Express Pharma

COVID-19 vaccine from Novavax over 90 per cent effective in US trial

Novavax has begun its regulatory filing in India in partnership with the Serum Institute of India, which is contracted to make Novavax shots

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Novavax reported late-stage data from its U.S.-based clinical trial showing its vaccine is more than 90 per cent effective against COVID-19 across a variety of variants of the virus.

The study of nearly 30,000 volunteers in the US and Mexico puts Novavax on track to file for emergency authorisation in the US and elsewhere in the third quarter of 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 the UK 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, 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, Glenn said.

Novavax said the vaccine was generally well-tolerated among participants. Side effects included headache, fatigue and muscle pain and were generally mild. A small number of participants experienced side effects described as severe.

Novavax remains on track to produce 100 million doses per month by the end of the third quarter of 2021 and 150 million doses per month in the fourth quarter of 2021, the company said.

Chief Executive Stanley Erck said that Novavax has begun its regulatory filing in India in partnership with the Serum Institute of India, which is contracted to make Novavax shots.

(Edits by EP News Bureau)

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