Is Valneva's Covid vaccine soon to be available in France? The European Union announced they have already pre-ordered the vaccine developed by the French-Austrian drugmaker as it sought marketing approval and is currently under rolling review by the European regulator. A few weeks ago, the laboratory announced they started "preparing to commence rolling submission for conditional approval with the European Medicines Agency".
A "new classic type of vaccine", explained this Thursday November 11 doctor and journalist Damien Mascret on France 2 TV channel, that requires two doses four weeks apart. It can be easily stored in the fridge, between 2 and 8°C (35.6 and 46.4°F). "It means the virus is bred and chemically killed. So, it will immunize you but does not risk to spread the disease. It is common knowledge because it is what we already used for the poliomyelitis vaccine", Mascret goes on.
Anyway, the vaccine shown "positive ropline results", as Valneva explained back to this past October 18th. "The trial met its co-primary endpoints", the press release reads while specifying the vaccine "demonstrated superiority against AZD1222 (AstraZeneca), in terms of geometric mean titer for neutralization antibodies, as well as non-inferiority in terms of seroconversion rates (SCR above 95% in both treatment groups) at two weeks after the second vaccination (i.e. Day 43) in adults aged 30 years and older."
The phase 3 of the trial has been performed in 4,012 people aged 18+ and the vaccine has been "generally well tolerated": "The tolerability profile of VLA2001 was significantly more favorable compared to the active comparator vaccine."
For the record, the vaccine relies on the “inactivated virus” technology, the standard form of vaccines so far, like products developed by Sinovac and Sinopharm. "This is a much more traditional approach to vaccine manufacture than the vaccines so far deployed in the UK, Europe and North America and these results suggest this vaccine candidate is on track to play an important role in overcoming the pandemic", Adam Finn, Professor of Paediatrics, University of Bristol, Trial Chief Investigator, said.
This new vaccine could be licensured "as quickly as possible" to "propose an alternative vaccine solution for people who have not yet been vaccinated", Thomas Lingelbach, Chief Executive Officer of Valneva, said. Furthermore, the laboratory announced they have "commenced rolling submission for initial approval with the UK’s Medicines and Healthcare products Regulatory Agency" as well as "preparing to commence rolling submission for conditional approval with the European Medicines Agency".
