RESEARCH

In this project, we will develop new statistical approaches to detect serious adverse events that can happen after vaccination, and we will apply these new approaches to existing data from a large health care system to evaluate COVID-19 vaccine safety.

The VISION Vaccine Effectiveness Network is a research collaboration between CDC, Westat, and multiple sites with integrated clinical, laboratory, and vaccination records in the United States that evaluate how well seasonal influenza (flu) vaccines protect people against flu, RSV vaccines protect people against RSV, and COVID-19 vaccines protect against COVID-19. VISION also assesses information on severe outcomes among people hospitalized with laboratory-confirmed flu and COVID-19 including intensive care unit (ICU) admission, invasive mechanical ventilation, and in-hospital death. These data help inform how well flu vaccines, RSV vaccines, and COVID-19 vaccines protect against severe outcomes.

This is a retrospective matched cohort study to evaluate the association between two doses of the recombinant zoster vaccine and dementia, Alzheimer’s disease, and mild cognitive impairment among Southern California adults>=65 years.

The goal of the Boostrix study is to examine pre-specified pregnancy-related adverse events in a cohort of women vaccinated with Boostrix at 27 weeks gestation or beyond compared to a matched historical unvaccinated control group.

The proposed study aims to compare the vaccine effectiveness (VE) against hospitalization for influenza between Flucelvax Quadrivalent and egg-based influenza vaccines used in Kaiser Permanente Southern California (KPSC) during the 2017-2018 season.

The proposed project will involve designing, piloting, evaluating, and expanding an SMS- and web-based Vaccine Safety Monitoring (VSM) system.

The vaccine effectiveness (VE) objectives are to estimate the VE of at least one RZV dose in preventing herpes zoster (HZ) in adults>=18 years of age with psoriasis (PsO) and psoriatic arthritis (PsA). The safety objectives are to assess the number of incident flare cases within 30 days following any RZV vaccination as compared to the risk in self-controlled comparison periods, in adults>=18 years of age with PsO and PsA.

The objectives of this study were to assess the effectiveness of PCV13 against severe COVID-19 outcomes and to assess the burden of PCV13-preventable illness attributable to COVID-19.

Pneumonia accounts for a substantial burden of morbidity and mortality among adults. Assessing the effectiveness of 20vPnC against all-cause pneumonia is critical to estimating the public health benefits of 20vPnC use among United States (US) adults in. These data may be used to guide implementation and use of pneumococcal conjugate vaccine (PnCs) among adults. While the 13vPnC estimates of vaccine effectiveness (VE) against all-cause outcomes were lower than those against vaccine-type (VT) outcomes, the actual impact of PnC against all-cause outcomes could be considerably greater than that estimated from VT outcomes.

The objectives of this study are to estimate the incidence of invasive pneumococcal disease (IPD), pneumococcal pneumonia (PP), all-cause pneumonia, and lower respiratory tract infections (LRTI) by Advisory Committee on Immunization Practices (ACIP)-defined risk profile in adults>=18 years.

The objective is to conduct a long-term study at KPSC to assess vaccine effectiveness among individuals receiving recombinant zoster vaccine (RZV) compared to individuals not receiving RZV.

The purpose of the study is to evaluate the safety and effectiveness of recombinant herpes zoster vaccine (RZV) in adults>=18 years of age with rheumatoid arthritis or inflammatory bowel disease (ulcerative colitis or Crohn’s disease).

The Recombinant Adjuvanted Zoster Vaccine (RZV, Shingrix®) was approved in 2017 by the FDA for the prevention of herpes zoster (HZ) in adults ages 50 years and older. With a potent adjuvant system, it is hypothesized that RZV could induce trained innate immunity. As the first approved and widely used vaccine with the novel AS01 adjuvant system, we are investigating the potential non-specific effect of RZV against COVID-19.

The current study proposes to evaluate the VE for influenza as well as the VE for COVID-19 both before and after the flu season as well as concurrently with influenza.

The current study proposes to evaluate the VE for influenza as well as the VE for COVID-19 both before and after the flu season as well as concurrently with influenza.

The objectives of this study are to conduct a retrospective cohort study to evaluate the long-term effectiveness of the zoster vaccine for preventing HZ and PHN among persons 60 years of age or older. Understanding the long-term duration of vaccine effectiveness will be critical for monitoring impact of the zoster vaccination program, as well as for informing policy decisions that the ACIP will face, such as the consideration of a booster dose, and determining the optimum age to begin vaccination.

The objectives of this large retrospective data-only study are to use two parallel study designs to assess the VE of Pfizer COVID-19 vaccine against 2 primary endpoints: 1.) Severe outcomes (COVID-19 associated hospitalization, ICU admission, and death); and 2.) Outpatient laboratory-confirmed COVID-19 diagnosis.

Respiratory Syncytial Virus (RSV) is a major cause of respiratory infection for infants and older adults. In this study, we will estimate vaccine effectiveness of Pfizer’s RSVpreF vaccine against RSV-related lower respiratory tract infection requiring hospitalization among KPSC older adults who are eligible for vaccination per current ACIP recommendations.

The primary objective of this post-marketing observational surveillance study is to compare the occurrence of acute myocardial infarction (AMI) in recipients of HEPLISAV-B with recipients of another hepatitis B vaccine. The study will also evaluate the incidence of new onset immune-mediated diseases, herpes zoster, and anaphylaxis in recipients of HEPLISAV-B compared to recipients of another hepatitis B vaccine.

To better understand the short-term impact of the introduction of RZV on clinical outcomes and payer budgets, GSK has developed a US-specific budget impact model that is utilized as a flexible tool for different types of US population-based decision makers. The model can be customized to reflect the patient population information and outcomes associated with RZV vaccination scenarios. We will describe the demographics, epidemiology, and health care utilization associated with herpes zoster in the KPSC population. This information will contribute to the inputs for the budget impact model.

The objective of this study is to assess the impact of the introduction of Tier 6 in Medicare Part D on zoster vaccination rates among persons who are 65 years or older with Medicare Part D coverage, accounting for secular factors such as vaccine supply, DTC advertising, increasing awareness of the zoster vaccine, and general promotion of vaccination among the elderly.

The purpose of this study is to provide critical information about the predictors of severe RSV disease, describe epidemiology and burden of hospitalized RSV disease in older adults, and assess healthcare utilization associated with hospitalized RSV disease in older adults in a community setting. A population of hospitalized older adults testing positive for influenza will also be identified for comparison purposes.

The objectives of this study are to conduct a retrospective cohort study to evaluate the long-term effectiveness of the zoster vaccine for preventing HZ and PHN among persons 60 years of age or older. Understanding the long-term duration of vaccine effectiveness will be critical for monitoring impact of the zoster vaccination program, as well as for informing policy decisions that the ACIP will face, such as the consideration of a booster dose, and determining the optimum age to begin vaccination.

The primary objective of this study is to calculate the incremental effectiveness of the 2-dose varicella vaccination regimen in preventing breakthrough disease compared to the 1-dose regimen among children aged 5 to 14 years in Antelope Valley, California.

This study will fulfill a post-marketing commitment between Novartis Vaccines and Diagnostics and the FDA to expand the safety profile of this vaccine in this age group. This is an observational study and is expected to span multiple years within KPSC. Subjects will be immunized with Menveo as part of their routine care. Subjects who have been vaccinated with Menveo and have experienced an event of interest during the first year are selected for analysis; and subjects are selected for analysis using the SCCS methodology, which sums the occurrence of events that fall within a risk window and those that do not fall within these windows.

The objective of the Menveo Pregnancy Registry is to evaluate pregnancy outcomes among women immunized with the Menveo vaccine within 28 days prior to conception or at any time during pregnancy. The primary outcomes of interest include major congenital malformation, preterm birth, and low birth weight. Other pregnancy outcomes will be collected, including spontaneous abortions and stillbirths.

This is a real-world study evaluating the effectiveness of mRNA-1083 (Moderna’s influenza and COVID-19 combination vaccine) in preventing seasonal Influenza and COVID-19 hospitalizations among adults 50 years and older. The Moderna protocol number is mRNA-1083-P904.

This observational study aims to assess the vaccine effectiveness of Arexvy in preventing laboratory-confirmed RSV-acute respiratory infection (ARI)/LRTD hospitalization in adults>=60 years at Kaiser Permanente Southern California, using a test-negative design.

Collect positive SARS-CoV-2 specimens and conduct sequencing to identify variant types.

This study is an observational post-marketing safety study required by the United States Food and Drug Administration (FDA). The primary objective of this study is to describe medical events that require emergency room visit or hospitalization in 6 months following MenACWY-CRM vaccination in children 2-23 months of age in a health maintenance organization (HMO) in the United States.

An observational cohort study to evaluate vaccine effectiveness of Moderna COVID-19 vaccine in preventing COVID-19 diagnosis and severe COVID-19 disease.

Comparative vaccine effectiveness of influenza vaccine in the 2022-2023 season.

RSV is a major cause of respiratory infection in both infants and older adults, and clinical manifestations can be severe. This study will evaluate the vaccine effectiveness of Pfizer’s ABRYSVO vaccine against RSV-related lower respiratory tract infection requiring hospitalization among Kaiser Permanente Southern California members ages 60 and older who are eligible for vaccination per current ACIP recommendations.

This project will describe characteristics of invasive pneumococcal disease (IPD) and otitis media (OM) cases by demographics (including socioecological characteristics), history of vaccination with conjugated pneumococcal vaccine (number of doses and dates) clinical characteristics, and outcomes, overall and by age and ACIP-defined risk groups.

The purpose of this mixed-methods study is to examine perceptions of COVID-19 vaccines among health care providers, willingness to receive and recommend COVID-19 vaccine, drivers of vaccine hesitancy, and needs for tailored interventions to support confidence in COVID-19 vaccines among health care providers and community members.

The purpose of this task order is for the contractors to contribute to the main functions of VSD COVID-19 vaccine safety activities. The work from this task order will support and contribute to the COVID-19 vaccine safety work of the VSD. The objective is to provide high quality electronic data specific to COVID-19 vaccine safety activities. Contractors will also contribute to vaccine safety assessments through their participation on vaccine safety monitoring and evaluation studies, and by conducting medical record reviews.

VSD is a multi-site study of vaccine safety in a network of managed care organizations from across the US. The VSD project allows for planned immunization safety studies as well as timely investigations of hypotheses that arise from review of medical literature, reports to the Vaccine Adverse Event Reporting System (VAERS), changes in immunization schedules, or the introduction of new vaccines.

The aims of the study are to determine the incidence of reactivation of Oka strain VZV in community-dwelling persons vaccinated with zoster vaccines; to test clinical isolates for evidence of recombination between vaccine and wild-type strains VZV; to identify risk factors of HZ among individuals vaccinated with zoster vaccines; to identify risk factors for post-herpetic neuralgia (PHN) among HZ cases who were either vaccinated or unvaccinated with zoster vaccines, and to compare the clinical manifestations and risk of PHN between vaccinated and unvaccinated individuals.