Authorized for use in many countries around the world, including the United States, AstraZeneca’s Evusheld is a one-of-a-kind COVID-19 product—with the rare ability to both prevent and treat infections.
But in AstraZeneca’s home country, it will not be available.
The U.K. said that it will not purchase the antibody combo, citing “insufficient data” on the duration of protection it provides against omicron and its subvariants.
The news is a blow to the roughly 500,000 immunocompromised people of the U.K., who can’t get an adequate response from vaccines and believed Evusheld was their best hope for protection from the virus.
They thought the treatment was on its way after the Medicines and Healthcare Products Regulatory Agency signed off on Evusheld on March 17.
But the most recent decision puts Evusheld on hold. Meanwhile, the Department of Health and Social Care (DHSC) has asked the National Health Service (NHS) and the National Institute for Health and Care Excellence (NICE) to investigate the medicine further. That guidance is not expected until April of next year.
“This is disappointing news for immunocompromised patients in the UK who continue to have a disproportionately high risk of infection and hospitalisation from COVID-19, many of whom will now be forced to continue shielding for another winter, whilst vulnerable people in many other countries are offered the protection of Evusheld," AZ said in a statement. "We will be seeking further discussions with government.”
The U.S. authorized the use of Evusheld in December of last year. The nod was based on data that showed a single dose—which consists of back-to-back injections—could provide protection to the immunocompromised for up to six months.
Subsequently, the company presented data that showed Evusheld was effective in protecting against omicron’s subvariants and in reducing the risk of severe disease in those recently infected.
Meanwhile, with Evusheld sanctioned for use in 32 countries, AZ is gathering real-world data on its effectiveness. The European Union has not procured the antibody combo but several countries in the bloc—including France, Germany and Spain—have made deals on their own to acquire it.
Helen Rowntree, the director of research, services and engagement at Blood Cancer UK, told the BBC that people who have blood cancer and other conditions are “absolutely devastated” and are “not understanding why this is taking so long.”
“We’re urging the government to meet with us and outline their rationale,” Rowntree said, as quoted by BBC.
EDITOR'S NOTE: A statement from AstraZeneca was added to this story after its original publication.