Novavax gets first authorisation for its COVID-19 jab

Novavax has been granted its first emergency use authorisation in Indonesia for COVID-19 vaccine NVX-CoV2373, and expects other regulators in India, the Philippines and other countries to follow suit in the coming weeks.

The vaccine is the first based on recombinant protein to be approved anywhere in the world, and has the key advantage over many of the currently approved jabs as it can be stored at regular refrigeration temperatures. That makes it well suited to distribution in countries where healthcare delivery is more challenging.

Indonesia falls into that category as it has a fragmented healthcare system, despite universal access,  which is amplified by the geographical hurdles associated with being an archipelago with 275 million people spread across 6,000 islands. Initial shipments into the country are expected to begin “imminently,” said Novavax.

Around a third (36%) of people in Indonesia have received two doses of a vaccine, while 58% have received one dose, according to the country’s Ministry of Health.

Novavax and its development partner Serum Institute of India have committed to provide more than 1.1 billion doses of the vaccine – codenamed NVX-CoV2373 – to COVAX, which has been set up to procure COVID-19 vaccines for lower-income countries.

NVX-CoV2373 destined for Indonesia will be made by Serum Institute, which has committed to producing 750 million doses for COVAX with Novavax pledging another 350 million. The two companies have said they expect to be producing doses at a rate of 150 million per month by year-end.

The World Health Organization (WHO) is also reviewing an emergency use listing for the vaccine, which achieved 90% protective efficacy overall in phase 3 trials carried out in the US and Mexico, with 100% efficacy against moderate to severe COVID-19 disease. The shot is given in two equal doses 21 days apart.

If that comes through, Novavax and Serum Institute will be able to start shipping supplies of the vaccine for distribution through COVAX, helping to speed up vaccination programmes in low- and middle-income countries.

Novavax has ambitions to supply NVX-CoV2373 to high-income markets as well, and has also filed for approval in the UK, EU, Australia and Canada, after a delay caused by questions about chemistry and manufacturing control (CMC) data in the dossier which held up a filing in the US.

It expects to submit the shot to the FDA before the end of the year, although isn’t expected to make a big impact in developed markets which are already well advanced in their primary and booster vaccination campaigns.

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