Last month, the UK Government scrapped a deal for Valneva’s Covid-19 vaccine, with Health Secretary Sajid Javid telling MPs later it had been “clear” the vaccine “would not get approval” by the Medicines and Healthcare products Regulatory Agency in the UK.
The firm said that the UK Government served notice over allegations of a breach of the agreement, which it “strenuously” denied.
The UK had about 100 million doses on order and Prime Minister Boris Johnson visited Valneva’s Scottish manufacturing site in Livingston in January.
In new phase three results reported on Monday, Valneva said its vaccine showed superior neutralising antibody titer levels compared with the comparator vaccine from AstraZeneca.
The company also said its vaccine – VLA2001 – induced broad T-cell responses, a part of the immune system believed to be involved in long-term immunity.
The phase three trial recruited 4,012 people across 26 trial sites in the UK.
The number of Covid-19 cases were similar between those given AstraZeneca or Valneva, the firm said.
It added that the complete absence of any severe Covid-19 cases may suggest that both vaccines used in the study prevented severe Covid-19 caused by circulating variants, mainly the Delta variant.
Adam Finn, professor of paediatrics at the University of Bristol and trial chief investigator, said: “The low levels of reactogenicity and high functional antibody responses alongside broad T-cell responses seen with this adjuvanted inactivated whole virus vaccine are both impressive and extremely encouraging.
“This is a much more traditional approach to vaccine manufacture than the vaccines so far deployed in the UK, Europe and North America and these results suggest this vaccine candidate is on track to play an important role in overcoming the pandemic.”
— Valneva (@valnevaSE) October 18, 2021
Thomas Lingelbach, chief executive officer of Valneva, said: “These results confirm the advantages often associated with inactivated whole virus vaccines.
“We are committed to bringing our differentiated vaccine candidate to licensure as quickly as possible and continue to believe that we will be able to make an important contribution to the global fight against the Covid-19 pandemic.”
Valneva started commercially manufacturing VLA2001 at its Livingston site, which it describes as a “globally qualified manufacturing site for viral vaccines”, in January this year.
The company’s site in Solna, Sweden, provides full “fill and finish” operations for VLA2001.
Valneva said it has scaled its manufacturing capabilities and commenced initial production to address the projected commercial demand for VLA2001.