Valneva’s Covid-19 vaccine has been approved by the UK regulator.
Valneva’s Covid-19 vaccine has been approved by the British regulator, the MHRA, reassuring news for the Franco-Austrian laboratory after the termination of its contract with the British government. “The Covid-19 vaccine developed by Valneva today received regulatory approval from the Medicines and Healthcare Products Regulatory Agency (MHRA),” the agency said in a statement on Thursday saying that the British regulator is the first in the world to approve it.
Valneva had already received authorization for the emergency use of VLA2001 in the Kingdom of Bahrain, which purchased one million doses from it. It is the sixth coronavirus vaccine to be licensed in the UK, joining those from AstraZeneca, Pfizer, Moderna, the single-dose Janssen (Johnson & Johnson), and Novavax. However, its use remains uncertain. This authorization comes seven months after a huge disappointment for the group: the termination by the British government of a contract for 100 million doses.
The government then invoked a breach by Valneva of its obligations, which the laboratory disputed. The anti-Covid vaccination campaign has also now clearly marked time in the United Kingdom, hard hit by the coronavirus pandemic with more than 171,000 deaths. More than 92% of the population aged 12 and over have already received a first dose of vaccine against Covid-19, 86.2% a second dose and 67.8% a booster dose.
Factory in Scotland
“The Independent Commission for Medicinal Products for Human Use and its expert task force on Covid-19 have carefully reviewed the available evidence and (…) the benefit/risk ratio is positive,” said Professor Munir Pirmohamed, chairman of this commission, quoted in this press release. He pointed out that for this vaccine, “two doses are needed before a robust antibody response is triggered. This means that people will need to be told that protection will only start after two doses.” A company of some 800 employees historically based in Saint-Herblain, near Nantes (western France), where it has its laboratories, Valneva has three sites outside France. Among these is a factory in Livingstone, near Edinburgh in Scotland, dedicated to the production of active substances for vaccines, including that of serum against Covid-19.
Its Covid-19 vaccine uses the well-known inactivated virus technology, a process that creates an immune response in patients by injecting them with a whole virus, deprived of its ability to harm. It’s the same technology that’s used in its Japanese encephalitis vaccine. It can be stored at the temperature of conventional refrigerators, which facilitates its use. In the UK it can be used in people aged 18 to 50, with the first and second doses taken at least 28 days apart. The clearance comes as the number of coronavirus-related deaths recorded each week in England and Wales continues to rise, though still well below levels seen in previous waves of the virus. The laboratory has also signed an agreement with the European Commission for the supply of a maximum of 60 million doses over two years in 2022 and 2023.