The South African Health Products Regulatory Agency (SAHPRA) has approved emergency use authorization (EUA) to Novavax and the Serum Institute of India (SII) for the former's Covid-19 vaccine candidate, NVX-CoV2373.

 

The companies filed a regulatory submission with the FDA, requesting an EUA for the vaccine candidate with Matrix-M adjuvant. SII will produce and market the recombinant nanoparticle protein-based shot as 'Covovax' in the region after receiving approval.

 

The most recent filing includes data from two Phase III clinical trials: PREVENT-19 and a UK trial.

 

The PREVENT-19 engaged nearly 30,000 people in the United States and Mexico, while the UK trial enrolled about 15,000 people.

 

The shot revealed an encouraging safety profile in these trials.

 

Furthermore, the vaccine was shown to have a low number of serious and severe adverse events that were balanced across the vaccine and placebo arms.

 

Common adverse events observed in clinical trials included headache, myalgia, nausea, arthralgia, and tenderness/pain at the injection site, among others.

 

"Novavax is grateful for our long history of partnership in South Africa to advance much-needed vaccines," said Stanley Erck, president and CEO of Novavax.

 

"This is demonstrated by the country's critical role in our protein-based Covid-19 vaccine Phase IIb clinical trial and booster study."

 

"Novavax and Serum Institute are committed to delivering the Covid-19 vaccine, which is based on well-understood technology, where it is most needed."

 

To date, the vaccine has been approved in more than 170 countries, including the World Health Organization's (WHO) emergency use listing (EUL) and the European Union's conditional marketing authorization.

 

Novavax submitted the final data package to the US Food and Drug Administration for the Covid-19 vaccine's European approval.