The protein-based Covid-19 vaccine is engineered from the genetic sequence of the SARS-CoV-2 virus’ initial strain. Credit: Prasesh Shiwakoti (Lomash) on Unsplash.

Novavax has obtained emergency use authorization (EUA) for its Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), from the Taiwan Food and Drug Administration for use in people of the age 18 years and above.

The protein-based vaccine is engineered from the genetic sequence of the SARS-CoV-2 virus’ initial strain.

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Developed utilising Novavax’s recombinant nanoparticle technology to generate antigen obtained from the coronavirus spike (S) protein, the vaccine is also formulated with the company’s saponin-based Matrix-M adjuvant.

The totality of preclinical, manufacturing and clinical trial findings that were submitted for analysis formed the basis for the EUA. 

This data comprises two Phase III clinical trials: PREVENT-19, which enrolled nearly 30,000 adult subjects in the US and Mexico as well as a UK-based trial with 15,000 adults. 

The vaccine showed an encouraging safety and tolerability profile in both trials.

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There were few serious and severe adverse events reported and were found to be balanced between vaccine and placebo arms. 

Novavax and Taiwan have carried out a supply agreement for Nuvaxovid and the vaccine doses for the country would be the first shipment to a nation taking part in the COVAX Facility. 

Novavax president and CEO Stanley Erck said: “The authorisation 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.”

Earlier this month, the US FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 21 to 0 recommending the EUA grant for Novavax’s NVX-CoV2373 for individuals aged 18 years and above.