/Thousands still cocooning from Covid-19 without access to potentially protective drug – The Irish Times

Thousands still cocooning from Covid-19 without access to potentially protective drug – The Irish Times

Emer Flynn says her youngest grandchild has never seen her without a mask “except through the window”. Her older grandchildren wonder why they can’t come over any more. Meeting the oldest of them, who is 17, for a coffee in the garden once a week “is the sum of my social life these days”.

Flynn is one of thousands of people whose immune system is compromised, and who continue to cocoon against Covid-19 long after the rest of society has returned to normal. For many in this group, vaccines don’t work and the only medication that might prevent infection is not available in Ireland.

“No one comes past the front door without a mask. We meet each other outdoors, all masked,” the 68-year-old grandmother, who was diagnosed with a form of leukaemia in 2018, says of her family. “It’s tough because I loved having them over for sleepovers.”

“I used to belong to a theatre club. I went to the cinema regularly with friends. I was a great walker. All that has gone by the wayside.”

The group of patients who have no protection against Covid due to a poor vaccine response include people with specific medical conditions, and those who have had a transplant or are taking immunosuppressant drugs. Not everyone in these categories is affected, but none of these patients can afford to take the risk of contracting Covid.

Many could benefit by taking Evusheld, an injectable monoclonal antibody which has been shown to reduce the risk of Covid for at least six months. Evusheld is authorised by the European Medicines Agency and is available in over 30 countries, but not in Ireland or the UK.

The Health Service Executive has been considering it since last April. The drug is being assessed for cost efficiency, with the results of a health technology assessment due next month. Possibly protracted price negotiations are then likely between the HSE and the manufacturer, AstraZeneca.

Strain of Covid-19

By the time this process is completed, a winter wave of Covid is likely to have passed through Ireland, and the virus may well have mutated in a way that renders the drug less effective.

“What is the HSE waiting for?” asks Prof Margaret Hannan, a consultant microbiologist in the Mater hospital in Dublin. “The studies are there and the strain of Covid-19 currently circulating is the one this drug works on. It may be out of date by the time it becomes available”.

Prof Hannan works close with the Mater’s lung transplant team. “We’re still losing patients to Covid, despite all the vaccinations and the boosters. Evusheld is something that can protect them – I cannot understand why we cannot access it, even if its use was ring-fenced for transplant recipients.”

Only one-third of lung transplant recipients developed immunity after one Covid-19 booster and 50 per cent after two boosters, a study published by Mater researchers has found.

“The vaccines don’t work for many immunocompromised, especially blood cancer patients, yet the only plan from public health is to offer them boosters,” says Michael Rynne of CLL [Chronic Lymphocytic Leukaemia] Ireland, a charity representing patients with leukaemia.

In the UK, patient groups have begun an awareness campaign, #Forgotten500k, on behalf of immunocompromised people with are still shielding and unable to work due to being at higher risk from the virus. In Ireland, these patients seem equally forgotten.

According to the National Immunisation Advisory Committee, conditions associated with a suboptimal response to vaccines include cancer patients receiving chemo, radiotherapy and other treatments; patients with advanced, metastatic or blood cancers; those with chronic kidney disease; patients on dialysis; many transplant patients; people living with HIV; some patients with genetic diseases and patients on specific drugs.

In a statement, the HSE said it commissioned the rapid review process for Evusheld on March 9th, 2022, and a full health technology assessment submission on August 16th. It said the National Centre for Pharmacoeconomics website is regularly updated and includes assessment outcomes.

Immune issues

Flynn, from Ranelagh, says she feels lucky “to have got this far in life without any health issues. But I feel for others with immune issues who have children in school or spouses who have to work. To be always on alert is very tough. I can isolate easily enough because I’m retired. I have a comfortable enough situation.”

Infectious disease consultant Dr Eoghan de Barra says many of the Covid-19 patients falling seriously ill now are those with depleted B cells; B cells are need to make antibodies. Those affected are taking therapies for other conditions that impair the body’s ability to make B cells.

Dr de Barra says the extent to which patients with weakened immune systems are impacted varies. “A huge number of people are really frightened, and are reluctant to go out and about. Some of them might be overthinking the risk, while others are right to be concerned.”

Evusheld is “the only game in town” for these patients, he notes, though “it has its problems”, including reduced effectiveness against some variants and a requirement to increase dose with time.

There is also a risk of giving vulnerable patients a false sense of security, he warns. “This group of patients are at risk of other things, and for many, Covid-19 is just an additional thing to protect against.”

Emer Flynn feels that while Evusheld is not a “miracle cure”, it could be “another tool in the box” of protection: “It is cruel that young people can’t get a medication that’s available everywhere else.”

Newer variants

It isn’t known how many patients are at risk because the vaccines do not work for them. In the US, 3 per cent of the population take immunosuppressive drugs – equivalent to 150,000 people here. It has been estimated that one-quarter of immunocompromised people are insufficiently protected.

In one study cited by the European Medicines Agency, Evusheld reduced the risk of Covid-19 infection by 77 per cent, with an estimated duration of protection of at least six months. It was carried out before the arrival of the Omicron variant, and early indications are that the drug may not protect against some of the newer variants circulating.

Meanwhile, the rollout of Paxlovid, an antiviral pill that can prevent people with Covid-19 becoming seriously ill, remains sluggish. Just 1,544 Paxlovid prescriptions have been provided in the community, according to the latest HSE data.

The National Immunisation Advisory Committee simply advises immunocompromised patients with a suboptimal response to vaccines to “observe all recommended public health and social measures to limit their Covid-19 exposure”.

Emer Flynn, meanwhile, will continue to live her life “as if I’m not protected”.

Even a cough from one of her grandchildren is a source of stress: “I would hate, if I died, to leave them with a legacy of wondering if they had infected me.”