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Scientific and Ethical Principles Underlying Recommendations From the Advisory Committee on Immunization Practices for COVID-19 Vaccination Implementation

2020; American Medical Association; Volume: 324; Issue: 20 Linguagem: Inglês

10.1001/jama.2020.20847

1538-3598

Beth P. Bell, José R. Romero, Grace M. Lee,

SARS-CoV-2 and COVID-19 Research

The continued global spread of the coronavirus disease 2019 (COVID-19) pandemic highlights the pressing need for safe and effective COVID-19 vaccines.Vaccine development efforts of unprecedented scale and speed are being pursued.Since June 2020, the Advisory Committee on Immunization Practices (ACIP) has held 4 public meetings to lay the groundwork for public health recommendations for COVID-19 vaccines.This Viewpoint summarizes the approach ACIP is taking in formulating recommendations, with a focus on the ethical principles and potential groups for allocation of vaccine doses when supply is limited.Recommendations will be issued after reviewing safety and effectiveness data and vaccines are licensed or authorized under Emergency Use Authorization by the Food and Drug Administration (FDA).The ACIP is an independent federal advisory committee body composed of experts external to the federal government from diverse medical and public health fields, as well as a consumer representative.The committee is charged with recommending how FDAlicensed or authorized vaccines should be used in the US civilian population. 1 These recommendations are provided to the director of the Centers for Disease Control and Prevention (CDC).If the CDC director approves the recommendations, they become official CDC recommendations for immunizations in the US.ACIP recommendations determine the vaccines that are covered under the Vaccines for Children program, which provides vaccines at no cost for Medicaid-insured, underinsured, and uninsured children.Under the provi-sionsoftheAffordableCareAct(ACA),recommendedvaccines are covered by health insurers and employersponsored health plans established after passage of the ACA. 1 Hence, while not binding, recommendations determinehowvaccinesareusedinthepublicsectorandsetthe standard for clinical practice in the private sector.ACIP meetings are open to the public and committee documents are publicly available, ensuring transparency in decision-making.The development of recommendations adheres to a rigorous and transparent process.Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methods facilitate a standardized approach to evaluating scientific evidence. 1The Evidence to Recommendations framework evaluates factors including feasibility and acceptability. 1 Hence, the ACIP aims to produce national vaccine recommendations that are both evidence-based and implementable.Implementing COVID-19 vaccination presents a number of unique, interrelated challenges.During its public meetings, the ACIP has characterized guiding principles, assembled and reviewed available data, and summarized considerations for allocation of initial doses.