Since the launch of the vaccination campaigns against the COVID-19 virus, many Europeans have expressed their wish to be able to benefit from a traditional vaccine, developed on the basis of an inactivated virus, and not a messenger RNA vaccine.
The Franco-Austrian pharmaceutical company Valneva has been working on such a virus for many months but keeps running into administrative obstacles that prevent it from offering its vaccine to the public.
At the end of April, Valneva’s vaccine was granted marketing authorisation by the Medicines and Healthcare products Regulatory Agency in Great Britain. Even though Boris Johnson’s government had given up on purchasing doses of the vaccine, this was a first major recognition.
At the same time, the European Union chose to extend approval deadlines for the traditional vaccine. Following the meeting of the European Medicines Agency’s committee, Valneva was presented with a new list of questions regarding its application to market its vaccine. The company had to provide new data and additional justifications in order to obtain a conditional marketing authorisation.
Valneva’s CEO Thomas Lingelbach said in a statement that he had answered the new questions on May 2nd and that he believed he had provided sufficient answers to the remaining questions. However, two weeks later, on Monday, May 16th, Valneva announced that it had received from the European Commission “a notice of intent to terminate the supply agreement” for its COVID-19 vaccine. The decision led to a 20% fall in Valneva’s share price on the Paris stock exchange. Since January 1st, the share price has fallen by over 60%.
The contract signed between the European Commission and the group gave the Commission the right to terminate it if the vaccine developed by Valneva, called VLA2001, had not received a marketing authorisation from the European Medicines Agency by April 30th, 2022. But the contract also stipulated that “Valneva had 30 days from 13 May 2022 to obtain a marketing authorisation or propose a plan to remedy the situation in an acceptable manner,” said the company, which is particularly disappointed by the European administration’s decision.
For Valneva, the door is not completely closed and the group intends to resume dialogue with the Commission to find common ground and obtain authorisation by June 2022 at the latest. The CEO does not intend to give up, as he explains that he regularly receives a very large number of requests from Europeans looking for a traditional vaccine solution against the COVID-19 virus.
