Novavax Inc (NVAX.O) reported late-stage data from its US-based clinical trial on Monday showing that its vaccine is over 90% effective against COVID-19 across a variety of variants of the virus.
The study of nearly 30,000 volunteers in the United States and Mexico puts Novavax on track to seek emergency clearance in the United States and elsewhere in the third quarter of 2021, the company said.
Novavax’s protein-based COVID-19 vaccine candidate was over 93% effective against the predominant COVID-19 variants that have raised concern among scientists and public health officials, Novavax said.
Protein vaccines are a conventional approach that uses purified pieces of the virus to stimulate an immune response, and pertussis and shingles vaccines again use this approach.
During testing, the B.1.1.7 variant first discovered in the UK became the most common variant in the US, he said.
Novavax has also detected variants of COVID-19 first found in Brazil, South Africa and India among its trial participants, Novavax director of research and development Dr Gregory Glenn told Reuters. .
The vaccine was 91% effective in volunteers at high risk of severe infection and 100% effective in preventing moderate and severe cases of COVID-19. It was around 70% effective against the COVID-19 variants that Novavax could not identify, Glenn said.
“In practice, it is very important that the vaccine can protect against a virus that swings wildly” in terms of new variants, Glenn said.
Novavax said the vaccine was generally well tolerated by participants. Side effects included headaches, fatigue, and muscle pain and were generally mild. A small number of participants experienced side effects described as serious.
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 by the fourth quarter of 2021, the company said.
The Maryland-based company has repeatedly pushed back production forecasts and struggled to access the raw materials and equipment needed to make its vaccine.
However, in a call to investors in May, CEO Stanley Erck said major barriers to manufacturing had been removed and all of its facilities could now produce COVID-19 vaccine on a commercial scale. Read more
Erck said Novavax has started its regulatory filing in India in partnership with the Serum Institute of India, which is engaged to manufacture Novavax injections.
Erck said his understanding is that SII is no longer constrained by commodity shortages.
SII said in March that US restrictions on exports of supplies used for vaccines limited its ability to increase production. Read more
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