Novovax gets WHO nod for COVID shot for developing countries


The World Health Organization (WHO) gave emergency-use status to a COVID-19 vaccine developed by Novavax, Inc., the first protein-based shot to get approval against the virus.

The WHO said Friday the vaccine, known as Covovax, could be used globally and will help accelerate 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 (EMA).

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. Novavax had suffered months of delay after manufacturing problems despite securing some of the largest funding from the Trump administration in the early stages of the pandemic.

The WHO said it will give its opinion on Nuvaxovid once the EMA issues its recommendation. The EMA has said it will meet on the matter on Dec. 20.

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 UK. The results showed efficacy of 96.4% against the original Covid strain and 86.3% against the Alpha variant that first arose in the UK. Data from a 30,000-person trial in the US 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 UK for authorization of its COVID-19 vaccine. The drugmaker has previously said it’s planning to apply for authorization in the US by yearend. The shot has already gained approval in the Philippines and Indonesia.  —