Novawax Seeks First Approval Of COVID Vaccine In Needy Countries

Vaccine maker Novavax announced Thursday that it has asked regulators in India, Indonesia and the Philippines to authorize emergency use of its COVID-19 vaccine, offering the vaccine to some low-income countries rather than wealthy countries with adequate supplies.

US-based Novavax has teamed up with Serum Institute of India to apply in three countries and plans to also request a World Health Organization review later this month, which should be part of the global COVAX vaccine program.

Novavax CEO Stanley Erk called the submissions “an important step towards accessing millions of doses of a safe and effective vaccine for countries that urgently need to control the pandemic.”

The company announced that it plans to file applications in the UK soon, followed by Europe, Australia, Canada and New Zealand, but not in the US until the end of the year.

The two-dose Novavax shot is made from laboratory-grown copies of the spike protein that covers the coronavirus. This is very different from other widely used vaccines, which provide the body with genetic instructions to make its own spike protein.

Novawax vaccines are easier to store and transport than some of the other options, and have long been expected to play an important role in increasing supplies to poor countries desperate for vaccines.

In June, Novavax announced that the vaccine has proven about 90% effective against symptomatic COVID-19 in a study involving nearly 30,000 people in the United States and Mexico. It also worked against the varieties prevalent in these countries at the time. The side effects were mostly mild.

Regarding the highly contagious delta variant that is now circulating in much of the world, Novavax also announced Thursday that the introduction of the booster six months after the second injection has activated antiviral antibodies that could fight this mutant.

Additional studies in the UK and other countries are testing whether Novavax vaccine can be used as a booster after other types of COVID-19 vaccines. Erk said the mixed data could lead to his vaccine becoming a “universal choice booster” in wealthy countries.

And the company said Indonesia has already expressed interest in using the Novavax vaccine as a booster after some Chinese-made injections.

The Gaithersburg, Maryland-based company said it plans to produce up to 100 million doses per month by the end of the third quarter and 150 million doses per month by the end of the year.

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