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SINGAPORE: Moderna has begun submitting initial data on its COVID-19 vaccine candidate to the Health Sciences Authority (HSA), as part of the process to assess its suitability for use in Singapore.
The biotech company “will continue to enter data as soon as it becomes available,” as agreed with the authority, an HSA spokesperson said Wednesday (Dec. 2) in response to inquiries from the CNA.
HSA said it has already begun evaluating the available data submitted by Moderna to ensure a “quick review.”
Moderna announced Monday that it was “moving forward” with the ongoing review process for approval with the HSA.
This follows the results of a late-stage phase 3 study showing that the vaccine was 94.1% effective against COVID-19 and 100% effective in preventing severe cases.
A continuous review process, or continuous submission, allows companies to submit real-time data from ongoing vaccine studies while regulatory review is taking place simultaneously.
READ: Moderna continues ‘ongoing review’ process for COVID-19 vaccine use in Singapore
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This ensures that Singapore has “early access to critical healthcare products to tackle the COVID-19 pandemic,” the authority added.
“This pathway could speed up the approval process while ensuring that there is adequate scientific evidence to support the quality, safety and efficacy of the product.
“Depending on the speed of data accumulation by the company, this reduces the regulatory response time, provided there are no significant adverse events and relevant studies to support safety and efficacy are submitted at the time of application of the product”.
Additionally, the company will need to submit ongoing data to support the safety and efficacy of the vaccine.
An expert committee, announced last month, will advise and assess the efficacy and safety of COVID-19 vaccine candidates in Singapore.
The committee is comprised of experts in infectious diseases, immunology and other relevant fields, who will recommend appropriate vaccines for use against COVID-19 in Singapore when available.
READ: Expert Committee to ‘Leverage Scientific and Clinical Experience’ to Evaluate COVID-19 Vaccines – MOH
Moderna said the ongoing review process has also begun with authorities from the European Union, Canada, Switzerland, Canada, the United Kingdom and Israel.
You are also seeking an emergency use authorization for the vaccine in the US and EU, as well as a prequalification or emergency use list with the World Health Organization.
Moderna said it expects to have about 20 million doses of its vaccine available in the United States by the end of the year, adding that it remains on track to manufacture between 500 million and 1 billion doses globally next year.
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