UK Terminates French COVID-19 Vaccine Supply Agreement
France-based Valneva SE announced today that it had received a termination notice from the UK Government (“HMG”) in relation to the Supply Agreement for its COVID-19 vaccine candidate, VLA2001.
The contract provides HMG with the right to terminate. HMG has alleged that the Company is in breach of its obligations under the Supply Agreement.
However, the 'Company strenuously denies this.'
Valneva confirmed it is continuing its VLA2001 vaccine development plan.
VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe.
Testing for the Company’s pivotal Phase 3 trial, Cov-Compare, is ongoing at Public Health England (“PHE”). Valneva recently announced that its Phase 3 results are expected to be available early in the fourth quarter of 2021.
And, these results will form part of its rolling submission for conditional approval of VLA2001 with the UK’s Medicines and Healthcare products Regulatory Agency (“MHRA”). Subject to these data and MHRA approval, Valneva believes that initial approval for VLA2001 could be granted in late 2021.
Valneva stated in its press release 'it has worked tirelessly, and to its best efforts, on the collaboration with HMG including investing significant resources and effort to respond to HMG’s requests for variant-derived vaccines.'
'Valneva continues to be committed to the development of VLA2001 and will increase its efforts with other potential customers to ensure that its inactivated vaccine can be used in the fight against the COVID-19 pandemic.'
Valneva SE is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. The Company has leveraged its expertise and capabilities to commercialize two vaccines successfully and rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease and the chikungunya virus.
Note: A report from Public Health England published on September 9, 2021, indicates the adult population in England may have already reached a significant level of immunity against the SARS-CoV-2 betacoronavirus that causes COVID-19.