We remain optimistic that Evusheld will retain its efficacy against Omicron variant
Dr Anil Kukreja, Vice President, Medical Affairs and Regulatory, AstraZeneca India, tells Akanki Sharma about Evusheld, which was designed by combining two potent antibodies with different and complementary activities against the virus, to evade potential resistance with the emergence of new COVID-19 variants
What is a monoclonal antibody cocktail? How is Evusheld different from Covishield vaccine or any other vaccine in the market?
Evusheld is a combination of two long-acting monoclonal antibodies (mAbs) – tixagevimab and cilgavimab – derived from convalescent patients after SARS-CoV-2 virus. Combining two monoclonal antibodies allows them to work synergistically to enhance the potential for improving the effectiveness of treatment, and to evade the potential resistance that might emerge with the appearance of new variants and strains of SARS-CoV2.15.
It is the only antibody therapy authorised for emergency use in the US for the pre-exposure prophylaxis (prevention) of COVID-19. The cocktail is intended to help protect the most vulnerable populations, such as the immunocompromised, who may not mount a sufficient immune response to COVID-19 vaccination.
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 also authorised for emergency use for prevention of COVID-19 in several other countries, including France, Spain, Germany, Italy, Bahrain and Egypt, with rolling reviews underway in the UK and the EU.
Tell us about the recent developments of this monoclonal antibody cocktail. Is this effective against all the variants of corona virus?
By combining two potent antibodies with different and complementary activities against the virus, Evusheld was designed to evade potential resistance with the emergence of new COVID-19 variants.
A new independent study by the US Food and Drug Administration (FDA) shows that Evusheld retains neutralising activity against the Omicron SARS-CoV-2 variant (B.1.1.529). The pre-clinical data was generated by pseudovirus testing of the full Omicron variant spike and showed that the combination of the antibodies comprising Evusheld, retains neutralisation activity against the Omicron variant.
These data add to the growing body of pre-clinical evidence demonstrating that Evusheld retains activity against all tested variants of concern to date.
The Omicron variant was not in circulation during the Evusheld clinical trials. Further data are needed to understand the implications of this observation in clinical practice. We are conducting additional studies to further evaluate Evusheld against the Omicron variant. Data from this research is anticipated soon.
We remain optimistic that Evusheld will retain its efficacy against the Omicron variant and continue to provide a robust level of protection.
What went behind making this long-acting antibody (LAAB)? Tell us in detail about what was found in the Provent and Tackle trials.
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. Despite the roll out of vaccines across the world, there remains an unmet need for vulnerable populations, including those who might receive little to no protection from vaccines or prior COVID-19 infection, such as those with suppressed immune systems.
These vulnerable populations may need added defence or more immediate protection than vaccines can provide, e.g., those with weakened immune systems, sub-optimal vaccine response, those that require immediate protection, highrisk patients with increased risk of exposure due to work or living situations.
The need for targetted prophylaxis will still be there even if we have multiple effective vaccines. There is also the need for treatmen