Covid: MHRA approve new anti-viral medication – reduces risk of symptomatic disease by 77%

Dr Amir Khan discusses 'variant proof' coronavirus vaccine

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Developed by AstraZeneca, Evusheld is for adults who are unlikely to mount an immune response from Covid vaccination, or for those whom vaccination is not recommended – adding a lifeline to those who are vulnerable to infection. Dr June Raine, MHRA Chief Executive, said: “After a careful review of the data, I am pleased to confirm that we have authorised 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.”

Dr Raine explained that “COVID-19 vaccines continue to be the first-line defence against Covid”.

However, Evusheld was created in response to a “small number of individuals” who experienced a previous allergic reaction to one of the vaccine ingredients.

“For these people, Evusheld could provide effective protection against COVID-19,” Dr Raine added.

Recipients will be given a single dose of tixagevimab and cilgavimab – two antibodies – via injections into a muscle, administered by a healthcare professional.

The medicine works by combining two long-acting antibodies that bind to the spike protein on the outside of the SARS-CoV-2 Covid virus.

This in turn prevents the virus from attaching to and entering human cells, thereby significantly reducing the risk of infection.

Before receiving this treatment, however, it’s important that the recipients are not currently infected with Covid or had recent known exposure to a person infected with the virus.

Professor Sir Munir Pirmohamed, Chair of the Commission on Human Medicines – who endorsed the approval of Evusheld – mentioned that, for those eligible, the “recommended dosage is 300mg of Evusheld”.

Professor Pirmohamed added: “But a higher dose of 600mg may be more appropriate for some COVID-19 variants.”

Clinical trials have demonstrated that Evusheld was found to reduce the risk of developing symptomatic Covid by 77 percent.

Symptoms of Covid

The Centers for Disease Control and Prevention (CDC) listed the symptoms of Covid, which includes:

  • Fever or chills
  • Cough
  • Shortness of breath or difficulty breathing
  • Fatigue
  • Muscle or body aches
  • Headache
  • New loss of taste or smell
  • Sore throat
  • Congestion or runny nose
  • Nausea or vomiting
  • Diarrhoea.

The symptoms of Covid typically appear between two to 14 days following exposure to the virus.

Meanwhile, the recipients of Evusheld gained protection from the virus for at least six months following a single dose.

The MHRA did, however, point out that “there is not yet enough data” to know how effective Evusheld is against Omicron, but work will be carried out to establish this.

Professor Pirmohamed made clear that “pre-exposure prophylaxis with Evusheld is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended”.

This means Evusheld is not a replacement for Covid vaccines already on offer, such as Moderna.

Evusheld is only for those who have reacted badly to current vaccines, or for other reasons, the vaccine has not been recommended for them.

Professor Pirmohamed assured: “The Commission on Human Medicines and its COVID-19 Therapeutics Expert Working Group has independently reviewed the data and endorses the MHRA’s regulatory approval of Evusheld.

“We have carefully reviewed data on the medicine’s safety, quality and effectiveness and are satisfied it meets the expected standards.”

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