Europe Recommends Inactivated Whole-virus COVID-19 Vaccine

France-based Valneva SE announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had recommended marketing authorization for Valneva's inactivated whole-virus COVID-19 vaccine, VLA2001, for use as primary vaccination in people from 18 to 50 years of age.

The CHMP concluded by consensus after a thorough evaluation that "the data on the vaccine were robust and met the EU criteria for efficacy, safety, and quality."

The European Commission (EC) will review the CHMP recommendation, and a decision on the marketing authorization is expected shortly.

If granted, this will be the first COVID-19 vaccine to receive standard marketing authorization in Europe, which would be valid in all European Union Member States and Iceland, Liechtenstein, and Norway.

Thomas Lingelbach, CEO of Valneva, commented in a press release issued on June 23, 2022, "We are pleased that the CHMP has recommended VLA2001, the only inactivated COVID-19 vaccine candidate in Europe, for full marketing authorization and are now looking forward to receiving marketing authorization from the EC."

"We hope the EC and its member states will recognize the potential advantages of an inactivated vaccine ..."

"Our aim is to further support public health in Europe by providing a new option for the 15% of Europeans over 18 who are not yet vaccinated."

The EMA's CHMP opinion follows conditional marketing authorization in the United Kingdom, granted in April 2022, emergency use authorization granted in the United Arab Emirates in May 2022, and Bahrain in March 2022.

VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe.

It is intended for active immunization of at-risk populations to prevent carriage and symptomatic infection with COVID-19 during the pandemic and for routine vaccination, including addressing new variants.

VLA2001 may also be suited for boosting, as repeat booster vaccinations have been shown to work well with the whole virus inactivated vaccines.

Note: This announcement was manually curated for mobile readership.