The checks and balances that uphold safe, effective immunization schedules

The checks and balances that uphold safe, effective immunization schedules | Donna Hallas, PhD, PPCNP-BC, CPNP, PMHS, FAANP, FAAN

The Intranasal influenza vaccine (FluMist) has received FFDA approval for parents to administer the vaccine at home to their healthy children between the ages of 2 and 17 years.¹ The Intranasal influenza vaccine was also approved for healthy individuals between the ages of 18 and 49 years to be administered by themselves at home.¹ An adolescent must be 18 years ]to self-administer the vaccine.¹ A report from Contemporary Pediatrics, discusses the rationale for the decision by the FDA which is the first time a vaccine has been available for at-home administration.²

In the article, Tina Tan, MD, editor-in-chief of Contemporary Pediatrics, a physician who specializes in infectious disease, discussed the need for clear instructions for the individuals who plan to administer the intranasal influenza vaccine, Flumist, to themselves or their children. Instructions for administering the vaccine at home is a critical component for success of this new initiative for home administration.

When vaccines are ordered in pediatric offices, the vaccine is documented in the office chart and on the respective state’s registry. Questions that must be addressed prior to implementation include: How will documentation of administering the vaccine be placed on state vaccine registries? How can providers be assured that the dose was administered by the parent to the child or by the individual to themselves? How will all individuals be educated and demonstrate understanding on the method to administer the influenza vaccine?

Role of the FDA in vaccine safety and efficacy

To assure the quality and safety of any vaccine, the FDA is responsible for critically reviewing the research data on the vaccine presented by the drug company for safety and effectiveness, and the benefits and possible risks for the populations who will receive the vaccine. Once a vaccine is approved and distribution occurs, the FDA continues to monitor the vaccine to identify any possible safety concerns. The FDA has followed their procedures to approve the intranasal influenza vaccine.

Role of the ACIP in vaccine safety and efficacy

Another committee that assesses the safety and efficacy of vaccines is Advisory Committee on Immunization Practices (ACIP). ACIP was established in March 1964 by the U.S. Surgeon General.³ “In 1972, ACIP was designated a federal advisory committee under the Federal Advisory Committee Act” (p.1).³ ACIP provides scientifically based recommendations to the CDC for implementation of the US. immunization programs for the pediatric and adult populations.

Today, ACIP is composed of 15 voting members, of which 14 individuals are vaccine experts and one individual that represents the consumers perspectives. In addition, there are 30 non-voting members who represent professional organizations, e.g., the American Academy of Pediatrics (AAP), the American College of Midwives (ACNM), and the National Association of Pediatric Nurse Practitioners (NAPNAP), etc. ACIP meetings are scheduled throughout the year and for full transparency, the meetings are open to the public, via online webcast. “The CDC Director reviews and decides whether to formally adopt ACIPs recommendations” (p. 1).³ At the time of this writing, there are significant concerns that the established ACIP committee may not continue as it has been established.

Providers role in vaccine safety and efficacy…Let our voices be heard

Why is it essential for all health care providers to be knowledgeable about and supportive of the roles of the FDA, ACIP, and the CDC in vaccine decision making and immunization schedules? For pediatric providers who worked during the years prior to the development of many of the vaccines we have available today, we experienced first-hand, how critically ill the child was who presented with epiglottis, meningitis, pertussis, and the frustration and overwhelming sadness we felt when treatments failed, and we lost a child. We cannot go back to such tragedies.

The checks and balances for safe and effective immunization schedules is the result of the work by scientists who develop the vaccines, the FDA, ACIP, and the CDC, who create safe and effective immunization schedules, and the providers who administer the vaccines and monitor and report any potential side effects. As health. care providers, it is imperative that we all continue to have our voices heard at state and national levels that immunizations are an essential component of health care…that we cannot tolerate a return to disease outbreaks that are vaccine preventable.

References

1. FDA approves nasal spray influenza vaccine for self- or caregiver-administration. News release. FDA. September 20, 2024. Accessed September 20, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-nasal-spray-influenza-vaccineself-or-caregiver-administration

2. Fitch J. FDA approves FluMist for self or caregiver administration. Contemporary Pediatrics, 33. 2025. Accessed February 21, 2025. https://cdn.sanity.io/files/0vv8moc6/contpeds/e8860d83f7c61a5c0871ced3cb130e16fac2ab40.pdf/CNTPED010225_Ezine.pdf

3. In Focus: Congressional Research Service. The advisory committee on immunization practices (ACIP). 2024. Accessed February 20, 2025. https://crsreports.congress.gov/product/pdf/IF/IF12317