The Franco-Austrian laboratory Valneva announced on April 21 the launch of a Phase III clinical study, the last step before a marketing application, of its candidate vaccine against Covid-19.
This study, called “Cov-Compare”, will aim to compare the immune response of Valneva’s vaccine candidate (VLA2001) with AstraZeneca’s Vaxzevria vaccine which is already authorized, the biotech said in a statement.
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4000 people involved
“About 4,000 participants will receive two doses of one of the vaccines”, explains Valneva, who specifies that the study will be carried out at around 25 sites in the United Kingdom.
“The main objective of the study is to demonstrate the superiority of VLA2001 compared to Vaxzevria two weeks after vaccination” by measuring the neutralizing antibodies specific to Covid-19, indicates Valneva.
The launch of the Cov-Compare study follows the announcement of Phase I-II clinical results which called for further development of the vaccine, the biotech said.
Authorization requests for the fall
Valneva adds that if the Phase III results are positive, it will submit marketing authorization applications “during the fall of 2021”.
VLA2001 is “currently the only inactivated and adjuvanted vaccine candidate against Covid-19 in clinical development in Europe”, underlines Valneva.
Earlier on April 21, the Franco-Austrian laboratory had announced that it was turning to country-by-country discussions to provide its vaccine candidate, believing that discussions with the EU had not made “significant progress” to date.