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The Food and Drug Administration is working full speed, in collaboration with public and private sector partners, to diagnose, treat, and prevent this disease. Presently, there are no FDA-approved products to prevent, treat, or cure COVID-19. Treatment at most hospitals focuses on the symptoms and complications related to the virus--for example, patients are given fluids or, in cases of more severe illness, put on ventilators.
The National Institute of Allergy and Infectious Diseases (N.I.A.I.D.) predicts a vaccine will be ready in a year to a year-and-a-half. Vaccines that come to market have gone through rigorous testing during clinical trials with healthy individuals--anything that is developed without proper methodologies could be ineffective or dangerous for the public.
In the United States, the companies that are initiating vaccine development have received funding from two organizations: the Biomedical Advanced Research and Development Authority (BARDA), which is a
division of the Department of Health and Human Services, and the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health. Some companies have received funding from the Coalition for Epidemic Preparedness Innovations (CEPI), a global organization based in Oslo. Other companies are funding trials by themselves or through partnerships with other life sciences companies.
Food and Drug Administration Resources
For questions about shortages of COVID-19 diagnostic tests, personal protective equipment, as well as,vaccines and clinical trials for treatment of COVID-19, see the following Food and Drug Administration resources:
- FDA’s COVID-19 FAQ is useful for addressing questions related to vaccines, biologics, human tissue products, drugs, medical devices and tests, and food products.
- 24/7 Hotline for Diagnostics: for questions about testing or shortages of testing, personal protective equipment, or other supplies, call the toll-free line at 1-888-463-6332 (1-888-INFO-FDA), then choose option (*). The line is available 24 hours a day to help address difficulties obtaining supplies for collecting patient samples for COVID-19 testing, including swabs, media needed for transport, and conservation of the samples, among other things. Please note, however, that FDA does not control the production volume or distribution of medical devices.
- Personal Protective Equipment: for questions on health care spot shortages of personal protective equipment or other supplies, call the toll-free line at 1-888-463-6332 (1-888-INFO-FDA), then choose option (*). The line is available 24 hours a day to help address difficulties obtaining supplies. Please note, however, that FDA does not control the production volume or distribution of medical devices.
- Drug Shortages: for questions or concerns about a drug shortage, related or unrelated to COVID-19, call: 855-543-3784 or 301-796-3400 or email email@example.com. The FDA's Drug Shortage web page has information related to current shortages.
Plasma Donations from Recovered COVID-19 Patients
People who have fully recovered from COVID-19 have antibodies in their plasma that can attack the virus. This convalescent plasma is being evaluated as treatment for patients seriously ill with COVID-19. The Red Cross has been asked by the U.S. Food and Drug Administration (FDA) to help identify prospective donors and manage the distribution of these products to hospitals treating patients in need.
People who have fully recovered from COVID-19 for at least two weeks are encouraged to consider donating plasma, which could potentially help save the lives of up to four patients. Those willing to donate are urged to visit the American Red Cross website at www.redcrossblood.org/plasma4covid or contact their local blood donor or plasma collection center.
Volunteering or Equipment Donations
If you looking to donate, volunteer, or provide critical supplies to help with the pandemic, visit https://www.fema.gov/coronavirus/how-to-help