This week, the U.S. Food and Drug Administration (FDA) issued a statement encouraging patients who have fully recovered from COVID-19 for at least 2 weeks to donate plasma, in order to ramp up supply of convalescent plasma for treatment of infected individuals. The agency also announced that spun synthetic swabs could be used for testing purposes in addition to cotton swabs, which may help close gaps in testing availability.
Plasma Donations
Stephen M. Hahn, MD
On April 16, FDA Commissioner Stephen M. Hahn, MD, issued the following statement:
As part of the all-of-America approach to fighting 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. We are 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 that have 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 that we evaluate this potential therapy in the context of clinical trials, through expanded access, as well as facilitate emergency access for individual patients, as appropriate.
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. A number of 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 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 centers 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 emergency investigational new drug applications. The American Red Cross has also set up a website for interested donors and the FDA continues to work with others in this area to help encourage additional donations.
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.
People who have fully recovered from COVID-19 for at least 2 weeks can contact their local blood or plasma collection center today to schedule an appointment. We encourage individuals to consider donating and hope this information will serve as a helpful resource to facilitate this important act of kindness.
Availability of Swabs for Testing
The FDA also announced a further expansion of COVID-19 testing options through the recognition that spun synthetic swabs—with a design similar to Q-tips—could be used to test patients by collecting a sample from the front of the nose.
As part of this effort, U.S. Cotton, the largest manufacturer of cotton swabs and a subsidiary of Parkdale-Mills, developed a polyester-based Q-tip–type swab that is fully synthetic for compatibility with COVID-19 testing. Harnessing its large-scale U.S.-based manufacturing capabilities, U.S. Cotton plans to produce these new polyester swabs in large quantities to help meet the needs for coronavirus diagnostic testing.
This finding that spun synthetic swabs could be used for COVID-19 testing is based on results from a clinical investigation that represents a collaboration between the FDA, UnitedHealth Group, the Gates Foundation, and Quantigen. The type of testing at the front of the nose used in this study is notable because it allows self-collection by patients, thereby limiting exposure of health-care providers; it is more comfortable for patients, and it can be performed by a swab that is more readily available and manufacturable at scale.
“This action today demonstrates the ingenuity that results from the FDA working in partnership with the private sector…. [W]e appreciate work by UnitedHealth Group, Quantigen, and the Gates Foundation to perform and support the clinical studies necessary for this advancement. We also want to acknowledge U.S. Cotton’s efforts to manufacture a new type of swab for COVID-19 testing that can be produced at scale. We appreciate the work of these collaborators to consider how these test supplies could be broadly distributed to meet not only the testing needs of the United States but also global needs around the pandemic. All of these actions by these American organizations will help continue to expand our testing capability,” said Dr. Hahn.
