Valneva may provide Europe with the only inactivated virus vaccine for COVID-19

Valneva SE is in advanced discussions with the European Commission (EC) for the supply of up to 60 million doses of its COVID-19 vaccine, VLA2001. VLA2001 is currently the only inactivated vaccine candidate in clinical trials against COVID-19 in Europe.

The VLA2001 vaccine candidate consists of inactivated whole virus particles of SARS-CoV-2 with high Spike (S) protein density, in combination with two adjuvants – alum and CpG 1018. Its potential benefits, aside from being manufactured by the same platform the company uses for its US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approved Japanese encephalitis vaccine, is that the efficacy of inactivated virus vaccines is well established and the vaccine is expected to conform with standard cold chain requirements (2-8°C).

VLA2001 entered Phase I/II clinical studies in December 2020 and Valneva expects to report initial safety and immunogenicity data in April 2021. Upon analysis of the data, the company said it will select the best dose and commence the second part of the Phase I/II clinical development. If clinical development is successful, an initial approval may be granted in the second half of 2021.

Thomas Lingelbach, Chief Executive Officer of Valneva, said: “Today’s announcement helps to ensure that millions of Europeans potentially have access to a proven and well-established inactivated vaccine approach, upon approval of VLA2001. We are grateful to the European Commission for their support and eager to partner with them to address the ongoing pandemic. We are deeply committed to providing broad access to our inactivated SARS-CoV-2 vaccine candidate and, as we proceed with clinical development, we will simultaneously continue working with partners, including the European Commission and the UK Government, to help us reach that goal. We increasingly see wider recognition that our vaccine will be one that the world cannot do without.”

In September 2020, the company signed an agreement with the UK government for the supply of up to 190 million doses of VLA2001. Under the agreement, if vaccine development is successful, the enterprise will provide the UK government with 60 million doses in the second half of 2021.

About VLA2001-201

VLA2001-201 is the first-in-human, randomised, double-blind, multicentre Phase I/II study evaluating three dose levels of VLA2001 (low, medium, high) for safety, tolerability and immunogenicity in a two-dose schedule with intra-muscular vaccinations three weeks apart. Overall, 150 healthy young adults aged 18 to 55 years will be recruited.