Novavax completes process for WHO emergency use approval of COVID-19 vaccine

FILE PHOTO: A woman holds a small bottle labeled with a “Coronavirus COVID-19 Vaccine” sticker and a medical syringe in front of displayed Novavax logo in this illustration taken, October 30, 2020. REUTERS/Dado Ruvic

Vaccine developer Novavax Inc said on Thursday it has completed the submission process for emergency use listing of its COVID-19 vaccine candidate with the World Health Organization.

The company submitted to the health agency all modules required for the evaluation of NVX-CoV2373, its protein-based COVID-19 vaccine, days after receiving its first emergency use authorization from Indonesia.

The company is also expecting regulators in countries including India and the Philippines to decide on its vaccine within weeks.

A green light 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 prepared to deliver its vaccine globally, Chief Executive Stanley Erck said in a statement. The company said it remains on track to file for U.S. approval by end of the year.

The Maryland-based vaccine developer reported a bigger net loss of $322.4 million, or $4.31 per share, for the third quarter, compared to $197.3 million a year earlier.

Revenue rose to $178.8 million, mainly due to increased development activities relating to its COVID vaccine, including services performed under the U.S. government agreement and royalties from licensing pacts.