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This Article is From Apr 14, 2022

Valneva’s Covid Vaccine Gets U.K. Clearance After Rocky Ride

Valneva Covid Vaccine Gets Approval from U.K. Regulator

Valneva SE's Covid-19 vaccine won approval from the U.K. drugs regulator, the shot's first regulatory clearance. The stock soared.

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 Thursday.  

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.”

Read More: U.K. Threw Vaccine Maker Under Bus Over Covid Deal, CEO Says

Valneva shares surged as much as 24% in Paris trading. Prior to today, the stock had 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.

©2022 Bloomberg L.P.

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