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§Valnevas Covid-19 vaccine elicits a stronger immune response with far fewer side effects than the Oxford/AstraZeneca jab, according to trial results published a month after the UK terminated a 1.4bn deal with the French vaccine maker.
The first data from the phase 3 trial showed that participants who were given the Valneva vaccine had more neutralising antibodies than those who received the AstraZeneca shot.
The strong results have renewed concerns about whether the UK government should have abandoned the contract, which was also designed to bolster domestic production capacity for future pandemics.
At the time, people familiar with data from a separate trial to assess booster doses said Valnevas vaccine had performed less well than others. The results of that trial, called Cov-Boost, are yet to be published.
About four-fifths of people aged over 12 in the UK have received a complete course of vaccination. The UK is likely to focus only on shots whose utility in boosting has been demonstrated.
But Clive Dix, former interim head of the UK vaccine task force, said it had been very dangerous to extrapolate from Cov-Boost to assess the vaccines overall performance.
It has come out as superior [to AstraZeneca] on all parameters, which means theres no reason to believe that the vaccine wont get approved, he said.
Shares in Valneva rose 43 per cent on Monday. They fell 42 per cent in one day last month after the UK said it was ending its agreement to purchase at least 100m doses of the vaccine. The government said it had terminated the contract for commercial reasons. Valneva would not comment.
Ministers have been accused of failing to give an adequate explanation for why they suddenly cancelled the contract. Sajid Javid, the health secretary, originally told the House of Commons that the vaccine would not receive regulatory approval.
But Javid was forced to correct the ministerial record, explaining that he had meant to say the vaccine had not yet won approval. That prompted Dix to call for Javids resignation.
Valneva has begun a rolling submission to the UKs Medicines and Healthcare products Regulatory Agency and is preparing to start the application procedure for conditional approval in the EU.
Thomas Lingelbach, Valnevas chief executive, pointed out a flaw in the Cov-Boost trial, saying it boosts very early, after two-and-a-half to three months. Valneva would be running its own trial in real booster settings, when peoples antibody response had significantly waned, he said.
Adam Finn, professor of paediatrics at the University of Bristol and trial chief investigator, said it would be hard to assess the Cov-Boost results when published because we do not know how boosting influences effectiveness.
The trial of more than 4,600 people was smaller than and designed differently to the previous phase 3 studies. The vaccine was compared with the AstraZeneca shot because it is no longer seen as ethical to use a placebo since approved jabs became available. The trial compared antibody levels with those elicited by the AstraZeneca vaccine, rather than producing an overall efficacy rate, based on the numbers who became sick. There were no severe cases of Covid-19 in either group.
Significantly fewer participants receiving the Valneva vaccine suffered from side effects, with no serious adverse events reported. Many countries have restricted the use of the AstraZeneca vaccine to older parts of their population, or dropped it completely, because of a rare blood-clotting side effect.
The UK government had invested in Valnevas Scottish manufacturing plant in Livingston, in part to shore up domestic production of vaccines.
Hannah Bardell, Scottish Nationalist MP for Livingston, said ministers had questions to answer about why they cancelled the Valneva contract. They need to urgently rethink their decision, she said.
The danger, Dix warned, was that the site doesnt get fully developed so the UK would not have the lasting legacy to protect against future pandemics for which it had hoped. Nor did cancelling a contract help the rest of the world, he said.
The government at one fell swoop has basically broken promises and killed off two of the objectives for the vaccines task force, Dix added.
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