US Biomedical Advanced Research and Development Authority (BARDA) has partnered with Ireland-based ICON to conduct clinical trials of Covid-19 vaccine candidates selected as part of “Project NextGen”.
A part of the US Government’s Strategic Preparedness and Response division, BARDA has launched Project NextGen to develop Covid-19 vaccines and therapies for current and future strains. To achieve this, BARDA plans to leverage its public-private partnerships. The government has plans to invest more than $5bn in the Project NextGen programme.
In June, the European Medicines Agency (EMA) identified the need to update the Covid-19 vaccines to include the XBB Omicron variant. The US Government seconded that sentiment, and last month, BARDA partnered with Regeneron to develop a Covid-19 monoclonal antibody vaccine candidate.
ICON’s government and public health solutions team will conduct a Phase IIb active comparator clinical trial to evaluate the efficacy of the next-generation Covid-19 vaccine, selected by BARDA, compared to the currently approved/authorised vaccines. The trial is expected to enrol 10,000 volunteers over a six-month period.
Although the Covid-19 trial activity has significantly decreased in the last two years, several trials have been initiated in 2023. As per GlobalData’s clinical trial database, more than 80 trials have been initiated for Covid-19 indication in the US and over 400 trials globally this year.
GlobalData is the parent company of Pharmaceutical Technology.
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ICON previously partnered with Evergreen Therapeutics to develop a Covid-19 drug therapy in 2021. The Ireland-based company also has a patent engagement platform that increased patient outreach and enrolment.
ICON has previously partnered with BARDA to conduct a clinical trial for an anthrax vaccine, AV7909. The vaccine comprises Emergent BioSolutions’s Biothrax combined with an immune system stimulant or adjuvant.