WHO Warns of Long Road Ahead with COVID-19… FDA Encourages Recovered Patients to Donate Plasma for Development of Blood-Related Therapies

WHO warns of long road ahead with COVID-19

The head of the World Health Organization (WHO) today said global COVID-19 activity is at different stages in different parts of the world and warned of a long road ahead with the virus.

The global COVID-19 total today reached 2,623,231 cases from 185 countries, along with 182,359 deaths, according to the Johns Hopkins online dashboard.

Worrying upward trends in a susceptible world

At a media telebriefing today, Tedros Adhanom Ghebreysus, PhD, the WHO’s director-general, said most of the epidemics in Western Europe have stabilized or are declining. However, there are worrying upward trends in Africa, Central and South America, and Eastern Europe, though numbers are still relatively low.

Most countries are still in the early stages of their epidemics, but some already-affected locations are seeing a resurgence. “Make no mistake: we have a long way to go. This virus will be with us for a long time,” Tedros said.

He said social distancing steps have suppressed transmission in many countries, but the virus is still extremely dangerous, and early evidence suggests that most of the world is still susceptible. “That means epidemics can easily re-ignite,” he said.

Communication key to weathering long lockdowns

Another danger is complacency, and he said people are understandably frustrated with stay-at-home orders and the threat to their livelihoods. Though the WHO understands and shares the desire to return to normal life, there must be a “new normal” that is healthier, safer, and better prepared, Tedros said.

Key steps in the response, such as finding and testing all suspected cases, should still be the backbone of the response, and it’s also important to engage and empower people, he said.

When asked about protests against stay-at-home orders, Mike Ryan, MD, who leads the WHO’s health emergencies program, said his work in different outbreak settings, including Ebola in the Democratic Republic of Congo, shows that a high level of trust between citizens and the government is key. “That’s a valuable thing to have in the bank,” he said. “They have to believe there’s a plan, that there’s a reason for doing this.”

If plans and the rationale for response actions are murky, communications are vulnerable to be gamed and directed in counterproductive ways, Ryan said.

The process should be a two-way dialogue, which promotes transparency and ensures consistency so that people aren’t hearing different messages, he said, adding that civil society should also play a role so that not all communications are purely governmental.

Coronavirus (COVID-19) Update: FDA Encourages Recovered Patients to Donate Plasma for Development of Blood-Related Therapies

As part of the all-of-America approach to fighting the COVID-19 pandemic, the U.S. Food and Drug Administration 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. Today, 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-ledExternal Link Disclaimer 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 (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 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 eIND applications. The American Red Cross has also set up a website for interested donors (www.redcross.org/plasma4covidExternal Link Disclaimer) 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 two 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.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.