The Austro-French group Valneva seeks approval of its corona vaccine VLA2001 as a booster after other vaccines or infections. For this purpose, a clinical trial with human volunteers has been started in the Netherlands, Valneva announced in a release Wednesday. For possible approval as a primary immunization against Covid-19 in the EU, the inactivated vaccine remains in the review process at the EMA drug agency.
But that review process is delayed. Valneva still hopes to receive conditional marketing approval for VLA2001 in the European Union this quarter, initially expected by the company in April – we reported on this here. However, the study has since been launched, which will provide booster data following either initial vaccination with an mRNA vaccine or natural covid-19 infection. If the data are positive, they could support possible approval of VLA2001 as a so-called heterologous booster vaccine after other vaccines.
Valneva booster at least six months after basic immunization
The study will enroll 150 participants who receive a VLA2001 booster vaccine at least six months after primary vaccination with an approved mRNA covid-19 vaccine or after natural covid-19 infection. Initial results are expected in the third quarter of 2022. “This study is significant as it will provide the first booster data in unvaccinated adults following natural Covid-19 infection,” reported Juan Carlos Jaramillo, Chief Medical Officer of Valneva.
- source: kleinezeitung.at/picture: pixabay.com
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