Valneva gets EU deal for COVID jab, and may sue UK
Shares in France's Valneva leaped after it got an EU order to supply 60 million doses of its COVID-19 vaccine VLA2001 over the next two years, including 27 million next year.
The deal for the adjuvanted, inactivated SARS-CoV-2 vaccine still depends on authorisation of the jab by the European Medicines Agency (EMA) which is due to start a rolling review of VLA2001 shortly, but Valneva thinks it could start delivering supplies to the EU in April next year.
A firm order for VLA2001 throws a lifeline to Valneva, which was hit hard when the UK government backed out of a supply deal for up to 190 million doses of the shot – valued at €1.4 billion – in September. That included a firm order for 100 million doses.
The government said Valneva had breached its obligations under the agreement, and Health Secretary Sajid Javid poured oil on the fire after telling Parliament that the vaccine would not have been approved by the UK drugs regulator – even though the data from its phase 3 trial wasn't yet available.
As it turned out, VLA2001 was shown to be better at stimulating neutralising antibody levels than an active comparator vaccine, AstraZeneca's Vaxzevria, with comparable seroconversion rates and fewer side effects, according to top-line results released by Valneva.
"Our Phase 3 results confirmed the advantages often associated with inactivated vaccines and we continue to believe that our differentiated vaccine candidate could make an important contribution to the global fight against the COVID-19 pandemic," said Valneva chief executive Thomas Lingelbach.
Seeking apology from Health Secretary
In comments made to BBC Radio Scotland, Valneva's chief financial officer David Lawrence said the biotech company was not ruling out "legal recourse" over remarks by Health Secretary Sajid Javid that VLA2001 would not be able to get UK approval.
Those remarks were eventually corrected in Hansard – the official record of parliamentary proceedings – but according to Lawrence had a devastating effect on Valneva.
"We had to do a lot of work to rebuild and restore confidence in the vaccine," he told the BBC. Javid's comments were "very clearly wrong," he continued, adding: "we'd love to hear an apology from him."
Lawrence said the company had been trying to reach an amicable resolution with the UK government since September but had not been able to do that, and "has not ruled out any…options" including a legal challenge.
The decision to terminate the deal was a big blow Valneva's manufacturing plant in Livingston, Scotland, which received millions of pounds of UK government investment as a credit for future vaccine supply. The plant will be used to meet the EU order, along with another facility in Sweden.
Shares in Valneva strengthened by a quarter after the EU deal was announced, recovering ground lost after the UK terminated its contract.