EU 'negotiating with Valneva' over COVID-19 vaccine contract

The European Commission is reportedly in advanced discussions with French biotech Valneva about picking up the contract to supply COVID-19 vaccines that was terminated by the UK government this week.

A French government source told Reuters that the EU is considering using the VLA2001 vaccine as part of its booster campaign plans, along with a shot from Sanofi and GlaxoSmithKline.

That would throw a lifeline to Valneva, which was rocked by the UK's decision to withdraw from the €1.4 billion order to supply up to 190 million doses of the purified inactivated SARS-CoV-2 vaccine, claiming that the company had breached its obligations under the agreement.

That included a firm order for 100 million doses, with the amount swelled by 40 million as recently as February.

Jab 'would not be approved'

Valneva denied that allegation, but suffered another blow yesterday when UK Health Secretary Sajid Javid told Parliament that the vaccine would not have been approved by the MHRA – even though the results of an ongoing late-stage trial (Cov-Compare) are not yet available.

The vaccine is being produced in Livingston, Scotland, and Javid said that the facility is important to the UK and Scottish governments, adding "we will be working together on to see what more we can do."

Responding to a question from Scottish National Party (SNP) MP Hannah Bardell – who represents the constituency where Valneva's UK manufacturing facility is located – Javid said that there were "commercial reasons" for the decision but that it was "clear" the vaccine would not be approved.

https://twitter.com/HannahB4LiviMP/status/1437786015167655938

"Obviously she is not recommending that we administer vaccines that do not get approval," said Javid.

The results of Cov-Compare are expected next month, although the Financial Times has reported that a preliminary look at the results suggested VLA2001 was less effective than other vaccines in the trial.

In a letter to participants in the phase 3 trial of VLA2001 sent after news of the cancelled contract emerged, Valneva reiterated its position that it is still expecting MHRA approval before the end of the year.

The company said yesterday it had also completed enrolment of the initial cohort in a phase 3 trial of VLA2001 involving participants aged 56 or over in New Zealand, with the number increased from 150 to 200 as a result of consultations with the EMA.

"Topline data from this cohort will read out in early 2022, and it is expected that the data will support additional regulatory submissions," said the biotech.