[Vaccine-manufacturing] Nature: The COVID vaccine pioneer behind southeast Asia’s first mRNA shot

Thiru Balasubramaniam thiru at keionline.org
Wed May 26 23:06:40 PDT 2021


https://www.nature.com/articles/d41586-021-01426-9

NEWS Q&A  26 MAY 2021

The COVID vaccine pioneer behind southeast Asia’s first mRNA shot

ChulaCov19 designer Kiat Ruxrungtham talks about his aim to make Thailand
an mRNA vaccine hub, and the challenge of competing with bigger rivals.

Smriti Mallapaty

Thailand is about to launch human trials of its first mRNA COVID-19
vaccine. If it is successful, the country could emerge as an important
supplier of mRNA vaccines in Asia, making it a small but significant player
in the dash to adopt the new technology.

Last year saw the launch of the first viable vaccines that use messenger
RNA to prompt an immune response, one developed by Pfizer in New York City
and BioNTech in Mainz, Germany, and the other by Moderna in Cambridge,
Massachusetts. These have proven highly effective against COVID-19, and
have so far been given to hundreds of millions of people.

In Asia, home-grown mRNA vaccines are already undergoing trials in China,
India and Japan. Thailand is a relative newcomer, but its efforts have
increased in urgency as its neighbouring nations across south and southeast
Asia suffer both vaccine shortages and renewed COVID-19 surges. Thailand is
now recording about 3,500 new infections a day — its biggest spike since
the pandemic began.

Nature spoke to immunologist Kiat Ruxrungtham, founder of the Chula Vaccine
Research Center at Chulalongkorn University in Bangkok, about his team’s
COVID-19 vaccine, called ChulaCov19.

What motivated you to develop your own vaccine?

During the H1N1 influenza pandemic in 2009–10, it took more than a year for
Thailand to get vaccines. We wanted to develop and manufacture our own so
that when a new pandemic hit, we wouldn’t have to wait. We might be too
late to fill the gap in the Thai market with our first-generation COVID-19
vaccine, but we have a chance to compete with second- and third-generation
vaccines against emerging variants. Our goal is to produce enough to supply
Thailand, and possibly also our neighbours, at an affordable price.

What inspired the shift to mRNA technology?

I founded my vaccine-research laboratory more than a decade ago and we have
been developing vaccines against dengue fever, leptospirosis and cancer
using many different technologies. In 2017, we invited the pioneer of mRNA
technology, Drew Weissman at the University of Pennsylvania in
Philadelphia, to speak at our annual forum. We then began working with
Weissman on mRNA vaccines for allergies. But when the pandemic hit, we
decided to focus on designing a COVID-19 vaccine instead.

The beauty of mRNA vaccines is that they are quicker to produce and can be
made at large scales, which reduces their cost in the long run. These
vaccines use small pieces of genetic material — mRNA — to tell cells to
make specific viral proteins, such as the spike protein that SARS-CoV-2
uses to enter host cells. They can be developed rapidly using information
about a virus’s genomic sequence, which means that we don’t need to wait
until emerging variants enter Thailand to begin developing vaccines against
them.

Tell me about your progress so far.

ChulaCov19 has shown promising results in unpublished preclinical studies
in mouse and primate models. We plan to begin phase I clinical trials in
people in June, and are already developing next-generation vaccines against
the B.1.351 and B.1.1.7 variants of the virus. We are also keeping a close
eye on B.1.617, which first emerged in India. We are happy to have come
this far, but it has taken us more than a year to enter human clinical
trials — almost a year behind major global pharmaceutical companies.

A technician at work at the Chula Vaccine Research Center of Chulalongkorn
University in Bangkok.Credit: Diego Azubel/EPA-EFE/Shutterstock

What clinical trials are you planning?

The initial phase I trial will include some 100 people to figure out the
appropriate dose for generating a good immune response. A US-based biotech
company will probably produce the first batch but, by September, we plan to
have the vaccines manufactured by the company BioNet-Asia in Bangkok. If
the quality and results are comparable, then our locally produced vaccines
will hopefully gain the trust of the government and investors.

Once we pass this milestone, we plan to conduct phase II trials, testing
the consistency of response in a few hundred volunteers, and then assessing
the safety of the vaccine in some 5,000 individuals. To test efficacy, we
will need to conduct phase III trials in tens of thousands of individuals.

How might you get approval for the vaccine without late-stage trials?

The World Health Organization, the US National Institutes of Health and
several other organizations around the world are working to determine the
level of neutralizing antibodies that a vaccine should induce to provide
adequate protection. This ‘correlate of protection’ could be used to assess
efficacy without conducting late-stage trials, as is commonly done for new
flu vaccines.

We have also asked colleagues in Singapore and Malaysia to send us blood
samples from people vaccinated with the Pfizer–BioNTech vaccine, and we
will collect samples from people in Thailand immunized with AstraZeneca’s
and Sinovac’s vaccines. If the immune response generated by our vaccines is
as good as or better than those induced by others, the Thai regulatory body
might consider approving ChulaCov19 for emergency use without phase III
trial results.

What have been the biggest challenges?

Funding has been a major obstacle. As we are an academic centre, the
majority of support is from the government. We had interesting preclinical
results as early as May 2020, but it took almost six months to get the
funds to start human trials. It also took time to transfer the know-how for
producing mRNA vaccines to a manufacturer in Thailand.

Would you benefit from COVID-19 vaccine patent waivers?

An agreement to waive patent protections for COVID-19 vaccines in low- and
middle-income countries would be wonderful. It would allow us to use
technologies that are currently unaffordable or inaccessible to us to make
our vaccine even better and cheaper. But waiving patents is only the first
step — you also need funding, local manufacturing capacity and access to
crucial raw materials.

doi: https://doi.org/10.1038/d41586-021-01426-9

This interview has been edited for length and clarity.


-- 
Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org


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