Singapore

HSA reviewing Novavax data after it applies for interim authorisation

A new Covid-19 vaccine could be available in Singapore, with American firm Novavax having applied for interim authorisation by 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 three trials shows that the non-mRNA vaccine has an efficacy rate of around 90 per cent across a variety of viral variants.

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

Trials among 30,000 participants for the vaccine in the United States 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 Britain demonstrated an efficacy rate 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 ST that it 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".

Singapore had signed an advance purchase agreement with the company in January to secure supplies of its vaccine.

Asked about the potential use of the vaccine as a booster, a Novavax spokesman said the company's filings to date have been for the vaccine to be used in a primary two-dose regime.

"We expect to apply for additional authorisations following the completion of our booster studies," added the spokesman.

The supply of the Novavax jab would make it the fifth vaccine available here - alongside Pfizer-BioNTech/Comirnaty, Moderna, Sinovac and Sinopharm.

coronavirus