BY KHIRTINI K . KUMARAN

is planning a significant investment of around RM280 million towards a plant that could make Malaysia self-sufficient in vaccines within two years .

It is in discussions with the Russian Direct Investment Fund ( RDIF ) and the Gamaleya National Research Institute of Russia and is investing in expanding a new manufacturing facility in Klang .

Duopharma Biotech Group Managing Director Leonard Ariff Abdul Shatar said the company was at the tail-end of constructing a facility in Klang , which was to have been a biological facility for protein therapeutics .

However , it plans to convert that into a vaccine-manufacturing facility by investing another RM200 million . It has already spent nearly RM80 million on the infrastructure so far .

He said it was expecting to have the certificate of completion and compliance ( CCC ) for the facility by the fourth quarter of this year .

“ We believe with the right terms and conditions , we could give Malaysia vaccine self-sufficiency within two years ,” he told The Health .

In terms of size , he said the facility would cater to the Malaysian population . There will also be the prospects of exporting to the Southeast Asian region .

Currently , the Sputnik V vaccine is being brought in the form of finished vials , given the urgency of the situation and in line with the government ’ s effort to expedite the national vaccination programme .

“ There is an argument that Malaysia would need some level of self-sufficiency in vaccine production in future .

“ And if Covid-19 becomes endemic and mutates , there will be a need for regular booster shots . Then , the economics for a

And if Covid-19 becomes endemic and mutates , there will be a need for regular booster shots . Then , the economics for a manufacturing facility becomes more feasible .”

manufacturing facility becomes more feasible .”

Manufacturing the vaccine

He said any manufacturing facility must be commercially sustainable .

“ Any investment that we do has to be in a technology that is robust and can stand the test of time .

“ The technology offered by Gamaleya is proven , and we believe the ability to manufacture a broader spectrum of vaccines is possible . You need an adaptable technology platform .”

Duopharma Biotech recently signed a term sheet agreement with RDIF to secure 6.4 million doses of the Sputnik V vaccine . It will also explore collaborating in research & development with RDIF and Gamaleya . Sputnik V is the first

registered vaccine globally . After some initial criticism against it , more than 50 countries have now registered it . It is one of three vaccines in the world with an efficacy rate of over 90 per cent .

In fact , Russia has always been at the forefront of vaccine development . It was the first to develop an Ebola vaccine .

Leonard Ariff said the vaccine was in the process of being registered with the National Pharmaceutical Regulatory Agency ( NPRA ) and Duopharma Biotech aims to obtain approval in March . If all goes well , Malaysians will be able to get their first Sputnik V doses in April .

The Sputnik V vaccine storage temperature is at -20 degrees Celcius or lower . There is a need for infrastructure for Duopharma Biotech to receive the vaccine and the MoH to administer the vaccine .

“ In anticipation of potential registration , we are now working out the logistics with the MoH . So , the registration and the logistic preparation is actually working in parallel .

“ We have signed a term sheet with the MoH , and it is still being negotiated ,” he said , expecting it to be completed in March into a definitive agreement .

He also shared that after discussing internally and understanding the timeline of MoH , Duopharma Biotech decided to begin with obtaining the finished multi-dose instead of going the fill-andfinish route . — The Health