As the world is already getting their doses of the Covid-19 vaccine and then there’s us. Malaysia will only be conducting its first phase 3 clinical trials for Covid-19 vaccine and the Ministry of Health (MOH) is looking for 3,000 healthy adults for the study.
The trials are said to be conducted at selected hospitals throughout the country as they need to see the effectiveness and safety of the vaccine. I mean, no one ones to receive a vaccine that can cause side effects, right?
As many would be concerned, the Institute for Clinical Research (ICR) has released a FAQ for those curious of the vaccine trials.
1) The Trial is only for healthy adults with no history of Covid-19
The COVID-19 vaccine study (NMRR-20-2514-57143) is offered to those 18 years old and above. The adults must not have a history of Covid-19 as it is purposed to see if the vaccine can prevent an individual of getting Covid-19. Results of the test may vary if an individual had contacted Covid-19 and had healed from it.
All individuals will be screened to determine their eligibility and more than one individual in a family can participate in the study.
A diverse group is required for the study to ensure that the vaccine works for everyone. It is aimed to include people from all walks of life to ensure the safety and effectiveness for all people.
2) What type of vaccine is this?
The process of making the vaccine is by killing the virus with chemicals ensuring it can’t multiply and cause any disease. This inactive virus is then used to make the vaccine similarly like flu, polio or even hepatitis A vaccines.
But do note, you can still be tested positive for Covid-19 but not because of the vaccine but because of community infection.
3) Is the vaccine Halal certified and recognized by JAKIM?
It has been stated in the FAQ that it is certified Halal by the Halal Certification Services Chongqing (HCS) (certificate number 2019ILC/L-056052820). Yes, it is also recognized by JAKIM as a foreign halal certification so not to worry.
4) 50% chance of getting actual vaccine during the study
Participants in this trial have a 50-50 chance of getting the actual vaccine during the study period.
During the phase 3 of the clinical trial, half of the volunteers will be given a placebo and the other half will be given the vaccine. Both you and the study team will not know which vaccine is administered into you until the end of the study. 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.
Not to worry, those who receive the placebo will eventually be given the real vaccine after approval for commercial use.
5) Study requires two doses
Participants of this study will receive a total of two doses of the vaccine. The 2nd jab will be given 14 days after the first injection administered through your arm.
6) Potential reactions from the vaccine
The FAQ states that base don pervious studies, the vaccine may cause some reactions such as pain, swelling, redness and itching at the injection site.
Some may also experience fatigue, fever, diarrhea and other side effects. They are all temporary and treatable according to the FAQ.
Man, I don’t mind getting all the symptoms, but I don’t ever want to face diarrhea.
There is no guarantee of long-term safety yet since the study is to know the 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.
If found to have side effects (adverse event), it will be temporarily paused in order for scientists and doctors to investigate the safety concern.
7) No quarantine but SOP still required
Participants are free to go on with their normal life but still required to adhere to the SOP which includes wearing a face mask when going out to crowded public spaces. The measures must be followed because you still have a 50% chance of receiving a placebo which does not have any protection.
8) Participation is free and compensation is provided.
No payment is required when taking part but there will be compensation for our time and transportation cost. Full details of the compensation will only be revealed during the process.
Volunteers are made to understand the studies risk and benefits, alternatives, privacy, payment and other details. You can also choose to not continue the study and exit at any time. Best part is no benefits or rights will be penalized when doing so.
9) What would you need to do?
There will be a few processes in the study. It will involve screening, consent, vaccination and follow-up visits. If you’re eligible to participate, you will need to visit the hospital on given dates to receive the vaccine or even placebo. A throat and nasal swab is also required and 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 along with any medication taken.
Sounds simple enough… I think…
10) The study will last for 12 months, with 6 follow-up visits
That’s pretty long… In addition to the 12 months and 6 follow up visits, you will also have 24 phone calls (I’m assuming this is with those conducting the study). You will need to inform the study doctor of any medication taken which includes traditional medicine and non-drug therapy. Even when needing medication during an emergency you must notify the study doctor.
11) 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: