News US trial shows Novavax vaccine is 90 per cent effective

US trial shows Novavax vaccine is 90 per cent effective

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Novavax Inc has reported late-stage data from a US clinical trial showing its vaccine is more than 90 per cent effective against COVID-19, including a host of variants.

The study of nearly 30,000 volunteers in the US and Mexico put Novavax on track to file for emergency authorisation in the US and elsewhere later in 2021, the company said.

Novavax’s protein-based COVID-19 vaccine candidate was more than 93 per cent effective against the predominant variants of COVID-19 that have been of concern among scientists and public health officials, Novavax said.

Protein-based vaccines are a conventional approach that use purified pieces of the virus to spur an immune response and vaccines again whooping cough and shingles employ this approach.

During the trial, the B.1.1.7 variant first discovered in Britain became the most common variant in the US, it said.

Novavax also detected variants of COVID-19 first found in Brazil, South Africa and India among its trial participants, Novavax’s head of research and development, Dr Gregory Glenn, told Reuters.

The vaccine was 91 per cent effective among volunteers at high risk of severe infection and 100 per cent effective in preventing moderate and severe cases of COVID-19. It was roughly 70 per cent effective against COVID-19 variants that Novavax was unable to identify, Dr Glenn said.

“Practically speaking, it’s very important that the vaccine can protect against a virus that is wildly swinging around” in terms of new variants, he said.

Novavax said the vaccine was generally well tolerated by participants.

Side effects included headaches, fatigue and muscle pain and were generally mild. A handful of participants had side effects described as severe.

Novavax said it remained on track to produce 100 million doses a month by the end of the third quarter of 2021 and 150 million doses a month in the fourth quarter of the year.

The Maryland company has repeatedly pushed back production forecasts and has struggled to access raw materials and equipment needed to make its vaccine.

However, in a May investor call, chief executive Stanley Erck said major manufacturing hurdles had been cleared and that all of its facilities could produce COVID-19 vaccine at commercial scale.

Mr Erck said Novavax had started regulatory filing in India, in partnership with the Serum Institute of India, which is contracted to make Novavax shots.

SII had said in March that US restrictions on exports of supplies used for vaccines were limiting its ability to scale up production.

Mr Erck said his understanding was that SII was no longer constrained by raw materials shortages.