Gaps Remain for Pediatric Medical Countermeasures

Jan 26, 2016 | Raymond Puerini

During public health emergencies, children are a particularly vulnerable population as they have unique physical, physiological, and psychological characteristics that vary from adults. Additionally, the medical products and formulations children need often differ from adults and some medical products may not have the same usage approvals for children as they do for adults. Earlier this month the American Academy of Pediatrics released a policy statement detailing the current governmental efforts to address the medical countermeasure (MCM) needs of pediatric populations during public health emergencies, disasters, or terrorism. Additionally the policy statement goes on to make the following recommendations to address the shortfalls that still remain to adequately accommodate the needs of pediatric populations:

  1. “In the interest of preparing to meet the needs of children exposed to public health emergencies, disasters, or acts of terrorism, federal, state, and local governments should acquire and maintain adequate amounts of MCMs appropriate for children of all ages in caches such as the SNS.
  2. Biomedical research funded by the federal government that involves MCMs should include reasonable steps to accommodate the special protections afforded to children as human subjects, but such protections should not justify the failure to identify pediatric indications for MCMs.
  3. Federal, state, and local government, along with private sector and community stakeholders, should address the needs of children and families in MCM implementation, distribution, and administration planning.
  4. The federal government should proactively identify anticipated uses of MCMs in children during a public health emergency and, where pediatric FDA-approved indications do not exist, establish a plan to collect sufficient data to support the issuance of a pre-event EUA that includes information such as safety and dosing information.
  5. The federal government should use existing entities with pediatric SMEs, such as the PHEMCE, PedsOB IPT, and the DHHS National Advisory Committee on Children and Disasters, and continue to collaborate with private sector partners offering pediatric expertise to provide advice and consultation on pediatric MCMs and MCM distribution planning.
  6. Pediatric health care professionals should be provided with access to current information on the appropriate use of MCMs and local distribution plans so that they can provide effective health care to children and advise families during a public health emergency.

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