Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Press Announcements

Press Announcements Home
          News & Events
          FDA Newsroom
          Press Announcements
          Coronavirus (COVID-19) Update: February 5, 2021Press Announcements FDA News Release
  Coronavirus (COVID-19) Update: February 5, 2021

  
  Share
    Post
    Linkedin

    Email
    PrintFor Immediate Release:
                  February 05, 2021
 

 

  The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) for Feb. 26, 2021, to discuss the request for emergency use authorization (EUA) for a COVID-19 vaccine from Janssen Biotech Inc. The FDA intends to make background materials available to the public, including the meeting agenda and committee roster, no later than two business days prior to the meeting. In general, advisory committees include a chair, members with scientific and public health expertise, and a consumer and industry representative. Additional members with specific expertise may be added for individual meetings as needed. The members of the VRBPAC are independent, scientific and public health experts from around the country who provide advice to the agency, which may include advice on the safety and effectiveness data submitted in the EUA request. However, final decisions on whether to authorize the vaccine for emergency use are made by the FDA.
	The FDA is alerting health care professionals and compounders of potential risks associated with compounding remdesivir drug products. The FDA cautions against compounding remdesivir drug products. The agency recommends health care providers utilize the FDA-approved drug for patients who are prescribed remdesivir. Compounded drugs are not FDA-approved. This means the FDA does not verify the safety, effectiveness, or quality of compounded drugs. Compounded drugs should only be used in patients whose medical needs cannot be met by an FDA-approved drug.
	On Feb. 4, the FDA revised the Letter of Authorization for COVID-19 convalescent plasma to limit the authorization to the use of high titer COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19 early in the disease course and to those hospitalized patients who have impaired humoral immunity and cannot produce an adequate antibody response. Data indicates that plasma with low levels of antibodies may not be effective in treating COVID-19. The revision was based upon data from new clinical trials analyzed or reported since the original EUA was issued in August 2020.
	On Feb. 4, the FDA issued a statement noting that as part of its commitment to a public and transparent process, the FDA is developing guidances for diagnostic, therapeutic and vaccine developers to help guide ongoing medical product development as they evaluate the impact of COVID-19 variants on their products.
	Testing updates:
	As of today, 322 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 239 molecular tests and sample collection devices, 69 antibody tests, and 14 antigen tests. There are 35 molecular authorizations that can be used with home-collected samples. There is one molecular prescription at-home test, one antigen prescription at-home test, and one over-the-counter (OTC) at-home antigen test.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.

  Related Information
  
  Related Information
              COVID-19 Vaccines
	Coronavirus Disease 2019 (COVID-19)

###
Inquiries
  
    
        
         Media:
                 
      
                            Lindsey O’Keefe
           
           
                      888-INFO-FDA
    Consumer:
                        888-INFO-FDA

                                                                                  Content current as of:
      02/05/2021
               
               
Regulated Product(s)
		 Biologics
			  			     			  			     Drugs
			     			  			     Medical DevicesHealth Topic(s)
			  Infectious Disease
			    			       			    			       Coronavirus   

        Follow FDA
            Follow @US_FDAon X
                Follow FDAon Facebook
                Follow @FDAMediaon XMore Press Announcements
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop