EU regulator asks for more COVID vaccine data from Valneva

Valneva said yesterday that the European Medicines Agency (EMA) had asked for more data on its COVID-19 vaccine.

The latest EMA setback comes after Britain earlier this month cleared the use of Valneva’s vaccine, becoming the first European country to give its shot the green light.

Valneva said the EMA Committee for Medicinal Products for Human Use (CHMP) had a fresh list of questions, including requests for additional data and for further justification of a conditional marketing authorisation for the vaccine.

“We are disappointed that the EMA has not considered our submissions sufficient to date. We remain fully committed and dedicated to working jointly with the regulators towards a product approval,” Thomas Lingelbach, CEO, Valneva, said in a statement.

The whole-virus inactivated COVID-19 vaccine developed by Valneva relies on technology that has been used for decades, for instance, in some shots against polio, influenza and hepatitis.

The shot is seen by some as having the potential to win over people wary of some vaccines which use newer mRNA technology.

Another advantage is that the vaccine can be stored at similar temperatures to those in a domestic fridge.

Getting the shot into arms has proved somewhat difficult for Valneva – this is not the first time it has been asked to provide additional information. In February, the company said it had received a list of questions from the EMA.

A spokesperson said in an email that Valneva was confident that its response to the first set of CHMP questions would be enough for the EMA to conclude their assessment, particularly after that data was deemed sufficient by the British drug regulator.

The company would welcome the opportunity to provide the vaccine for use in Britain, but, so far, the government has not made such a decision, the spokesperson added.

The British government in September ditched a 1.4 billion euro ($1.5 billion) deal to buy the vaccine from Valneva in September, alleging the company was in breach of its obligations. Valneva denied the charge.

The company is in talks with the Scottish government to supply up to 25,000 doses to the National Health Service and frontline workers in Scotland.

Valneva scored its first approval in Bahrain, which granted its vaccine emergency use authorisation in early March, and has since begun to deploy it.

Yesterday, Valneva said it would respond to the EMA’s latest request in the coming days. If the regulator accepts its response, then the company expects a conditional marketing authorisation this quarter.

Valneva signed a deal with the European Commission in November 2021 to supply up to 60 million doses of vaccine over two years, including 24.3 million doses in 2022.

The approach involves growing the virus in a lab, then rendering it completely inactive so it cannot infect cells or replicate in the body, but can still trigger an immune response.

Edits by EP News Bureau