Thursday, March 30, 2023

Novavax Launches Advanced Covid Vaccine Trial in US

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Novavax is launching an advanced stage trial of its Covid-19 vaccine in the United States and Mexico, fueled by a grant of up to $ 1.6 billion from the Trump administration’s Operation Warp Speed ​​program.

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

Novavax is already testing its vaccine in a phase 3 trial UK in partnership with the UK Vaccine Task Force and a Phase 2 study in South Africa.

Stanley Erck, CEO of Novavax, thanked Operation Warp Speed, which gave the company one of its largest grants vaccine manufacturers.

“With the Covid-19 pandemic raging across 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.

Novavax shares have climbed 2781% since the beginning of the year on the hope of its Covid-19 vaccine. The stock suffered a huge drop in 2016 when its vaccine against respiratory syncytial virus, a common disease that can be serious in infants and adults, failed in a clinical trial. The company has no approved vaccine.

Novavax vaccine is stable between 2 and 8 C and therefore does not require ultra-cold chain for transportation and distribution required by BioNTech / Pfizer’s jab.

Biotechnology plans to recruit people particularly vulnerable to Covid-19 for its trial, including ensuring that a quarter of participants are over 65 and at least 15% are black.

Data from the UK Novavax trial, which will be used to seek regulatory approval in the UK and Europe, is expected in the first quarter of next year, after registration ends at the end November.

Attracting enough participants to the United States may be more difficult now there are vaccines that have received emergency use approvals from the Food and Drug Administration.

Gregory M. Glenn, President of Research and Development at Novavax, said: “We want to reassure participants that we are working to ensure that their participation in our trial does not negatively affect their ability to be vaccinated. timely.”

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