SINGAPORE — A COVID-19 vaccine candidate co-developed by Duke-National University of Singapore (NUS) Medical School and American biotech company Arcturus Therapeutics has received approval from authorities here to run clinical trials, with human dosing to begin “as soon as possible”.
In a joint press release on Tuesday (21 July), the two organisations said that the Singapore’s Health Sciences Authority (HSA) has given them the go-ahead to proceed. The vaccine candidate is the first ever to be developed in Singapore.
Last month, the scientists involved in the development said the human trials were planned to start in August.
They will first evaluate several dose levels of the vaccine, or LUNAR-COV19, in up to 108 adults, including older volunteers.
Follow-up tests will be conducted to evaluate safety, tolerability, and the extent and duration of the humoral and cellular immune response. Humoral immunity involves substances found in body fluids.
Professor Ooi Eng Eong, deputy director of Duke-NUS’ emerging infectious diseases programme, noted that preclinical studies on LUNAR-COV19 showed “very promising findings”, including the possibility that a single dose may be sufficient to trigger robust and durable immune responses against the novel coronavirus.
He said, "We are very eager to start the first-in-human clinical trial here in Singapore and advance Lunar-COV19 on its journey to becoming a potential commercial vaccine."
The vaccine works on the relatively untested Messenger RNA (mRNA) technology, which instructs human cells to make specific coronavirus proteins that produce an immune response. Prior animal data has demonstrated robust humoral and cellular immunity elicited at low doses, said both organisations.
“The LUNAR-COV19 profile is meaningfully differentiated and may facilitate the mass vaccine campaigns necessary to target hundreds of millions of individuals globally,” said Arcturus Therapeutics president and chief executive Joseph Payne.
Duke-NUS Medical School dean Professor Thomas M. Coffman said, “There is a tremendous global imperative to develop effective preventive measures for COVID-19 infections. We are heartened by the rapid and promising progress in our vaccine collaboration with Arcturus as we move forward into clinical trials.”
There are 24 vaccine candidates in clinical evaluation and 142 in preclinical evaluation as of Tuesday, according to the World Health Organization.
Experts have said that vaccines for the virus would take at least one year to 18 months to develop, but warned that they might not be able to completely protect people from the disease.
Local authorities have earlier assured that if and when an effective vaccine becomes available, every Singaporean who needs it can get it at an affordable price.
To date, Singapore has 48,744 COVID-19 cases, the majority of whom are foreign workers living in dormitories.
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