October 18, 2021
Valneva has disclosed positive initial results for its anti-covid vaccine candidate, the only virus-inactivated candidate among those in clinical development in Europe.
The Franco-Austrian laboratory Valneva announced on Monday positive initial results in the context of its phase 3 trials for its candidate vaccine against Covid-19.
“The trial met its two primary endpoints,” argued the company, based in Saint-Herblain, in the suburb of Nantes. In a comparison with AstraZeneca’s vaccine, Valneva’s vaccine, called VLA2001, “demonstrated superiority to the AZD1222 vaccine in terms of average neutralizing antibody titers (…) as well as non-inferiority in terms of seroconversion rate (SCR greater than 95% in the two vaccinated groups) two weeks after the second injection (i.e. on day 43) in adults aged 30 and over. ”The announcement of these results Monday morning makes Valneva action jump of more than 32% on the Paris Stock Exchange.
A favorable tolerance profile
As part of the pivotal Phase 3 trial, 4,012 participants aged 18 and more were recruited from 26 UK sites. The vaccine candidate was generally well tolerated. The tolerance profile was statistically significantly more favorable compared to the other vaccine used in the trial.
To induce effective and lasting immunity, an inactivated virus must also be combined with adjuvants.
The VLA2001 is currently the only candidate inactivated virus vaccine against Covid-19 in clinical development in Europe. The most commonly used inactivated virus vaccines and live attenuated virus vaccines rely on an injection whole virus or part of the virus previously rendered harmless in order to trigger an immune response in case of infection.
The virus produced is concentrated, killed by the action of a chemical agent and then purified. Which requires special facilities to grow the virus or bacteria safe and longer production time. To induce effective and lasting immunity, an inactivated virus must also be associated with adjuvants.
Besides the fact that they are well known, the advantage of these vaccines is that they can be administered to people with weakened immune systems. The ease of storage of this candidate vaccine, between 2 and 8 degrees, also gives it an advantage over competitors.
“This is a much more traditional approach to vaccine manufacturing than the vaccines that have been deployed so far in the UK, Europe and the US.”
Principal investigator of the trial
Valneva already produces the Japanese encephalitis vaccine Ixiaro using the same process. Chinese vaccines Sinovac and Sinopharm Also work on this principle, just like flu and polio vaccines. In clinical trials, Valneva vaccine has been administered in two doses for the majority of participants.
“This is a much more traditional approach manufacture of vaccines than the vaccines that have been deployed so far in the UK, Europe and the US, and these results suggest that this vaccine candidate is on track to play an important role in the fight against pandemic “, commented Adam Finn, principal investigator of the trial and professor of pediatrics at the University of Bristol, cited in the press release.
Termination across the Channel
According to France, the European Union is still interested in Valneva’s vaccine and is continuing its negotiations.
This announcement comes a little over a month later termination by the UK government of its contract for 100 million doses. The information had caused the title of Valneva to fall heavily on the stock market. The French government then assured that the European Union (EU) was still interested in Valneva’s vaccine and was continuing its negotiations.
For Thomas Lingelbach, CEO of Valneva, “these excellent results confirm the benefits often associated with inactivated whole virus vaccines “. He adds that the laboratory wishes to register its vaccine candidate “as quickly as possible” in order to “offer an alternative vaccine solution to people who have not yet been vaccinated”.
The laboratory indicates that it has started the gradual submission of the initial authorization application file from the British Health Agency (MHRA), which requires “a final validation of one of the tests used in the test”, currently “in progress”. He is also preparing a progressive submission from the European Medicines Agency (EMA), as part of a conditional authorization request.
Exit the first vaccine from CureVac
As a reminder, the German biotechnology company CureVac, which had also signed a supply agreement with the EU, recently stopped the development of its first vaccine candidate against the coronavirus – based on messenger RNA technology – because of disappointing clinical results. CureVac has indicated that it is focusing on a second generation vaccine, for which it is collaborating with British pharmaceutical company GlaxoSmithkline (GSK).