Moderna seeking HSA approval for use of its Covid-19 vaccine here


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

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

Moderna chief executive Stephane Bancel told The Straits Times yesterday that the company is in talks with the Health Sciences Authority (HSA).

“We’ve started sending to Singapore all the information that we have, and we’re having a very good dialogue with (HSA),” 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 has been given.

The Straits Times has approached HSA for comment.

Last month, Health Minister Gan Kim Yong said Singapore will work on securing a portfolio of Covid-19 vaccines instead of relying on just one vaccine.

On Monday, Moderna applied for emergency use authorisation of its vaccine in the United States, following the release of the full results from its late-stage clinical trial, which showed the vaccine was 94.1 per cent effective in preventing Covid-19, and 100 per cent effective in preventing severe disease.

The US filing sets Moderna’s product up as the second vaccine likely to receive US emergency use authorisation this year, on the heels of another Covid-19 vaccine front runner by Pfizer and BioNTech.

Both vaccines protect against severe forms of the disease, but the data is not yet clear about whether they will prevent people who have been vaccinated from spreading Sars-CoV-2 – the virus which causes Covid-19.

Both vaccines leverage a new technology called messenger RNA (mRNA). There are no mRNA vaccines currently available on the market.

But Mr Bancel said people can be confident about safety. He said mRNA vaccines have been tested on humans, citing clinical trials in Germany that took place before the Covid-19 pandemic.

Mr Bancel also noted that no severe adverse events had occurred among volunteers during the late-stage clinical trial for Moderna’s 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 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),” Mr Bancel said in a video interview.

The mRNA platform involves injecting snippets of the viral genetic code into the body to stimulate the human immune system to mount a defence against the invading virus.

The mRNA molecule fully degrades in the…

Read More: Moderna seeking HSA approval for use of its Covid-19 vaccine here

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