Valneva SE is preparing to seek regulatory approval for its experimental Covid-19 vaccine after showing it elicits better immunity than AstraZeneca Plc’s shot.
Patients injected with two doses of the product had more antibodies — a proxy for protection against the coronavirus — and fewer side effects than those who got the Astra shot in a study of about 4,000 adults, Valneva said in a statement Monday. Both groups had the same number of Covid cases and no patient got severely ill, the company said.
The French drugmaker said it’s preparing to start a rolling submission process with the European Medicines Agency to try to gain approval in the European Union. It has already started submitting data to the U.K.’s drug regulator, although the government there canceled its order for the vaccine last month.
The company said Monday it’s making a final validation to verify the integrity of its data at the request of the U.K. regulator before it can submit the study report.
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.
“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 in overcoming the pandemic,” said Adam Finn, the clinical trial’s lead investigator.