Valneva has reported positive topline results from the Phase III pivotal trial of its inactivated, adjuvanted Covid-19 vaccine candidate, VLA2001. The trial met its co-primary endpoints; VLA2001 demonstrated superior neutralising antibody titre levels compared to AstraZeneca’s AZD1222 (ChAdOx1-S) and achieved antibody seroconversion rate above 95%. The trial included 4,012 participants across 26 trial sites in the UK. The company aims to secure initial approval in the UK by the end of 2021. Last month, the UK government terminated a contract with Valneva to supply the vaccine.
The South African health products regulator has reportedly refused to approve Russia’s Sputnik V Covid-19 vaccine. According to an AFP report, the regulator said that it will not approve the vaccine as some studies indicated that Sputnik V can increase the risk of HIV infection among men. However, the Gamaleya Centre, which developed Sputnik V, said that such concerns were “completely unfounded”.
The European Medicines Agency (EMA) has commenced a review to extend the use of Pfizer’s Covid-19 vaccine to young children aged five to 11. The agency started the review after Pfizer and German partner BioNTech submitted data seeking the extension of use for their vaccine, Comirnaty. Currently, the vaccine is authorised for use in people aged 12 and older. EMA’s human medicines committee (CHMP) will now assess the data and results from an ongoing study, and then forward its opinion to the European Commission.