The drug is a combination of two long-acting antibodies which bind to the spike protein on the outside of the virus, preventing it from attaching to and entering human cells.
Dr June Raine, MHRA Chief Executive said after “careful review” of the data the drug has been approved “to help protect against the effects of Covid-19”.
She said: “While the Covid-19 vaccines continue to be the first-line defense against Covid-19, we know that some people may not respond adequately to these vaccines and for a small number of individuals Covid-19 vaccines may not be recommended for other reasons, such as a previous allergic reaction to one of the vaccine ingredients.
“For these people, Evusheld could provide effective protection against Covid-19.”
It is understood the UK currently does not have any doses of Evushelf on order, but the government’s Therapeutics Taskforce is actively engaging with AstraZeneca before making further decisions.
MHRA said there is not yet enough data to know if the drug is effective against Omicron and it will continue to work with the manufacturer to establish this.
In December Sir Mene Pangalos, head of research and development for AstraZeneca, suggested it would protect against the variant.
“Consistent data … now provide confidence that Evusheld, a combination of two highly potent antibodies, retains neutralizing activity against the omicron variant at a level that will continue to provide benefit to patients,” he said.
Professor Sir Munir Pirmohamed, the chairman of the Commission on Human Medicines, said the commission was “satisfied” that the medicine meets the “expected standards” for approval.
He added: “The recommended dosage is 300mg of Evusheld, but a higher dose of 600mg may be more appropriate for some Covid-19 variants. All this is outlined in the summary of product characteristics.
“Pre-exposure prophylaxis with Evusheld is not a substitute for vaccination in individuals for whom Covid-19 vaccination is recommended.”
Gemma Peters, the chief executive of Blood Cancer UK, welcomed the approval of the drug but said the Government is still yet to set out plans for how it would be used in the UK.
“For some time, we have been urging the Government to set out its approach to using preventative treatments for people who have not responded well to the vaccines, and it is disappointing that it has not yet done so,” she said.
“We hope the MHRA’s approval of Evusheld will prompt a sense of government urgency on this that has so far been lacking. Many people with blood cancer have now spent almost two years avoiding social interaction – the Government needs to do more to support them to be able to start getting back to normal. “