Moderna seeks approval for the use of its COVID-19 vaccine in Singapore

If all goes well, the first batch of vaccines could arrive as early as December. PHOTO: REUTERS

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

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

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

“We started sending all the information we have to Singapore and we are having a very good dialogue with them,” he said.

“Of course, it is their decision how long they need to be comfortable with the data, because their (priority) is to ensure security, but I anticipate that it could be maybe in December, maybe in January.”

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

ST has reached out to the HSA for comment.

Last month, Health Minister Gan Kim Yong said Singapore would work to secure a portfolio of Covid-19 vaccines to serve different segments of the population rather than relying on a single vaccine.

Moderna requested authorization for the emergency use of its Covid-19 vaccine in the United States on Monday, following the publication of the full results of its late-stage clinical trial.

The results of the trial, in which 30,000 people participated, had shown that the vaccine was 94.1 percent effective in preventing Covid-19 and 100 percent effective in preventing serious diseases caused by the coronavirus. .

The filing in the US establishes Moderna’s product as the second vaccine likely to receive US emergency use authorization this year.

Pfizer and BioNTech, the two companies behind another Covid-19 vaccine leader, have also applied for emergency use authorization for their vaccine in the U.S. Pfizer said the final results of the last stage of the trial of that Covid-19 vaccine was shown to be 95 percent effective.

Both vaccines protect most people against severe forms of the disease, but the data is still unclear on whether the vaccines will prevent them from spreading Sars-CoV-2, the virus that causes Covid-19.

Mr. Bancel indicated it on Tuesday.

But he added: “We are going to get that data, and I anticipate that we should know if the vaccine prevents or how well it prevents infection from one human to another… in the new year.

“So we are getting closer but we don’t have all the data,” he said in an exclusive interview with ST.

He said the company was on track to produce 20 million doses by the end of December, and 500 million to 1 billion in 2021. Each person should receive two doses of the vaccine, administered one month apart.

Both Moderna and Pfizer-BioNTech vaccines take advantage of a new technology called messenger RNA (mRNA). There are currently no mRNA vaccines available on the market.

But Bancel assured that people can trust their safety.

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

He also noted that there had been no serious adverse events among the volunteers during the late-stage clinical trial of the Covid-19 vaccine.

“If you look at all vaccines, across all technologies, known to regulators, serious side effects generally occur within six weeks of injection,” he said.

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

“We crossed that threshold in the second half of November, that’s why we were able to present (the application),” he explained in a video interview.

The mRNA platform involves injecting fragments of the viral genetic code into the body to stimulate the human immune system to mount a defense against the invading coronavirus.

But the mRNA molecule is completely degraded in the body within 48 hours, Bancel explained.

“Furthermore, the molecule does not enter the nucleus of the human cell, it does not touch the human DNA,” he explained.

When asked if Moderna would consider expanding to Singapore, Bancel said there are no plans to do so yet.

“We have been so busy working on the vaccine that we have not had time to think about expansion,” he said.

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

Bancel added: “I am confident that we will find ways to collaborate more and more with Singapore.”

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