Novavax begins late-stage trial of COVID-19 vaccine in the UK

Novavax has begun a late-stage trial of its experimental COVID-19 vaccine in the UK, which could support filings for a licence in the UK, EU and other countries.

The UK government has already signed an agreement with the US biotech to buy 60 million doses of the vaccine in August if trials work out.

It’s one of several agreements with major vaccine makers as the UK hedges its bets over which of the shots will get okayed by regulators first.

Novavax’s study is expected to recruit up to 10,000 participants aged between 18 and 84 years old over the next four to six weeks.

Novavax is based in the US but is collaborating with Fujifilm Diosynth Biotechnologies on a manufacturing operation in Stockton-on-Tees in the UK, in addition to sites in the US.

The UK site is expected to produce up to 180 million doses annually boosting the global supply of the vaccine, called NVX-CoV2373, for other markets.

In all Novavax said it expects to have capacity to produce two billion doses of the protein-based vaccine by next year.

The study has two main goals – the first occurrence of confirmed COVID-19 at least seven days after the second study vaccine in volunteers who have not been previously infected with SARS-CoV-2.

The second main goal is first occurrence of symptomatic moderate or severe COVID-19 at least seven days after the second study vaccination in volunteers not previously affected by the virus.

Both these goals will be confirmed with polymerase chain reaction (PCR) technology.

At least a quarter of the participants will be over the age of 65 and it will prioritise groups most affected by the disease, the company said.

AstraZeneca and the University of Oxford are seemingly in pole position in the race to get a vaccine to market, according to the World Health Organization.

But trials of that vaccine are still on hold in the US after a safety scare earlier this month, although testing has resumed elsewhere in the world.

US Health and Human Services Secretary Alex Azar told CNBC said that the trial remains on hold while federal investigators seek “answers to important questions” over its safety.

He said that the “plan is by the book, we’re keeping patient safety at the centre of everything we do.”

Feature image courtesy of Rocky Mountain Laboraties/NIH

 

 

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