Comments made by Mitchell Warren to the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) Meeting on October 22, 2020 about COVID-19 vaccine development and use authorization.
Public Comment from Mitchell Warren, Executive Director, AVAC At the Vaccines and Related Biological Products Advisory Committee (VRBPAC) Meeting
The Next-Generation of Biomedical Prevention: Now What
Slides presented by AVAC Executive Director Mitchell Warren at the PEPFAR Scientific Advisory Board meeting taking place over October 7-8, 2020.
Understanding the EMA Opinion and Next Steps for the Dapivirine Vaginal Ring
On July 24, 2020, the European Medicines Agency (EMA) announced a positive regulatory opinion from on the Dapivirine Vaginal Ring as an HIV prevention option for cisgender women age 18 and older. This document helps advocates to understand the steps that can and must be taken now that the EMA has provided its opinion. Read it here.
Global Investment in HIV Cure Research and Development in 2019
In 2014, the HIV Vaccines and Microbicides Resource Tracking Working Group and AVAC began a
A Leap Forward For the Dapivirine Vaginal Ring, the Next Steps Are Critical
After decades of research and advocacy, the Dapivirine Vaginal Ring is now one step closer to becoming available as a discreet, woman-initiated HIV prevention option. In July, the European Medicines Agency (EMA) issued a positive opinion for the ring, allowing the next steps in the regulatory process to go forward. Download this podcast to hear five different perspectives on the ring, how it expands HIV prevention options for women, and the most important next steps to bring the ring to women who need it.
Regulatory Approval Primer for Vaccine Advocates
The difference between speed and cutting corners can be one of life or death for individuals, and of impact versus impasse for societies. Advancing a vaccine candidate without peer-reviewed research results and thorough regulatory review can also undermine confidence in public institutions and vaccines generally. Global health advocates have an essential role to play as watchdogs of the regulatory systems that have worked well for decades, but may be vulnerable to global pressure for a vaccine and the current politicization of science.
COVID-19 Vaccine Pipeline PowerPoint Presentation
This set of slides offers advocates a view of the funders, platforms, research phase and considerations for some of the front-runner candidates.
Cheat Sheet: COVID-19 Vaccine Pipeline
This three-pager offers advocates an at-a-glance view of the funders, platforms, research phase and considerations for some of the front-runner candidates.
Advocates’ Guide: The risks and benefits of expedited COVID-19 vaccine research
This guide highlights the strategies being implemented to shorten the COVID-19 vaccine development timeline and the benefits, risks and key takeaways for each.
Designing a New Generation of HIV Prevention Efficacy Trials
Designing trials to test new HIV prevention modalities remains crucial; high rates of new infections persist in communities all over the world. Even with effective tools becoming more accessible, it’s clear no single option fits every need. But those same options make the design of future trials increasingly complex. Bill Snow, AVAC co-founder and senior advisor, explores this issue in Designing a New Generation of Prevention Efficacy Trials. The report lays out basic concepts in innovations in trial design and an analysis of the implications for advocacy.