HHS Authorizes Pharmacists to Administer Childhood Vaccines

HHS recently issued a third amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to expand access to lifesaving childhood vaccines during the COVID-19 pandemic.

The increased access to vaccines decreases the risk of vaccine-preventable disease outbreaks as children in the US prepare to return to daycare, preschool, and school.

"Today’s action means easier access to lifesaving vaccines for our children, as we seek to ensure immunization rates remain high during the COVID-19 pandemic,” said HHS Secretary Alex Azar.

“The Trump Administration has worked to allow pharmacists—alongside all of America’s heroic healthcare workers—to practice at the top of their license, empowering the public with more options to protect their health and well-being.”

The amendment authorizes state-licensed pharmacists or pharmacy interns under supervision, to order and administer vaccines to individuals ages three to 18 years of age.

Pharmacists already play a vital role in annual influenza vaccinations, but the amendment will give them a bigger part to play in a post-pandemic world.

“Given the potential danger of serious influenza and continuing COVID-19 outbreaks this autumn and the impact that such concurrent outbreaks may have on our population, our healthcare system, and our whole-of-nation response to the COVID-19 pandemic, we must quickly expand access to influenza vaccinations,” HHS said in the amendment.

“Allowing more qualified pharmacists to administer the influenza vaccine to children will make vaccinations more accessible.”

HHS’ motive for increasing access to vaccines was a May 2020 CDC report, which found that there was a drop in routine childhood immunizations as a result of families staying home because of COVID-19.

Brett P. Giroir, MD, HHS assistant secretary for health noted that there can be major damage done to a child when he/she suffers from a vaccine preventable diseases, including severe brain damage.

“The cornerstone of public health, vaccines, makes these dreaded diseases preventable. As we expand options during the COVID-19 response, we are also reminding parents, grandparents, and caretakers that there is no substitute for a critically important well-child visit with a pediatrician or other licensed primary care provider when available,” he said.

But there are several requirements regarding vaccine administration.

First, the vaccine must be approved or licensed by FDA and must be ordered and administered according to the CDC’s Advisory Committee on Immunization Practices (ACIP) immunization schedules.

The licensed pharmacist must also complete a practical training program of at least 20 hours, including hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition of treatment emergency reactions to vaccines.

The pharmacist must also have a current certificate in basic cardiopulmonary resuscitation and must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State-licensing period, HHS stated.

Additionally, the pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction and is required to inform their patients and the adult caregivers of the importance of a visit with a pediatrician or primary care provider.

“HHS is expanding access to childhood vaccines to avoid preventable diseases in children, additional strains on the healthcare system, and any further increase in avoidable adverse health consequences—particularly if such complications coincide with an additional resurgence of COVID-19,” HHS concluded.

In mid-July, the World Health Organization and UNICEF warned that the decrease in children receiving life-saving vaccines is due to the disruption in the delivery and uptake of immunization services caused by the pandemic.

These disruptions threaten to undo the progress already made to reach more children and adolescents with a wider range of vaccines.

WHO noted preliminary data for the first four months of 2020 showed a substantial drop in the number of children completing three doses of the vaccine against diphtheria, tetanus and pertussis (DTP3).

This is the first time in 28 years that there may be a reduction in DTP3 coverage, the organization said.

“Vaccines are one of the most powerful tools in the history of public health, and more children are now being immunized than ever before,” said Tedros Adhanom Ghebreyesus, MD, WHO Director-General.

“But the pandemic has put those gains at risk. The avoidable suffering and death caused by children missing out on routine immunizations could be far greater than COVID-19 itself. But it doesn’t have to be that way. Vaccines can be delivered safely even during the pandemic, and we are calling on countries to ensure these essential life-saving programmes continue.”