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Coronavirus UK: Britain may pull out of deal for a million doses of AstraZeneca’s antibody drug

The UK may pull out of plans to buy a million doses of AstraZeneca’s experimental Covid antibody drug, it was claimed today.

Ministers announced an order for the doses from the British-Swedish pharmaceutical giant in November and said the final deal would depend on clinical trial results.

But Britain is now considering a U-turn, two sources familiar with negotiations told Bloomberg.

The UK’s agreement was non-binding and it is having massive success with the vaccine rollout, with two thirds of adults now immunised and deaths and hospital admissions expected to be suppressed by the jabs in any third wave.

Officials are reconsidering the possible role of the antibody cocktails, known as monoclonal antibodies, which inject infected patients with the immune cells it would take them weeks to make naturally.

Britain is already on a mission to find antiviral drugs to fight the virus at home, with Boris Johnson pledging simple Covid drugs will be available by autumn this year. 

AstraZeneca’s trials in the UK have not yet finished and the results are expected in the coming weeks. The Department for Health and Social Care and AstraZeneca did not respond to comment requests before publication.

The UK may pull out of plans to order 1million doses of AstraZeneca’s antibody drug, it has been revealed

Monoclonal antibodies are lab-produced molecules that mimic human antibodies — disease-fighting proteins made by the immune system

Monoclonal antibody treatments are different from vaccines because they are used to treat people already ill with the virus rather than protecting them before infection. 

But treatments based on the disease-fighting proteins, which are more expensive than jabs, have also shown promise in preventing infection.

They work by pumping antibodies — natural virus-fighting molecules — into people to boost their immune system.  

AstraZeneca’s AZD7442 treatment uses an IV drip to infuse a combination of two antibodies into a patient’s blood stream. Using two long-acting antibodies (LAABs) is thought to make the treatment better against different strains of the virus.

It is developed by harvesting working antibodies from people who have already had coronavirus and cloning them in a lab. 

A phase III trial on 5,000 people — including 1,000 from nine sites in the UK — began in November. 

Speaking at the time, Business Secretary Alok Sharma confirmed Britain had made a preliminary agreement with AstraZeneca for 1million doses pending trial results.

He said: ‘I am very proud that the UK is the first country in the world to begin this invaluable study, and that a fifth of trial volunteers will be from Britain – a testament to our fantastic life sciences sector and the willingness of our people to come forward to help others… 

‘That is why we have procured 1million doses of AstraZeneca’s long-acting antibody treatment if it meets robust safety and effectiveness standards.’

Despite the UK reconsidering its order, the US announced an agreement with AstraZeneca in March to increase its order by 500,000 doses, taking its total up to 700,000.

There are currently three monoclonal antibody treatments that have been given emergency use authorisation in the US.

But there is not yet robust data showing their efficacy against new variants, which have become dominant in many parts of the world.

Antibodies are super-specific to the shape of the virus that triggered them, and ones developed to fight the original Wuhan variant, for example, are less effective against the South African, Brazilian or Indian strains of the virus.  

Monoclonal antibody therapies approved in the US include pharmaceutical firm Eli Lilly’s bamlanivimab and etesevimab.

Another treatment approved by American regulators and made by the firm Regeneron was used on Donald Trump last year during his Covid battle, and may have helped the former President recover.

No antibody therapies have so far been approved in the UK, where the only hospital treatments for Covid patients are steroids for people already on ventilators or with dangerously low oxygen levels. 

NHS doctors can also give hospitalised coronavirus patients arthritis drugs alongside the steroid dexamethasone, which studies have shown can cut the risk of dying by up to half. 

The treatment is different to a vaccine because it does not train the body to develop immunity and a vaccine can’t be used when someone is already sick.

Vaccines usually inject someone with a part of the virus so their body can learn how to fight it in a safe environment by being exposed to it for real. 

The antibody therapy would be limited and would not lead to the body making more of its own antibodies.

Monoclonal antibodies are already being used to treat tetanus, Ebola and diphtheria and are described as ‘one of the most powerful tools in modern medicine’.

WHAT ARE MONOCLONAL ANTIBODIES AND DO THEY WORK? 

Monoclonal antibody therapy is a form of immunotherapy that uses monoclonal antibodies (mAb). 

It’s given as an injection under the skin or through a drip into a vein. 

The treatment works in many different ways. It can work in a vaccine-like way, protecting a patient from severe disease, or can help to stimulate the patient’s immune system to attack antigens. 

Hybridoma technology is one method for producing large numbers of monoclonal antibodies – identical antibodies that are clones of a unique parent cell.

The process starts by injecting an animal, such as a mouse, with an antigen that provokes an immune response.  

B cells produces antibodies that bind to the antigen. These antibody producing B-cells are then harvested and used to culture more antibodies. 

The monoclonal antibodies are screened against their ability to work, with initial experiments in animals.

AstraZeneca AZD7442

Does it work?

A phase three clinical trial of 5,000 participants — which included 1,000 people from nine sites in the UK — began in November.

Results for the trial are expected in the coming weeks. 

Has it been approved? 

Not yet but the company will seek emergency use authorisation in the US if it is shown to work in trials. 

GlaxoSmithKline Vir-7831

Does it work?

A global phase three clinical trial of 583 patients showed the drug cuts the risk of infected Covid patients dying by up to 85 per cent.

A separate lab study has found Vir-7831 is effective against the main current Covid variants, including the Kent, South African and Brazilian strains, the firm said. 

Has it been approved?

Not yet, but GSK plans to immediately seek an emergency use authorisation in the US and approval in other countries.

Eli Lilly bamlanivimab 

Does it work?

Phase three clinical trials in October showed bamlanivab was effective in treating mild-to-moderate Covid patients. 

But research released in February suggests the drug is ineffective against the South African and Brazilian Covid strains.

Has it been approved?

The US Food and Drug Administration gave emergency use authorisation to bamlanivimab for the treatment of mild-to-moderate Covid in adult and pediatric patients in November last year.

Eli Lilly etesevimab

Does it work?

A phase three clinical trial of 769 people aged 12 and over with mild-to-moderate Covid yesterday showed etesevimab to be effective in treating Covid when administered in combination with bamlanivimab.

The trial included people who were considered high-risk because of their age or underlying conditions. 

Has it been approved?

The US Food and Drug Administration gave emergency use authorisation for bamlanivimab and etesevimab administered together for the treatment of mild to moderate Covid in adults and pediatric patients.

Etesevimab has not been given authorisation for treatment on its own. 

Regeneron 

Does it work? 

Regeneron’s coronavirus antibody drug reduces the risk of getting Covid after exposure by 50 percent, January trial results suggest.

The treatment prevented all of the 186 people who got the drug after being exposed to coronavirus from developing symptomatic Covid. 

Former US President Donald Trump was given the drug as part of his successful treatment for Covid in November.

Has it been approved? 

Regeneron’s cocktail has been given emergency use authorisation by the FDA. 

Although it wasn’t approved, the company agreed to supply a single dose for Mr Trump at the request of his physician under ‘compassionate use’ provisions.

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