A Covid-19 vaccine developed by the French company Valneva has received the green light from the UK’s drug regulator. The EMA, meanwhile, is proving harder to convince.
The UK’s relationship with the French vaccine developer Valneva has run hot and cold over the past two years.
In 2020, the UK government invested in Valneva’s manufacturing facilities in Scotland and signed up for 60 million doses of the firm’s vaccine upon approval. In late 2021, the UK government terminated the contract, explaining that the vaccine wouldn’t have gained approval. This month, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) cleared any doubt on the issue by approving the use of Valneva’s Covid-19 vaccine in adults between 18 and 50 years of age.
The approval was based on promising phase III results last year, where the inactivated whole-virus vaccine provoked comparable immune responses against Covid-19 infections to those produced by AstraZeneca’s viral vector vaccine. Valneva’s candidate also shows fewer side effects than many approved vaccines. Valneva is now working on getting the vaccine approved for elderly people and as a booster shot.
The UK is the second nation to approve Valneva’s vaccine following Bahrain in March. However, Valneva doesn’t expect to roll out its product in the UK in bulk anytime soon because the government canceled its supply contract. Instead, the firm is negotiating with the Scottish authorities to supply 25,000 doses. Additionally, the vaccine’s success with the stringent MHRA could serve as a springboard for getting the candidate approved in other regions and by the World Health Organization.
“The fact that the vaccine can be stored in a regular refrigerator will make it much easier to deploy in remote areas and in areas lacking resilient cold chains,” said Eleanor Riley, Professor of Immunology and Infectious Disease at the University of Edinburgh, who is not involved in Valneva’s vaccine program. In comparison, the approved mRNA vaccine from BioNTech/Pfizer must be stored at a temperature of -80°C.
“Whilst the initial vaccine rollout is more or less complete in Europe and North America, there are still large areas of Africa, Asia, and South America where vaccination rates remain woefully low; anything that eases access to vaccines in these areas will be hugely valuable,” Riley added.
Rather than targeting the spike protein of the virus behind Covid-19 as current vaccines do, Valneva’s candidate trains the immune system with a killed form of the whole virus. This means the immune system could better recognize and fight forms of Covid-19 even when the spike protein evolves to evade detection.
“This authorization could pave the way for the availability of an alternative vaccine solution for the UK population,” stated Thomas Lingelbach, Chief Executive Officer of Valneva. “We continue to receive messages every day from people who are looking for a more traditional vaccine approach.”
While the UK’s MHRA welcomed Valneva’s candidate, the EMA has proved harder to sway and requested more information this week. With the firm’s stock price dropping by 14% on the morning of the announcement, Valneva aims to resolve the EMA’s questions and receive a positive opinion in early 2022. A positive opinion is typically followed by an approval by the European Commission within a few months.
Once Valneva’s Covid-19 candidate reaches the European market, the firm expects to supply 60 million doses to the region as part of a supply contract with the EU.
There are many other candidate Covid-19 vaccines in the queue for approval in Europe. The most advanced include a protein vaccine developed by Hipra in Spain, an inactivated vaccine from Sinovac in China, and a protein vaccine developed by Sanofi and GSK. Russia’s Sputnik V is also in rolling review with the EMA, but given the raging war in Ukraine, its chances of reaching the EU market are all but dashed.
25 April 2022: Updated to include latest feedback from the EMA
Cover image via Anastasiia Slynko