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NIHR-supported Valneva COVID vaccine trial reports positive results

A large-scale, NIHR-supported study of Valneva’s COVID-19 vaccine candidate has reported positive results - with participants who received the VLA2001 vaccine generating high levels of neutralising antibodies against the disease.

The phase 3 Cov-Compare trial, compared Valneva’s VLA2001 COVID-19 vaccine candidate, against the AstraZeneca AZD1222 (ChAdOx1-S) vaccine.

Topline results published by Valneva in a press release this week show that VLA2001 generated a stronger immune response than the AstraZeneca (AZ) vaccine - with higher levels of neutralising COVID-19 antibodies in the blood compared to AZD1222.

VLA2001 had a high neutralising antibody seroconversion rate of above 95%, two weeks after vaccination - with results comparable to the AZ vaccine.

Researchers also found no severe cases of COVID-19 amongst participants receiving the Valneva vaccine, despite the Delta variant being in circulation during the trial.

A total of 4,012 participants were recruited across the UK, with over 20 NIHR-supported trial sites contributing to the study - with all participants receiving two active vaccine doses of either vaccine, administered at four week intervals.

As an inactivated, adjuvanted vaccine, VLA2001 is made in the same way as flu and polio vaccines - using an inactivated whole virus - a dead version of coronavirus that cannot cause disease. It is the only one of its kind currently in clinical development in Europe.

Recruitment to the study was completed at the beginning of June 2021, after it launched at the end of April, following positive results from the phase 1/2 study data.

Professor Andy Ustianowski, NIHR Clinical Lead for the COVID-19 Vaccination Programme and Joint National Infection Specialty Lead said:

“We want to sincerely thank every single one of the participants involved in this pivotal trial. These positive results - together with the fact that the vaccine can be stored in a fridge and so more easily distributed - suggest that VLA2001 will have an important part to play in the continued battle against COVID-19, right around the world.”

Professor Adam Finn, Chief Investigator of Cov-Compare, University of Bristol said:

“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.”

Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, said:

“I would like to thank the trial investigators as well as all trial participants and collaborators, especially the National Institute for Health Research and the clinical teams within the NHS research centres as well as Public Health England. This outcome shows the value of the collaboration that we started in September 2020 and we could not have achieved this milestone without them.”