Valneva Says Covid Shot Beat AstraZeneca’s in Trial, Seeks EU Approval

19 Oct 2021, 01:26 AM IST

(Bloomberg) -- Valneva SE’s experimental Covid-19 vaccine elicited better immunity than AstraZeneca Plc’s shot in a clinical trial that will pave the way for regulatory submissions and sent the shares up as much as 46%.

Patients had more antibodies -- a proxy for protection against the coronavirus -- and fewer side effects after two doses of the Valneva vaccine in a U.K. study of about 4,000 adults, the drugmaker said Monday. Both groups had the same number of Covid cases and no patient got severely ill, the company said.

The positive results are a boon to Valneva, which finds itself in the uncomfortable position of having developed and prepared to manufacture the vaccine for a country that no longer wants it. The U.K. government last month canceled its supply contract, saying the company had breached its obligations, which Valneva contests.

The French drugmaker’s chief medical officer, Juan Carlos Jaramillo, declined to comment at a press briefing Monday on what breach may have occurred or whether the contract was salvageable. He said the company would continue to manufacture the shot in Scotland for the time being. Valneva is also in contract discussions with the European Union as well as Covax, he said.

Valneva made the unusual choice of comparing its experimental vaccine to an approved product -- the one developed by Astra and the University of Oxford -- rather than a placebo, as Chief Executive Officer Thomas Lingelbach said using a dummy injection wouldn’t be ethical at that point in the vaccine rollout.

The company could only directly compare the shot in people aged over 30 after the U.K. restricted use of the Astra vaccine because of problems with blood clots. Younger adults only received the Valneva shot.

The trial design means it’s hard to come up with an efficacy estimate to compare to that of other vaccines, but the data suggest it’s probably at the high end of what was seen for the Astra shot, Jean-Jacques Le Fur, an analyst at Brian Garnier, wrote in a note to clients.

Others who reviewed the data came to similar conclusions. “Valneva’s vaccine has a chance of being as good as AstraZeneca’s, though we aren’t convinced it will have better efficacy,” said Sam Fazeli of Bloomberg Intelligence.

Trial researchers cautioned against attempts to estimate an efficacy figure from the numbers. The company won’t know the true effectiveness of the vaccine until it’s used outside trials, Adam Finn, the chief trial investigator, said Monday.

“It’s really important to understand that the efficacy of a vaccine is not proportional to the antibody titers that it generates,” said Finn, who is also on the U.K. government’s vaccination advisory panel. “You need enough antibody to do the job” and once you’re over that threshold, having more doesn’t necessarily mean you’re better protected.

Valneva said Monday it’s preparing to start a rolling submission process with the European Medicines Agency to try to gain swift approval in the EU.

In the U.K., the company has already started a similar rolling submission and is expecting to apply for authorization in November in the hope it will be approved by year-end, Jaramillo said.

The initial request for authorization will likely be limited to adults aged 18 to 55, he said. Due to the advanced stage of the U.K.’s vaccine rollout when the trials started, the company couldn’t recruit enough older people and is carrying out a separate study for volunteers aged 56 and over in New Zealand. Data from that and adolescent trials will hopefully be added later to expand use.

The shares rose 35% to 16.16 euros at 2:30 p.m. in Paris.

Different Approach

Valneva’s vaccine works by taking a sample of the disease that has been killed and using it to stimulate an immune response without creating infection. The technique is one of the oldest forms of vaccine-making, with the first polio vaccine developed using the same inactivated approach in the 1950s.

“This is a much more traditional approach to vaccine manufacture than the vaccines so far deployed in the U.K., Europe and North America and these results suggest this vaccine candidate is on track to play an important role,” said Finn.

The company didn’t report much detail from the trial, which sought to show that Valneva’s vaccine elicited more neutralizing antibodies than Astra’s two weeks after the second injection. The shots were administered four weeks apart. The researchers also found that patients reported fewer side effects.