Novavax delays US trials for COVID vaccine and says late-stage study will begin ‘in coming weeks’

Novavax delays US trials for its coronavirus vaccine AGAIN and says late-stage study will begin ‘in the coming weeks’ as it struggles to scale up production of its jab

  • Novovax delayed the start of its late-stage US trials for the second time after initially declaring a start date in October and then November
  • The company said it had problems scaling up its manufacturing and plans to begin ‘in the coming weeks’
  • Late-stage trials have begun in the UK and in South Africa, with interim results expected in early 2021 
  • Novavax’s vaccine uses synthesized pieces of the surface protein that the coronavirus uses to invade human cells and spurs antibody production

Vaccine maker Novavax said on Monday it has pushed back the start of US trials for its experimental coronavirus vaccine and expects them to begin ‘in the coming weeks.’

This is the second time the Maryland-based company has rescheduled the start date of its late-stage Phase III trials.

Novovax first flagged an October start date, which was hampered by issues in scaling up its manufacturing and then stated it would begin in November before delaying yet again.

The firm plans to use vaccine material produced at commercial scale for the trial in the US and Mexico and has been working closely with the US Food and Drug Administration (FDA) to greenlight the use of the vaccine made at a North Carolina plant.

Meanwhile, Novovax has completed enrollment for its 15,000 participant UK trial and expects interim data as soon as the first quarter of 2021. 

Novavax’s vaccine uses synthesized pieces of the surface protein that the coronavirus uses to invade human cells and spurs antibody production. Pictured: Three potential coronavirus vaccines are kept in a tray at Novavax labs in Gaithersburg, Maryland, March 20

Novavax, which has not produced a vaccine before, created a shot that contains synthesized pieces of the surface protein that the coronavirus uses to invade human cells.

The idea is that the protein will cause human cells to spur production of antibodies to fight the infection.   

The inoculation, named NVX-CoV2373, was given with or without an adjuvant, which is an agent that boosts the immune response. 

In early US trials, participants were split into four groups and given five micrograms or 25 micrograms of the vaccine or the placebo with or without the extra ingredient.

For those who were immunized they were given the jab via intramuscular injection about 21 days apart. 

Researchers found that volunteers generated high levels of neutralizing antibodies and T-cells, both of which are needed to build up immunity.

What’s more, the levels were higher than those seen among patients who’ve recovered from COVID-19, the disease caused by the virus.    

Eight study participants experienced adverse side effects after receiving a second vaccine dose during the trial, although none required medical intervention, the company said.

Headache, fatigue, and muscle pain were among the more common side effects, and the vaccine was ‘well tolerated’ overall, according to a statement.

Novavax said the addition of the adjuvant did enhance the effect of the vaccine in the study. 

Currently, Novovax is running trials in four countries, including in the UK and South Africa.

Of the 15,000 participants in the UK trial, more than 25 percent are over the age of 65, while a large proportion of volunteers had underlying co-morbid medical conditions generally representative of the population.

In South Africa, Novoax is running a fully-enrolled Phase 2b trial, which has 4,400 volunteers, including 245 who are medically stable, HIV positive participants. 

Efficacy data from that trial could also be available in the first quarter of next year. 

When late-stage trials begin in the US, it will be the fifth coronavirus vaccine to do so, following Pfizer inc, Moderna Inc, AstraZeneca Plc and Johnson & Johnson.

In July, Novovax was awarded $1.6 billion from the federal government’s Operation Warp Speed to fund its Phase III trial and to scale-up manufacturing. 


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