A group of patient bodies, charities and senior clinicians have urged the Government to approve the use of life-saving COVID-19 antibody treatments
A letter, written by a group of 20 patient bodies, charities and senior clinicians, calls for rapid approval of monoclonal antibody treatments, including REGN-COV2, which is already approved by the FDA.
Data from the UK RECOVERY trial has shown that the drug can reduce the risk of hospitalisation and death from COVID-19 by 70%, suggesting that it could save six lives for every 100 people treated.
Despite the positive trial results and it already being used in the US and across Europe, REGN-COV2 has not yet been approved for use in the UK by the MHRA.
Hyper IgM syndrome
Chris Sheasby, 45, Hertfordshire, lives with the rare immune system disorder Hyper IgM syndrome. His body does not produce antiviral antibodies and has no immune memory, meaning the current COVID-19 vaccine won’t protect him from the virus.
He is one person calling for the immediate approval of life-saving monoclonal antibody treatments, and specifically, REGN-COV2, which he says should be offered to immunodeficient patients after any known exposure to COVID-19.
From February 2020, Chris has been following the data on the COVID-19 pandemic with acute attention. From day one, he has managed his own risk, reduced contact with people before it was advised and home-schooled his children before it was required. He has been in some form of lockdown now for 18 months.
“I cried at the beginning of the pandemic because I gave myself a 50/50 chance of getting through this.”
When the vaccine roll-out began, Chris knew that he needed an alternative ‘exit strategy’ – he needed to “buy time” until science developed a solution for him and the 750,000 immune-compromised people in the UK.
Now science does have a solution, in the form of monoclonal antibody treatments, which are already being used in the US and other European countries. However, these drugs are currently not being offered in the UK.
As total easing of restrictions were announced, Chris felt his world close in: “I felt despair, that my exit strategy I had planned wasn’t going to be enough. Because science has an answer but it can’t be delivered because the Government isn’t going to allow it to happen. I had no hope. They don’t care – I don’t think they know we exist.
“I don’t care about them opening nightclubs or bars, that doesn’t impact me, but taking away masks and social distancing is terrifying.
“What frightens me is that I’ve tried so hard to limit the risk on my life and now I have no control over this.”
Dr Effrossyni Gkrania-Klotsas, Mr Sheasby’s doctor at Cambridge University Hospital, was surprised not to be given access to any monoclonal antibodies. “I tried everything to get hold of a monoclonal antibody for Chris, including REGN-COV2, as soon as he had been exposed to COVID-19, but without success. Thankfully he didn’t get infected but it could be so different next time. As clinicians, we are incredibly frustrated, unable to treat our patients with medicines that are sitting on the shelf and ready to go. I have heard from colleagues in other hospitals that people with chronic conditions are dying. And they will continue to die needlessly from COVID-19 unless a monoclonal antibody is approved in the UK, as is the case for REGN-COV2 in the US and Europe”.
Susan Walsh, CEO of Immunodeficiency UK said: “This treatment is the only existing safety net for at least half a million people. So-called Freedom Day has created an underclass of vulnerable people who are not free to participate in society, currently sheltering as restrictions are lifted.
“The Government has failed to set a strategic plan of providing protection to affected patient communities and we deserve equal health parity. The Government has a responsibility to all its citizens but has forgotten this community and their families, whose lives are now limited through fear.”
The letter in full
Whilst the Prime Minister and many in the UK celebrated ‘Freedom Day’ on Monday 19th July, hundreds of thousands of immune-deficient and immune suppressed people felt their worlds close in. As restrictions on masks and social distancing were lifted, the risks to them only increased.
There is no plan for this group and we believe this has created an underclass of people who are not free to participate in society. This group, around 500,000 people in the UK, includes not only those whose bodies cannot produce antibodies and do not respond to vaccine protection but also their families, who have to weigh up the potential risk to their loved ones with every interaction they make.
Adults who are immune-deficient and immune-suppressed in the UK are at an increased risk of illness (morbidity) and death (mortality) following COVID-19. Yet the UK Government has offered no clear guidelines as to how they will be protected.
We are calling for a clear plan of action to support this group and the urgent approval of potentially life-saving treatments which are being used elsewhere in the world, which have the potential to save thousands of lives.
Monoclonal antibody therapy is an artificial antibody designed to fight the infection just as the natural immune system would. One such treatment, known as REGN-COV2, has shown a relative risk reduction of 70% in hospitalization and death, compared with a placebo and data from the UK RECOVERY trial suggests this drug could be offered to a third of patients hospitalised with severe COVID-19, saving six lives for every 100 people treated.
Despite being used in the US and across Europe in Italy and Germany, and with positive trial results, REGN-COV2 has not yet been approved for use in the UK by the MHRA. Without expedited access via the MHRA, there can be no consideration to compassionate access for those immune-deficient and immune suppressed people who are particularly at risk of severe disease. This is critical if we are to make this treatment available for emergency use in these highly vulnerable patients.
This is just the first in a series of potentially life-saving monoclonal antibody treatments that could provide a critical safety net for this group and needs priority review. Without medical treatment available to them, the only option they currently have is to avoid infection by living in isolation, which continues to have a significant impact on the physical and mental wellbeing of both themselves and their families.
We urge The Rt Hon Sajid Javid MP to review the timescale for licensing these drugs for use in the UK for immune-deficient and immune suppressed people and to set out a clear plan to protect these vulnerable people.