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: December 17, 2021Press Announcements FDA News Release
  Coronavirus (COVID-19) Update: December 17, 2021

  
  Share
    Post
    Linkedin

    Email
    PrintFor Immediate Release:
                  December 17, 2021
 

  
      
       

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

On December 15, 2021, the FDA approved an abbreviated new drug application (ANDA 211538) for Vasopressin Injection, 20 Units/mL Multiple Dose Vials, indicated to increase blood pressure in adults with vasodilatory shock (sudden relaxation of blood vessels) who remain hypotensive (low blood pressure) despite fluids and catecholamines (a class of neurotransmitters). The most common adverse reactions include decreased cardiac output, bradycardia (slow heart rate), tachyarrhythmias (rapid heart rate), hyponatremia (low sodium levels), and ischemia (inadequate blood supply to a part of the body). This action is the first approval of an ANDA for this product. The FDA recognizes the increased demand for certain products during the COVID-19 public health emergency, and we remain deeply committed to facilitating access to medical products to help address critical needs of the American public.
	On December 16, 2021, the FDA approved a manufacturing change for Comirnaty (COVID-19 Vaccine, mRNA) to include a formulation that uses a different buffer. Buffers help maintain a vaccine’s pH (a measure of how acidic or alkaline a solution is) and stability. This new formulation is more stable at refrigerated temperatures for longer periods of time, permitting greater flexibility for vaccination providers. This formulation of Comirnaty does not need to be diluted before use, thus, vaccination providers can more readily prepare and deliver appropriate doses. The new formulation contains Tris buffer, a commonly used buffer in other FDA-approved vaccines and biologics. The FDA previously authorized this vaccine formulation for the Pfizer-BioNTech COVID-19 Vaccine in October. The FDA-approved Comirnaty (COVID-19 Vaccine, mRNA) and Pfizer-BioNTech COVID-19 Vaccine authorized for Emergency Use Authorization (EUA) for individuals 12 years of age and older, when prepared according to their respective instructions for use, can be used interchangeably.
	Testing updates:
	As of today, 422 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 292 molecular tests and sample collection devices, 89 antibody and other immune response tests and 41 antigen tests. There are 67 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one EUA for a molecular prescription at-home test, three EUAs for antigen prescription at-home tests, 11 EUAs for antigen over-the-counter (OTC) at-home tests and three EUAs for molecular OTC at-home tests.
		The FDA has authorized 22 antigen tests and nine molecular tests for serial screening programs. The FDA has also authorized 720 revisions to EUA authorizations.Related Information
  
  Related Information
              COVID-19 Vaccines
	Coronavirus Disease 2019 (COVID-19)

###
  Boilerplate
      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.
Inquiries
  
    
        
         Media:
                 
      
                            Alison Hunt
           
           
                      888-INFO-FDA
    Consumer:
                        888-INFO-FDA

                                                                                  Content current as of:
      12/17/2021
               
               
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