Novavax seeks WHO emergency use approval for COVID-19 Vaccine

By Amirtha P S, Desk Reporter
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The American biotechnology company, Novavax has completed the submission process for emergency use listing of its COVID-19 vaccine candidate with the World Health Organization (WHO).

Novavax has submitted all modules required for the regulatory evaluation of NVX-COV2373, its protein-based COVID-19 vaccine to the health agency days after receiving its first emergency use authorization from Indonesia.  

“Today’s submission reflects our continued focus on accelerating access and equitable distribution as we work to bring our vaccine to people in need around the globe,” said Mr. Stanley C. Erck, President and Chief Executive Officer, Novavax. 

Novavax will make further submissions to enable vaccine supply from additional manufacturing sites in Novavax’s global supply chain. The company is also expecting regulators in countries including India and the Philippines to decide on its vaccine within weeks.

The submission includes clinical data from PREVENT-19, a pivotal Phase 3 trial of 30,000 participants in the US and Mexico that showed 100 percent protection against moderate and severe disease and 90.4 percent efficacy overall. Greenlight from the WHO would set the stage for Novavax to begin shipping doses to the COVAX program that supplies shots to low-income countries.

Novavax is also targeting to provide booster doses to high- and low-income countries around the world. “We expect the need for boosters will continue in the coming years. Over the coming months, we will be able to support supply to additional markets in need of boosters,” Mr. Erck said.

The Maryland-based vaccine developer reported a bigger net loss of $322.4 million for the third quarter, compared with $197.3 million a year earlier.

Novavax revenue in the third quarter of 2021 was $178.8 million, compared to $157 million in the same period in 2020. It was mainly due to increased development activities relating to its COVID vaccine, including services performed under the US government agreement and royalties from licensing pacts.

Related: US FDA advisers recommend Pfizer COVID-19 vaccine for children