Valneva Said to Be Near EU Vaccine Deal After Talks Resume

The European Union is closing in on a deal with Valneva SE to purchase its Covid-19 vaccine for the region after resurrecting talks abandoned earlier this year, according to people with knowledge of the situation.

The EU and the French biotech are a few weeks away from finalizing a so-called advance purchase agreement, said the people, who didn’t want to be identified because the discussions aren’t public. The European Commission told EU ambassadors last month that it would be negotiating a deal with Valneva after 20 member states had “expressed interest” in a joint contract, according to a diplomatic note seen by Bloomberg.

Valneva’s shot would complement the bloc’s stable of vaccines with a different approach. The product, which is up against AstraZeneca Plc’s in clinical tests, is an inactivated vaccine -- an old-school method also used for polio and hepatitis inoculations. Because it targets the whole virus rather than just the spike protein, it could potentially stand up better to variants.

Valneva had said in April that it was “de-prioritizing” the discussions with the commission and focusing on doing deals on a country-by-country basis. One factor in the breakdown of talks was the priority Valneva was giving to U.K. supplies. The U.K. helped fund the trials and manufacture of the vaccine, and the priority access was baked into the deal with Britain in September.

The EU and Valneva first started talking in the third quarter last year, with the company saying in January that the discussions were advanced. In an interview in April, after Valneva had called off the talks, Chief Executive Officer Thomas Lingelbach said they had gone “in circles” without progress. The renewed effort suggests the EU may now be flexible on the priority issue.

A spokesperson for the commission said it doesn’t comment on ongoing negotiations with vaccine developers. Valneva declined to immediately comment.

Vaccine Trials

Valneva’s vaccine is the only inactivated candidate in clinical trials in Europe, which involves taking a sample of the disease that has been killed and using it to stimulate an immune response. The shot could be suitable for more vulnerable groups, such as those with weakened immune systems and pregnant women, or complement other vaccines as a booster.

The product is in advanced-stage trials, with more than 4,000 participants enrolled and the first results expected by September. Unusually, the candidate isn’t being compared with a placebo. It must show superiority to Astra’s vaccine on a two-dose schedule given four weeks apart based on immunogenicity data rather than efficacy -- the number of infections prevented -- as Astra’s has already been shown to protect against symptomatic Covid-19.

The trial was further complicated by the U.K.’s decision to restrict use of the Astra shot to people over age 30 when the trial started and later to the over-40s due to the risk of rare blood clots. For that reason, younger adults in the study have only received the Valneva inoculation.