Singapore's HSA reviewing Covid-19 vaccine data from Moderna

The Health Sciences Authority (HSA) has started evaluating the available data submitted by Covid-19 vaccine developer Moderna "to ensure expeditious review", the authority said yesterday.

HSA said it has been in discussion with the American biotechnology company on the submission plan for its vaccine.

"Moderna has started submitting initial data and will continue to roll in data as soon as they become available as agreed with HSA," said the HSA spokesman.

This rolling submission process allows companies to submit real-time data from ongoing studies while HSA conducts the regulatory review simultaneously.

The spokesman said this pathway could speed up the approval process, while ensuring that there is adequate scientific evidence to support the quality, safety and efficacy of the product.

"Depending on the speed of data accrual by the company, this reduces the regulatory turnaround time, provided there are no significant adverse events, and relevant studies to support safety and efficacy are submitted by the time of product application," she added.

The company will also be required to submit ongoing data to support the safety and efficacy of the vaccine, said the HSA spokesman.

Moderna chief executive Stephane Bancel had told The Straits Times on Tuesday night that the company is in talks with HSA to approve the use of the firm's vaccine here.

If all goes well, the first batch of vaccines could arrive here as early as this month, he said.

Mr Bancel also noted that the Singapore Government has been proactive in ordering doses for people here, although he declined to provide figures.

"The Singapore Government, very early, back in the summer, has been ordering doses for its inhabitants, and has been ordering more recently with more data," Mr Bancel said in the video interview.

Moderna had on Monday released the full results from its late-stage clinical trial, which involved 30,000 people. The study had shown that the vaccine was 94.1 per cent effective in preventing Covid-19, and 100 per cent effective at preventing severe disease from the coronavirus.

Moderna said it has applied for US emergency use authorisation of the vaccine, following a similar move made earlier by Pfizer and BioNTech - the firms behind another Covid-19 vaccine front runner.

Britain yesterday granted temporary authorisation for emergency use of the Pfizer-BioNTech vaccine there - the first emergency use authorisation in the world.

Health Minister Gan Kim Yong had said last month that Singapore would work on securing a portfolio of Covid-19 vaccines to cater to different segments of the population instead of relying on just one vaccine.

But HSA's spokesman declined to say if other firms had approached it to approve the use of other Covid-19 vaccines here, citing proprietary reasons.