Valneva Expands Trials on COVID-19 Vaccine Candidate

By Reuters Staff

September 24, 2021

PARIS (Reuters) - French vaccine maker Valneva is expanding trials of a COVID-19 vaccine candidate called VLA2001, and remains in talks with the European Commission over a potential contract, the company said on Thursday.

Valneva shares plunged 42% after Britain said on Sept 13 that it cancelled its contract for about 100 million doses of the vaccine the company is developing, partly over concerns about when it would win approval for use.

"Valneva continues discussions with the European Commission regarding a potential VLA2001 supply contract," the company said in a statement.

"The company is also actively pursuing opportunities to make VLA2001 available to other customers, subject to positive Cov-Compare data and regulatory approval."

Its shares rose 6.5% on Thursday, up around 33% from a low hit on Monday and up 82% since the start of the year.

Valneva's vaccine candidate, which relies on an inactivated virus similar to traditional flu vaccines, is seen by some as having the potential to win over people wary of vaccines that use new mRNA technology.

In addition to inactivated SARS-CoV-2, the vaccine contains Dynavax's CpG 1018 adjuvant.

"Topline results from the pivotal Cov-Compare trial are expected early in the fourth quarter of 2021 and are intended to form the basis for potential regulatory approval in adults," Valneva said.

Chief Executive Thomas Lingelbach added "We're confident that many countries, and regulators, will want to have the opportunity to consider our inactivated COVID-19 vaccine."

Valneva said it has started to recruit adolescents, aged 12 to 17 years, in the UK. A further expansion of the study to include volunteers younger than 12 years old is also envisaged, subject to data from the adolescent group.

The VLA2001 candidate vaccine is also now being evaluated in elderly volunteers in New Zealand, Valneva said.

Last week, British health minister Sajid Javid told lawmakers it was "clear" that Valneva's vaccine would not be approved by Britain's medicine regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).

His answer has now been corrected on the official parliamentary record to remove the phrase "would not get approval", replacing it with "has not yet gained approval... and may not."

A government spokesman said that it would not comment on commercial decisions but the cancellation of the contract would have "no impact on our vaccine supplies for the autumn".

"Clinical trials for the Valneva candidate vaccine have not yet been completed," he said. "As such, our independent medicines regulator - the MHRA - has not approved the Valneva candidate vaccine for use in the UK."

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