In response to the decrease in childhood vaccinations, largely due to COVID-19, HHS has authorized pharmacists to administer childhood vaccinations to limit the risk of increased rate of infection disease.
Changes in health care access, COVID-19 mitigation strategies, and parental concerns about potentially exposing children to COVID-19 during well child visits, has led to a significant decrease in routine pediatric vaccine ordering and doses administered. The decrease in childhood vaccination rates is a public health threat and a collateral harm caused by COVID-19. To address this public health threat, HHS has amended the Declaration for medical countermeasures against COVID-19. The Declaration has been amended address COVID-19’s impact on the decrease in the rate of childhood vaccinations, and to include pharmacists as covered persons for the purposes of administering childhood vaccinations (Notice, 85 FR 52136, August 24, 2020).
Declaration. The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes HHS to issue a declaration to provide liability immunity to certain individuals and entities (covered persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures, except for claims involving "willful misconduct." On January 31, 2020, HHS declared a public health emergency for the United States to aid in the response of the nation’s health care community to the COVID-19 outbreak, and that declaration was renewed in April and July.
On March 10, 2020, HHS issued a Declaration under the PREP Act for medical countermeasures against COVID-19. This declaration was amended on April 10 to extend liability immunity to covered countermeasures authorized under the Coronavirus Aid, Relief, and Economic Security (CARES) Act, and again on June 4 to clarify that covered countermeasures include qualified countermeasures that limit the harm COVID-19 might otherwise cause.
Vaccination rates. The CDC reported a decrease in rates of routine childhood vaccinations due to changes in healthcare access, social distancing, and other COVID-19 mitigation strategies. According to the CDC, the identified declines in routine pediatric vaccine ordering and doses administered might indicate that U.S. children and their communities face increased risks for outbreaks of vaccine-preventable diseases. The decrease in childhood-vaccination rates is a public health threat and a collateral harm caused by COVID-19.
Amendment. HHS has now amended the Declaration to identify certain State-licensed pharmacists and pharmacy interns as qualified persons covered under the PREP Act. The amendment authorizes them to administer any vaccine that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP’s standard immunization schedule. According to HHS, Pharmacists are well positioned to increase access to vaccinations, particularly in certain areas or for certain populations that have too few pediatricians and other primary-care providers, or that are otherwise medically underserved. They also often offer extended hours and added convenience, and already play a significant role in annual influenza vaccination. The pharmacist or intern must meet certain requirements to qualify for administering vaccines, including completing certain training and holding certain certificates. These requirements are consistent with those in states that already permit licensed pharmacists to order and administer vaccines to children.
Additionally, the decrease in ACIP-recommended childhood vaccinations and the resulting increased risk of associated diseases, adverse health conditions, and other threats are categories of harms otherwise caused by COVID-19. Therefore, HHS amended the declaration to clarify that the category of disease, health condition, or threat for which HHS recommends the administration or use of the covered countermeasures is not only COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom, but also other diseases, health conditions, or threats that may have been caused by COVID-19, SARS-CoV-2, or a virus mutating therefrom, including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infection diseases.
FederalRegisterIssuances: Notices DrugNews
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