Source: Daily Mail
A first-of-its-kind drug that stops people from catching Covid has been approved in the UK by the country's medical watchdog.
Evusheld was found to slash the risk of getting symptomatic Covid by around 80 percent for up to six months in a clinical trial last year.
The antibody cocktail, made by AstraZeneca, will be used for immunosuppressed people who are less likely to get strong protection from vaccines.
Evusheld was found to slash the risk of getting symptomatic Covid by around 80 percent for up to six months in a clinical trial last year.
Britain is believed to have ordered a million doses of the drug, which has been used on vulnerable people in the US since December.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) said its review found Evusheld provided 'long-lasting protection'.
But the watchdog admits it's unclear how well it will work on Omicron or BA.2, with officials suggesting a higher dose might be 'more appropriate' for these variants.
Evusheld is administered via two injections at the same time and uses antibodies - immune proteins - that have been modified in a lab to make them last longer.
While vaccines train the body to muster its own response to Covid, the drug skips this process and makes the antibodies readily available.
In some patients, such as those on chemotherapy, their immune systems are so weak that even after vaccination they struggle to mount a response.
There are believed to be around 500,000 immunocompromised people in the UK who could benefit from the drug.
Dr. June Raine, chief executive of the MHRA said: 'After a careful review of the data, I am pleased to confirm that we have authorized another medicine to help protect against the effects of COVID-19.
'Evusheld is a “pre-exposure prophylaxis” treatment, meaning it is taken to prevent COVID-19 before the risk of acquiring infection. One dose has been found to provide long-lasting protection against this disease for up to six months.'
She insisted that vaccines were still the UK's 'first-line defense' but added: 'We know that some people may not respond adequately to these vaccines.
'For these people, Evusheld could provide effective protection against COVID-19.'
The MHRA's approval means the NHS can now negotiate a price with the drugmaker and decide who should be eligible.
A six-month study last year found the drug provided 77 percent protection against falling ill with Covid after six months in unvaccinated vulnerable people.
At the time, when the Delta variant was dominant, it represented even higher efficacy than two vaccine doses, which wane significantly in six months.
But there are questions about how well the antibody cocktail will perform against Omicron and its subvariant BA.2, which are more resistant to antibodies.
The Government’s independent advisory body, the Commission on Human Medicines, has endorsed the drug's approval.
Its chair, Professor Sir Munir Pirmohamed, said: 'We have carefully reviewed data on the medicine’s safety, quality and effectiveness and are satisfied it meets the expected standards.'
He suggested a stronger dose may be needed to provide high protection against some Covid variants.
'The recommended dosage is 300 mg of Evusheld but a higher dose of 600 mg may be more appropriate for some COVID-19 variants,' he said.
Evusheld, also called AZD7442, contains two types of lab-made antibodies and is given to patients via an injection into the arm, similar to some vaccines.
It is made by extracting the proteins from patients who have recovered from the virus, and then manipulating them in a lab to make them last longer than natural antibodies.
They bind to the virus' spike protein — which it uses to invade cells — to stop an infection, or to prevent the virus from multiplying when it does infect.
Antibodies are created by the immune system in response to the virus, either through vaccination or natural infection, in order to help the body fight it off in the future.
The current vaccines train a person's body to recognize Covid, but the immune system still needs to produce its own antibodies. The latest therapy skips that process, making the antibodies readily available.
Patients undergoing chemotherapy, which reduces the effectiveness of the body's immune system, or taking immunosuppressive drugs following an organ transplant are among those who don't always get full protection from jabs.
How does the Evusheld treatment work?
Evusheld, also called AZD7442, contains two types of lab-made antibodies known as tixagevimab and cilgavimab.
These antibodies have been developed from plasma donated by patients who recovered from a Covid infection.
They have been manipulated in a lab to last longer.
They bind to the virus' spike protein — which it uses to invade cells — to stop an infection, or to prevent the virus from multiplying when it does infect.
Antibodies are created by the immune system in response to the virus, either through vaccination or natural infection, in order to help the body fight if off in the future.
The current vaccines train a person's body to recognize Covid, but the immune system still needs to produce its own antibodies.
The latest therapy skips that process, making the antibodies readily available.