Novel Coronavirus Disease (COVID-19) Resources

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The Plasma Protein Therapeutics Association (PPTA) and its member companies are closely monitoring the rapidly changing information landscape regarding the spread of Novel Coronavirus 2019 (COVID-19) and wish to be a resource for patients, plasma donors, policymakers, and other stakeholders during this pandemic.

Plasma donors save lives! Your donations are even more essential during the current COVID-19 pandemic to ensure patients with rare diseases can keep receiving their lifesaving treatments. Authorities in the U.S. and in the EU have published guidance documents recognizing the essential nature of plasma donation. Please click here to find a plasma donation center near you.

Resources below include:

Safety

As it has done for nearly three decades, PPTA endeavors to be a trusted resource and to share important information about the safety of plasma-derived products and the safety of plasma donation.

Based on the established processes of virus inactivation and removal during manufacturing of plasma-derived products, PPTA concludes that SARS-CoV-2, the virus that causes COVID-19, is not a concern for the safety margins of plasma protein therapies manufactured by PPTA member companies. PPTA’s full statement on the safety of plasma-derived products can be read here.

Plasma donors save lives by donating at plasma centers that collect blood plasma used to manufacture lifesaving pharmaceuticals. PPTA wants to remind current and potential new plasma donors in the United States and in the European Union to know that:

  • plasma donation continues to be a safe process,
  • there have been no blood-borne transmissions of the coronavirus, and
  • the need for plasma donations is just as great as ever!

We encourage people interested in plasma donation to visit www.donatingplasma.org to find a center near them.

Advocacy

As part of its advocacy in support of the needs of patients and plasma donors, PPTA is in touch with decision-makers in the U.S. and the EU. Copies of recent correspondence with decision-makers in the U.S. and EU can be found here.

On March 28, 2020, the U.S. Department of Homeland Security released an updated guidance document that continued to enumerate source plasma donation as part of the critical infrastructure.

Plasma donation centers have been classified as being within the category of essential, critical infrastructure (health care and pharmaceutical supply) that is exempted from general lockdown or closure directives.

The European Centre for Disease Prevention and Control and the European Commission consider that:

  • plasma donors, plasma collection centers and plasma as essential. National competent authorities should include plasma collection centers in their lists of essential services during the Corona pandemic
  • national policies should prioritise the supply of personal protective equipment, such as face masks and gloves, for plasma centers in the same way as for hospitals;
  • national competent authorities should establish plasma contingency planning and encourage plasma donations for the development of PDMPs
  • substances of Human Origin, including plasma for the manufacturing of PDMPs are essential goods and services for which cross-border and free circulation within the EU is crucial

PPTA will continue advocating for patients and donors with authorities in the U.S. and the EU.

Addressing the Challenges

Though the critical need for plasma to treat patients remains unchanged, COVID-19 precautions implemented in the interest of the public health is taking precedence in some U.S. and EU locations. PPTA members are meeting these requirements, and some have already shared steps they are taking to develop test kits and treatments for the virus as well as the illness caused by the virus.

We are facing a crisis unlike anything any of us have faced before, but PPTA remains steadfastly committed to its mission to promote the availability of — and access to — safe and effective plasma protein therapies for all patients, no matter where they are around the world. With that in mind, PPTA and its member companies will continue working with patients, advocacy groups, plasma donors, governmental authorities, and others every day as we all work together to ensure donors are able to continue donating their essential plasma and that patients can safely access their therapies.

For More Information

Please email Mat Gulick, PPTA’s Director of Global Communications, to learn more about PPTA’s activities throughout this current situation on behalf of plasma donors and the patients who rely on their donations.

Additional Resources:

APLUS
The American Plasma Users Coalition supports plasma donor recognition & home infusion.

CDC
Response updates from the U.S. Centers for Disease Control & Prevention.

ECDC
See updates from the European Centre for Disease Prevention and Control.

“ECDC publishes "Coronavirus disease 2019 (COVID-19) and supply of substances of human origin in the EU/EEA”

EMA
Find the newest information from the European Medicines Agency.

European Commission
Read the Guidelines for border management measures to protect health and ensure the availability of goods and essential services.

The EU Commission clarifies that plasma for manufacturing medicinal products is considered an essential good/service for which free circulation in the EU is crucial.

FDA
Find more information from the U.S. Food and Drug Administration.

Guidance for Industry: "Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency"

Guidance for Industry: "Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products"

IPOPI
The International Patent Organisation for Primary Immunodeficiencies published an open letter calling on authorities around the world to ensure sufficient plasma and blood availability during and after the COVID-19 pandemic.

PPTA
Read the Association’s “Donor History Questionnaire” Response to the COVID-19 Outbreak.

Current considerations for plasma donation centers for COVID-19.

The White House
The President’s Coronavirus Guidelines for America.

WHO
Get the latest information from the World Health Organization.

WHO publishes "Maintaining a safe and adequate blood supply during the pandemic outbreak of coronavirus disease (COVID-19)."

This information will be updated, as needed, based on new information and additional activities PPTA undertakes to ensure the availability of plasma protein therapies and donors’ ongoing ability to donate plasma.

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