French biotech Valneva reported positive Phase 3 results in a trial that pitched it against the Oxford/AstraZeneca jab, setting it up for potential U.K. authorization by the end of the year, the company announced on Monday.
Based on a U.K. trial of 4,012 participants, Valneva said that its vaccine stimulated the creation of protective antibodies at around a
40 percent higher rate compared with AstraZeneca’s vaccine and was better tolerated.
The vaccine also prevented coronavirus infections at a similar rate to the Oxford/AstraZeneca shot, and there were no serious cases across both groups, the company said. A placebo-controlled trial was not possible on ethical grounds, given the arrival of authorized vaccines.
Chief Medical Officer Juan Carlos Jaramillo told journalists in a briefing that Valneva is positioning the jab as a first-vaccination course for people in the U.K., Europe, North America and around the world.
“I think there's very much a role for this vaccine, even in places where the programs are well advanced,” added Adam Finn, chief investigator.
The biotech began a rolling review in August with the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) and plans to finalize its submission in November. It expects an initial approval, “hopefully by the year-end,” Jaramillo said. A European decision is anticipated early next year.
This will initially be for those aged 18 to 55, based on the trial participants. The company anticipates expanding its use to older and younger people based on ongoing trials. Valneva is also carrying out a booster study with its inactivated virus vaccine.
Investors reacted positively to Valneva's announcement, sending its shares 36% higher in European trading.
While it’s positive news for the French company, which chose the U.K. for its clinical development as well as for manufacturing its vaccine, it’s tainted by a lack of buyers.
Britain last month terminated its contract to buy 190 million doses; the first 60 million doses were expected in the first quarter of 2022.
The U.K. alleged that Valneva was in breach of its obligations under the supply agreement, which the company said it strenuously denied.
A Department of Health and Social Care spokesperson said on Monday in an emailed statement that they had "received the latest interim clinical trial data,” but did not address whether the contract was still salvageable.
Meanwhile, the company has been in prolonged talks with the European Commission but has not completed an agreement due to issues over agreeing to a supply schedule.
Jaramillo said he was unable to comment on the U.K.’s contract but said EU discussions “are happening as we speak.”
Meanwhile, MHRA approval could pave the way for World Health Organization pre-qualification, Finn pointed out.
Valneva is preparing to submit a rolling review with the European Medicines Agency and anticipates a decision in the first quarter of 2022.
The Valneva shot is the only vaccine in clinical development in Europe based on a whole inactivated, adjuvanted virus — a more traditional form of vaccine than mRNA or adenoviral-vector shots. Similar technology is used in the Chinese vaccines from Sinopharm and Sinovac.
In terms of safety, Valneva said that participants who received its vaccine reported “significantly fewer” adverse side-effects when compared with Oxford/AstraZeneca.
In addition, analysis shows that the shot provoked the creation of a broad spectrum of T-cells, which, along with antibodies, give protection against the coronavirus and are understood to be linked with long-term immunity.
Given that the vaccine contains the whole inactivated virus, T-cell immune responses were detected not only against the S (spike) protein but also against other parts of the virus known as M and N proteins. To date, all EU authorized vaccines only target the spike protein.
This broader approach “theoretically provide[s] you with some security if you like against viral evolution,” said Finn.
This story has been updated.
Source : https://www.politico.eu/article/valneva-reports-positive-results-for-coronavirus-vaccine/751