By Reuters Staff
BERLIN (Reuters) – German biotech firm CureVac has started a large Phase 2b/3 clinical trial of its COVID-19 vaccine candidate, banking on the same technology that has allowed rivals BioNTech and Moderna to lead the development race.
“The goal is to have interim results in the first quarter of 2021, which will form the basis – provided the data is good, and we are hopeful – for filing a so-called rolling submission with regulators,” Chief Executive Franz-Werner Haas told Reuters on Monday.
The trial will assess the safety and efficacy in adults of various ages and is expected to include more than 35,000 participants in Europe and Latin America, the company said.
The study aims to demonstrate the efficacy of its vaccine candidate in preventing first episodes of confirmed cases of COVID-19 of any severity as well as preventing moderate to severe confirmed cases of COVID-19 in participants who have never been infected with SARS-CoV-2, CureVac said.
CureVac’s vaccine candidate is based on messenger RNA, a technology that has been shown separately by Moderna and an alliance of BioNTech and Pfizer to be about 95% effective, far above expectations.
The Pfizer compound was the first to be launched in Western countries, winning emergency approval in the United States and Britain, among other nations.
CureVac’s vaccine candidate is one of three German vaccine projects that the German government is supporting with about 750 million euros ($911 million) in total. The European Commission has already secured up to 405 million doses of the vaccine.
Haas reiterated that CureVac does not intend to introduce its vaccine in the United States during the pandemic as the government there had already secured sufficient vaccine quantities from rivals.
The company would, however, seek discussions with the Food and Drug Administration with a view to a U.S. market launch after the pandemic has been brought under control.
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