(BFM Bourse) – Slowed down by additional questions addressed to Valneva by the European Medicines Agency, the review process for the marketing application for its Covid vaccine nevertheless continues to move forward. This gives the company the opportunity to receive or not receive service for an order for several tens of millions of doses within a few days.
Valneva’s only certainty about the soap opera of the European Commission’s proposed purchase of up to 60 million doses of the Covid-19 vaccine candidate VLA2001: the result is close! But the future of this gigantic order is likely to be decided within a few days.
Since the November 2021 sales contract allowed for a lack of approval on April 30, the European Commission has indeed notified the company of its intention to terminate the order if that approval is not received soon. A kind of ultimatum, giving Valneva 30 days from May 13 to get this permission to sell or offer a “plan to correct the situation in an acceptable way.”
A complex regulatory process leading to a possible market launch has been delayed due to additional inquiries from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) regarding the VLA2001 dossier, to which Valneva responded.
Deadline June 12
Giving hope to investors, the biotechnology company Tricolor has announced that it has taken an important step in the process in the form of the agency’s acceptance of the filing of an authorization file. Concretely, this means that the incremental data analysis phase has been completed and the formal evaluation phase can proceed. Therefore, Valneva believes that the CHMP can present its opinion in June 2022. According to the agency-reported calendar, its committee should meet next … between June 20 and 23, knowing that the deadline is short. Principle until June 12th.
The formal decision rests with the European Commission (which in practice systematically follows the opinion of the Committee for Medicinal Products for Human Use).
“The EMA’s acceptance of the VLA2001 registration dossier is an important step towards product registration,” said Thomas Lingelbach, Chairman of the Board of Valneva, without daring to predict the date. “We remain determined and are working together with regulators, Member States of the European Union and the European Commission to make more traditional and proven Covid-19 vaccination technologies available to Europeans.”
More classic inactivated viral vaccine
The firm is convinced that its vaccine could make an important contribution to the fight against the pandemic, thanks to the more traditional inactivated whole virus approach, which is likely to convince some people who are turning away from more innovative technologies such as messenger RNA. In this context, in addition to the approach taken at Commission level, Valneva has entered into direct dialogue with some Member States interested in a non-activated approach.
In addition, if the Commission finally terminates the contract at the end of the current process, Valneva specified that she would not have to return the contributions received.
Guillaume Bair – © 2022 BFM Bourse