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Roadmap to making our own vaccines

Malaysia has officially entered the global race to develop Covid-19 vaccines, following the recent announcement by Health Minister Datuk Seri Dr Adham Baba. Apart from looking at the timeline for the country to come up with those vaccines, the scientific community is also gearing up for improved level of preparedness in the face of other pandemics without relying on others. In this interview with the 'New Straits Times', Institute for Medical Research director Dr Tahir Aris tells the NST what is being done.

Question: What is the development stage now for both the mRNA (messenger ribonucleic acid) and inactivated virus vaccines?

Answer: We started initiatives into vaccine development from the early part of the epidemic last year. We chose to embark on two platforms, namely the mRNA and inactivated virus vaccines.

Discussions and planning have started since March last year. However, the laboratory work began only after we received research funding from the Health Ministry.

We started work on the inactivated virus vaccine in January this year, while the mRNA project began in November last year. Both the vaccines' research and development (R&D) are at exploratory or early stages only.

For the inactivated virus vaccine, we have managed to isolate, identify and propagate the potential strain. The next step is to optimise the inactivation process.

After this stage, we will proceed to use animal models. The progress of this vaccine is going according to plan.

The mRNA vaccine is still at "proof-of-concept" stage, where the specific viral gene sequences are being analysed. This stage is very important to ensure that the candidate vaccine is able to elicit the immune response against SARS-CoV-2.

Q: How much has the ministry allocated to develop the vaccines?

A: The budget approved for the development of the vaccines are for laboratory and animal studies only, amounting to RM3.1 million. Additional funding will be applied for pre-clinical and clinical studies.

Q: Is the initiative undertaken wholly by the Institute for Medical Research (IMR) and the Health Ministry, or is it a joint venture with others? Can you identify other parties developing these vaccines?

A: Our researchers in these projects have background experience in microbiology, immunology and vaccinology. The projects are IMR's initiative in collaboration with the Higher Education and the Agriculture and Food Industry Ministries.

The inactivated virus (vaccine) team is headed by Dr Rozainanee Mohd Zain, a consultant clinical virologist in the Virology Unit of the Infectious Diseases Research Centre at IMR.

We are collaborating with Universiti Putra Malaysia's Veterinary Medicine Faculty and the Veterinary Research Institute (VRI) in Ipoh.

At this point, the mRNA vaccine is wholly an IMR initiative. Dr Masita Arip, a consultant microbiologist and immunologist at IMR's Allergy and Immunology Research Centre, is heading the project.

Q: Who will own the intellectual property (IP) rights if the research or R&D for both vaccines succeed?

A: An MoU will be signed between the parties involved and this will include the terms and conditions on IP rights. The researchers and institutions, or universities involved, will share the rights.

Q: Can you elaborate on the timeline?

A: The laboratory studies of the inactivated vaccine, including the pre-clinical studies on animals, are to be done by the end of next year (Pre-clinical studies are expected to start in August and animal studies conducted at VRI are expected to be completed by March next year).

This includes analysis on the efficacy and safety of the potential vaccine. We hope to start phase 1 of the clinical studies by January 2023. For mRNA vaccine, we plan to start the clinical trial by 2025.

Q: Can you elaborate on the process of developing the inactivated virus vaccine? How do you address the bio-security hazards?

A: One of the project activities for the inactivated vaccine is to grow selected SARS-CoV-2 in a suitable cell line to get more viruses in higher titre. The source of SARS-CoV-2 is obtained from selected patient samples, which is suitable as the vaccine candidate.

This work needs to be performed in a Level 3 Biosafety (BSL-3) laboratory, which is a higher containment laboratory. Only trained personnel are allowed to work in a BSL-3 laboratory. The laboratory is readily available at IMR, Setia Alam.

Q: Are there other pharmaceutical companies developing vaccines in the country, or is such research restricted to the Health Ministry only?

A: Covid-19 vaccine research is not restricted to the ministry. There are universities and other pharmaceutical companies which are also developing their own vaccines.

Pharmaniaga (Bhd) is doing the fill-and-finish process of producing the vaccine. There are also vaccine R&D arms in universities. However, there is not much information on them.

Q: What can you share about other companies or institutions in Malaysia that are currently part of the race, and the type of vaccines that they are developing? Do they involve cooperating with IMR/NIH?

A: IMR/NIH is not in charge of monitoring Covid-19 vaccine research conducted by other companies or entities in Malaysia.

Universiti Malaya's Tropical Infectious Diseases Research, Education Centre, Universiti Sains Malaysia and the International Medical University are among the higher-learning institutions working to develop vaccines too, which IMR has been roped in to collaborate.

However, I'm unable to share the details, as we have signed a non-disclosure agreement.

Currently the Roadmap for Vaccine Development in the country is being drafted under the purview of Science, Technology and Innovation Ministry (Mosti). This roadmap is a collaborative effort between Mosti and the Health, Higher Education and Defence Ministries.

Q: What is IMR's chance of coming up with a working vaccine within the stipulated timelines? Are you optimistic or prepared for it to go either way, based on the overall vaccine R&D success rates and the timelines?

A: This is a relatively new venture for IMR. I'm optimistic with the stipulated timelines for these two projects.

The inactivated virus vaccine is progressing really well.

Of course, we cannot compete with (other) institutions that have been conducting vaccine research for a long time. However, we are taking small confident steps towards achieving our goals.

Q: Why does Malaysia need its own vaccines now, when the market is filling up with products from other countries? Would our resources be better spent towards researching the virus in the hopes of finding a cure or proper treatment? What are the benefits of going through such a tedious process, knowing that chances of any discovery (of a viable vaccine) could be slim?

A: Before we faced this pandemic, we felt that way too — buying is cheaper and easier. However, when it happened, we realised that we cannot depend entirely on others and that we need to develop our own capacity in producing vaccines.

We don't want to have total dependency on others, we need to stand on our own. This is our mentality now when it comes to vaccines development. We'll never know what pandemic may strike in the future. At least, by making headway with these two platforms, we will gain some experience in vaccine R&D to prepare us for other pandemics.

Malaysia also needs to have its own vaccine manufacturing facilities, so we can produce our vaccines quickly and protect our population. We should be able to be self-sufficient as we face future pandemics, in terms of having our own vaccines.

The vaccine technologies that IMR researchers are developing is not only for Covid-19. The technology can be used for other viruses or bacteria, and even immunotherapy, which is important in the country. IMR is strengthening its human resources to realise the Roadmap for Vaccine Development in Malaysia.

Q: How do we make sure that the (vaccine) candidates get regulatory approvals?

A: The IMR researchers are working closely with the National Pharmaceutical Regulatory Agency (NPRA) to ensure that all the requirements are met. This measure is to make sure that the candidate vaccines will surpass all stages in order to be used in the country.

The regulatory bodies will be involved from the beginning of the project, so we know what needs to be done and comply with it. We want our vaccines to be safe and efficacious for human use. Therefore, adhering to the requirements by the regulatory body is of utmost importance.

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