French company Valneva which develop the COVID-19 vaccine, has obtained the green light from the UK’s regulator, and EMA will make its own decision in the coming weeks.
Over the past two years, the UK’s relationship with the French vaccine developer Valneva was not favourable for two years.
The UK government invested in Valneva’s manufacturing facilities in Scotland in 2020 and signed up for 60 million doses of the firm’s vaccine upon approval.
The UK government terminated the contract in late 2021, explaining that the vaccine wouldn’t have gained approval to be administered in the UK.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) cleared all the doubts this month; and issued the approval for the valenva’s Covid-19 vaccine in adults aged between 18 and 50 years.
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 older 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 has cancelled 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 the World Health Organization.
Eleanor Riley, Professor of Immunology and Infectious Disease at the University of Edinburgh, said that the vaccine could be stored in a regular refrigerator will make it much easier to deploy in remote areas and areas lacking resilient cold chains.
Professor Eleanor Riley is not involved in Valneva’s vaccine program.
Moreover, the approved mRNA vaccine from BioNTech/Pfizer is prescribed to be stored at -80°C temperature.