Valneva’s COVID-19 vaccine was approved by Britain’s medicines and health products regulator, the MHRA, on Thursday, reassuring news for the Franco-Austrian laboratory after the termination of its contract with the British government.
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Valneva had already received authorization for the emergency use of its VLA2001 vaccine in the Kingdom of Bahrain, which bought one million doses from it. His serum is being reviewed by the European regulator.
It is the sixth coronavirus vaccine to be authorized in the UK, joining those from AstraZeneca, Pfizer, Moderna, the single-dose Janssen (Johnson & Johnson), and Novavax.
Based on an inactivated virus, Valneva’s vaccine uses classic technology, which could tempt patients reluctant to new processes such as the use of messenger RNA.
“This authorization could pave the way for the availability of an alternative vaccine solution for the British population,” reacted Thomas Lingelbach, chairman of the management board of Valneva, quoted in a press release. It “could also lead to new marketing authorizations in other regions of the world”, he added.
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.
Valneva said it was in discussion with the Scottish government for the supply of up to 25,000 doses for public health service employees and people who come into contact with the disease in the course of their work.
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 MHRA clearance comes after a review by the Independent Commission for Medicinal Products for Human Use and its expert Covid-19 task force concluded that the ‘benefit/risk balance is positive’, the professor said. Munir Pirmohamed, chairman of this commission, quoted in a press release from the MHRA.
For this vaccine, “two doses are required before a robust antibody response is triggered,” he stressed.
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, stripped 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 may be used in people aged 18 to 50, with an interval of at least 28 days between the first and second dose.
The number of coronavirus-related deaths recorded each week in England and Wales continues to rise, but remains well below levels seen in previous waves of the virus.
The Franco-Austrian 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.