Private Company Says MOH Has Approved Its Phase 3 Clinical Trial Of COVID-19 Vaccine
A property developer has obtained the Ministry of Health's approval for its Phase 3 clinical trial study of inactivated COVID-19 trial vaccines in Malaysia, as per its announcement on Bursa Malaysia
With the approval, the property developer Yong Tai Berhad — under its healthcare subsidiary YTB Healthcare Sdn Bhd (YTBH) — has become the first private company to initiate and sponsor the Phase 3 clinical trial of the COVID-19 vaccines in Malaysia.
"The board wishes to announce that Medical Review & Ethics Committee (MREC) had vide its letter dated 23 April approved the said Phase 3 Clinical Trial study to be carried out in Malaysia involving 3,000 subjects," Yong Tai stated in its Bursa Malaysia filing on 26 April.
However, there has been no such announcement from MOH on this matter so far.
The company expects to commence the Phase 3 clinical trial by the second quarter of 2021.
Yong Tai said that YTBH has already formalised the Phase 3 clinical trial with its strategic partner in China since December last year
The private company's China-based partner is Shenzhen Kangtai Biological Products Co Ltd (SZKT), one of the largest vaccine manufacturers in China.
Calling the approval from MOH timely, YTB chief executive officer and executive director Datuk Wira Boo Kuang Loon said that it came after the company's proactive efforts over the past four months to ensure all regulatory and safety requirements are met for them to obtain the approval for Phase 3 clinical trial.
"With our collaboration, we are looking to help escalate the country's target to achieve herd immunity against COVID-19 and potentially bring in SZKT to set up their production centre in Malaysia," Boo said.
"This will also help to attract huge investment into Malaysia, as well as transfer technical know-how to local workers, and create job opportunities in the pharmaceutical sector."
The group wants to roll out the distribution of SZKT's vaccine by the third quarter of 2021, subject to approval by the National Pharmaceutical Regulatory Authority (NPRA) for emergency usage
"We have an ambition to roll out the distribution of the vaccine by the third quarter this year, subject to the approval by NPRA for emergency usage. So far, the COVID-19 vaccines are procured by the government and administered for free to the public. The regulators have already approved the Pfizer-BioNTech vaccine, China's Sinovac, and Britain's AstraZeneca," Boo said.
"So far, we have only seen around 2.4% of the population that has obtained at least one dose of the vaccine. It is still a long way and we believe that involvement of a local private sector in the distribution of vaccine will help to escalate the country's goal to achieve herd immunity against COVID-19."
The approval also grants YHBH exclusive distributorship rights
Under the collaboration with the China-based SZKT, YTBH will be granted exclusive distributorship rights in Malaysia on a vaccine procurement programme of at least 10 million doses per year, with an option to purchase an additional 10 million doses per year, for a five-year period, said Yong Tai.
"In the event of unsold doses, the surplus shall be allowed to be sold with permission in other ASEAN and Indian subcontinent countries," the group added in its statement.
In December last year, the YTB CEO had said that the company's two main businesses — tourism and property — were the worst-hit sectors amidst the pandemic and the company needed to find a way to survive
Speaking to The Edge Malaysia, Boo said, "We don't see the tourism and property sectors recovering significantly in the next two years. That is why we want to be involved in vaccine distribution."
According to him, the company "cannot keep pumping money" into the property sector.
Meanwhile, the government is opening up an appointment system to allow adults aged 18 and above to get the AstraZeneca vaccine on a "first come, first served" basis, starting first with Selangor and KL:
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