Montgomery Medicine No. 796

How are Vaccines Approved?

I have been asked to write about how vaccines are approved in the United States. Two pivotal committees play crucial roles in ensuring the safety and efficacy of vaccines: the Vaccines and Related Biological Products Advisory Committee (VRBPAC) and the Advisory Committee on Immunization Practices (ACIP). While both are integral to vaccine oversight, they serve distinct functions and have members with specialized knowledge.

The VRBPAC operates under the auspices of the Food and Drug Administration (FDA). Its primary responsibility is to evaluate data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products intended for human disease prevention, treatment, or diagnosis. This committee provides recommendations to the FDA Commissioner on regulatory issues, including the approval of new vaccines. The VRBPAC consists of 15 voting members, including the Chair, selected by the FDA Commissioner or their designee. These members are authorities in fields such as immunology, molecular biology, virology, bacteriology, epidemiology, biostatistics, and related scientific areas. Additionally, the committee includes a consumer representative to provide perspectives on the social and community aspects of vaccination, and a non-voting industry representative to offer insights from the vaccine manufacturing sector.

In contrast, the ACIP is an advisory committee within the Centers for Disease Control and Prevention (CDC). Established in 1964 by the U.S. Surgeon General, its mission is to provide advice and guidance on effective control of vaccine-preventable diseases in the U.S. civilian population. The ACIP develops written recommendations for the routine administration of vaccines to both pediatric and adult populations, including vaccination schedules that take into account appropriate timing, dosage, and contraindications. These recommendations are considered official federal guidelines upon approval by the CDC Director. Similarly to VRBPAC, the committee comprises up to 15 voting members, experts in fields such as immunization practices, public health, vaccine research, and clinical use of vaccines. At least one member is a consumer representative, providing perspectives on social and community aspects of immunization programs. Members are appointed by the Secretary of Health and Human Services and serve four-year terms. The ACIP also includes non-voting ex officio members from federal agencies involved with vaccine issues and non-voting liaison representatives from various medical and professional societies and organizations.

Given the critical nature of their work, both committees have policies to manage conflicts of interest among their members. For the VRBPAC, members are required to disclose any financial interests that could be affected by the committee’s recommendations. The FDA reviews these disclosures to determine if a conflict exists. In certain cases, the FDA may grant waivers allowing members with potential conflicts to participate in discussions, provided these conflicts are publicly disclosed during meetings. This process ensures transparency and maintains public trust in the committee’s recommendations.

Similarly, the ACIP mandates that all members complete an annual confidential financial disclosure report. These reports are reviewed by the ACIP Secretariat, the CDC’s Federal Advisory Committee Management Branch, and the Office of General Counsel at CDC. Members are required to disclose any potential conflicts at the beginning of each meeting. If a conflict is identified, the member may be asked to recuse themselves from discussions and decision-making related to that specific issue. This rigorous process ensures that the committee’s recommendations are based on unbiased evaluations of scientific evidence.

Conflicts of interest can significantly impact the credibility and acceptance of a committee’s recommendations. If committee members have financial ties to vaccine manufacturers, it could lead to perceptions that recommendations are influenced by industry interests rather than public health considerations. Such perceptions can erode public trust in vaccination programs, potentially leading to decreased vaccine uptake and increased vulnerability to vaccine-preventable diseases. Therefore, managing conflicts of interest is essential to uphold the integrity of public health recommendations.

It is imperative that the experts serving on these committees are well-respected in their fields and do not exhibit political bias. The credibility of vaccine recommendations hinges on the perceived impartiality and expertise of committee members. Any indication of political influence or bias can undermine public trust, leading to vaccine hesitancy and decreased immunization rates. Therefore, maintaining a non-partisan stance and focusing solely on scientific evidence are crucial for the effective functioning of these committees.

Recently, the sudden unexplained cancellation of key advisory committee meetings has raised concerns about potential delays in vaccine production and distribution. The annual selection of flu strains is a time-sensitive process, requiring a six-month production cycle to ensure vaccines are available before the onset of the flu season. Without the timely input of VRBPAC, there is apprehension that vaccine manufacturers may lack the essential information needed to produce and distribute targeted vaccines effectively. Similarly, postponements in ACIP meetings could delay critical vaccination guidelines, affecting public health responses to various vaccine-preventable diseases.