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Regulatory Focus™ > News Articles > 2020 > 9 > Pharmacists can give COVID-19 vaccines, says HHS

Pharmacists can give COVID-19 vaccines, says HHS

Posted 11 September 2020 | By Kari Oakes 

Pharmacists can give COVID-19 vaccines, says HHS

The US Department of Health and Human Services has authorized all state-licensed pharmacists and pharmacy interns who have completed required training to administer vaccines for COVID-19 when they become available.
The new guidance, dated 3 September 2020, supersedes any state or local laws that “prohibit or effectively prohibits” pharmacists and interns who would otherwise be able to perform vaccination under the new HHS directive.
However, the guidance sets certain requirements: the vaccine must be authorized or licensed by the US Food and Drug Administration (FDA), and recommendations from the Advisory Committee on Immunization Practices (ACIP) must be followed.
Also, pharmacists and interns must complete an approved training program that includes hands-on injections and evaluation of indications and contraindications, as well as emergency evaluation and treatment of vaccine reactions. Vaccine administrators must also be CPR certified.
The guidance also lays out recordkeeping requirements and specific requirements for vaccinating minors that include the obligation to inform caregivers of minor patients of the importance of well-child visits with primary care providers.
At a meeting of ACIP in August 2020, the manufacturers of two leading messenger RNA (mRNA) vaccine candidates discussed their preliminary ideas about availability, supply, and distribution of vaccines. No mRNA vaccine has yet been approved for any indication, but the cold storage chain required for both the Moderna and Pfizer/BioNTech vaccines will be a consideration for retail pharmacy administration of these vaccines should they be authorized or approved.
According to data presented by the companies at the ACIP meeting, Pfizer will require transport and storage temperatures of -70 degrees Celsius for its mRNA candidate COVID-19 vaccine, while the Moderna candidate requires -20 degrees Celsius for safe transport and storage.


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Tags: coronavirus, HHS, US