Novovax, Serum Institute seeking emergency approval for use in South Africa

Gaithersburg: Vaccine manufacturer Novovax in conjunction with the Serum Institute of India (SII) are seeking emergency regulatory approval for the deployment of their COVID-19 vaccine NVX-CoV2373 in South Africa. A request was submitted by the two bodies to the South African Health Products Regulatory Agency (SAHPRA) on Monday.

Novavax has manufactured a recombinant nanoparticle protein-based Covid-19 vaccine candidate with Matrix-M adjuvant. If Emergency Use Approval (EUA) is granted, then the Novovax and SII will be able to manufacture the vaccine in South Africa under the brand name 'Covovax', the vaccine manufacturer said in a statement on Monday.

"Novavax is thankful for our long-standing history of partnership in South Africa to advance much-needed vaccines. This is exemplified by the country's vital role in the Phase 2b clinical trial and booster study of our protein-based Covid-19 vaccine," said Stanley C Erck, President and Chief Executive Officer, Novavax.

"Novavax and Serum Institute remains focused on delivering the Covid-19 vaccine - built on well-understood technology - where it is needed most. We look forward to SAHPRA's review and, if authorized, delivering the vaccine to help South Africa control the pandemic," Erck added.

South Africa recently overcame its latest wave of the pandemic driven by the highly infectious Omicron variant of COVID-19 that was discovered in the country at the end of November last year. Novovax had already stated that it's vaccine provided adequate antibody coverage against the highly-transmissable variant.

Covovax has already received approval for use in 179 countries, including emergency use in India, Indonesia and the Philippines as well as by the World Health Organisation. The company expects to submit a request for EUA for the vaccine in the US after one month in accordance with guidance from the FDA regarding the submission of all EUA vaccines.

The PREVENT-19 trial involving 30,000 participants in the US and Mexico achieved 90.4% efficacy overall. A trial conducted in the U.K. with 14,039 participants was designed as a randomized, placebo-controlled, observer-blinded study and achieved overall efficacy of 89.7%