Singapore

HSA reviews vaccine data as Moderna seeks approval

Biotech firm will continue to roll in data from ongoing studies to speed up process while ensuring safety

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

Moderna must also submit ongoing data to support the safety and efficacy of the vaccine, said the HSA spokesman.

Moderna chief executive Stephane Bancel told The Straits Times on Tuesday that it is in talks with HSA to approve the use of its 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.

Moderna on Monday released the full results from its late-stage clinical trial. The study had shown the vaccine was 94.1 per cent effective in preventing Covid-19 and 100 per cent effective at preventing severe disease from the virus.

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

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

coronavirus