US-based biotechnology firm Novavax has filed an application seeking interim authorisation from the Singapore Health Sciences Authority (HSA) for its Covid-19 vaccine, NVX-CoV2373, under the Pandemic Special Access Route.
The recombinant nanoparticle protein-based shot, with Matrix-M adjuvant, is created from the genetic sequence of the initial SARS-CoV-2 viral strain.
Novavax’s licensing application consisted of clinical data from two Phase III trials.
A total of 30,000 subjects in the US and Mexico were enrolled in the PREVENT-19 trial, in which the vaccine was found to offer complete protection against moderate to severe Covid-19.
The vaccine also demonstrated an efficacy of 90.4% in the trial.
In addition, in a UK trial that enrolled 15,000 subjects, NVX-CoV2373 was found to have an overall efficacy of 89.7%.
The data package related to the chemistry, manufacturing and controls presented to HSA and other regulatory authorities is based on Novavax’s manufacturing agreement with SII .
The NVX-CoV2373 vaccine is currently authorised for emergency use in Indonesia and the Philippines.
Novavax president and CEO Stanley Erck said: “Today’s filing reinforces our ongoing commitment to delivering our Covid-19 vaccine, built on a proven, well-understood vaccine platform, to help end the pandemic.
“Each additional market submission marks further progress in delivering our vaccine to the world, which we believe may help address major obstacles to global vaccination, including global distribution challenges and vaccine hesitancy.”
Novavax and the Serum Institute of India (SII) recently received authorisation in India and Emergency Use Listing from the World Health Organisation (WHO).
The company is also pursuing regulatory authorisation for NVX-CoV2373 in the UK, Australia, New Zealand, South Korea, Canada and the European Union.
Novavax expects to file the complete module for authorisation of the vaccine with the US Food and Drug Administration (FDA) by the end of this year.