Evusheld adds a layer of protection to those with weakened immune systems – ETHealthworld.com

Intro : Dr. Anil Kukreja, Vice-President Medical Affairs & Regulatory, AstraZeneca India Ltd spoke to ETHealthworld's Prathiba Raju and elucidated how Evusheld is specifically intended to protect the most vulnerable populations, including immunocompromised patients. The vulnerable groups may receive limited or no protection from vaccines and currently have few options in the face of COVID-19 and remain at high-risk.

How does the first-ever monoclonal antibody cocktail work on immunocompromised patients and how the medicine aims to prevent Covid-19 infection in such patients?

Preventing immunocompromised individuals from getting COVID-19 rather than waiting to treat this vulnerable population once they become infected is an important goal in the fight against the pandemic. Evusheld is intended to protect the most vulnerable populations, including the immunocompromised, who may receive limited or no protection from vaccines and currently have few options in the face of the rapid rise in COVID-19 cases seen in recent weeks and remain at high-risk.

Evusheld is synthesised in a laboratory to mimic the bodys natural infection-fighting antibodies. Therapeutic antibodies can offer almost immediate protection by neutralizing the SARS-CoV-2 virus and activating an immune response. Evusheld is a combination of two long-acting monoclonal antibodies (mAbs) -tixagevimab and cilgavimab -derived from convalescent patients after SARS-CoV-2 virus. Each mAb was engineered with: AZs proprietary YTE half-life extension technology, which more than triples the durability of its action compared to conventional antibodies.The reduced Fc receptor binding technology to minimise the risk of antibody-dependent enhancement of disease.

It binds to distinct sites on the SARS-CoV-2 spike protein. The aim is that by targeting the spike protein, the antibody will neutralise the effects of the SARS-CoV-2 virus by affecting its capacity to infect healthy cells.

Evusheld (AZD7442) is a long-acting antibody (LAAB) combination, engineered with AstraZeneca's proprietary half-life extension technology to increase the therapy's durability upto 12 months, following a single administration. It has been designed to attach to the spike protein of SARS-CoV-2 at two different sites. In addition, Evusheld contains infection-fighting proteins called monoclonal antibodies. The half-life extension more than triples the durability of its action compared to conventional antibodies. It is specifically intended to protect the most vulnerable populations, including immunocompromised patients. The vulnerable groups may receive limited or no protection from vaccines and currently have few options in the face of COVID-19 and remain at high-risk.What is the status of availability of this antibody treatment in India? How will it help in containing the spread of COVID- 19? With most of the people in India with co-morbidities already taken first two doses of COVID vaccines and also administration booster shots, why should they take Evusheld?

We are committed to working with international and government agencies around the world to make Evusheld accessible so that countries can potentially add it to their arsenal to tackle COVID-19. Regulatory dossiers are being compiled per the requirements of various countries including India. We are sharing this emerging therapeutic option as evidence generated with stakeholders and seeking their insights to arrive at our strategy, regulatory filing and timelines.

It is the first long-acting antibody to demonstrate robust efficacy in both prevention and treatment of COVID-19. There is a growing body of evidence underlining the potential of our LAAB to make a real difference in the fight against COVID-19, especially for vulnerable populations. It showed robust, long-lasting protection against symptomatic COVID-19 that continues for at least six months, as demonstrated in the PROVENT Phase III trial. In PROVENT, Evusheld reduced the risk of developing symptomatic COVID-19 by 77 percent at the primary analysis and 83 percent at a six-month analysis compared to placebo.

What is its distinct cohort of compounds, can it contain all COVID-19 Variants of Concern?

Evusheld, is one of only two antibody therapies authorised for use to retain neutralising activity against all other variants of concern tested to date.At least, in the pre-clinical in vitro studies, we have seen that the antibody cocktail is active against all the strains that have been identified so far. The most recent study by USFDA also found it to be retaining the neutralising activity against Omicron variant.

It is said that a person receives two injections, it protects from the illness for only about 6 months, how many doses should be taken and the frequency. Does it differ as per the age? How effective is it for patients using immunosuppressants like long standing systemic steroids or chemotherapy?Preliminary data from a Phase I study show high neutralizing antibody titers for at least nine months, with potential to offer protection for up to 12 months following a single dose. Some information provided is based on a pre-print and has not undergone peer review.Do you think antiviral COVID-19 drugs should be seen as the next step in the fight against the virus, apart from vaccination?

No one vaccine or therapy can eliminate COVID-19, but multiple approaches could help to reduce the spread of the virus, defend those most vulnerable to infection, deliver better outcomes for patients and ultimately allow the world to return to normal.

Vaccines have the potential to provide long-term protection against COVID-19 but require a healthy immune system and can take a few weeks to generate a virus-specific immune response. While vaccines are helping people around the world,not everyone who receives a vaccine can produce antibodies,or produce antibodies at a level which is sufficient to protect them from COVID-19.These vulnerable populations may need added or more immediate protection.

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Evusheld adds a layer of protection to those with weakened immune systems - ETHealthworld.com