SINGAPORE: Moderna has started submitting initial data on its COVID-19 vaccine candidate to the Health Sciences Authority (HSA), as part of the process to evaluate its suitability for use in Singapore.
The biotechnology company “will continue to roll in data as soon as they become available”, as agreed with the authority, said a spokesperson for HSA on Wednesday (Dec 2) in response to queries by CNA.
HSA said it has already started evaluating the available data submitted by Moderna to ensure “expeditious review”.
Moderna announced on Monday that it was “forging ahead” with the rolling review process for approval with HSA.
This follows the results of a late-stage Phase 3 study showing that the vaccine was 94.1 per cent effective against COVID-19 and 100 per cent effective in preventing severe cases
A rolling review, or rolling submission, process allows companies to submit real-time data from ongoing studies of the vaccine while the regulatory review is conducted simultaneously.
READ: Moderna continuing 'rolling review' process for use of COVID-19 vaccine in Singapore
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This ensures that Singapore has “early access to critical health products to deal with 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 accrual by the company, this reduces the regulatory turnaround time, provided there are no significant adverse events, and relevant studies to support safety and efficacy are submitted by the time of product application.”
Additionally, the company will be required to submit ongoing data to support the safety and efficacy of the vaccine.
An expert committee, announced last month, will advice and assess the efficacy and safety of COVID-19 vaccine candidates in Singapore.
The committee comprises experts in infectious diseases, immunology and other relevant fields, who will recommend the appropriate vaccines for use against COVID-19 in Singapore when they become available.
READ: Expert committee to 'leverage scientific and clinical expertise' to assess COVID-19 vaccines – MOH
Moderna said it has also started the rolling review process with authorities in the European Union, Canada, Switzerland, Canada, the United Kingdom and Israel.
It is also seeking emergency use authorisation for the vaccine in the US and the EU, as well as prequalification or emergency use listing with the World Health Organization.
Moderna said it expects to have about 20 million doses of its vaccine available in the US by the end of the year, adding that it remains on track to manufacture 500 million to 1 billion doses globally next year.
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