Covid-19: UK approves Valneva vaccine for adults under 50BMJ 2022; 377 doi: https://doi.org/10.1136/bmj.o985 (Published 14 April 2022) Cite this as: BMJ 2022;377:o985
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted Valneva’s covid-19 vaccine (VLA2001) conditional marketing authorisation for use in people aged 18 to 50 years, with the first and second doses to be taken at least 28 days apart.
The approval makes VLA2001 the first whole virus inactivated vaccine approved for use against covid-19 in the UK. Unlike most other covid-19 vaccines, Valneva’s does not just target the SARS-CoV-2 spike protein, but rather the whole virus.
Valneva is now in discussion with the Scottish government to supply up to 25 000 doses of the vaccine to the NHS and frontline workers in Scotland.
The MHRA announcement follows a rocky relationship between Valneva and the UK government, after the latter initially partnered with the French biotech company to trial and manufacture the vaccine.1 A year later (September 2021), however, the government suddenly terminated its supply agreement citing an alleged breach of contract.2 At the time, Valneva’s chief executive officer Thomas Lingelbach said that the company had been thrown “under the bus.”3
A phase 3 trial carried out in the UK compared the vaccine with the Oxford-AstraZeneca vaccine. Preliminary results indicated that VLA2001 produces substantially higher concentrations of neutralising antibodies than the AstraZeneca vaccine,4 but the full results have not yet been published.
MHRA chief executive June Raine said, “Our approval of the covid-19 vaccine made by Valneva today follows a rigorous review of the safety, quality, and effectiveness of this vaccine and expert advice from the government’s independent scientific advisory body, the Commission on Human Medicines.”
The MHRA has said that two doses of Valneva’s vaccine are required “before a robust antibody response is raised” and that people should be made aware that “protection will only start after two doses.”
The authorisation comes after the Bahraini National Health Regulatory Authority granted the vaccine emergency use authorisation in March. A rolling review process is also ongoing with the European Medicines Agency.
VLA2001 is stored between 2°C and 8°C, meaning it only requires refrigeration and e can be used in countries where storage at very low temperatures is not possible.
Adam Finn, professor of paediatrics at the University of Bristol and chief investigator of the Valneva vaccine clinical development programme in the UK, said that, although the vaccine would not be available in the UK any time soon because of the cancelled contract, the authorisation was good news. “This is a critical milestone towards WHO emergency use authorisation,” he said. “It is also the first approval of a covid-19 vaccine based on immunogenicity (compared to an already authorised vaccine), thus a pointer towards approval of future novel and reformulated vaccines.”
“It’s a good idea to have several types of vaccine and several vaccines of each type. This increases supplies, increases alternative supplies (so reducing unexpected shortages), and increases the numbers of options in terms of effectiveness over time and safety as experience grows.”
Competing interests: EM is a participant in the Valneva covid-19 vaccine trial.