Lack of evidence for AstraZeneca’s COVID-19 vaccine says UK Department of Health

The UK’s Department of Health and Social Care has decided not to buy AstraZeneca’s COVID-19 drug, Evusheld, due to a lack of evidence about the vaccine’s effectiveness against the Omicron variant.

Evusheld – tixagevimab co-packaged with cilgavimab – is a preventative treatment that is given before people have been exposed to the virus.

Patient groups and charities have called upon the government to reassess its position due to the potential impact the decision will have on clinically vulnerable people during the winter.

Developed by AstraZeneca, Evusheld is a combination of two antibodies that work against COVID-19 by boosting protection for those with weakened immune systems, including those who are organ transplant recipients or blood cancer patients.

Although adult clinical trials demonstrated a 77% reduction in the risk of developing COVID-19 symptoms for at least six months following a single dose, the UK government has asked for additional evidence to support its longer-term protection against Omicron.

Evusheld was approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in March this year.

The Department of Health and Social Care says it has conducted a ‘robust review’ of Evusheld, concluding that there is ‘currently insufficient data on the duration of protection offered’ by the vaccine ‘in relation to the Omicron variant’.

Speaking out against the decision, Blood Cancer UK said many would be ‘left feeling let down and vulnerable’ by the rejection to supply Evusheld.

Helen Rowntree, director of research, services and engagement at Blood Cancer UK, said: "We're urging the government to meet with us and outline their rationale for this decision.

"For months now Evusheld has been used in countries including the US and Israel and there is a significant body of evidence showing that this drug can reduce the chance of dying from COVID-19 in those who are most vulnerable.”

She added that the government’s decision “will mean that many people who are immunocompromised will be left with no other option than to isolate themselves from their loved ones".

Charities including Blood Cancer UK, the Anthony Nolan Trust and the MS Society and Action for Pulmonary Fibrosis have submitted a letter to the UK Health Secretary, Steve Barclay, contending that the strong clinical support for Evusheld is clear, but that it is being held to an ‘impossible standard of evolving evidence’.

The National Institute for Health and Care Excellence plans to conduct a review, due to begin in autumn this year, but results from the review are not expected to be reported until April 2023.