It proved itself superior to AZD1222 (ChAdOx1-S), the vaccine by Astrazeneca-Oxford, in terms of geometric mean titer for neutralization antibodies.
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French vaccine maker Valneva saw its shares jump 30% today after the company reported positive topline results from the Phase III trial of its COVID-19 vaccine candidate VLA2001.
The company revealed that its inactivated, adjuvanted VLA2001 vaccine successfully met both of its primary endpoints in the Phase III Cov-Compare trial. It proved itself superior to AZD1222 (ChAdOx1-S), the vaccine by AstraZeneca-Oxford, in terms of geometric mean titer for neutralization antibodies. VLA2001 had a GMT of 803.5, while AZD1222 recorded 576.6.
Valneva’s vaccine was also well-tolerated, with fewer adverse events up to a week post-vaccination. Injection site reactions logged at 73.2%, compared to AZD1222’s 91.1%. In comparison, systemic reactions for VLA2001 were at only 70.2% against 91.1%. VLA2001 is administered via intramuscular injection twice, with four weeks in between.
The Cov-Compare trial involved 4,012 participants aged 18 years and up who tested across 26 trial locations in the UK. It has yet to commence tests for the adolescent group but has already started recruiting participants.
Given the positive results, the company is reportedly preparing to begin trials for participants aged 5 to 12 years old soon, along with a booster dose analysis.
“The low levels of reactogenicity and high functional antibody responses alongside broad T-cell responses seen with this adjuvanted inactivated whole virus vaccine are both impressive and extremely encouraging. 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,” said Adam Finn, professor of pediatrics at the University of Bristol and trial chief investigator, in a statement.
At present, VLA2001 is the only whole virus, inactivated, adjuvanted vaccine COVID-19 undergoing clinical trials in Europe. It is produced using Valneva’s Vero-cell platform, utilizing its manufacturing technology for its licensed Japanese encephalitis vaccine IXIARO. VLA2001 includes inactivated whole virus particles of SARS-CoV-2 with high S-protein and two adjuvants, CpG 1018 and alum. Manufacturing for VLA2001 is now on a final industrial scale.
“These results confirm the advantages often associated with inactivated whole virus vaccines. We are committed to bringing our differentiated vaccine candidate to licensure as quickly as possible and continue to believe that we will be able to 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,” commented Thomas Lingelbach, chief executive officer of Valneva, in the same press release.
Valneva has begun a rolling submission for initial approval with The Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK and is getting ready to apply for conditional approval with the European Medicines Agency. The MHRA requires a final assay validation to verify VLA2001-301 data.
