Valneva to Start Final Covid Shot Trials After Positive Data

(Bloomberg) -- Valneva SE plans to start final-phase trials on its Covid-19 vaccine candidate this month after positive early-stage studies, a step forward for an old-school shot that’s backed by the U.K. government.

The French company said Tuesday a phase 1/2 test produced significant levels of antibodies in more than 90% of participants and raised no safety concerns. Valneva shares rose as much as 8.4% in Paris trading.

The vaccine uses a sample of the virus that has been killed to stimulate an immune response without causing the disease -- an approach that has been used for decades with inoculations for polio and hepatitis A. The shots currently in use in the U.K. use novel technology to deliver instructions for cells to target portions of the virus and spur immunity.

Valneva has said the well-established safety profile of inactivated jabs may allow a successful shot to be used in a broader group of people than the newer technologies. By using the whole virus rather than tackling part of it, like the messenger RNA vaccines from Pfizer Inc. and Moderna Inc. or the adenoviral vector vaccines from AstraZeneca Plc and Johnson & Johnson, Valneva’s shot could also potentially tackle mutations better.

Another Weapon

In the early-stage trials, which involved 153 adults aged 18 to 55, the company studied three different dosing levels given three weeks apart, with the highest dose proving the most effective. The company said Tuesday it is working with the U.K. government on the potential development and supply of variant vaccines.

The results “provide renewed hope that a vaccine using a whole inactivated virus might provide strong protection against variants,” U.K. Vaccines Minister Nadhim Zawahi said in the statement. If the vaccine gets U.K. regulatory approval, “this will be another powerful weapon in our arsenal to beat this pandemic.”

Valneva’s is the only vaccine based on an inactivated virus that’s this far along in clinical trials in Europe. A shot produced by China’s Sinopharm also relies on the traditional approach.

Read more: French Pharma Bets on Old School Approach for Covid Vaccine

Valneva may also be the first drugmaker to run a head-to-head trial pre-approval against another Covid vaccine in the U.K.

Chief Executive Officer Thomas Lingelbach said in an interview in February the company didn’t see using a placebo at this stage in the vaccine rollout as ethical, and was in discussions with the U.K. regulator about using another vaccine as a comparator in the trials. The company didn’t give an update on the plans Tuesday.

U.K. Role

The U.K. has signed a deal worth as much as 1.4 billion pounds ($1.9 billion) to receive as many as 190 million doses of the shot between 2021 and 2025. The British government is also investing in the biotech’s Scottish manufacturing plant, where the vaccine will be created.

In light of the potential plans to adapt the vaccine to variants, Valneva expects the delivery of the first 60 million doses to extend into the first quarter of 2022.

The vaccine contains an adjuvant supplied by Dynavax Technologies Corp. Adjuvants are substances used to generate a more robust immune response to a vaccine.

©2021 Bloomberg L.P.