The FDA is working to address the coronavirus disease 2019 (COVID-19) outbreak and keep you and your family informed on the latest developments. Here are answers to some frequently asked questions from consumers about monoclonal antibodies, infusion locations, and vaccines. Q: What is a monoclonal antibody? A: Monoclonal antibodies are laboratory-produced molecules that act as substitute antibodies that can restore, enhance or mimic the immune system's attack on cells. Monoclonal antibodies for COVID-19 may block the virus that causes COVID-19 from attaching to human cells, making it more difficult for the virus to reproduce and cause harm. Monoclonal antibodies may also neutralize a virus. Q: Where are infusions of monoclonal antibody treatments available? A: The following websites contain information regarding access to monoclonal antibody treatments for COVID-19: Monoclonal antibody treatments for COVID-19 may only be administered in settings in which health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and have the ability to activate the emergency medical system (EMS), if necessary. Please speak with your doctor or contact your local or state public health department for more information. Q: Are there any vaccines available to prevent COVID-19? A: Yes. On Dec. 11, 2020, the FDA issued the first Emergency Use Authorization for a COVID-19 vaccine, and on Dec. 18, 2020, authorized a second COVID-19 vaccine. Additionally, the FDA is working with other vaccine developers, researchers, and manufacturers to help expedite the development and availability of medical products such as additional vaccines, monoclonal antibodies, and other drugs to prevent or treat COVID-19. Read more about what the FDA is doing to mitigate the effects of COVID-19. The FDA has scheduled a public meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) at 9 a.m. Friday, Feb. 26, to discuss a request for an EUA of another COVID-19 vaccine. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. To watch the web conference meeting, visit: Although the VRBPAC members provide advice to the agency, which may include advice on the safety and effectiveness data submitted in the EUA request, final decisions on whether to authorize the vaccine for emergency use are made by the FDA. Read this Consumer Update to learn more about how advisory committees help the FDA make sound decisions based on the best science available, and watch this video to learn about EUAs. For information about vaccine clinical trials for COVID-19 visit clinicaltrials.gov and the COVID-19 Prevention Network. Note: The information on clinicaltrials.gov is provided by the sponsor or principal investigator of a clinical trial. The listing of a study on the site does not reflect evaluation or endorsement of the trial by the federal government. For more information about COVID-19, visit: |
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