A Study to Learn About How Well Yearly Updates to the COVID-19 Vaccine Work to Protect People From COVID-19 and How Much Money People Spend on Healthcare for COVID-19
brief summary
The purpose of this study is to learn about how well the yearly updates to the COVID-19 vaccine work in adults (age 18 years and above) with a healthy immune system (the body's cells, tissues and organs that work together to protect your body) and in children (age 6 months to 17 years). This study will use a collection of insurance claims and state vaccine registry data called HealthVerity. All patient names and other identifying information is removed. This study will include children who: * Are 6 months of age to 17 years of age * Are enrolled for at least 6 months in a row in a health insurance plan that provides data to HealthVerity * Are enrolled for at least 6 months in a row in a prescription drug insurance plan that provides data to HealthVerity * Live in the same US state for 6 months in a row * Live in a US state that requires COVID-19 vaccine reporting and provides all vaccine history data to HealthVerity * Do not have mismatches in sex and/or year of birth between any of the available datasets * Do not have records of having had COVID-19 and/or any COVID-19 vaccine in the 90 days before the start of the study This study will include adults who: * Are 18 years of age and older * Are enrolled for at least 12 months in a row in a health insurance plan that provides data to HealthVerity * Are enrolled for at least 12 months in a row in a prescription drug insurance plan that provides data to HealthVerity * Have lived in the same US state for at least 12 months * Live in a US state that requires COVID-19 reporting and provides all vaccine history data to HealthVerity * Do not have mismatches in sex and/or year of birth between any of the available datasets * Do not have records of having had COVID-19 and/or any COVID-19 vaccine in the 90 days before the start of the study This study will use the data that has already been collected, and no treatment or vaccine will be given in the study. People who match the information above will be followed in the HealthVerity database for up to 6 months following the first day that a new COVID-19 vaccine is available. This information will be reviewed to see if any of the following happen: * they had a COVID-19 vaccine * they're diagnosed with COVID-19 in a doctor's office * they visit the emergency department for COVID-19 * they visit urgent care for COVID-19 * they are hospitalized for COVID-19 The experiences of people who received a COVID-19 vaccine will be compared to the experiences of people who did not receive the vaccine. This will help to understand how well the Pfizer-BioNTech COVID-19 vaccine works at stopping COVID-19.
detailed description
Rationale and Background
On April 6, 2022, members of the United States (US) Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the Food and Drug Administration (FDA) voted for the first time to update COVID-19 vaccine strain compositions from the original wildtype formulation to a formulation that better matched currently circulating variants. In a commentary in the Journal of the American Medical Association (JAMA) Network Open one month later, Dr Peter Marks (director of the Center for Biologics Evaluation and Research), Dr Janet Woodcock (principal deputy FDA commissioner) and Dr Robert Califf (FDA commissioner) argued
"Better alignment between the variant(s) covered by the vaccine and circulating variant(s) of SARS-CoV-2 might be expected to prevent a broader spectrum of disease, potentially for a longer time".
The US Centers for Disease Control and Prevention (CDC)'s Advisory Committee on Immunization Practices (ACIP) voted in each of 2022, 2023 and 2024 to recommend updated COVID-19 vaccines as authorized or approved by FDA in persons ≥ 6 months. There is therefore a need to evaluate effectiveness of these updated products on an annual basis, against a variety of health outcomes.
Research Question and Objectives
The research question for this study is "What is the real-world effectiveness of BNT162b2 formulations?"
Primary objective:
1. To evaluate vaccine effectiveness (VE) of BNT162b2 formulations in non-immunocompromised adults (age 18+) against COVID-19 related endpoints, by age, comorbid conditions of interest and adapted vaccine formulation.
Secondary objective: 2. To measure COVID-19 VE of BNT162b2 formulations in pediatrics (age \< 18) against COVID-19 related endpoints, by age and adapted vaccine formulation.
Research Methods
Study Design
For all aims of this study, vaccination status will be measured as a time-varying exposure. Exposed person-time begins 14 days after receipt of a BNT162b2 formulation. Unexposed person-time is unvaccinated person-time, as well as 0-13 days after vaccination. The unexposed group will be further stratified by previous status.
official title
Effectiveness of BNT162b2 Annual Updated Formulations, Using Administrative Claims Data Tokenized to State Vaccine Registries