healthy adults with no history of COVID-19
The COVID-19 vaccine study (NMRR-20-2514-57143) is only offered to healthy adults aged 18 years old and above, that have not been tested positive for COVID-19. The purpose of the test is to ensure that it can prevent an individual of getting COVID-19 to ensure people are protected. The results of the vaccine efficacy in the study may be affected if it included individuals who have recovered from COVID-19.
All individuals will be screened by a health officer to determine their eligibility. More than one individual in a family may participate in the study provided they pass the screening.
The study requires a diverse group of volunteers to ensure that the vaccine works for everyone. They aim to include people from all walks of life so that they can ensure that the study vaccine is safe and effective for all people.
What type of vaccine is this?
The study uses an inactivated vaccine against COVID-19 and it’s developed by the Institute of Medical Biology Chinese Academy of Medical Sciences (IMBCAMS) in China. This is their first phase 3 trial to be conducted outside of China.
The process of making the vaccine is by killing the whole virus with chemical so that it can’t multiply and cause disease. This inactivated virus is then used to make vaccines which is a similar approach as producing flu vaccine, inactivated polio or hepatitis A vaccines.
It is impossible to get COVID-19 from the vaccination as it contains inactivated virus particles which cannot cause an infection. However, there’s a potential that you may test positive for COVID-19 due to community infection and it’s not caused by the vaccine itself.
The vaccine is certified Halal and recognised by JAKIM
The FAQ states that the vaccine is certified Halal by the Halal Certification Services Chongqing (HCS) (certificate number 2019ILC/L-056052820). The certification is also recognised by JAKIM as a foreign halal certification body or authority.
50% chance of getting actual vaccine during the study
By participating in the trial, there’s a 50-50 chance of getting the actual vaccine during the study period. During the phase 3 clinical trial, half of the volunteers will be given a placebo and another half will be given the vaccine. This is to enable the study to determine the number of infections among those who received the vaccine and the placebo.
When you participate in the study, both you and the study team will not know if you’ve received the placebo until the study ends. Using the “randomised, double-blinded, placebo-controlled clinical trial” approach, the details will be kept a secret to ensure the integrity of the study and to avoid bias.
All volunteers that received the placebo will be eventually given the actual vaccine once it has been approved for commercial use.
Study requires two doses
During the study, you’ll receive two doses. After receiving the first jab, you’ll receive the second injection on the 14th day. It will be administered through injection on your arm.
Potential reactions from the vaccine
The FAQ states that based on previous studies, the vaccine may cause some reactions such as pain, swelling, redness and itching at the injection site. Those that received the jab may experience fatigue, fever, diarrhea and other side effects. However, it said that the effects are usually temporary and treatable.
The long term safety aspect is still unknown and it trial aims to study its safety profile for up to one year. If there’s any incident during the study, it will be investigated by the relevant parties. The sponsor will be responsible if it’s proven to be caused by the study vaccine and a trial insurance will be triggered to provide the compensation to the volunteer.
The study may be paused temporary if a possible side effect (adverse event) is detected. It is stated that studies are designed to pause when an unexpected health event (safety signal) is detected so that scientists and doctors can investigate the safety concerns.
No quarantine but SOP still required
By participating in the study, you are free to go on with your normal life. However, you are still required to adhere to the SOP including wearing a face mask when going out to crowded public spaces. All safety measures must be followed especially when there’s a 50% chance that you’ve received a placebo which offers no protection.
Participation is free and compensation is provided
Volunteers are not required to pay anything to take part in the study. However, they will compensate you for your time and transportation costs. The full details of the compensation will only be revealed during the informed consent process.
During the “informed consent” process, volunteers are made to understand what will happen during the study, risks and benefits, alternatives, privacy, payment and other details. You may choose yes or not to continue with the study. Volunteers may choose to exit the study at any time without losing your rights or benefits or being penalised.
What would you need to do?
The study involves screening, consent, vaccination and follow-up visits. If you’re eligible to participate, you will need to visit the hospital during the given dates to receive the vaccine or placebo. Volunteers will require to provide one throat and nasal swab, some blood and urine (for women of childbearing age) samples, complete records of Daily Cards and Contact Cards, and inform the study of any symptoms that you have and any medications taken.
Study will last for 12 months, with 6 follow-up visits
The study will take 12 months to complete and it involves 6 follow-up visits to the hospital and 24 phone calls. During the study, you must inform the study doctor of any medication you’ve taken and this includes traditional medicine and non-drug therapy. You may take medication during an emergency and you must notify your study doctor.
No pregnancy and blood donation allowed during the study
The FAQ also states that partners are required to take effective contraceptive method to prevent pregnancy during the 12-month trial period. Donation of sperm and egg during the trial is also not allowed.
At the same time, blood donors are not allowed to donate. You can only donate blood after you completed the entire follow-up period.
Where to sign up?
The vaccine trial will be conducted at 9 hospitals and it is expected to start on 21st January 2021. If you’re interested, you may contact the following numbers:
For more info, you can read the full FAQ.
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