French-Austrian vaccine developer Valneva on Wednesday announced that it had launched a Phase 3 trial of its candidate vaccine against COVID-19—the last testing stage before seeking regulatory approval.
The study, which has been dubbed “Cov-Compare”, will compare how participants’ immune systems respond to Valneva’s VLA2001 vaccine with how they respond to AstraZeneca’s coronavirus shot.
“Approximately 4,000 participants will receive two doses of either vaccine,” said Valneva, adding that the study would be carried out at around 25 sites in the United Kingdom.
The main objective of the study is to show the superiority of VLA2001 compared to the AstraZeneca shot two weeks after vaccination, in terms of the level of antibodies that fight the coronavirus, the company added.
If the results of the trial are positive, “Valneva aims to make regulatory submissions for initial approval in the autumn of 2021.”
Unlike most high-profile coronavirus shots, which use various methods to prime the immune system to fight the coronavirus, Valneva’s version is based on an “inactivated” version of the coronavirus itself.
The company said earlier Wednesday that it would “deprioritise” centralised talks with the European Commission to supply its coronavirus shot across the 27-nation EU, switching instead to “a country by country basis”.
Chief executive Thomas Lingelbach complained of a lack of “meaningful progress” in talks with the European Commission.
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