Much of the emergency use authorization (EUA) issued by the FDA in tackling the coronavirus pandemic has thus far focused on diagnostic tests. While these tests serve as invaluable tools to address the pandemic, finding a cure to Covid-19 remains the ultimate goal. Its elusiveness, however, has prompted many researchers to explore effective Covid-19 treatment options. A recent EUA for the use of convalescent plasma as a treatment option indicates a slow yet growing market for Covid-19 treatments and by extension a timely inflection point in the fight against the pandemic.
Convalescent plasma has been a well-established method for over a century in treating many viral diseases, including but not limited to SARS, measles, and polio. It is a form of passive immunity, where infected patients develop antibodies in their plasma as they recover and subsequently donate some of their plasma to accelerate other patients’ recovery. Researchers from the Mayo Clinic who led the Expanded Access Program (EAP) reported that transfusing high antibody levels within three days of diagnosis resulted in reduced death rates. The report’s findings had contributed to the EUA of convalescent plasma treatment by the FDA, which comes at a pivotal time when currently existing Covid-19 treatment options and their efficacy are limited. GlobalData expects this EUA will provide much-needed relief for thousands of US patients infected with this disease.
According to GlobalData’s Covid-19 Dashboard, a cumulative number of 2 million patients have recovered from the virus in the US. Not all can donate their plasma, however, as there are several important requirements for donating, such as having sufficient antibody counts. Furthermore, some patients may experience limited supplies of plasma, owing to blood type incompatibility. Despite these constraints, if all eligible convalescent patients were to donate their plasma on a recurring basis, a significant portion of the 3.5 million US patients currently with an active case could be treated.
As of now, few treatment options exist for Covid-19, none of which has been proven to effectively treat all cases. Remdesivir has been shown to accelerate patient recovery, albeit mostly for those who were treated early on in their infection. Dexamethasone has been used to treat the hyper-immune responses that develop among some patients, but not the disease itself. A vaccine has yet to be developed, with questions regarding its cost, global access, and efficacy remaining unanswered. This highlights the dire need for additional treatment options to be made available immediately, and the FDA has clearly addressed this challenge with this recent EUA.