Novavax seeks OK for emergency use of Covid vaccine in India, Indonesia

Vaccine maker Novavax announced Thursday it has asked regulators in India, Indonesia and the Philippines to allow emergency use of its COVID-19 vaccine -- offering its shot to some low-income countries before rich ones with ample supplies.

US-based Novavax partnered with the Serum Institute of India to apply in the three countries, and plans later this month to also seek the World Health Organization review needed to be part of the COVAX global vaccine programme.

Novavax CEO Stanley Erck called the submissions an important step toward access to millions of doses of a safe and effective vaccine for countries with an urgent need to control the pandemic.

The company announced it also plans to submit applications in Britain soon, followed by Europe, Australia, Canada and New Zealand, but not in the US until later in the year.

The Novavax two-dose shot is made with lab-grown copies of the spike protein that coats the coronavirus. That's very different than other widely used vaccines that deliver genetic instructions for the body to make its own spike protein.

The Novavax shots are easier to store and transport than some other options, and have long been expected to play an important role in increasing supplies in poor countries desperate for more vaccine.

In June, Novavax announced the vaccine had proved about 90% effective against symptomatic COVID-19 in a study of nearly 30,000 people in the U.S. and Mexico. It also worked against variants circulating in those countries at the time. Side effects were mostly mild.

As for the highly contagious delta variant that now is circulating in much of the world, Novavax also announced Thursday that giving a booster six months after a second shot revved up virus-fighting antibodies that could tackle that mutant.

Additional studies in Britain and elsewhere are testing if the Novavax shot could be used as a booster after other types of COVID-19 vaccines. Erck said that mix-and-match data might lead to its vaccine becoming the universal booster of choice in rich countries.

And the company said Indonesia already had expressed interest in using the Novavax vaccine as a booster following some Chinese-made shots.

The Gaithersburg, Maryland, company said it was on track to produce up to 100 million doses a month by the end of the third quarter and 150 million doses a month by year's end.