Covovax, India's COVID-19 vaccine, receives emergency approval: WHO

The World Health Organization gave emergency-use status to a COVID-19 vaccine developed by Novavax Inc., the ninth shot to get such approval.

The WHO said Friday the vaccine, known as Covovax, will help vaccination drives in lower-income countries. Covovax is a product based on Nuvaxovid, a vaccine made by Novavax that's still under assessment by the European Medicines Agency. Novovax shares rose as much as 10%.

The approval is welcome news for the Covax global vaccine-distribution scheme as Novavax and the Serum Institute of India, which produces Covovax under license, have pledged to provide the program with 1.1 billion doses.

The WHO said it will give its opinion on Nuvaxovid once the EMA issues its recommendation.

The Maryland-based company's vaccine mimics the coronavirus's spike protein, sparking an immune response that prepares the body for a real infection. It requires two doses three weeks apart and can be stored at refrigerator temperatures, making it easier to transport than some messenger RNA shots.

Earlier this year, the drugmaker submitted clinical data to Britain's Medicines and Healthcare products Regulatory Agency from a trial of 15,000 volunteers across the U.K. The results showed efficacy of 96.4% against the original Covid strain and 86.3% against the alpha variant that first arose in the U.K. Data from a 30,000-person trial in the U.S. and Mexico has also demonstrated 100% protection against moderate and severe disease.

Novavax has not yet disclosed how its vaccine fares against the fast-spreading omicron variant but has said its working on a version of its vaccine that will target the strain first detected in South Africa.

Novavax has already applied to the U.K. for authorization of its Covid-19 vaccine. The drugmaker has previously said it's planning to apply for authorization in the U.S. by year-end. The shot has already gained approval in the Philippines and Indonesia.