Novavax launches late-stage Covid vaccine trial in US

Novavax launches late-stage Covid vaccine trial in US


Novavax is launching a late stage trial of its Covid-19 vaccine in the US and Mexico, fuelled by an award of up to $1.6bn from the Trump administration’s Operation Warp Speed programme. 

The Maryland-based biotech company kicks off the trial at 115 sites on Monday, aiming to recruit up to 30,000 participants. Two-thirds will receive the vaccine, with the remaining one-third taking a placebo. 

Novavax is already testing its vaccine in a phase 3 trial in the UK in partnership with Britain’s vaccines task force and a phase 2 study in South Africa. 

Stanley Erck, Novavax chief executive, thanked Operation Warp Speed, which gave the company one of its largest grants to vaccine makers.

“With the Covid-19 pandemic raging around the globe, this trial is a critical step in building the global portfolio of safe and effective vaccines to protect the world’s population,” he said. 

Shares in Novavax have soared 2,781 per cent since the start of the year on hopes for its Covid-19 vaccine. The stock had suffered a huge drop in 2016 when its vaccine for respiratory syncytial virus, a common illness that can be serious for infants and adults, failed in a clinical trial. The company does not have any approved vaccines. 

Novavax’s vaccine is stable at between 2 and 8 C, and so does not require the special ultra-cold chain for transportation and distribution needed by BioNTech/Pfizer’s jab.

The biotech plans to recruit people who are particularly vulnerable to Covid-19 for its trial, including ensuring a quarter of participants are over 65 and at least 15 per cent are black.

Data from Novavax’s UK trial, which will be used to apply for regulatory approval in the UK and Europe, is expected in the first quarter of next year, after it finished enrolment at the end of November.

Attracting enough participants in the US may be more difficult now there are vaccines that have received emergency use authorisations from the Food and Drug Administration. 

Gregory M. Glenn, president of research and development at Novavax, said: “We wish to reassure participants that we are working to ensure that their involvement in our trial does not negatively impact their ability to be vaccinated at the appropriate time.”

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