Moderna continuing 'rolling review' process for use of COVID-19 vaccine in Singapore

Moderna continuing 'rolling review' process for use of COVID-19 vaccine in Singapore

FILE PHOTO: A researcher works in a lab run by Moderna
Screengrab of a video showing a researcher in a lab run by Moderna. (Photo: Moderna/Handout via REUTERS)

SINGAPORE: Moderna is "forging ahead" with the "rolling review" process for its COVID-19 vaccine candidate with Singapore's Health Sciences Authority (HSA), the American biotechnology company said in a press statement on Monday (Nov 30) night.

The announcement followed the results of a late-stage Phase 3 study involving about 30,000 participants in the United States, which showed that the vaccine was 94.1 per cent effective against COVID-19 and 100 per cent effective in preventing severe cases. 

A rolling review expedites the review process by allowing the developer of a drug or vaccine to submit sections of their application as they are completed, according to the US Food and Drug Administration (FDA) website.

Apart from Singapore, Moderna said it has also started the rolling review process with authorities in the European Union, Canada, Switzerland, the United Kingdom and Israel.

It is also seeking emergency use authorisation for its vaccine in the US and EU, and prequalification or emergency use listing with the World Health Organization.

READ: Commentary – A COVID-19 vaccine in Singapore? Here's what has to happen first

"This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1 per cent efficacy and importantly, the ability to prevent severe COVID-19 disease," said Moderna CEO Stephane Bancel in the statement.

"We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalisations and death."

He added: "We will file today for an emergency use authorisation from the FDA and continue forging ahead with the rolling reviews that have already been initiated with several regulatory agencies around the globe."

CNA has contacted HSA for more information on the review.

Moderna said it expects to have about 20 million doses of its vaccine, which uses the concept of messenger RNA or mRNA, available in the US by the end of 2020.

It remains "on track" to manufacture 500 million to 1 billion vaccine doses globally in 2021, the company added.

READ: Expert committee to 'leverage scientific and clinical expertise' to assess COVID-19 vaccines – MOH

Moderna is among several drugmakers racing to develop a safe and effective vaccine for the coronavirus, which has killed more than 1.4 million people globally.

American pharmaceutical company Arcturus Therapeutics Holdings and Duke-NUS Medical School are also jointly developing a COVID-19 vaccine that started human trials in August.

Singapore's vaccine strategy is advised by an expert committee that comprises experts in infectious diseases, immunology and other relevant fields.

"The expert committee will leverage scientific and clinical expertise to assess vaccine candidates, and recommend the appropriate vaccines for use against COVID-19 in Singapore when they become available,"​​​​​​ the Ministry of Health said in announcing it to the public last month.

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Source: CNA/dv

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