Moderna seeking HSA approval for use of Covid-19 vaccine in Singapore

SINGAPORE - American biotechnology company Moderna has asked the authorities in Singapore to approve the use of its Covid-19 vaccine here.

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

Moderna chief executive Stephane Bancel told The Straits Times on Tuesday night (Dec 1) that the company is in talks with the Health Sciences Authority (HSA) in Singapore.

"We've started sending to Singapore, all the information that we have, and we're having a very good dialogue with them," he said.

"It is of course their decision how long they need to be comfortable with the data, because their (priority) is to ensure safety, but I anticipate that it could be maybe in December, maybe in January."

Mr Bancel declined to give details on the number of doses that Singapore would receive, citing confidentiality clauses, but said Moderna will be ready to ship its vaccines here "right away" once approval is given.

ST has approached the HSA for comment.

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.

Moderna 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.

Pfizer and BioNTech - the two firms behind another Covid-19 vaccine front runner - have also applied for emergency use authorisation of their vaccine in the US. Pfizer said final results from the late-stage trial of that Covid-19 vaccine showed it was 95 per cent effective.

Both vaccines protect most people against severe forms of the disease, but the data is not yet clear about whether the vaccines will stop them from spreading Sars-CoV-2 - the virus which causes Covid-19.

Mr Bancel indicated as much on Tuesday.

But he added: "We're going to get that data, and I anticipate we should know about whether the vaccine prevents, or how well does it prevent infection from one human to another... in the new year.

"So we're getting close but we don't have all the data," he said in an exclusive interview with ST.

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He has said that the company was on track to produce 20 million doses by the end of December, and from 500 million to a billion in 2021. Each person has to have two doses of the vaccine, administered a month apart.

But Mr Bancel gave the assurance that people can be confident about its safety.

He said mRNA vaccines have been tested on humans before, citing clinical trials in Germany that took place before the Covid-19 pandemic.

He also noted that no severe adverse events had occurred among volunteers during the late-stage clinical trial for the Covid-19 vaccine.

"If you look at all vaccines, across all technologies, known to regulators, any serious side effects usually happen within six weeks of the jab," he said.

This is why the US Food and Drug Administration (FDA) had asked Moderna to submit its application for emergency approval only after eight weeks of safety data being collected.

"We crossed that threshold in the second half of November, which is why we were able to submit (the application)," he explained in a video interview.

But mRNA molecule fully degrades in the body within 48 hours, Mr Bancel explained.

"Moreover, the molecule does not enter the nucleus of the human cell, does not touch the human DNA," he explained.

Asked if Moderna would consider expanding to Singapore, Mr Bancel said that there are no plans to do so yet.

"We have been so busy working on the vaccine that we have had no time to think about expansion," he said.

But he said that he has been to Singapore 20 times, and is aware that the Republic is a "great biotech hub", with an educated workforce that has strong work ethics.

Mr Bancel added: "I'm sure we'll find ways to collaborate more and more with Singapore."

This article was first published in The Straits Times.