Novavax has received interim authorisation from the Singapore Health Sciences Authority (HSA) for its recombinant, adjuvanted Covid-19 vaccine, Nuvaxovid (NVX-CoV2373).
The vaccine is intended for active immunisation to prevent the disease in people aged 18 years and above.
A protein-based vaccine, NVX-CoV2373 is made from the genetic sequence of the first SARS-CoV-2 viral strain.
The vaccine is formulated with the company’s Matrix-M, a saponin-based adjuvant to boost immune response and elicit greater neutralising antibody levels.
With the latest development, Nuvaxovid became the first protein-based Covid-19 vaccine to obtain authorisation for usage in the country.
The initial vaccine doses are anticipated to reach Singapore by next month-end.
Novavax presented clinical trial findings comprising results from two Phase III trials carried out in the US, Mexico and the UK to the HSA for analysis.
In the US and Mexico, the PREVENT-19 trial analysed the vaccine in nearly 30,000 adult subjects while the UK trial enrolled 15,000 subjects of the same age group.
The vaccine showed efficacy and encouraging safety and tolerability profile in both trials.
Headache, myalgia, nausea, tenderness/pain at the injection site, arthralgia, malaise and fatigue were the most common adverse reactions reported in the trial.
Novavax president and CEO Stanley Erck said: “We thank the HSA for its partnership and we are proud that Singapore is now part of the growing list of regions to have authorised the Novavax vaccine and will have a protein-based option.
“This authorisation demonstrates our commitment to deliver our Covid-19 vaccine, built on a well-understood vaccine platform, worldwide to help combat the evolving pandemic.”
Earlier this month, New Zealand’s Medsafe granted provisional approval for the vaccine for active immunisation to prevent Covid-19 in adults.