Reuters, April 25, London/Paris – The European Medicines Agency (EMA) requested additional information about the Lyme disease COVID-19 vaccine, according to French pharmaceutical company Valneva (VLS.PA), prompting a dramatic decline in its stock price.
The latest EMA setback comes after Britain allowed the use of Valneva’s vaccine earlier this month, becoming the first European nation to do so.
According to Valneva, the EMA Committee for Medicinal Products for Human Use (CHMP) has a new set of inquiries, including demands for more information and justification for the vaccine’s conditional marketing authorization
“We regret that the EMA has not yet found our submissions to be adequate. We are still completely committed to cooperating with the authorities in order to get a product approved “Thomas Lingelbach, CEO of Valneva, stated in a statement.
The shares of Valneva dropped by around 15.5%, making it its worst day since January 4.
The whole-virus-inactivated Lyme disease COVID-19 vaccine created by Valneva is based on technology that has been used for years in shots for polio, influenza, and hepatitis, among other diseases.
The virus is grown in a lab before being rendered fully dormant, preventing it from replicating or infecting cells while yet having the ability to elicit an immunological response.
Various believe that the shot has the ability to win over those who are sceptical of some vaccines that employ more modern mRNA technology.
The vaccine may be kept at temperatures that are comparable to those in a standard refrigerator, which is an additional benefit.
Valneva has had some difficulty getting the shot into action; this isn’t the first time further information has been requested of it. The business claimed to have received a list of inquiries from the EMA in February.
A spokesman stated in an email that Valneva was certain that its answers to the first round of CHMP inquiries would be adequate for the EMA to wrap up its evaluation, especially because the British pharma authority had already deemed the information sufficient.
The company would be happy to offer the vaccine for use in Britain, but the government has not yet made a decision in this regard, the spokeswoman continued.
In September, the British government abandoned a 1.4 billion euro ($1.5 billion) contract with Valneva to purchase the vaccine on the grounds that the business had broken its commitments. Valneva refuted the accusation.
The business and the Scottish government are negotiating for the corporation to provide up to 25,000 doses to the National Health Service and frontline staff in Scotland.
Bahrain was the first country to approve Valneva; the country authorized the vaccine’s emergency use in early March and has since started using it.
On Monday, Valneva announced that it would answer the EMA’s most recent request soon. The company anticipates receiving a conditional marketing authorization this quarter if the regulator accepts its response.
In November 2021, Valneva and the European Commission agreed on a two-year supply agreement for up to 60 million doses of vaccine, including 24.3 million doses in 2022.