Nuvaxovid is a protein-based ready-to-use vaccine developed by creating copies of the surface spike protein of SARS-CoV-2, a virus that is responsible for Covid-19
A product shot of Nuvaxovid. (Credit: Novavax)
Novavax has received full approval for its prototype Covid-19 vaccine Nuvaxovid (NVX-CoV2373) from Singapore’s Health Sciences Authority (HSA) for individuals aged 12 and older.
Nuvaxovid is a protein-based ready-to-use vaccine developed by creating copies of the surface spike protein of SARS-CoV-2, a virus that is responsible for Covid-19.
The Singaporean health authority has approved NVX-CoV2373 for active immunisation for Covid-19 prevention.
HSA has included Nuvaxovid in the National Vaccination Programme as a protein-based non-mRNA option to prevent Covid-19.
The updated Covid-19 vaccine has been approved for use in the US for the immunisation season of 2023–2024.
Novavax’s vaccine induces neutralising antibody responses against the XBB.1.5, XBB.1.16, XBB.2.3, BA.2.86, EG.5.1, FL.1.5.1, and XBB.1.16.6 variants that are currently in circulation.
Additional non-clinical findings showed that responses against EG.5.1 and XBB.1.16.6 were generated by the Novavax vaccination in CD4+ polyfunctional cellular (T-cell) cells.
These findings suggest that the vaccine can activate both immune system components and might trigger a widespread immune response against currently circulating variations, the American biotechnology company said.
Novavax president and CEO John Jacobs said: “Today’s full approval of our prototype vaccine will enable us to file for approval of our updated protein-based non-mRNA Covid-19 vaccine in the coming weeks.
“We continue to work closely with HSA to ensure a protein-based vaccine is part of the portfolio for Singaporeans to protect themselves against Covid-19.”
In a similar development, the biotechnology major also received full marketing authorisation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the Nuvaxovid vaccine.
The authorisation was based on the results from two Phase 3 trials, PREVENT-19 conducted in the US and Mexico, a Phase 3 study in the UK, as well as a Phase 2a/b trial in South Africa.
In these studies, Novavax proved the efficacy and safety of their prototype vaccine when administered as a primary series to people 12 years of age and older.
The company also showed the immunogenicity and safety of the vaccine when administered as a booster to people 18 years of age and older.