VLA2001, an adjuvanted COVID-19 vaccine from French vaccine company Valneva, has met both its primary endpoints in a phase 3 trial, resulting in higher levels of neutralising antibodies than seen with the AstraZeneca vaccine.
In addition to a strong immune response, VLA2001 also offers a tolerability profile that is statistically significant better than AstraZeneca, with fewer adverse reactions reported especially in the older population.
Valneva hit the headlines this summer when the UK government cancelled a €1.4bn vaccine contract citing contractual breaches, even though the vaccine is set to be manufactured in Scotland. The UK health secretary Sajid Javid later clarified, claiming that VLA2001 would not be approved by the country’s regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).
The company’s share price rose steeply on the latest news of the phase 3 trials, although it has yet to return to the high prices seen in September before the UK government terminated the supply agreement.
Describing responses to the Valneva vaccine in the Cov-Compare trial as “both impressive and extremely encouraging”, chief investigator and professor of paediatrics at the University of Bristol, Adam Finn, said: “This is a much more traditional approach to vaccine manufacture… and these results suggest this vaccine candidate is on track to play an important role in overcoming the pandemic.”
VLA2001 is an inactivated whole virus vaccine, employing a similar approach to the flu vaccine.
“These results confirm the advantages often associated with inactivated whole virus vaccines,” said Valneva CEO, Thomas Lingelbach, adding that VLA2001 will make “an important contribution to the global fight against the COVID-19 pandemic. We are keen to propose an alternative vaccine solution for people who have not yet been vaccinated”.
Valneva is already feeding data to the MHRA as part of a rolling submission for approval and has announced that it will do the same with the European Medicines Agency.
Cov-Compare is a pivotal phase 3 trial that involved more than 4,000 participants aged 18 years and older across 26 trial sites in the United Kingdom. VLA2001 has a busy development programme including a trial in older people currently underway in New Zealand, an expansion of Cov-Compare trial in adolescents, a new trial looking at children aged 5-12 years of age and a booster trial.
The manufacturing process for VLA2001 has already been upscaled to final industrial scale.