EFFORTS are ongoing to develop a Malaysian-made Covid-19 vaccine.
Researchers are hoping it will be effective against the new variants of the coronavirus, including the Delta strain, known to be more resistant and transmissible.
“All variants of concern including the Delta, Alpha and Beta variants, are taken into consideration in designing the vaccines,” says one of the head researchers in the initiative, Institute for Medical Research (IMR) director Dr Tahir Aris.
Currently, IMR under the Health Ministry is taking the lead in this ambitious project, together with other collaborators.
Two types of vaccines are being developed now.
The first involves the mRNA (messenger RNA) method – solely an IMR initiative for now.
Examples of mRNA vaccines are Pfizer-BioNTech and Moderna, which teach our cells how to make a protein that triggers an immune response inside our bodies.
The second type involves the inactivated vaccine approach, similar to the Sinovac vaccine, which stimulates our immune response using viruses that have been killed using high temperatures, chemicals or radiation.
For the inactivated vaccine, IMR is joining forces with experts from Universiti Putra Malaysia (UPM) and the Veterinary Research Institute (VRI) under the Veterinary Services Department (DVS). There are 26 experts are behind the effort – 12 from IMR, and seven each from UPM and VRI, respectively.
The all-Malaysian team is made up of microbiologists, pathologists, biomedical researchers, vaccine experts and veterinarians from the three organisations.
While the government has secured enough vaccines from overseas to cover over 100% of our population, this project means a lot to Malaysia because it goes beyond the war against Covid-19.
“The main reason why Malaysia needs its own vaccine is because we should have preparedness for the current pandemic as well as future ones.
“Malaysia needs to have the capabilities to produce vaccines when needed and be self-sufficient,” Dr Tahir says.
Vaccine technologies can be used for other viruses or bacteria and even immunotherapy, he adds.
In the lab
For now, the action is focused in the lab.
The inactivated vaccine is currently at the propagation stage – a process involving virus multiplication in host cells, explains Dr Tahir.
“The next step will be the virus inactivation stage.
“If the inactivation works well, we will go into preclinical studies involving small animals,” he says, adding that a suitable mice model will be used.
With successful preclinical stages, the vaccines will then go through clinical studies involving humans.
Such tests will be conducted by the Institute for Clinical Research, which will decide on the clinical trial design and the number of people.
The tests will involve volunteers from the Malaysian public.
“All these phases need to fulfill requirements from the National Pharmaceutical Regulatory Agency (NPRA).
“Once the vaccines have achieved the required effectiveness and safety and are approved by NPRA, it can be used by the Malaysian public,” Dr Tahir says.
As for the mRNA vaccine, it is currently at the cloning stage, which is carried out to amplify the genetic material needed for the study. For a country that is just about to start developing its own vaccine, Dr Tahir says the best option is to try the easiest technology for a vaccine that has been proven to work.
“The inactivated vaccine platform was chosen at the start of the pandemic because of the availability of the virus culture at IMR and it can be done faster compared to other ways,” he says.
He however hopes Malaysia will have more facilities for vaccine study, such as Biosafety Laboratory Level 3 (BSL3) laboratories.
To illustrate its importance, the BSL3 facility in the VRI will be used for animal trials in the research.
“Vaccine research in Malaysia needs continuous support from the government and public in terms of funding, facilities and participation in clinical trials,” Dr Tahir stresses.
High efficacy targeted
More time is still needed before we can have a Malaysian-made vaccine, but for now, the results look promising.
The inactivated vaccine has shown good progress with 100% efficacy so far.
This is based on preliminary stages in research last year, says UPM faculty of veterinary medicine professor Datuk Dr Mohd Hair Bejo, another head researcher.
“However, it might later vary from 95% to 100% in its efficacy, depending on the number of sample sizes, the time of coronavirus infection and pandemic situation in the area or country during the clinical trials,” he elaborates.
Dr Mohd Hair, who is also the UPM Putra Science Park director, says the inactivated virus method is a well-used and established technology in vaccine development.
“Different vaccine technologies have their own advantages and disadvantages.
“The inactivated virus technology has advantages on the use of the whole SARS-CoV-2 virus to produce different versions of the vaccine to act against Covid-19 variants,” he explains.
When the vaccine development proceeds to human clinical trials, Dr Mohd Hair says standard protocols advised and required by the authorities will be strictly followed.
“Clinical trials involving humans will most likely take place in government hospitals,” he adds.
He stresses the importance of Malaysia being able to produce our own vaccine against infectious and zoonotic diseases.
“Covid-19 may be one of the worst pandemics, but it is not the first and foreseeably, not the last.
“Learning from past and current experiences, Malaysia has no choice but to be resilient and more prepared to respond to new challenges and waves of impact if another pandemic hits,” Dr Mohd Hair says.
As the agency assisting in animal trials, the DVS says VRI officers will be involved in setting up facilities for such tests.
The department assures that the animals used in the study will be treated with very minimal suffering.
“Ethical measures will be used in the trials involving animals, and will be based on standards set by the Animal Care and Use Committee, and VRI’s Laboratory Biosafety Manual,” it adds.
Two types of studies will be conducted, namely one on safety and the other on efficacy.
“Details on the protocol for both the safety and efficacy tests are prepared by IMR,” the DVS says.
On its BSL3 facility, the department stresses it is important for the equipment used in the animal trials to be in good working condition.
“To ensure this, we must have continuous maintenance allocations for scheduled services and budgets for repairs in case of any breakdowns,” says the DVS.
It lauds the inter-agency cooperation in this endeavour as knowledge, skills and technologies can be shared among them.
“We hope to do the best for the nation. In turn, we hope the nation will give us its full support,” it adds.