FDA encourages plasma donations from recovered patients for blood therapy development
In a bid to fight the COVID-19 pandemic, the FDA has been working with partners across the U.S. government, academia and industry to expedite the development and availability of critical medical products to treat this novel virus. FDA is now providing an update on one potential treatment called convalescent plasma and encouraging those who have recovered from COVID-19 to donate plasma to help others fight this disease.
Convalescent plasma is an antibody-rich product made from blood donated by people who have recovered from the disease caused by the virus. Prior experience with respiratory viruses and limited data emerged from China, suggest that convalescent plasma has the potential to lessen the severity or shorten the length of illness caused by COVID-19. It is important to evaluate this potential therapy in the context of clinical trials, through expanded access, as well as facilitate emergency access for individual patients.
The response to the agency’s recently announced national efforts to facilitate the development of and access to convalescent plasma has been tremendous. More than 1,040 sites and 950 physician investigators nationwide have signed on to participate in the Mayo Clinic-led expanded access protocol. Numerous clinical trials are also taking place to evaluate the safety and efficacy of convalescent plasma and the FDA has granted numerous single patient emergency investigational new drug (eIND) applications as well.
As this work moves forward, the key to ensuring the availability of convalescent plasma to those in greatest need is getting recovered COVID-19 patients to donate plasma. The FDA has launched a new webpage to guide recovered COVID-19 patients to local blood or plasma collection centres to discuss their eligibility and potentially schedule an appointment to donate. The webpage also provides information for those interested in participating in the expanded access protocol, conducting clinical trials or submitting eIND applications.
During this challenging time, many people are asking what they can do to contribute to the COVID-19 response. Those individuals who have recovered from COVID-19 could have an immediate impact in helping others who are severely ill. In fact, one donation has the potential to help up to four patients. Convalescent plasma can also be used to manufacture a biological product called hyperimmune globulin, which can similarly be used to treat patients with COVID-19.
Source: World Pharma News