Building the U.S. COVID-19 vaccine effectiveness program: Past successes and future directions

Ruth Link-Gelles; Amadea Britton; Katherine E Fleming-Dutra; CDC COVID-19 Vaccine Effectiveness Team

doi:10.1016/j.vaccine.2023.12.002

Building the U.S. COVID-19 vaccine effectiveness program: Past successes and future directions

Vaccine. 2023 Dec 20:S0264-410X(23)01435-4. doi: 10.1016/j.vaccine.2023.12.002. Online ahead of print.

Authors

Ruth Link-Gelles¹, Amadea Britton², Katherine E Fleming-Dutra²; CDC COVID-19 Vaccine Effectiveness Team

Affiliations

¹ National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA, United States; United States Public Health Serivce Commission Corps, Rockville, MD, United States. Electronic address: hzt7@cdc.gov.
² National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA, United States.

PMID: 38129285
DOI: 10.1016/j.vaccine.2023.12.002

Abstract

COVID-19 vaccines were originally authorized in the United States in December 2020 on the basis of safety, immunogenicity, and clinical efficacy data from randomized controlled trials (RCTs). However, real-world vaccine effectiveness (VE) data are necessary to provide information on how the vaccines work in populations not included in the RCTs (e.g., nursing home residents), against new SARS-CoV-2 variants, with increasing time since vaccination, and in populations with increasing levels of prior infection. The goal of CDC's COVID-19 VE program is to provide timely and robust data to support ongoing policy decisions and implementation of vaccination and includes VE platforms to study the spectrum of illness, from infection to critical illness. Challenges to estimating VE include accurate ascertainment of vaccination history, outcome status, changing rates of prior infection, emergence of new variants, and appropriate interpretation of absolute and relative VE measures. CDC COVID-19 VE platforms have played a pivotal role in numerous vaccine policy decisions since 2021 and will continue to play a key role in future decisions as the vaccine program moves from an emergency response to a routine schedule.

Keywords: COVID-19; Moderna; Pfizer-BioNTech; Vaccine effectiveness.

Published by Elsevier Ltd.