EU May Cancel Valneva Covid Vaccine Order

19.05.2022 - The European Commission has indicated it may cancel an advance purchase agreement with Valneva that calls for the France-headquartered biotech to supply 60 million doses of its Covid-19 vaccine candidate over a two-year period up to 2023. A clause in the 2021 contract provided for termination if the European Medicines Agency (EMA) failed to grant conditional marketing authorization before the end of April 2022.

The EU’s health watchdog has been conducting a rolling review of the vaccine since December 2021, but only contacted the manufacturer about providing additional data on Apr. 25, 2022. Valneva said it had responded swiftly but the agency’s Vaccination Steering Board was already in the process of invoking the termination clause.  For its part, the board has now said it is open to finding a remedy.

While Valneva believes the chances are good that the EMA’s Committee for Medicinal Products for Human Use (CHMP) will greenlight VLA2001 by Jun. 12, should the company not receive clearance by the extended deadline it can still propose an alternative remediation plan for member states wanting to order on their own.

Thomas Lingelbach, CEO of the vaccine-specialized biotech, called the Commission’s move “regrettable, “especially as he said the company “continues to receive messages from Europeans looking for a more traditional vaccine solution.” Valneva has started a dialogue with member states who may be interested, he said.

Since the beginning of this month, the vaccine maker that resulted from the merger of a French and an Austrian company has been conducting trials with its shot as a booster. Valneva’s is the only European-made inactivated-virus Covid-19 shot that has undergone clinical testing in the region and the only one to date to contain the whole virus rather than just the spike protein.  The adjuvant is made by Dynavax in the US.

To date, VLA2001 has received conditional clearance in Bahrain and United Arab Emirates and was quietly greenlit in late April by the UK, where its future had looked in doubt. Although the British government, praising the vaccine’s potential, in July 2021 had ordered 60 million doses with options for additional doses up to 2025, in September 2021 it abruptly tore up the contract, saying Valneva had breached it – a claim the company denied.

The apparent rupture of the deal potentially worth £1.4 billion was particularly  unexpected as London had already pledged to help finance the scale-up of manufacturing capacity at Valneva’s Scottish plant in Livingston, West Lothian – the vaccine is also made in Sweden.

UK health secretary Sajid Javid told Parliament at the time that the shot would not have been approved.  Commentators on the recent clearance said the government may have reconsidered after trials conducted in the country showed VLA2001 to have e effectiveness comparable to AstraZeneca’s viral vector shot Vaxzevria in protecting against the virus and with fewer side effects.

According to reports, Valneva is now going ahead with at least some of the delivery volume agreed with the UK. Some 2,500 doses will be earmarked for deployment in Scotland.

Author: Dede Williams, Freelance Journalist