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: FDA Advisory Committee Meeting to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of AgePress Announcements FDA News Release
  Coronavirus (COVID-19) Update: FDA Advisory Committee Meeting to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of Age

  
  Share
    Post
    Linkedin

    Email
    PrintFor Immediate Release:
                  February 01, 2022
 

  
      
       

  Español

Today, the U.S. Food and Drug Administration is announcing a virtual meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 15 to discuss the request for emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine for use in children 6 months through 4 years of age.

**“Having a safe and effective vaccine available for children in this age group is a priority for the agency and we’re committed to a timely review of the data, which the agency asked Pfizer to submit in light of the recent Omicron surge. Furthermore, children are not small adults. Because they’re still growing and developing, it’s critical that these vaccines are evaluated in well-designed and well-conducted clinical trials,” said Acting FDA Commissioner Janet Woodcock, M.D. "In the meantime, the best way to protect children, including when they are at school or daycare, is to practice social distancing and masking in accordance with public health recommendations, and for their family members and caretakers to get vaccinated or receive a booster dose when eligible.”**
 
The FDA authorized the Pfizer-BioNTech COVID-19 Vaccine for use in children 5 through 11 years of age in October 2021 and recently authorized the use of a single booster dose in individuals 12 through 15 years of age and older. As of Dec. 19, 2021, according the Centers for Disease Control and Prevention (CDC), 8.7 million COVID-19 vaccinations have been given to kids 5 through 11 years of age, which is about one-third of the approximately 24 million U.S. kids this age in the U.S. There are approximately 18 million children less than 5 years of age in the U.S.

**“The need for a safe and effective vaccine for our youngest children is significant, particularly given the rapid spread of the omicron variant, the notable rise in the number of hospitalizations in young children with severe disease, and the possibility that future variants could cause severe disease in those who are unvaccinated,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “As we have done for other COVID-19 vaccine authorizations, this meeting will help ensure that the public has a clear understanding of the data and information the FDA will evaluate as it considers whether to authorize the vaccine. We are committed to a transparent process, which will include input from our external advisors.”**

The FDA intends to make background material available to the public, including the meeting agenda and committee roster, no later than two business days before the meeting.

In general, advisory committees include a Chair, members with scientific, medical and public health expertise and a consumer and industry representative.

The FDA intends to livestream the VRBPAC meeting on the agency’s YouTube channel; the meeting will also be webcast from the FDA website.

  Related Information
  
  Related Information
              Vaccines and Related Biological Products Advisory Committee
	Comirnaty and Pfizer-BioNTech COVID-19 Vaccine
	COVID-19 Vaccines
	Emergency Use Authorization for Vaccines Explained

###
  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:
                 
      
                            FDA Office of Media Affairs
           
           
                      301-796-4540
    Consumer:
                        888-INFO-FDA

                                                                                  Content current as of:
      02/01/2022
               
               
Regulated Product(s)
		 BiologicsHealth 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