Singapore

Novavax applies for approval to use its Covid-19 vaccine in S'pore


SINGAPORE – A new Covid-19 vaccine could be available in Singapore, with American firm Novavax having applied for interim authorisation with the Health Sciences Authority (HSA).

Confirming this, the authority told The Straits Times that Novavax had submitted data in its application via the Pandemic Special Access Route on Nov 22.

“HSA has commenced a careful and thorough rolling review of the data to ensure that the vaccine meets requirements for quality, safety, and efficacy for interim authorisation before it is approved for use in Singapore,” said its spokesman.

She added that the time taken for the review could range from several weeks to months, depending on the completeness of the data submitted and the time taken by the company to respond to HSA’s queries that may surface during regulatory evaluation.

According to the US biotechnology company, clinical trial data compiled from two Phase 3 trials show that the non-MRNA vaccine has around a 90 per cent efficacy rate across a variety of viral variants.

The vaccine is given in two 0.5ml doses, and 21 days apart.

Trials among 30,000 participants for the vaccine in the US and Mexico demonstrated 100 per cent protection against moderate and severe disease, and a 90.4 per cent efficacy rate.

Similarly, a trial of 15,000 participants in the UK demonstrated efficacy of 96.4 per cent against the original virus strain, 86.3 per cent against the Alpha (B.1.1.7) variant and 89.7 per cent efficacy overall, said the company.

Novavax said in response to queries from The Straits Times that the company is ready to begin delivery of its vaccine doses as soon as it receives “regulatory authorisation and completion of any release requirements by the authorities”.

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Singapore had signed an advance purchase agreement with the company in January this year (2021) to secure supplies of its vaccine.

Health Minister Ong Ye Kung had said in June that the Ministry of Health has been looking for good quality vaccines which are safe and effective, to be part of the national vaccination programme.

As Novavax is a protein-based vaccine, it uses a laboratory-made version of the Sars-CoV-2 spike protein to stimulate an immune response.

The supply of the Novavax vaccine would make it the fifth vaccine available here – alongside Pfizer, Moderna, Sinovac and Sinopharm. Sinopharm has not been included in the national vaccination programme as it has not applied for interim approval for use, as at Oct 23.





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