Pediatric Medical Countermeasures

Resources for Public Health Preparedness

Due to physiological differences, children’s responses to drugs may differ from those of adults. Developing products to diagnose and treat children poses many challenges, especially when developing medical countermeasures (MCMs), such as vaccines, drugs, and medical devices, that may be used in a public health emergency.

Public health emergencies could include the accidental or deliberate release of a biological, chemical, radiological, or nuclear (CBRN) substance, newly recognized naturally occurring infectious diseases, and natural disasters.

FDA is working to foster the development of safe and effective MCMs that may be needed during public health emergencies, including those for use in pediatric populations and young adults (less than 21 years of age). 

The resources below include information about these MCMs, and some of the scientific, ethical, and regulatory issues related to the development of pediatric MCMs and public health preparedness.

FDA Contacts

FDA Medical Countermeasures Initiative (MCMi)
Office of Counterterrorism and Emerging Threats
AskMCMi@fda.hhs.gov

FDA Office of Pediatric Therapeutics (also see Pediatrics)
OPT@fda.hhs.gov

NOTE: Non-FDA links below are included for reference, and do not necessarily reflect FDA's positions or opinions. Consistent with FDA website policies and disclaimer, reference in any referred (linked) website to commercial products, services, manufacturers, or companies does not constitute an endorsement by the U.S. government, the Department of Health and Human Services, or FDA.

FDA Guidance

• Search for FDA guidance documents
• Guidances and Other Information of Special Interest to MCM Stakeholders (including pediatrics)
• FDA issues two draft guidances for industry to support the approval of pediatric drug products (May 17, 2023)

FDA Pediatric Pages

Public information from FDA about pediatric topics and MCMs, including workshops, Advisory Committee meetings, presentations, and events

• Pediatric Medical Countermeasures (drugs)
  From FDA's Center for Drug Evaluation and Research (CDER), this page lists approved MCMs regulated by CDER and other considerations for bioterrorism and radiation emergencies
• Pediatrics
  Comprehensive science and research information, not limited to MCMs, from FDA’s Office of Pediatric Therapeutics on pediatric product development, including issues related to labeling, ethics, safety, and other regulatory considerations
• Pediatric Medical Devices
  Pediatric medical devices treat or diagnose diseases and conditions from birth through age 21. Some products are designed specifically for children, while others are borrowed from adult applications or produced for more general use
• Pediatric Product Development
  Many of FDA's initiatives around pediatrics have aimed to improve medical product research in children. Learn more about pediatric product development
• COVID-19 Vaccines
  Including information from FDA about vaccines for pediatric populations
• Pediatric Medical Device Development public meeting (Silver Spring, MD and webcast)
  August 13-14, 2018 - To identify strategies to enhance the medical device ecosystem to cultivate development and innovation of devices that serve the unique needs of pediatric populations
• Advancing the Development of Pediatric Therapeutics (ADEPT): Successes and Challenges of Performing Long-Term Pediatric Safety Studies - workshop materials [ARCHIVED]
  April 13-14, 2016 - Discussion with experts regarding the length of pediatric safety studies, including an exposition of the successes and challenges of long-term safety studies in children, and suggestions for study design and implementation
• 2013 Meeting Materials, Pediatric Advisory Committee to the Food and Drug Administration [ARCHIVED]
  September 19-20, 2013 - Meeting transcript and presentations, including a Pediatric Ethics Subcommittee discussion of the ethical issues involved in development of pediatric MCMs
• Workshop presentations: Ethical and Regulatory Challenges in the Development of Pediatric Medical Countermeasures [ARCHIVED]
  February 15-16, 2012 – Public workshop hosted by FDA, featuring science and ethics tracks - agenda and presentations

Ethical Considerations for Pediatric MCM Research

Additional information from FDA and other sources about ethical considerations for pediatric populations in MCM research and product development (also see FDA Pediatric Pages above)

• Global Regulators Envision Paradigm Shift Toward Inclusion of Pregnant and Breastfeeding Women in Clinical Research for Medicines and Vaccines
  July 2021 - "Concerned about the dearth of information available on the safety and effectiveness of medical products for pregnant and breastfeeding women, the FDA and many of its regulatory counterparts around the world say it is time to address inadequacies in research through a paradigm shift in the approach to studying medical products in these populations."
• Safeguarding Children: Pediatric Medical Countermeasure Research [ARCHIVED]
  March 2013 – Report from the Presidential Commission for the Study of Bioethical Issues
• Current Ethical and Regulatory Framework for Pediatric Product Development [ARCHIVED] (PDF, 756 KB)
  May 17, 2012 - Presidential Commission for the Study of Bioethical Issues meeting - presentation by Dr. Robert "Skip" Nelson (see next items for additional meeting info.)
• Presidential Commission for the Study of Bioethical Issues - Meeting Nine
  May 17, 2012 - Meeting information, including webcast video, transcripts, presentations and other coverage of pediatric MCM discussions [ARCHIVED]
• Special Considerations for Research with Children - transcript of session [ARCHIVED] (PDF, 122 KB)
  May 17, 2012 - Presidential Commission for the Study of Bioethical Issues meeting – includes FDA presentation by Dr. Robert "Skip" Nelson

Additional Resources

Resources from other sources, including other government agencies

• HHS Child and Adolescent Health Emergency Planning Toolkit
  14 million children in the U.S. have special health care needs, and meeting those needs becomes more challenging during disasters. This new toolkit can help health care, public health, and social services professionals meet their disaster health needs (March 2023)
• National Advisory Committee on Children and Disasters (NACCD)
  The Advisory Committee will provide advice and consultation to the HHS Secretary on pediatric medical disaster planning, preparedness, response, and recovery with respect to the medical and public health needs of children in relation to disasters
• Best Pharmaceuticals for Children Act (BPCA) Priority Lists of Pediatric Therapeutic Needs
  Lists organized by therapeutic area, including biodefense research priorities (developed by NIH in consultation with FDA and experts in pediatric research)
• Children in Disasters and Emergencies: Health Information Guide (NIH/NLM)
  A compendium of resources related to medical and public health issues of children in disasters and emergencies; links to journal articles and other materials that may be useful in preparedness, mitigation, response and recovery activities
• Children and Disasters (AAP)
  Information about pediatric disaster preparedness, from the American Academy of Pediatrics
• Caring for Children in a Disaster (CDC)
  Children are more vulnerable than adults in emergency situations; information about how children are different, tools and resources, and specific threats
• Radiation Emergency Medical Management (REMM)
  Treatment and diagnosis information for healthcare providers (including pediatric resources) about radiation emergencies
• Planning for Kids: Preparedness and Pediatrics (CDC)
  Information about a tabletop exercise for first responders, and resources for parents and caregivers
• National Pediatric Readiness Assessment
  For emergency departments: complete this assessment and track your improvement over time
• National Pediatric Disaster Coalition
  The mission of the National Pediatric Disaster Coalition (NPDC) is to advance community preparedness, mitigation, response and recovery for infants, children, and their families in disasters
• In the Event of Bioterrorism: Protecting Families from Deadly Diseases
  Information for parents, from the American Academy of Pediatrics (includes Spanish and audio versions)
• Resilient Children/Resilient Communities Toolbox
  The RCRC Toolbox was developed under a partnership between the National Center for Disaster Preparedness at Columbia University and Save the Children
• Pediatric Medical Countermeasure Roundtable for Health Security Meeting Report (PDF, 436 KB)
  October 13-14, 2010 – Meeting convened by the HHS PHEMCE
• Challenges in the Use of Anthrax Vaccine Adsorbed (AVA) in the Pediatric Population as a Component of Post-Exposure Prophylaxis (PEP) [ARCHIVED] (PDF, 780 KB)
  October 2011 - Report of the National Biodefense Science Board
• Emergency Preparedness and Response Resources for Maternal and Child Health (MCH) Populations
  June 16, 2015 – Recording of a webinar hosted by the Association of Maternal and Child Health Programs (AMCHP) (1 hour)
• 2014-2015 Report of the CHILD Working Group (PDF, 608 KB)
  February 2017 - HHS updates on: behavioral health; medical countermeasures; child physical health, EMS, and pediatric transport; child care, child welfare, and human services; pregnant and breastfeeding women and newborns; and children at heightened risk
• Zika Virus, Still a Threat - Updates and Implementation
  December 13, 2017 - American Academy of Pediatrics (AAP) webinar video recording (54 minutes)
• Pediatric Issues in Disasters (PDF, 6.4 MB)
  February 13, 2018 - ASPR TRACIE webinar materials
• PHEMCE Strategy and Implementation Plan
  From the HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) – includes information about pediatric populations
• COVID-19 Resources for Pediatric Healthcare Leaders and Clinicians
  From HHS
• Infant and Young Child Feeding in Emergencies (IYCF-E) Toolkit
  From CDC

Pediatric and Pregnancy Resources for Emerging Infectious Diseases

• From CDC:
  • Information about COVID-19 Vaccines for People who Are Pregnant or Breastfeeding
  • Clinical Considerations for mpox in Children and Adolescents
  • Clinical Considerations for mpox in People Who are Pregnant or Breastfeeding
  • Zika virus information for healthcare providers
  • Zika and Pregnancy
• Zika Training for Health Care Providers
  Training options for obstetric healthcare providers, pediatricians, and nurses, from CDC

Related Links

• Pediatrics
• What are Medical Countermeasures?
• Vaccines for Children - A Guide for Parents and Caregivers