At the outset of the pandemic, the UK government and Valneva were quick to create a €1.4bn ($1.65bn) five-year deal: to not only supply the UK with up to 190 million doses of the French company's COVID-19 vaccine candidate once authorized; but also to boost manufacturing capacity at the company's Livingston site in Scotland.
In September last year, however, the UK government cancelled the contract: accusing Valneva of being in breach of its supply agreement obligations with Valneva ‘strenuously denying’ this claim.
The French vaccine specialist yesterday announced that a settlement had been reached: although told BioPharma-Reporter it was not able to offer any further details on the terms agreed.
“The settlement agreement resolves certain matters relating to the obligations of the company and HMG [Her Majesty’s Government] following the termination of the supply agreement and in relation to the separate agreement relating to clinical trials of VLA2001 in the United Kingdom, which remains in place,” says the company's statement, published yesterday.
“The company continues to have certain other obligations pursuant to provisions of the supply agreement that survive its termination.”
In February, manufacturing plans in Scotland were revived with research and development funding of up to £20m ($24m) from Scottish Enterprise, a government agency. The first grant of up to £12.5m is supporting R&D related to the manufacture of VLA2001, while the second grant of £7.5m is helping develop manufacturing processes for other vaccine candidates.
VLA2001 received Conditional Marketing Authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA) in April, for primary immunization in adults 18 – 50 years old.
Key EU committee vote due next week
Valneva champions the traditional approach of its COVID-19 vaccine: with VLA2001 being the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against the virus in Europe.
After the cancelled contract in the UK, the company’s main focus has been the EU with a deal for up to 60 million doses in the balance. But the vaccine has not yet been authorized in the bloc, and discussions with the European Medicines Agency (EMA) and the European Commission (EC) rumble on.
In May, the EC announced its intent to terminate the Advanced Purchase Agreement (APA) given that the vaccine had not received marketing authorization from the EMA (under the terms of the APA). While Valenva has proposed a remediation plan and provided required additional information to the EMA – again under the conditions of the APA – it noted in a statement last week that volume indications may not be sufficient to maintain the APA.
“Following receipt of the EC’s notice of intent to terminate the APA, Valneva proposed a remediation plan, which is now subject to further discussion within the EC and among the participating member states," it said in a statement published on June 10.
“Some member states have confirmed their interest in having an inactivated, adjuvanted whole-virus vaccine solution in their portfolio. However, the preliminary, unofficial volume indications received from the EC would not be sufficient to ensure the sustainability of Valneva’s COVID-19 vaccine program. This would also impede the future development of the program beyond the current product profile.
“If such indications are confirmed, Valneva will not be able to enter into an amendment to the APA that could allow for a reduced order, and the EC is thus likely to terminate the agreement. As a result, Europeans would not have access to Valneva’s inactivated vaccine VLA2001.”
The EMA’s Committee for Medicinal Products for Human Use (CHMP) is expected to take a vote next week, which will then go to the EMA and EC.
Further authorizations
Valneva has received authorization for the vaccine in the United Arab Emirates and Bahrain alongside the UK.
“Valneva also continues to work with agencies outside of the EU for potential future approvals and additional purchase agreements,” says the company.