About

Andy Stergachis is a Professor of Pharmacy and Global Health and an Adjunct Professor of Health Services and Epidemiology at the University of Washington. He is the Director of the Global Medicines Program at the university. His research focuses on drug safety, pharmaceutical outcomes, and clinical epidemiology, with significant contributions to advancing the safety of medications and vaccines. He has developed and evaluated novel approaches for safety surveillance of vaccines and essential medicines, including those for HIV/AIDS, and for evaluating pharmacy-based services in low- and middle-income countries. His recent projects include pharmacovigilance system strengthening, active safety surveillance of TB preventive therapy for people living with HIV, and assessing the global burden of antimicrobial resistance. He has authored 237 peer-reviewed publications and has served in leadership roles such as Editor-in-Chief of the Journal of the American Pharmacists Association. He is a member of several professional organizations, including the National Academy of Medicine, and has mentored numerous students and trainees.

Research topics

• Medicine
• Political Science
• Nursing
• Biology
• Microbiology
• Environmental health
• Medical education
• Internal medicine
• Intensive care medicine
• Emergency medicine
• Family medicine
• Pharmacology
• Psychiatry
• Socioeconomics
• Pediatrics
• Geography
• Demography
• Psychology
• Economics
• Public relations

Selected publications

• Acceptability, Appropriateness, and Feasibility of Administering Long-Acting Injectable Antipsychotics in Community Pharmacies

  Psychiatric Services · 2026-02-05

  article

  OBJECTIVE: Long-acting injectable antipsychotics (LAIAs) are evidence-based treatments for schizophrenia with demonstrated improved adherence and health outcomes relative to oral antipsychotics. Despite their benefits, LAIAs remain underprescribed. Administering LAIAs in community pharmacies could improve uptake, but the feasibility of integrating new services in this setting is often disregarded. The authors aimed to evaluate the feasibility, acceptability, and appropriateness of administering LAIAs in community pharmacies in Washington State. METHODS: Community pharmacy staff and psychiatric clinicians in Washington State were recruited, via both purposive and snowball sampling, through the Washington State Pharmacy Association and University of Washington's Department of Psychiatry and Behavioral Sciences. Participants' perceptions were assessed via a cross-sectional survey that included a questionnaire completed by pharmacy staff and three measures completed by psychiatric clinicians. For all outcomes, higher scores indicated more favorable responses. The data were analyzed with descriptive statistics. Simple linear regression models and comparisons across respondent groups were performed where possible. RESULTS: Ninety-three respondents initiated a survey; 89 met eligibility criteria. The pharmacists' mean scores were 4.98 (out of 6) for acceptability, 4.34 (out of 6) for feasibility, and 3.91 (out of 5) for appropriateness; the pharmacy technicians' mean respective scores were 5.43, 4.28, and 3.90. The clinicians' scores (measured on a 5-point Likert scale) were 4.20 for acceptability, 4.01 for appropriateness, and 3.92 for feasibility. CONCLUSIONS: The respondents surveyed viewed LAIA administration in community pharmacies as acceptable, appropriate, and feasible, indicating compatibility with early implementation efforts to support service development and expansion.

  PublisherDOI

• Maternal and Pediatric Use of Vaccines for Mpox: A Living Systematic Review and Meta-analysis of Safety and Effectiveness

  Drug Safety · 2026-03-06 · 1 citations

  articleOpen access

  BACKGROUND: Mpox is a re-emerging zoonotic infection caused by an Orthopoxvirus closely related to smallpox. The 2022-23 global outbreak prompted rapid use of vaccinia-based vaccines, historically developed for smallpox and those of the latest generation used for mpox prevention. Assessing their safety and effectiveness in pregnant persons and children is critical to guide policies protecting populations at an elevated risk of severe illness. OBJECTIVE: This study assessed the safety and effectiveness of mpox and historical smallpox vaccines, administered during pregnancy and childhood. METHODS: We conducted a living systematic review and meta-analysis (PROSPERO CRD42024591322/CRD42024586205) following Cochrane, World Health Organization, and Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) standards. We searched biweekly across major databases, trial registries, preprints, and gray literature (inception to September 2025) for studies evaluating the safety and effectiveness of vaccinia-based smallpox vaccines, including historical (first- and second-generation) and modern (third-generation) vaccines, in maternal and pediatric populations. Reviewers independently conducted study selection, data extraction, and risk-of-bias assessment. Meta-analyses employed random-effects models, and results are presented through an interactive dashboard and a living platform. RESULTS: We included 27 clinical studies (1949-2025), involving 1,406,771 children/adolescents (eight studies) and 11,482 pregnant persons (19 studies). Most maternal data came from first-generation vaccines (Lister, Finnish, Dryvax, APSV). These vaccines were not associated with an increased risk of spontaneous abortion (risk ratio [RR] 1.02, 95% confidence interval [CI] 0.70-1.48), stillbirth (RR 1.02, 95% CI 0.70-1.48), or preterm birth (RR 1.08, 95% CI 0.78-1.50), but were linked to a higher risk of congenital anomalies (RR 1.25, 95% CI 1.01-1.54). Fifty-two fetal vaccinia cases were reported globally up to 1978, with none since. Evidence on second- (ACAM2000) and third-generation (MVA-BN) non-replicating vaccines remains limited. In children, serious adverse events were rare, and MVA-BN caused only mild self-limiting reactions. No study assessed vaccine effectiveness in pregnant persons, while limited pediatric data suggested possible protection after post-exposure prophylaxis. CONCLUSIONS: Vaccinia-based vaccines appear generally safe in pregnancy and children. However, evidence on the safety and effectiveness of third-generation mpox vaccines is still scarce. High-quality prospective studies and strengthened pharmacovigilance are urgently needed to inform policy and clinical decision making.

  PublisherOA PDFDOI

• Pharmacy access and shingles vaccinations in the US: a propensity score matching analysis

  Vaccine · 2026-01-30

  articleSenior author
  PublisherDOI

• P-185. Safety, Efficacy and Immunogenicity of Chikungunya Vaccines: A Living Systematic Review and Meta-Analysis

  Open Forum Infectious Diseases · 2026-01-01

  articleOpen access

  Abstract Background Chikungunya virus is a re-emerging global threat. Two vaccines—one live-attenuated and one virus-like particle (VLP)—have received approval. However, comparative safety and immunogenicity data across platforms and special populations remain limited. Methods We conducted a living systematic review (LSR) and meta-analysis of clinical and preclinical studies evaluating the safety and immunogenicity of chikungunya vaccines. Databases were searched biweekly (2014–2025). Outcomes included adverse events, pregnancy outcomes, and immunogenicity (seroprotection, seroconversion), stratified by age group, vaccine platform (live-attenuated, VLP, mRNA, vector), and baseline serostatus. Meta-analyses used random-effects models; absolute and relative risks were calculated with 95% confidence intervals (CI). Results We included 55 studies (18 clinical, 37 preclinical). Trials enrolled 8,279 vaccinated participants: 7,560 adults and 719 adolescents. Two studies reported 16 post-vaccination pregnancies, with five spontaneous abortions—three assessed as unrelated and two reported as unrelated serious adverse events in independent safety review. In seronegative adults, live-attenuated vaccines were associated with increased risk of arthralgia (RR 2.95, 95% CI 2.29–3.79), fever (RR 11.01, 95% CI 6.37–19.03), and headache (RR 2.07, 95% CI 1.78–2.40); similar trends were observed in adolescents. Seroprotection outcomes were reported as incremental proportions (IP) comparing vaccinated and placebo groups. In adolescents, IPs were 0.94 (95% CI 0.87–1.01) with VLA1553 and 0.68 (95% CI 0.59–0.76) with PXVX0317 at 30 days, increasing to 0.95 (95% CI 0.90–1.00) at 365 days. In adults, VLA1553 reached 0.99 (95% CI 0.97–1.01) at 30 days; PXVX0317 reached 0.86 (95% CI 0.81–0.91) at 30 days and 0.74 (95% CI 0.68–0.81) at 365 days; mRNA-1388 maintained 1.00 (95% CI 0.76–1.24) throughout. Seroconversion mirrored seroprotection. Conclusion Chikungunya vaccines show high immunogenicity across platforms. Live-attenuated vaccines are more reactogenic in seronegative individuals. Data on pregnancy remains limited. Our LSR supports continued evidence synthesis and post-licensure safety monitoring. Disclosures Flor M. Munoz, MD, Merck: Advisor/Consultant|Pfizer: Advisor/Consultant|Pfizer: Grant/Research Support

  PublisherOA PDFDOI

• A template tool for the evaluation of vaccines for emerging pathogens to be used for pregnant and breast-feeding women

  Vaccine · 2025-07-18 · 1 citations

  reviewOpen access

  Vaccination during pregnancy provides effective protection against pathogens that increase the risk of maternal and infant morbidity and mortality for mothers and their infants. The SARS-CoV-2 pandemic demonstrated the need for the inclusion of pregnant and breast-feeding women in research and development of vaccines for emerging pathogens, such as Ebola, Zika, Lassa fever, Chikungunya, and influenza virus of pandemic potential. The COVID-19 Vaccines Global Access (COVAX) Maternal Immunization Working Group (MIWG), in collaboration with the Coalition for Epidemic Preparedness Innovation and the Safety Platform for Emergency Vaccines (CEPI-SPEAC) developed a standardized template with key considerations to guide the assessment of vaccines against emerging pathogens in pregnant and breast-feeding women. The aim of this tool is to enable key stakeholders to perform an early structured assessment of the overall potential benefit and risk for maternal immunization against an emerging pathogen. It can also be used to support risk management and pharmacovigilance planning, communication strategies, policy development, and acceptance of vaccination during pregnancy in future pandemics.

  PublisherDOI

• Umbrella review of the safety of Chikungunya vaccine platforms used in other vaccines

  Human Vaccines & Immunotherapeutics · 2025-02-11 · 3 citations

  reviewOpen access

  mosquitoes, is a significant global health concern. Various vaccine platforms have been explored to combat CHIKV, including formalin inactivation, live-attenuated strains, virus-like particles (VLPs), viral vectors, and mRNA technologies. This umbrella review synthesizes evidence on the safety profiles of vaccine platforms used in Chikungunya vaccines that have been applied in other vaccines, focusing on adverse events of special interest (AESI) in pregnant persons, children, and adolescents. A comprehensive overview of systematic reviews (SRs) was conducted. Results: Seven systematic reviews were included and complemented with primary studies. Vaccines like influenza, human papillomavirus (HPV), and COVID-19, which share platforms with Chikungunya vaccines, showed no significant increase in AESI. Moderate-to high-quality SRs supported favorable safety profiles. Vaccines sharing platforms with Chikungunya vaccines generally exhibit acceptable safety profiles in pregnant persons, children, and adolescents.

  PublisherDOI

• Incremental cost of pre- and post-exposure prophylaxis service provision via an online pharmacy in Kenya

  medRxiv · 2025-03-17

  preprintOpen access

  ABSTRACT Background Online pharmacy HIV pre- and post-exposure prophylaxis (PrEP/PEP) provision is a novel strategy to expand HIV prevention coverage. In the ePrEP pilot study, we found online pharmacy PrEP/PEP was feasible and reached populations at HIV risk in Kenya. However, program costs data are lacking. Methods We conducted a costing within the ePrEP pilot study in Nairobi from 11/01/2022-12/29/2023. We obtained costs from expense reports and conducted time-and-motion observations and staff interviews. We estimated total and unit costs in the first year of implementation, cost per client and per PrEP client-month (2023 US Dollars (USD)). Results Overall, 229 clients initiated PrEP (507 months of PrEP coverage) and 1320 initiated PEP. Based on observed program volume, annual financial cost was $109,945 USD (PrEP: $19,456; PEP: $90,489). Cost per client was higher for PrEP than PEP ($85 vs $68.6), and cost per PrEP client-month was $38 (mean duration: 2.2 months). Main drivers of financial costs were courier-delivery of HIV testing kits and drugs (PrEP: 50.6%; PEP: 40.5%), demand generation (PrEP: 25.9%; PEP: 32.1%), and equipment, system development, and utilities (PrEP: 9.3%; PEP: 9.8%). Assuming a scaled-up client volume of 2500 (PrEP: 370; PEP: 2130) reduced per-client financial costs for PrEP ($65.5) and PEP ($56) and cost per PrEP client-month ($29.6). Conclusions Costs of online PrEP/PEP provision is likely higher than clinic-based PrEP. Implementing cost sharing models including charging clients for HIV testing and optimizing courier delivery routes can increase program efficiencies. Our cost estimates can inform economic evaluations of online PrEP/PEP delivery.

  PublisherOA PDFDOI

• Online delivery of oral HIV pre‐ and post‐exposure prophylaxis: findings from the ePrEP Kenya pilot

  Journal of the International AIDS Society · 2025-06-01 · 7 citations

  articleOpen access

  INTRODUCTION: The expansion of telecommunication networks and smartphones in many African countries could be leveraged to deliver HIV prevention products directly to consumers. In collaboration with a private e-commerce platform and online pharmacy in Kenya, MYDAWA, we piloted a new model of HIV pre- and post-exposure prophylaxis (PrEP/PEP) delivery. METHODS: In the ePrEP Kenya pilot (NCT05377138), individuals living in Nairobi and Mombasa Counties could complete a free telehealth visit with a remote clinician to assess eligibility for online PrEP/PEP (i.e. ≥18 years; no medical contraindications). Eligible individuals could order HIV testing services-courier delivered to clients' choice location-for a fee of 250 KES (∼$2 USD) for self-testing or 150 KES (∼$1 USD) for provider-administered rapid diagnostic testing. Following confirmation of clients' HIV-negative status (via an uploaded test result image), free PrEP/PEP drugs from government supply were courier delivered with or separately from HIV testing services. Clients paid a delivery fee ≤149 KES (∼$1 USD) per courier visit. RESULTS: From October 2022 to December 2023, we screened 2257 individuals and enrolled 1915. Most PrEP/PEP clients were men (63%, 1428/1915), ≥25 years (72%, 1631/1915) and never married (80%, 1796/1915); few had ever used PrEP (3%, 48/1915) or PEP (14%, 263/1915). At enrolment, 227 (12%) were preliminarily eligible for PrEP and 1688 (88%) for PEP. Among PrEP-eligible clients, 89% (203/227) completed HIV testing and 92% (208/227) received PrEP; among PEP-eligible clients, 92% (1551/1688) completed HIV testing and 92% (1549/1688) received PEP. Most PrEP/PEP clients completed HIV testing within 6 hours of their telehealth visit (53%, 927/1757) and had drugs delivered with testing services (88%, 1546/1757). Among PrEP clients eligible for follow-up, 47% (120/256) continued PrEP and 4% (10/256) initiated PEP following PrEP discontinuation. Among PEP clients eligible for follow-up, 7% (99/1428) repeated PEP use and 6% (83/1428) transitioned from PEP to PrEP.). CONCLUSIONS: Online PrEP/PEP delivery could expand access to prevention services by reaching individuals not engaged in existing delivery platforms. The uptake of online PEP was five times greater than PrEP, underscoring an unmet demand for PEP and highlighting the potential for online pharmacies to deliver time-sensitive PEP services.

  PublisherOA PDFDOI

• Safety, immunogenicity, and effectiveness of chikungunya vaccines in pregnant persons, children, and adolescents: a protocol for a living systematic review and meta-analysis

  Reproductive Health · 2025-04-18 · 5 citations

  articleOpen access

  BACKGROUND: Chikungunya virus significantly impacts public health, primarily affecting regions in Africa and the Americas (predominantly Latin America and the Caribbean). Despite the global spread of the virus and its clinical manifestations and complications in vulnerable populations such as children and pregnant persons, no widely available vaccine is currently available. With recent advancements in vaccine development, there is a need to systematically evaluate the emerging evidence on the safety, immunogenicity, and efficacy of chikungunya vaccine candidates. This protocol outlines a living systematic review designed to continuously assess the growing research on chikungunya vaccines, focusing on diverse populations, including children and pregnant persons. We aim to provide up-to-date evidence to inform public health decisions and vaccine recommendations as new data is available. METHODS: Our objective is to carry out a living systematic review and meta-analysis through biweekly searches in medical databases and clinical trial registries, aiming to identify relevant chikungunya vaccines studies on pregnant individuals, children, and adolescents. Pairs of reviewers will independently screen studies, extract data, and assess the risk of bias. Clinical trials, quasi-experimental studies, and observational studies, including case reports, will be considered for inclusion. Main outcomes will include the safety, efficacy, and effectiveness of chikungunya vaccines in pregnant individuals (including neonatal outcomes), as well as in children and adolescents. Reactogenicity and immunogenicity will be considered as secondary outcomes. Paired meta-analyses, incorporating predefined subgroup and sensitivity analyses, will be performed. Evidence certainty will be assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. DISCUSSION: This living systematic review and meta-analysis will continuously assess the safety, immunogenicity, and effectiveness of chikungunya vaccines in pregnant persons, children, and adolescents. Given the significant disease burden and potential complications in these populations, synthesizing emerging evidence is crucial for guiding immunization policies and clinical recommendations. By maintaining an updated analysis, this review will provide timely insights for public health agencies, researchers, and clinicians involved in vaccine implementation and maternal-child health. STUDY REGISTRATION: Two protocols were registered in the International Prospective Register of Systematic Reviews database, CRD42024514513 and CRD42024516754.

  PublisherOA PDFDOI

• A global living systematic review and meta-analysis hub of emerging vaccines in pregnancy and childhood

  Reproductive Health · 2025-07-18 · 2 citations

  reviewOpen access

  The COVID-19 pandemic accelerated vaccine development and generated a rapidly evolving body of evidence before and after the vaccine rollout. We developed a robust online platform to efficiently synthesize this emerging information for current and future challenges. Expanding upon our interactive living systematic review-initially focused on COVID-19- we now include chikungunya and Lassa fever (with protocols presented in this issue), Mpox, and Disease X ( https://www.safeinpregnancy.org ). We aim to continuously monitor and periodically update and disseminate high-quality data on vaccine safety, efficacy, effectiveness, and immunogenicity in pregnancy and childhood. This platform computes real-time meta-analyses and features a visualization tool to present findings in a clear and accessible manner, supporting decision-making, vaccine development pipelines, and implementation strategies worldwide. It is also designed to integrate data on a hub of emerging vaccines in pregnancy and childhood and reflects a collaborative effort among multiple organizations.

  PublisherOA PDFDOI

Recent grants

• NIH Grant R01HS007834

  NIH · $1.0M · 1998

Frequent coauthors

• Hershel Jick

  117 shared

• Janet R. Daling

  77 shared

• Fred E. Heidrich

  Group Health Cooperative

  75 shared

• Delia Scholes

  Kaiser Permanente Washington Health Research Institute

  67 shared

• David Perera

  Medical Research Council

  62 shared

• Noel S. Weiss

  University of Washington

  60 shared

• Walter E. Stamm

  53 shared

• King K. Holmes

  University of Washington

  44 shared

Labs

• Plein Center for AgingPI

Education

• Ph.D., Social & Administrative Pharmacy

  University of Minnesota

• M.S., Pharmacy Administration

  University of Minnesota

• Other

  Washington State University

Awards & honors

• Elected Member of the National Academy of Medicine
• Fellow of the International Society for Pharmacoepidemiology
• Fellow of the American Pharmacists Association
• Fellow of the American Association for the Advancement of Sc…
• Fellow of the Washington State Pharmacy Association