Specialty vaccine company, Valneva, has been given marketing authorization in Europe for its inactivated whole-virus COVID-19 vaccine VLA2001.
This is a turnaround from the company’s situation in May of this year when the stock price was knocked down by 20% when gaining traction in the EU was proving to be a struggle. Despite authorization from the UK’s drug regulator, The European Medicines Agency (EMA) at this time declined to recommend the approval until undisclosed questions had been answered.
The EMA supports the development of medicines that address unmet medical needs and in the interest of public health can grant the conditional authorization. These are usually given to medicines on less comprehensive clinical data than what is usually required but where the benefit of immediate availability of the medicine outweighs the risk inherent in the fact additional data is still required.
Standards met
With the standards now being met and the authorization granted, VLA2001 can be used as primary vaccination in people from 18 to 50 years of age and the authorization will cover all 28 European Union Member States as well as Iceland, Liechtenstein, and Norway.
Thomas Lingelbach, chief executive officer of Valneva said: “We are extremely pleased that the EC granted full marketing authorization for VLA2001. We have shown that Valneva has the expertise to bring a vaccine all the way from bench to market. Since we began working on VLA2001, we have continued to receive messages from Europeans who are waiting for a more traditional vaccine technology.”
Lingelbach said now the company has received this full marketing authorization, it is hoped that the EC and its member states will place orders that reflect this demand.
He added: “There are still 15% of Europeans over 18 are not yet vaccinated, and we believe that making our inactivated vaccine available could increase vaccination coverage and have a meaningful impact on public health.”
European Medicine Agency
The EC’s approval follows recommendations yesterday (June 24) from the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) to grant marketing authorization.
As well as the UK, this new marketing authorization in Europe follows emergency use authorization granted in the United Arab Emirates and Bahrain in May 2022 and March 2022, respectively.
VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants, alum and CpG 1018. This adjuvant combination has consistently been proven to induce higher antibody levels in preclinical experiments than alum-only formulations.