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AVAC welcomes today’s opinion from the European Medicines Agency (EMA) that recommends the Dapivirine Vaginal Ring as an additional HIV prevention option for cisgender women 18 and older. The EMA action moves a much-needed woman-initiated HIV prevention option one step closer to reaching women who need it. To help advocates understand this key development, AVAC has created a new ‘primer’ on the issue with everything advocates need to know about what’s happened and must happen next.
Read on for more information, links to new resources, next steps for advocates, and registration details for a webinar on Wednesday, July 29 at 10am EDT to discuss this welcome development.
Every day brings fresh news of the ways that the pandemics of HIV, COVID and gender-based violence are harming women and adolescents—along with many other groups. In this context of rising risk, giving women options to choose from is essential. This includes options for HIV prevention, contraception and overall health that work within their lives.
The EMA opinion came from its Human Medicines Committee, which reviewed the existing data under a mechanism that allows the EMA to provide regulatory views on products that are intended for use outside the European Union. The opinion states that the “Dapivirine Vaginal Ring (dapivirine) used to reduce the risk of infection with the human immunodeficiency virus type 1 (HIV-1), in combination with safer sex practices when oral pre-exposure prophylaxis (PrEP) is not used, cannot be used or is not available.” It also calls for further safety and efficacy data to be collected in younger women, and for monitoring of women who acquire HIV while using the ring, to understand if drug resistance arises.
AVAC’s partners have been at the forefront, informing conversations about the Dapivirine Vaginal Ring trials and their results. As Manju Chatani-Gada, AVAC Director of Partnerships & Capacity Strengthening said in AVAC’s press release earlier today, “This is a long-awaited day for the thousands of women in Africa, Europe and the US, who participated in clinical trials of the ring and those of us who have advocated for access to the ring and other women-initiated prevention options for two decades. Women have been waiting for an HIV prevention option that they can use discreetly and easily, and for many the ring could be that product,” Click here to see more of the women-led, youth-centered activism on this issue to date.
Advocates, the International Partnership for Microbicides (IPM) which developed the ring, implementers, policy makers and other stakeholders are gearing up for the next stage in securing access to this product. The ring is the first biomedical strategy designed expressly for reducing risk through receptive vaginal sex to receive a positive regulatory opinion since the female condom in 1993.
And use these resources to deepen your knowledge of the ring, its implications for cisgender women’s HIV prevention, and the essential next steps to translate positive research and regulatory opinion into impact:
- In AVAC’s Understanding the EMA Opinion: Next Steps for Dapivirine Vaginal Ring, we provide background on the research and lay out next steps for swift regulatory review, development and funding of an implementation agenda, and a woman-led approach to introduction at the global, country and community level.
- The Common Agenda offers a planning guide for stakeholders working on the introduction of the monthly Dapivirine Vaginal Ring, developed by the OPTIONS Consortium in collaboration with IPM.
As public health indicators continue to show unacceptably high rates of HIV among adolescent girls and young women, this positive regulatory opinion is a source of hope and a call to action. Now is the time for accelerated work on evidence-based implementation, funding and the political commitment needed to both scale up a choice-based platform of HIV prevention that includes the ring, oral PrEP and the female condom.
Join us in the work ahead, watch for webinars, calls, podcasts and more.