FY22 - It's all to play for here!, page-15

Ethics Paper COVID-19:

As nations and counties try to stem the 3^rd wave of Covid-19 (in particular the Delta Variant), with the focus on mass vaccination, social distancing and hygiene, and therapies supporting the immune system, the most vulnerable group is being overlooked/ undertreated. These are the patients that end up in the Intensive Care Unit, many of which require mechanical ventilation. Despite the best efforts of medical professionals and nursing care, many of these patients will not survive.

There are limited pharmaceutical options that will help this group. The pharmaceutical standard of care (SOC) at the time of writing is steroids (i.e. Dexamethasone). However, adding Mesoblast’s mesenchymal stem cells (MSCs) to this SOC has been shown to significantly and statistically reduce mortality in patients under 65 years of age in this patient population.

This brings into question are we really doing all we can to protect the most vulnerable of our citizens where all other treatments have failed? Why are these patients currently not given the option of MSCs which may be their last hope of life?

This is an ethical issue because there is valid science to support MSCs in this population (in short to combat the lethal inflammation cascade of the lungs and organs) which if left unchecked may result in death without the addition of MSCs to the current SOC.

This is also an ethical issue because increasingly Intensive Care Units are at capacity treating COVID patients, thus preventing other patients requiring emergency treatment (such as stroke victims). This leads us to question whether we are doing enough as society to help our most vulnerable in their hours of need.

What’s more, there is much to be gained by extending the option of MSC treatment to patients in the pre specified group (maybe subject to meeting clinical markers) to ensure all patients in need are given their best chance of survival.

Should the FDA and other regulatory bodies grant an Emergency Use Authorisation (EUA) for MSC treatment to hospitalised COVID patients (which has shown in previous trials to be extremely safe) then the benefits society would be multiple.

Less death, less morbidity, less anxiety, less heartache for loved ones, a more compassionate and fairer society, more progress and economic benefits, more lives saved for non-Covid emergencies etc etc.

I ask you to spread the word that there is a cost effective treatment today that can save many lives right here right now if it is added to the SOC for the many hospitalised Covid patients that just want to breath easily. It’s been shown to firstly do no harm and has real life saving potential and very likely significant downstream health and financial benefits.

Let’s unite and fight off the long lasting impacts that Delta and any further variants may throw at us as a global society.

Let’s stay strong and safe and do what is right.