HSA reviewing Moderna's Covid-19 vaccine data as firm seeks approval for its use in S'pore

HSA said it has been in discussion with Moderna on the submission plan for its vaccine.
HSA said it has been in discussion with Moderna on the submission plan for its vaccine.PHOTO: AFP

SINGAPORE - 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 on Wednesday (Dec 2).

HSA said in response to queries from The Straits Times that 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 data to the authorities while the trials are being conducted, instead of submitting data only at the end of each phase of the trial.

HSA had earlier explained that such rolling submissions 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.

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.

Last month, Health Minister Gan Kim Yong said 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 the HSA spokesman declined to say if other firms had also approached the authority to approve the use of other Covid-19 vaccines here, citing proprietary reasons.

Moderna's application to the Singapore authorities for use of its Covid-19 vaccine here comes as Britain granted temporary authorisation for emergency use of another Covid-19 vaccine candidate developed by Pfizer and BioNTech.

"Today's emergency use authorisation in the UK marks a historic moment in the fight against Covid-19," said Pfizer chairman and chief executive officer Albert Bourla in a statement on Wednesday.

"This authorisation is a goal we have been working toward since we first declared that science will win, and we applaud the Medicines and Healthcare Products Regulatory Agency for their ability to conduct a careful assessment and take timely action to help protect the people of the UK," he added.

Moderna had on Monday applied for emergency use authorisation of its Covid-19 vaccine in the United States, following the release of the full results from its late-stage clinical trial.

The results of the trial, which involved 30,000 people, 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.

The filing in the US sets Moderna's product up as the second vaccine likely to receive US emergency use authorisation this year.