Update: HHS Expands Access to Childhood Vaccines during COVID-19 Pandemic

The concern of the American Academy of Pediatrics (AAP) and the American Medical Association (AMA) now weighs in on the pushback.

September is “National Immunization Awareness Month” and in the spirit of access of vaccines for children, the U.S. Department of Health and Human Services (HHS) issued a 3^rd amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to increase access to lifesaving childhood vaccines and decrease the risk of vaccine-preventable disease outbreaks as children across the United States return to daycare, preschool and school.

According to HHS Secretary Alex Azar, “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…” However, this action is being met with resistance from the American Academy of Pediatrics (AAP).

The amendment authorizes State-licensed pharmacists (and pharmacy interns acting under their supervision to administer vaccines, if the pharmacy intern is licensed or registered by his or her State board of pharmacy) to order and administer vaccines to individuals ages three through 18 years, subject to several requirements. The requirements include at a minimum,

• The vaccine must be approved or licensed by the Food and Drug Administration (FDA).
• The vaccination must be ordered and administered according to the CDC’s Advisory Committee on Immunization Practices (ACIP) immunization schedules.
• The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.
• The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each State licensing period.
• The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient’s primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine.
• The licensed pharmacist must inform his or her childhood-vaccination patients and the adult caregivers accompanying the children of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients as appropriate.

The above requirements are consistent with many States that already permit licensed pharmacists to order and administer vaccines to children.

Because of the pandemic, a May 2020 (CDC) report found a marked drop in routine childhood immunizations as a result of families staying at home. While families followed public health warnings about not going out, the result was many missed routine vaccinations. This decrease in childhood-vaccination rates is considered a public health threat.

According to HHS Assistant Secretary for Health Brett P. Giroir, M.D., “The cornerstone of public health, vaccines, makes these dreaded diseases preventable.”

HHS’s argument is that 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, is necessary.

However, the AAP (American Academy of Pediatrics), opposed the HHS decision authorizing all state-licensed pharmacists to order and administer vaccines to children aged 3 to 18 years.

The AMA also, issued a statement on August 29, saying, “Children must have access to vaccines, but COVID-19 should not allow leeway around scope-of-practice laws. We oppose HHS’s declaration allowing pharmacists and pharmacy interns to administer vaccines to children between 3 and 18 years old.

AAP argues, that “there is more to well-visits than just administering vaccines — the visits provide pediatricians an opportunity to care for patients in ways that a pharmacist cannot”.

Although catching up and getting better immunization rates is everyone’s goal, the AAP is making a valid and important point in their objection,” said Infectious Diseases in Children Chief Medical Editor Richard F. Jacobs, MD, professor emeritus at University of Arkansas for Medical Sciences, who called the HHS decision “probably well-meaning [but] not in the best interest of our children.”

“The visit for immunizations is only part of the visit to the pediatrician,” Jacobs said. “Preventive screening, routine exam updates, counseling, parents’ questions and, importantly, getting to talk to the child or adolescent are vitally important. All of this could be lost with the new HHS directive.”

Creating a new vaccination system is unnecessary and will not provide children with the same level of optimal medical care they receive from a pediatrician who knows the child’s medical history, according to the AAP. There is a disconnect in the giving of vaccines “only” and the child well-check encounter along with their childhood vaccines.

“We do more at our visits than just give vaccines,” AAP President Sally Goza, MD, FAAP, told Healio. “That’s when our patients come in and we can talk to them about risk taking, we can talk to the teenagers about anxiety and depression, other things that may be going on in their lives, what’s happening in school, all of those things. It’s very important not to just look at vaccines as being just vaccines.” There are also discussions with parents about vaccine hesitancy during well visits, that would not be had by pharmacists as that would be outside their scope of practice.

Further, a pharmacist does not have evaluation and management discussion services under a payer policy. That is not their role. Their discussions are limited to the injections and the CDC rules on the administration of those vaccines. Period. There is no counseling service billable or afforded to a pharmacist under their licensure to expand beyond the vaccine.

(We saw this problem with the COVID-19 counseling services. Pharmacists alone cannot bill for counseling under their license only a physician or QHP can)

“We’re trying to address vaccine hesitancy among parents, which is one of the reasons immunization rates are dropping,” Dr. Goza continued. “People don’t really want to go and get vaccines. So, they come in and we do a lot of talking about what vaccines children need and why they need them and what they protect against. We just don’t feel [that] creating a system that duplicates what we already do is going to really help get people in who are not really wanting to vaccinate anyway.”

According to the AAP, few pharmacies participate in the Vaccines for Children program, the federal program that provides immunizations to children at no cost to children whose families cannot afford them. This will widen health inequities even further than what children have faced during the COVID-19 pandemic, the AAP said.

“People trust their pediatricians,” Goza said. “They come to us, they ask us, ‘What do you think about that vaccine? Would you give it to your child?’ These conversations are between the parents, child and pediatrician. Further, even though a Pharmacist may encourage a well-check with the child’s pediatrician or primary care physician, most fear that they won’t schedule this visit if the vaccines were already taken care of.

Vaccines administered by a Pharmacist could be likened to a flu shot. Go in, get your shot, and leave all in a five-minute, drive by. There is typically no follow up with adults with their family doctor unless they get sick. This should not be the same for our pediatric population.

The AAP argued that the HHS decision superseded state laws governing pharmacist-delivered vaccinations and used the COVID-19 pandemic as justification to create policy changes that go beyond care related to COVID-19.

“Instead of creating difficult and low-quality systems to deliver that health care — those vaccines — we would love for the government to invest in the frontline physicians who are already doing this important work,” Dr. Goza said. “We’re taking care of these kids. We want to get them vaccinated.”

Once the pandemic ends or the PHE is lifted, a shift in this policy should take place. Time will tell.