Covid-19: Valneva’s vaccine produces stronger immune response than AstraZeneca’s, company reportsBMJ 2021; 375 doi: https://doi.org/10.1136/bmj.n2551 (Published 18 October 2021) Cite this as: BMJ 2021;375:n2551
Valneva’s covid-19 vaccine produces significantly higher concentrations of neutralising antibodies than the Oxford-AstraZeneca vaccine does, preliminary trial results show.
The phase III trial included just over 4000 adult volunteers across 26 sites in the UK, of whom 1040 under 30s and 1977 over 30s received Valneva’s vaccine and 995 over 30s were given AstraZeneca’s.
In a press release Valneva reported that the trial met its primary endpoints, with the vaccine showing superiority over the AstraZeneca vaccine in terms of neutralising antibody concentrations and was non-inferior in terms of seroconversion rates (above 95% in both groups), two weeks after the second dose in the over 30s.1
Valneva is a French company that specialises in vaccine development, with manufacturing sites around the world. It is also working on a vaccine for Lyme disease and a single shot vaccine candidate for chikungunya.
Further analysis of the results showed that the vaccine induced T cell activity against the spike (74.3%), nucleoprotein (45.9%), and matrix (20.3%) proteins.
Unlike previous covid-19 vaccine trials, this phase III trial assessed immunogenicity rather than efficacy. However, the company still reported that, when looking at covid-19 cases among participants (an exploratory endpoint), the numbers in the groups were similar. No severe cases of covid-19 were seen in either the Valneva or AstraZeneca group.
The Valneva vaccine, which is the only adjuvanted, inactivated, whole virus vaccine being tested in Europe, will be manufactured in Scotland and Sweden.
It is currently undergoing the UK Medicines and Healthcare Products Regulatory Agency’s rolling submission process, and a decision is expected by the end of 2021. The company is also in discussions with the European Medicines Agency and the European Commission regarding approval and potential contracts. Approval is initially expected for use in 18 to 55 year olds, with trials in older volunteers still ongoing.
In September the health and social care secretary for England, Sajid Javid, said that the MHRA would not approve the vaccine. He was speaking in the Houses of Parliament about the UK cancelling its 100 million dose Valneva contract.
Speaking at a Science Media Centre briefing on the results, trial chief investigator Adam Finn said, “We don’t really know why he said that. It has been corrected in Hansard, so he’s acknowledged that he got it wrong. But he hasn’t actually explained, to me at least, exactly what led to that comment.
“Certainly the data that we presented today are pretty much as good as we could have hoped for in terms of the strategy towards authorisation that MHRA have set out. So I think we are cautiously optimistic that we will indeed achieve authorisation.”
The press release said that the vaccine was generally well tolerated and was “significantly more favourable” in comparison with the AstraZeneca vaccine, with participants who received Valneva reporting fewer injection site reactions (73.2% v 91.1% for AstraZeneca; P<0.0001) and systemic reactions (70.2% v 91.1%, P<0.0001).
No unsolicited serious adverse events related to treatment were reported, and the overall safety profile among participants in the younger age group vaccinated with Valneva was similar to that in the older age group, the company said.
Competing interests: EM is a participant in the Valneva covid-19 vaccine trial.
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