August 8, 2022

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Britain should follow the US and approve AstraZeneca’s breakthrough drug to stop hundreds of thousands...

Britain should follow the US and approve AstraZeneca’s breakthrough drug to stop hundreds of thousands of vulnerable adults from becoming ill in the oncoming Omicron wave, experts said today. 
The antibody cocktail, called Evusheld, was found to slash the risk of falling ill with Covid by around 80 per cent.
Last night it received emergency approval in the US for over-12s who are severely immunocompromised, including cancer and organ transplant recipients. 
Doctors say the move will bolster the immune system of the most at-risk adults, who get less of a benefit from vaccines. 
Britain has already ordered a million doses of the drug, which is given through two consecutive injections to the arm, while the US has ordered 700,000.
The UK’s medicines regulator is considering the treatment as part of a rolling review, but neither AstraZeneca or the watchdog could advise when it could be approved in Britain.
But experts told MailOnline it’s ‘vital’ the 500,000 adults with a weak immune system are protected against the Omicron variant, so it is ‘important’ to approve the drug in the UK.
The treatment is targeted at immunocompromised people who are at increased risk of Covid, because they do not produce an adequate immune response to vaccination. 

Evusheld, which is given to patients through two consecutive injections to the arm, was shown to neutralise all Covid strains that came before Omicron and provided an 83 per cent protection against developing symptomatic Covid for at least six months

Professor Lawrence Young, a virologist at the University of Warwick, told MailOnline: ‘This is a very restricted population but one where other approaches to protection are vital.’
And early data suggests it will work against Omicron, he said.
AstraZeneca itself published data showing it worked on all Covid strains that came before the super-mutant variant, offering protection against symptoms for at least six months. 
Professor Young said: ‘It is important that we have this (Evusheld) available in the UK as a backup.’

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How does the Evusheld treatment work?

AZD7442 is made from two long acting antibodies, tixagevimab and cilgavimab.
These antibodies have been developed from B-cells donated by patients who recovered from a Covid infection. 
B-cells are a type of white blood cell forming part of the body’s immune system and generate antibodies.
Antibodies are a type of protein found in blood which binds to and neutralises foreign substances like bacteria and viruses preventing them from harming healthy cells. 
However, after an infection has passed, the level of antibodies in the body eventually decreases.
So in AZD7442, scientists modified the two antibodies to last longer than conventional ones. 
This is what gives the treatment the long-lasting protection of up to 12 months according to Astrazeneca.

Dr Kovilen Sawmynaden, principal scientist at medical research charity LifeArc, said the US decision to approve the treatment is ‘great news’ for a large proportion of immunocompromised people who don’t respond to the vaccine or cannot have it. 
It is for this reason they are recommended a third dose in Britain after just eight weeks, as well as a booster. 
‘However, efficacy against Omicron is still to be determined and it will be interesting to see how future-proof this drug remains,’ Dr Sawmynaden said.
She added: ‘Recently approved monoclonal drugs in the UK are currently only available as treatment options.
‘Because of this, this new drug would bring real value in our fight to help protect the UK’s immunocompromised population, if a similar application was to be made to the MHRA.’
The UK has already approved antibody treatments ronapreve, which can prevent and treat Covid, and sotrovimab, which cuts the risk of severe illness among infected people. 
If the UK follows America, Evusheld would be the first Covid treatment in Britain to be given as a prophylaxis, with the intention of stopping people from getting ill in the first place. 
Current vaccines train the body to recognise Covid — but the immune system still needs to produce its own antibodies.  
Evusheld skips that process, making the antibodies readily available.
It contains two types of lab-made antibodies, which are extracted from survivors before being artificially manipulated to last longer. 
The proteins bind to the virus’ spike protein — which it uses to invade cells — to stop an infection, or to prevent the pathogen from replicating. 
Most people’s immune systems produce antibodies in response to the virus, either through vaccination or natural infection, in order to help the body fight it off in the future.
But many immunosuppressed people have an immune system that is so weak that even after vaccination, their body struggles to mount a response.
AstraZeneca trialled Evusheld on 5,000 immunosuppressed people across 87 sites in the US, UK, Spain, France and Belgium. Two-thirds of volunteers were given a 300mg dose of Evusheld.
Six months after the injection, those who had the drug were 83 per cent less likely to have symptomatic Covid six months later.
And among those who were given Evusheld and caught Covid, no severe illness or deaths were recorded.
AstraZeneca will monitor the participants for 15 months to determine how long the injection offers protection for.
The company said none of Omicron’s mutations suggest that the treatment would work any less effectively against the variant, but studies are underway to confirm this.
The US Food and Drug Administration yesterday announced that it would dish out the injections to over-12s with moderate to severely compromised immune systems or a history of severe adverse reaction to Covid vaccines or what they are made of.
Dr Krishna Prasad, the MHRA’s deputy director of licensing, told MailOnline that drug approval applications are commercially sensitive, so details of when it could approve the drug cannot be shared.
She added: ‘Any that are received will be evaluated in the shortest time possible while maintaining our high standards of safety, quality and effectiveness.’
It comes as the Prime Minister last night confirmed the UK would move to Plan B in an attempt to control the spread of Omicron.
Just 568 cases have been confirmed across the UK, but Government scientists believe there are 20 times more cases than those that have been identified.
And health chiefs warned the country could see 1,000 hospitalisations a day by the end of the month if no action was taken. 

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