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SINGAPORE: Moderna is “moving forward” with the “ongoing review” process for its COVID-19 candidate vaccine with the Singapore Health Sciences Authority (HSA), the US biotech company said in a press release Monday ( November 30) at 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% effective against COVID-19 and 100% effective at preventing cases. serious.
Ongoing review speeds up the review process by allowing the developer of a drug or vaccine to submit sections of its application as they are completed, according to the U.S. Food and Drug Administration (FDA) website.
In addition to Singapore, Moderna said it has also begun the ongoing review process with authorities from the European Union, Canada, Switzerland, the United Kingdom and Israel.
You are also seeking emergency use authorization for your vaccine in the US and EU, and prequalification or emergency use list with the World Health Organization.
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“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1 percent efficacy and, more importantly, the ability to prevent severe COVID-19 disease,” said the director Moderna executive Stephane Bancel in the statement.
“We believe that our vaccine will provide a powerful new tool that can change the course of this pandemic and help prevent serious illness, hospitalizations and death.”
He added: “We will apply for an emergency use authorization from the FDA today and continue to move forward with the ongoing reviews that have already begun with various regulatory agencies around the world.”
CNA has contacted the HSA for more information on the review.
Moderna said it expects to have around 20 million doses of its vaccine, which uses the concept of messenger RNA or mRNA, available in the United States by the end of 2020.
It remains “on track” to manufacture 500 million to 1 billion doses of vaccines globally in 2021, the company added.
READ: Expert Committee to ‘Leverage Scientific and Clinical Experience’ to Evaluate COVID-19 Vaccines – MOH
Moderna is among several drug makers competing to develop a safe and effective vaccine against the coronavirus, which has killed more than 1.4 million people worldwide.
American pharmaceutical company Arcturus Therapeutics Holdings and Duke-NUS School of Medicine are also jointly developing a COVID-19 vaccine that began human trials in August.
Singapore’s vaccine strategy is advised by an expert committee that includes experts in infectious diseases, immunology and other relevant fields.
“The expert committee will draw on scientific and clinical expertise to evaluate candidate vaccines and will recommend suitable vaccines for use against COVID-19 in Singapore when they become available,” the Health Ministry said in announcing it to the public last month.
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