Thousands still in 'Covid lockdown' amid row over Evusheld

Known as a "pre-exposure prophylaxis", Evusheld is designed for patients who are unlikely to mount an immune response to Covid vaccines or for whom the vaccines are unsuitable (for example, due to specific allergies).

Unlike antivirals - which are only administered once patients have tested positive - Evusheld reduces the likelihood of infection in the first place for those most at risk from Covid, as well as giving them better protection against serious illness.

READ MORE: When even the 'experts' turn antivaxx, we have a problem 

Its use was authorised back in March by the UK Medicines and Healthcare products Regulatory Agency (MHRA) after meeting required standards on safety, quality and effectiveness.

Yet seven months on, patients who had pinned their hopes on Evusheld as a way back to something resembling normal life have been left in limbo after the UK Government's Rapid Covid-19 Oversight Group (RCOG) - an expert panel - concluded that current data is "insufficient to warrant emergency procurement of the drug".

"When 32 countries have reviewed the data and come to a very different finding compared to the UK, that raises eyebrows," said Dr Lennard Lee, a lecturer in medical oncology at Oxford University who represents a group of more than 125 clinicians across 17 disciplines who are pressing the Government to make Evusheld available this winter.

Dr Lennard Lee (Image: lee)

Lee, who previously headed up the UK Covid Cancer Programme - providing world-first evidence that chemotherapy could be delivered safely during the pandemic - now advises Westminster's All-Party Parliamentary Group (APPG) for Vulnerable Groups to Pandemics through his role as the national clinical immunocompromised champion.

He is in no doubt that Evusheld should be rolled out, and quickly.

"The impact on patients is big," said Lee.

"There are three benefits of treatment: the direct health benefits, the mental health benefits, and it also helps the healthcare system, because we've got 1000 hospital admissions a day at the moment and, on top of that, many of these people end up in ICU - and we know that Covid ICU admissions are weeks and months.

"So it could help the healthcare system to recover."

For now, Evusheld has been batted onto NICE for review which, even if fast-tracked, will take until next year to complete.

Meanwhile, the Scottish Government - who could opt to independently procure the medicine for NHS Scotland - is deferring to RCOG.

Among the main objections is that Evusheld was evaluated when Delta was the dominant variant. At that time, it gave roughly 80 per cent protection against infection.

While this is reduced with Omicron, Lee said it continues to provide a robust defence against serious illness.

He said: "The real-world data that's coming out now is showing 80-90% protection against hospitalisation.

"If patients are looking for parity of protection [compared to the general population] because they haven't responded to vaccinations, they've got that with Evusheld."

As well as clinicians, thousands of patients and charities are also begging for an urgent U-turn on Evusheld.

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Martin Eve, a professor of literature who leads the Evusheld for the UK patient group, is among those still shielding due to acute kidney failure and severe immunosuppression.

Tests show that, despite six vaccinations, the 36-year-old has produced no detectable antibody response.

He continues to work from home and asks anyone visiting to isolate for 10 days beforehand, but considers himself one of the lucky ones.

"Some of our members are actually living apart from their families," said Eve.

"One of our members has a rented flat opposite the house where her husband and daughter live, and she's spent two and a half years living apart from them so that her daughter can go to school safely, without giving her the virus.

"I also get weekly emails from people telling me they're suicidal, that they've given up their jobs. It's a really tricky situation for many people.

"For people in my situation, we're basically still in 2020. I might have some T cell immunity, but that's not guaranteed. I can't take the risk.

"People with my condition had a 27% infection-fatality ratio. Do I want to take the risk of a one in four chance of dying from a horrible respiratory virus for the sake of some kind of social interaction?"

Professor Martin Eve (Image: PA)

Recently Scotland's Health Secretary, Humza Yousaf, voiced support for randomised control trials of Evusheld in the UK - something suggested by RCOG, but rejected by AstraZeneca and unpopular with patients who say they would be too worried about taking part in case they ended up on a placebo.

"It's completely unethical at this point," said Eve.

"We have real-world data showing 90% efficacy against preventing death, so that's like saying we've got a parachute that works 90% of the time in the real-world but we want to test it by only giving it to 50% of people jumping out of a plane.

"We've got five people dying a day in our community from Covid. We need it this winter."

For chartered surveyor Nikola Brigden, the delays are costing her and her husband, Scott, 47, valuable time with loved ones following his diagnosis with mantle cell lymphoma - a rare and aggressive form of blood cancer - in March last year.

His current drug regime makes it impossible for him to mount a normal antibody response to vaccination.

Nikola Brigden with her husband, Scott (Image: PA)

She said: "We can't mix with family. We can't go out for something to eat.

"I lost my Dad a couple of years ago so my Mum's on her own, but I haven't been able to see her or give her a hug for over a year. It's not great.

"Because of Scott's prognosis, his potential life expectancy is around five to 10 years, realistically, so for the Government to kick Evusheld into the long grass with the NICE appraisal is another year that we won't get back. It's a really cruel decision."

Brigden, 53, added that, with Evusheld, her husband would feel safe returning to work piloting underwater vehicles for oil companies.

"We know it's not a silver bullet, but Scott hasn't worked since last March - and he could still do his job.

"Right now, the problem is that he'd have to get on a plane to get there, but if he had Evusheld he would just mask up. He wears filtered masks anyway."

The latest statistics from the Office for National Statistics suggest Covid is on the rise again, with one in 35 now infected in England.

In Scotland, the trend is less certain, but an estimated one in 50 had Covid by the end of September.

READ MORE: Why are we cutting Covid testing in hospitals at the start of winter?

Married father-of-three Mark Oakley has spent the last two and a half years shielding, including eight months spent living in a summer house in the garden when rates have been high or someone in the family had Covid or was pinged as a contact.

The 52-year-old, who has pulmonary sarcoidosis - a rare autoimmune disease which affects his lungs - was also forced to give up his landscaping business at the beginning of the pandemic due to the risks from the virus.

"It's been so tough the past couple of years, so when you get some sort of hope - then it gets taken away from you - it was a real punch in the stomach," he said of the decision to stall Evusheld.

"It's like being in an escape room where you can see the key to get out, but you can't reach it through the bars."

Oakley, who also helps to run the Evusheld patient group, said the stories are "desperate".

He said: "We had a story of one guy who had to go into A&E in an ambulance and the only place they could find to keep him separate from everyone was to put him in a storecupboard, and he was in there for eight hours.

"It's terrifying. People are desperate not to do anything that will have them end up in hospital."

A spokesman for the Scottish Government said it understands the worries immunocompromised patients have about Covid, and has prioritised them for vaccination, free tests, and treatments such as antivirals, but that there are "remaining questions" about Evusheld's effectiveness against Omicron.

He added: “We continue to closely monitor the outcome of further research to ensure that any decisions to make Evusheld available to eligible individuals in Scotland in the future are based on the best available evidence."

The UK Government said RCOG has considered the evidence base for Evusheld 11 times in 18 months, starting in February 2021, and is "keeping it under active review".