EU Regulator Recommends AstraZeneca’s COVID Vaccine Alternative: What Is It?
AstraZeneca's preventive treatment is an antibody cocktail that has already been approved by the US FDA.
AstraZeneca's COVID-19 prevention shot has been recommended by the European Union's Drug regulatory body, the EMA (European Medicines Agency).
The preventive treatment, called Evusheld, is an antibody cocktail therapy meant for those who can't take the vaccine, or for whom the vaccine is inadequate—usually because of underlying health issues.
The EMA, in a statment released on 24 March, said that they were recommending the authorisation of the preventive treatment for everyone over the age of 12 that weighs over 40 kgs.
Here's what to know about the antibody cocktail COVID prevention treatment.
Why Has EMA Backed Evusheld?
Interim phase 3 trial data, released by the company in November 2021, showed that just one dose (300 mg) of Evusheld (previously known as AZD7442) reduces the risk of developing symptomatic COVID-19 by 83 percent, for at least 6 months.
EMA's own evaluation of the final trial data, however, found the treatment to be 77 percent effective in reducing the risk of COVID infection for the same duration of time, according to their statement.
The Phase 3 clinical trial,
Was conducted in 87 sites across Europe.
Involved more than 5000 participants.
More than 75 percent of the participants at baseline were high risk patients who already had co-morbidities.
"0.2% (8 out of 3,441) had lab-confirmed breakthrough COVID-19 after treatment, compared with 1.0% (17 out of 1,731) of the people who received placebo."European Medical Association
The EMA also added, "the safety profile of Evusheld was favourable and side effects were generally mild, with a small number of people reporting reactions at the injection site or hypersensitivity."
The EMA's Committee for Medicinal Products for Human Use concluded that the benefits of the treatment outweighed the risks.
Based on their evaluation results, they said, they are recommending that the preventive treatment be authorised for use in all European Union member states.
FAQ: What Do We Know About Evusheld?
What is it?
The antibody cocktail is a combination of Tixagevimab and Cilgavimab. It is derived from B-cells donated by convalescent patients after SARS-CoV-2 virus, according to AstraZeneca.
The antibody drugs used in this preventive treatment are different from the ones used in the antibody cocktails used for the treatment of COVID.
How is it administered?
The treatment is administered through two consecutive 150 mg injections of Tixagevimab and Cilgavimab.
Who is it meant for?
The antibody cocktail is an alternative for COVID-19 vaccines for people who cannot take the vaccines due to underlying health conditions. It can also help pad up protection in high risk patients for whom the vaccines are not adequate.
According to AstraZeneca, this includes,
People with blood cancers or other cancers being treated with chemotherapy
Patients on dialysis
People taking medications after an organ transplant
Those taking immunosuppressive drugs for conditions including multiple sclerosis and rheumatoid arthritis.
The person must also be above the age of 12 and weigh over 40 kgs to make the cut.
Who is it not recommended for?
Children below the age of 12.
It should also not be given to someone who is currently infected with COVID, or has come into contact with a COVID positive person recently.
Does it protect against Omicron?
"Laboratory studies show that the Omicron BA.1 variant may be less sensitive to tixagevimab and cilgavimab at 150 mg doses than the Omicron BA.2 variant."European Medical Association
They added that studies were ongoing to figure out if switching up doses may help counter this issue.
Has it been approved anywhere else?
Yes, Evusheld has already been authorised for use in the Us. In fact, it is the first antibody cocktail for COVID prevention to be approved in the states.
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