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

By Mrinalika Roy and Carl O'Donnell

(Reuters) -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 first authorization of the COVID-19 vaccine... will fill a vital need for Indonesia, which is the fourth most populous nation on earth and continues to work to procure sufficient vaccine for its population," Chief Executive Stanley Erck said during an investor call.

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, Erck said in a statement. Novavax's partner, Serum Institute in India, has already manufactured "tens of millions" of doses that are ready for shipment, Erck added during the call.

The company said it remains on track to file for U.S. approval by end of the year.

It also expects to provide booster doses to high- and low-income countries around the world and to be prepared to submit for regulatory authorization of its shots for children in the first quarter of 2021, Erck said.

"We expect the need for boosters will continue in the coming years," he said. "Over the coming months, we will be able to support supply to additional markets in need of boosters."

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

(Reporting by Mrinalika Roy in Bengaluru and Carl O'Donnell in New York; Editing by Arun Koyyur and Dan Grebler)