Covid-19 vaccine trials in Singapore expedited with use of real-time data

Such rolling submissions allow regulators to conduct simultaneous real-time review of the data available to date. ST PHOTO: CHONG JUN LIANG

SINGAPORE - Covid-19 vaccine trials are being expedited in Singapore in a way that could halve the time it would normally take to have a new vaccine approved.

The Health Sciences Authority (HSA) told The Straits Times that this is to ensure that "Singapore has continued access to critical health products to deal with the Covid-19 pandemic".

What it is doing is to allow for "a rolling submission process" so that, instead of submitting data to the authorities at the end of each phase of the trial, companies may do so while the trials are being conducted.

The HSA said pharmaceutical companies can submit real-time clinical and manufacturing data to support the safety and efficacy of the vaccine, while the clinical trials and studies are ongoing.

Such rolling submissions, it explained, allow regulators to conduct simultaneous real-time review of the data available to date, instead of waiting for all the data to be gathered before submission.

Its spokesman said this speeds up the approval process while ensuring that relevant safeguards are in place. She added that doing so could "reduce the regulatory turnaround time by half the usual timelines", provided there are no significant adverse events.

The spokesman said the authority is also providing "early consultation and advice to guide companies in the clinical development of vaccines and regulatory requirements for product authorisation from HSA".

The European Medicines Agency - the approving authority for the European Union the way the HSA is for Singapore - said on Oct 1 that it had initiated a similar rolling review of AstraZeneca and the University of Oxford's Covid-19 vaccine candidate AZD1222.

There is currently only one Covid-19 vaccine candidate being tested here, the Lunar-CoV19 jointly developed by Duke-NUS and Arcturus Therapeutics Holdings.

Professor Ooi Eng Eong of Duke-NUS School of Medicine, the principal investigator here for the vaccine, said getting the vaccine from concept through pre-clinical studies to phase one and two clinical trials in less than five months would not have been possible without HSA's willingness to accept real-time data.

It normally takes years for a new vaccine to get to the market.

He said: "Rolling submission of our pre-clinical data was very useful to ensure that all the necessary data to support our clinical trial was reviewed and approved swiftly."

Approval for trialling the vaccine here was given in July and the first phase involving young healthy volunteers, each getting one injection of varying doses, started in August.

In the second phase, with people up to the age of 80, participants are each given two doses of the vaccine.

In both phases, some of the participants are given a placebo instead of the vaccine. Altogether, slightly more than 100 people are involved.

This trial should end in December and the study of the trial completed by January.

Prof Ooi said doing a combined phase one and two trial allowed them "to transition swiftly from testing a range of different doses of vaccines in healthy young adults to a larger cohort of volunteers that include older adults using a narrowed range of doses".

He added: "These sets of data would then enable us to decide on the vaccination strategy for phase three clinical trial."

It is necessary to test the vaccine in older people as vaccines are often less effective for them.

Phase three usually involves large numbers of people to establish the effectiveness and safety of the vaccine in the population at large.

The World Health Organisation's Oct 2 update said there were 42 candidate vaccines in clinical evaluation - including Lunar-CoV19 - and 151 in pre-clinical evaluation.

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