Valneva Working on Remediation Plan for COVID-19 Vaccine Candidate

(Reuters) – French drugmaker Valneva said on Friday it had proposed a remediation plan after receiving the European Commission’s notice of intent to terminate the advance purchase agreement for its inactivated-virus COVID-19 vaccine candidate.

“Some member states have confirmed their interest in having an inactivated, adjuvanted whole-virus vaccine solution in their portfolio,” the company said in a statement.

“However, the preliminary, unofficial volume indications received from the EC (European Commission) would not be sufficient to ensure the sustainability of Valneva’s COVID-19 vaccine programme.”

Valneva had warned on May 16 that its COVID-19 vaccine agreement with the European Commission was likely to be scrapped as Brussels had informed the company of its intent to terminate the advance purchase agreement.

“We hope that the EC and its member states will continue to evaluate the potential advantages of an inactivated vaccine,” Valneva Chief Executive Thomas Lingelbach said in a statement.

The drugmaker said that as a result it had proposed a remediation plan, which is now subject to further discussions within the EC and among the participating member states.

In parallel, the regulatory process with the European Medicines Agency (EMA) continues as planned, the company said, and the agency’s Committee for Medicinal Products for Human Use is set to take a final vote during the week of June 21 on whether to endorse the vaccine. In April, EMA asked the company to provide more data on the vaccine.

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