French specialist vaccine company Valneva has signed a deal with the European Commission (EC) to supply up to 60 million doses of its vaccine candidate VLA 2001 to the European Union by the end of 2023.
The agreement – which could see 27 million doses delivered next year – has been approved by the EC but still needs to be confirmed by each member state, at which point each state can indicate its required volumes of the vaccine.
Valneva announced last month that VLA2001 met both its primary endpoints in a phase 3 trial, delivering higher levels of neutralising antibodies than seen with the AstraZeneca vaccine and a better safety profile.
Prior to the phase 3 results, the UK government controversially cancelled a €1.4bn vaccine contract with the company, due to the belief of health secretary, Sajid Javid, that the candidate would not be approved by the UK’s regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).
Access to VLA2001 in Europe is dependent on approval by the European Medicines Agency (EMA), which is expected to start a rolling review of VLA2001 shortly. Valneva expects to start supplying the vaccine in April 2022.
“The Valneva vaccine adds another option to our broad portfolio, once it is proven to be safe and effective by the European Medicines Agency,” said EU health commissioner Stella Kyriakides. “The message remains the same: trust the science, and vaccinate, vaccinate, vaccinate.”
Valneva CEO, Thomas Lingelbach, said the company continued to receive messages from people across the world who are “waiting for an inactivated vaccine”. He added: “We are deeply committed to bringing an alternative vaccine solution to the market as quickly as possible and continue to work tirelessly to achieve that.”
VLA2001 is fundamentally different to the four approved COVID-19 vaccines and is the only whole-virus adjuvanted candidate in clinical trials in Europe. Adjuvants help to stimulate an immune response against the antigen.
The vaccine, created using Valneva’s Vero-cell platform, sees inactivated SARS-CoV-2 virus particles combined with two adjuvants, alum and CpG 1018. The latter was developed by Dynavax and is included in its hepatitis B vaccine Heplisav-B.
Valneva has already increased its manufacturing process for VLA2001 to industrial scale.
Shares in the company jumped by 20% on the news of the deal with the European Union, the eighth agreement made by the bloc to tackle the COVID-19 pandemic.