First Inactivated COVID-19 Vaccine in European Union Goes into Clinical Trial

France-based Valneva recently initiated a phase 1/2 clinical trial for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001. This candidate is the first inactivated vaccine against COVID-19 to commence clinical development in the European Union.

The study is a randomized, double blind and placebo-controlled trial evaluating the safety and immunogenicity for 3 dose levels in approximately 150 healthy adults. The trial will be conducted in study sites across the United Kingdom and is supported by the UK’s National Institute for Health Research (NIHR).

“The objective of this trial is to show and prove safety of the vaccine candidate, but also to understand the immunological profile that we will be able to generate through different doses of the trial, and ultimately the dose decision,” Valneva CEO Thomas Lingelbach, said.

In addition to the COVID-19 vaccine, Valneva develops commercial vaccines for other unmet medical needs including Lyme disease and chikungunya. The company is using the platform of their licensed Japanese encephalitis vaccine for their COVID-19 vaccine candidate.

One of the advantages of this platform is that inactivated vaccines are well-known and have a long track record having been in existence since the 1950s.

“Inactivated vaccines come with a well understood profile in terms of immunogenicity, antibody resistance, safety and this is known across very different target groups and populations,” Lingelbach said.

The primary endpoint read-out will be 2 weeks after completion of the 2-dose primary immunization which takes place 3 weeks apart. Based on this data, including the selection of the optimal dose currently expected in the early second quarter of next year, additional trials are expected. The company plans to include more than 4000 participants in the additional trials.

They are hoping for an initial regulatory approval in the fourth quarter of 2021.

In September, the company announced a partnership with the UK government. Under the agreement, if the VLA2001 vaccine is approved, Valneva will provide the UK with 60 million doses in the second half of 2021. The UK government has options over provision of a further 130 million doses from 2022-2025. The UK government is also investing up-front in the scale up and development of the vaccine, with the investment being recouped against the vaccine supply.

Contagion spoke to Lingelbach about the vaccine’s platform, the UK partnership, the timeline for their approvals, and potential supplies if approved.