Valneva’s Covid vaccine gets UK clearance after rocky ride

Bloomberg: Valneva SE’s Covid-19 vaccine won approval from the UK drugs regulator, the shot’s first regulatory clearance after a series of setbacks.

The decision caps “a rigorous review” of the vaccine’s safety and effectiveness, June Raine, chief executive of the Medicines and Healthcare Products Regulatory Agency, said in a statement.

It’s unclear what plans the U.K., which has approved another five coronavirus immunizations, has for the shot. The product suffered a blow when a study testing seven different vaccines as boosters found Valneva’s was one of those that raised antibody levels the least. The research was conducted before omicron became the dominant variant.

The relationship between the French drugmaker and the U.K. government has been patchy. After championing the shot’s development, Britain canceled a contract worth up to 1.4 billion euros ($1.75 billion), saying the company had breached its supply deal. Chief Executive Officer Thomas Lingelbach said in an interview last year that the government threw Valneva “under the bus.”

Valneva shares were suspended on the Paris stock exchange pending a statement. The stock has dropped almost 40% since the start of the year.

The company uses an inactivated version of the virus to stimulate an immune response, an approach widely used in the production of flu and polio immunizations. It’s the only Covid vaccine using that tried-and-true technology to reach advanced trials in the U.S. and Europe.

The approval comes well over a year after the clearance of messenger-RNA shots developed by Moderna Inc. and the partnership between Pfizer Inc. and Germany’s BioNTech SE. Billions of those vaccines have already been administered worldwide.

The European Union has ordered 60 million doses of the vaccine, but its regulator still hasn’t approved the homegrown product. The company said in January that a third dose of its shot neutralized the omicron variant in early lab studies.