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Novavax announced it has filed for interim authorisation of its non-mRNA Covid-19 vaccine under Singapore's Pandemic Special Access Route (PSAR).

The U.S. biotechnology company said in a statement on Nov. 24 it has submitted its protein-based Covid-19 vaccine, NVX-CoV2373, to the Health Sciences Authority (HSA) for regulatory evaluation.

HSA said in response that Novavax had submitted its data for its PSAR application on Nov. 22.

It could take weeks or months to approve its use here depending on several factors.

Non-mRNA vaccine

Novavax's Covid-19 vaccine is engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes Covid-19.

Its vaccination regimen calls for two 5-microgram doses injected 21 days apart.

The PSAR allows HSA to grant interim authorisation for critical novel vaccines, medicines and medical devices during a pandemic.

The vaccines approved under Singapore's Covid-19 vaccination programme include mRNA vaccines, Pfizer-BioNTech and Moderna, and non-mRNA vaccine Sinovac-CoronaVac.

The Sinopharm vaccine is also available in Singapore, but has not been included in the national vaccination programme.

What HSA said

HSA said in response to media queries: "HSA has commenced a careful and thorough rolling review of the data to ensure that the vaccine meets the requirements for quality, safety and efficacy for interim authorisation before it is approved for use in Singapore."

HSA added the time taken for the review would depend on the "completeness" of the data submitted for evaluation.

The amount of time taken would also depend on how long it takes Novavax to respond to HSA queries on issues that may surface during the evaluation.

"The review timeline may vary from several weeks, if the data is complete and meets the stipulated standards, to months, if there are data gaps and inconsistencies in the dossiers," HSA added.

In June, Health Minister Ong Ye Kung said Singapore had signed an advance purchase agreement with Novavax in January 2021.

The Ministry of Health (MOH) said on Sep. 13 that Singapore hopes to secure a diverse portfolio of vaccines to cater to the clinical needs of different segments of the population.

Efficacy of Novavax

One trial of 30,000 participants in the U.S. and Mexico showed 100 per cent protection against moderate and severe disease, as well as an efficacy of 90.4 per cent.

Another trial in the UK involving 15,000 participants showed an efficacy of 96.4 per cent against the original Covid-19 strain, 86.3 per cent against the B117 or Alpha variant, and 89.7 per cent "overall" efficacy.

"In both trials, NVX-CoV2373 demonstrated a reassuring safety and tolerability profile," Novavax said.

Top photo via Jernej Furman Flickr

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