BIO supports retaining current vaccine recommendation categories

BIO’s comments advise strengthening communication and clarity of recommendations, and maintaining access.

The Advisory Committee on Immunization Practices (ACIP) should remain the body responsible for making vaccine recommendations, and ACIP’s recommendation categories do not need to be changed, BIO tells the Department of Health and Human Services (HHS).

The Biotechnology Innovation Organization (BIO) made these comments in its Sept. 20 response to a HHS request for information (RFI) that asks “whether the categories currently used in Federal vaccine recommendations are adequate.” The RFI contained a proposal on restructuring ACIP’s established vaccine categories, which currently include: routine (universal) recommendations, risk-based recommendations, and recommendations based on shared clinical decision-making.

“The current vaccine recommendation categories were developed to translate ACIP’s scientific assessment into clear clinical guidance about which populations could be considered for a vaccine and under what circumstances, while supporting consistent implementation, coverage, and access,” say BIO’s comments, prepared by Phyllis Arthur, BIO EVP and Chief of Global Health. “The categories were not intended to signal different standards of evidence or different levels of confidence in vaccine safety and effectiveness.”

Some of BIO’s specific recommendations include:

Maintain ACIP’s authority

“All policymaking should reflect that ACIP is tasked with making vaccine recommendations, while other entities are tasked with different and specific areas of vaccine policy,” BIO comments say. “Grounded in its statutory role, decades of experience rigorously evaluating vaccine evidence through a transparent and deliberative process, and its critical ties to vaccine coverage, access, and the broader public health system, ACIP remains the appropriate federal entity for developing vaccine recommendations, consistent with the distinct responsibilities established by Congress.”

The comments also note that the well-established complementary roles of ACIP—through the Centers for Disease Control and Prevention—the Food and Drug Administration (FDA), and other agencies have historically delivered an effective federal vaccine system.

Existing categories work and should be explained

“Changes to the recommendation categories are not needed; if any change is made, it should be led by ACIP and include opportunity for meaningful public comment,” according to BIO’s input. “BIO believes the current recommendation categories provide an appropriate framework to support vaccination decisions.”

BIO underlines the importance of making it clear that the Shared Clinical Decision-Making (SCDM) category does not mean a vaccine is less important than others. An SCDM recommendation simply indicates a healthcare provider and patient should discuss whether to administer the vaccine because the expected benefit may depend on an individual’s specific circumstances.

“Importantly, the use of SCDM should not diminish vaccine confidence or create the perception that these vaccines are less valuable or less appropriate for patients who may benefit from them,” the comments say.

Avoid threats to patient access

Because federal and state vaccine schedules are defined by ACIP, changes to the meaning or status of an ACIP category could have consequences beyond clinical guidance.

BIO therefore wants HHS to make it clear that routine, risk-based, and SCDM vaccines all remain ACIP-recommended vaccines, so that patients maintain their insurance coverage. This extends to other access programs as well, including: the Vaccines for Children program, state pharmacist scope-of-practice laws, and hospital/facility vaccination requirements, among others.

“Americans who want to receive vaccines should be able to do so without cost-sharing, regardless of how a vaccine recommendation is categorized,” writes BIO.

Read BIO’s full comments.

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