The vaccine has also been recommended by the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) for expanded authorisation in Europe
Novavax Covid-19 vaccine Nuvaxovid vial. (Credit: Novavax)
US-based vaccines developer Novavax has received regulatory authorisation for its Covid-19 vaccine Nuvaxovid, also called NVX-CoV2373, in Taiwan.
Taiwan’s Food and Drug Administration has granted emergency use authorisation (EUA) for Nuvaxovid, for use in people aged 18 years and above.
The regulatory authorisation was supported by the totality of preclinical, manufacturing and clinical trial data Novavax has submitted for review.
The data includes results from two Phase 3 clinical trials, PREVENT-19 which evaluated nearly 30,000 participants in the US and Mexico and a UK trial with 15,000 adult participants.
In both clinical trials, the vaccine has shown efficacy with superior safety and tolerability profile, said Novavax.
Novavax president and chief executive officer Stanley Erck said: “Today’s authorization in Taiwan is a testament to our continued global efforts to ensure access to diversified vaccine options.
“As we continue to see surges of Covid-19, we believe that additional vaccine options will bolster the global vaccination rate and help reduce the impact of Covid-19.”
Nuvaxovid is a protein-based vaccine developed using the company’s recombinant nanoparticle technology and its patented saponin-based Matrix-M adjuvant technology.
The vaccine has been authorised in more than 40 countries, for use in people aged 18 and above, and has received Emergency Use Listing from the World Health Organization.
The US vaccine maker has executed a supply agreement with Taiwan and is set to ship the initial doses of Nuvaxovid to the country under the COVAX Facility.
In a separate development, European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recommended expanded conditional marketing authorization (CMA) for Nuvaxovid.
Nuvaxovid received CMA from the European Commission (EC) to prevent Covid-19 in individuals aged 18 years and above in December last year.
The expanded CMA allows active immunisation of the Covid-19 vaccine in adolescents, aged 12 through 17 in the European Union (EU).
Erck added: “This recommendation brings us closer to offering adolescents in the EU the first protein-based Covid-19 vaccine developed using an innovative approach to traditional technology.”
Furthermore, Novavax has filed a Supplement to New Drug Submission (sNDA) with Health Canada to expand the indication of Nuvaxovid to include adolescents aged 12 to 17 years.