Kick-starting Phase III clinical trial in Malaysia

Boo (second left), Jaziri (second right) and other delegates posing for a photo during the arrival of the inactivated vaccines.

KUCHING: YTB Healthcare Sdn Bhd (YTBH), a subsidiary of Yong Tai Bhd (YTB), has received the first batch of inactivated Covid-19 vaccine which was developed by the group’s strategic partner, Shenzhen Kangtai Biological Products Co Ltd (SZKT).

The group is the first private company to receive Covid-19 vaccines in Malaysia, which are used for the Phase III clinical trial.

The arrival of the vaccine, witnessed by Malaysian United Indigenous Parti (Bersatu) Sarawak chairman Senator Jaziri Alkaf Abdillah Suffian, sets the path for YTBH to roll out the Phase III clinical trial in Malaysia.

It said that it follows the National Pharmaceutical Regulatory Agency’s (NPRA) approval granted on June 3 for the Clinical Trial Import License (CTIL).

Jaziri said he is proud to witness the arrival of this vaccine, which would kick-start the Phase III clinical trial in Malaysia.

“Given the resurgence of Covid-19 cases recently, the supply of vaccines become even more important in our fight against this pandemic,” he added in a statement today (June 11).

“The government welcomes initiatives by private sectors to bring in additional vaccines in our fight against Covid-19,” he said.

Jaziri believe that the clinical trials are going to be important tools to help contain the virus and make a big difference for the country and the world.

“On a long term plan, we hope to bring SZKT to set up a vaccine research and development centre, together with a production plant in Malaysia.

“This coincides well with this locally conducted clinical trial, where data from the locals are collected.

“Most of the trials are conducted overseas. With a vaccine production plant in Malaysia with local data available, this will equip the country with the ability to face and respond to a potential future outbreak or new diseases,” said Jaziri.

YTB’s chief executive officer and executive director Datuk Wira Boo Kuang Loon said his group are thrilled with the effort and the milestone that has been achieved.

“I believe so far, we are the only private company that is able to bring a new type of Covid-19 vaccine into Malaysia, not to mention the first to commit and roll out Phase III clinical trial,” he said.

According to him, SZKT’s vaccine has obtained the Emergency Use Authorisation (EUA) granted by the Chinese government.

SZKT has also commenced its vaccination programme in China, and has been used to vaccinate millions of Chinese citizens since June 1.

“Once we roll out the Phase III clinical trial and with few months of accelerated data, we hope to apply for the Conditional Registration Approval, for the adoption of the Vaccine.

“We also hope for more volunteers to sign up with this trial, as more data collected will expedite the trial and ultimately get Malaysians back to normalcy through herd immunity,” said Boo.

It said Phase III of the clinical trial will enrol 3,000 subjects from Malaysia, and the subjects will receive the vaccine in two doses 28 days apart.

Jaziri mentioned that it is important that Malaysia, and Sarawak in particular, must achieve herd immunity as soon as possible for the purpose of economic recovery and the wellbeing of our people.