How does it stand now?
On June 11th, 2021, Yong Tai Bhd has announced that its subsidiary YTB Healthcare Sdn Bhd (YTBH) today received the first batch of an inactivated Covid-19 vaccine developed by China-based Shenzhen Kangtai Biological Products Co Ltd (SZKT). Yong Tai is the exclusive distributor for SZKT's vaccine with a period of five years (renewable) for no less than 20 million doses yearly. The company expects this venture to create a strong income stream and contribute positively to the group.
Earlier on June 3rd 2021, Yong Tai Bhd said its healthcare unit is set to undertake the Covid-19 vaccine phase three clinical trial in Malaysia after the National Pharmaceutical Regulatory Agency (NPRA) granted its approval for the clinical trial import licence. The approval granted by NPRA to YTB Healthcare Sdn Bhd follows the earlier approval received from the Medical Review Ethics Committee (MREC).
The approval also coincides with the Emergency Use Authorisation (EUA) granted by China's government recently for the inactivated Covid-19 vaccine KCONVAC developed by the group’s strategic partner, Shenzhen Kangtai Biological Products Co Ltd (SZKT). SZKT has commenced its KCONVAC vaccination programme in China, with the first batch of more than 500,000 doses administered on June 1.
Yong Tai Berhad will be the first private company to conduct the phase III clinical trial for Covid-19 vaccine in Malaysia. SZKT has already undergone the Phase I and II clinical trials in China since last year with encouraging results. With the approval now granted for emergency use in China, Yong Tai is cautiously optimistic that the results of Phase III clinical trial in Malaysia will show promising results. Hence, Yong Tai would proceed with the application for the EUA in Malaysia, following the roll-out of the phase three clinical trial.
How the vaccine approval stage stands at this point of time in the world?
As of June 13, 2021, there are 17 vaccines approved in the world by at least one country. Let us take note that most of the approved vaccines are yet to complete the Phase 3 trials but given conditional approval/authorization by the related regulatory agencies.
How is the situation in Malaysia?
As of June 11, 2021, Malaysia has 3 approved vaccines with the other 2 vaccines in clinical trials stage.
Soon, YongTai's SZKT vaccine will join the list.
It is important to note that all vaccines used currently in Malaysia (Pfizer, AstraZeneca, Sinovac) are under the conditional registration approval. None have completed their full trial.
So, why were they approved then? To be able to answer it, we need to understand how the approval system works.
Vaccine candidates are tested many times in progressively larger clinical trials to ensure they are safe and effective.
The first clinical studies in humans are phase 1 clinical trials which primarily assess the initial safety of the vaccine and identify the correct dose. Phase I clinical trials typically enroll tens or hundreds of healthy adults.
Vaccine candidates that show promise then move on to phase 2 clinical trials. Phase 2 clinical trials are larger studies designed to assess safety and to determine how well the vaccine activates the immune system response in healthy individuals. Typically hundreds or thousands of people participate in phase 2 trials. Sometimes phase 1 and phase 2 trials are combined into phase 1/2 trials where the aims of both the phase 1 and phase 2 trials are achieved.
Phase 3 clinical trials are the final test of the vaccine prior to approval. In phase 3 trials, the vaccine is given to tens of thousands of healthy volunteers to determine whether the vaccine protects them from becoming sick. Typically, phase 3 trials enroll those at highest risk of the disease. If the vaccine proves to be safe and effective throughout these trials, all of the evidence will be reviewed by regulatory agencies who will determine whether to approve it for widespread use.
Once approved, vaccines continue to be monitored for safety and effectiveness. In addition, once approved, public health officials must implement detailed and transparent plans to deliver vaccines to individuals and communities who need them.
Thus, it can be concluded that the use of emergency authorization and conditional use allows the vaccines to be administered based on:
1) Overwhelming number of approvals obtained in other countries
2) Phase 1 and Phase 2 trials data with optimistic results
With the above considerations, YongTai's SKZT vaccine has high possiblity to obtain conditional approvals.
Timing is also essential for vaccine approval. The current vacinnation rate in Malaysia has to be increased in order to achieve herd immunity as the Covid19 spread rate has been exponential lately.
Since March 2021, the country has only fully vaccinated 4.1% of its total population.
SZKT's vaccine has obtained the Emergency Use Authorisation granted by the government of China. SZKT has also commenced its vaccination programme in China, which has been used to vaccinate millions of Chinese citizens since June 1, 2021.
Given the resurgence of Covid-19 cases recently, the supply of vaccine has become even more important in the fight against this pandemic. In The Edge Market article (Yong Tai receives first batch of SZKT's vaccine, paves way to launch phase 3 clinical trial in Malaysia, June 11, 2021), Senator Jaziri Alkaf Abdillah Suffian stated that the government hopes to bring SZKT to set up a vaccine research and development centre together with a production plant in Malaysia.
Havng SKZT as the strategic vaccine development partner, it is believed that YongTai can meet the volume demand if it arises.
After all, one of the most important task for the Malaysian governement right now is to match the 80% vaccinated population target for herd immunity, around 25-26 million of the toal Malaysians.
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