Research Roundup: EMA issues positive opinion on dapivirine ring, promising early COVID-19 vaccine results, and inhalable COVID-19 treatment in development
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The European Medicines Agency (EMA) issued a positive opinion on the monthly dapivirine vaginal ring, developed by GHTC member the International Partnership for Microbicides (IPM), for use by cisgender women 18 and older in developing countries to reduce HIV risk. The ring—designed to help address women’s unmet need for HIV prevention methods—is the first long-acting HIV prevention product. The EMA opinion recommended the ring’s use in combination with safer sex practices when daily oral pre-exposure prophylaxis (PrEP) is not used or cannot be used. Efficacy data indicated the dapivirine ring reduced women’s HIV risk by 35 percent and showed no safety concerns with long-term use. This EMA decision paves the way for review by the World Health Organization (WHO) and regulatory bodies in each country where it is intended for use. IPM is continuing market and implementation research and working on rollout plans, with a hope for making the ring available in some communities with urgent need sometime in 2021.
Three laboratories working on COVID-19 vaccines released promising results last week, reporting their findings from early human trials. The three vaccine candidates—developed by Oxford University/AstraZeneca, CanSino Biologics, and Pfizer/BioNTech—all produced strong immune responses with antibody levels similar to those seen in patients who have recovered from COVID-19. The developers also indicated that immunity is likely to require a second vaccine dose. Scientists have cautioned that lab results from these early vaccine trials do not guarantee COVID-19 disease prevention. Among outstanding questions is the long-term efficacy and effects of these candidates, as the trials have only measured results over a few weeks. The three developers that released results last week—along with Moderna, which reported its vaccine candidate’s positive immune response the week prior—will continue further human trials in the upcoming months.
A study conducted by the UK-based company Synairgen reported positive results for a potential new COVID-19 treatment method: an inhaled form of interferon beta, a naturally occurring antiviral protein more commonly used in its injectable form to treat diseases like multiple sclerosis. Results from the study of 101 patients, not yet published in a peer-reviewed journal, showed that hospitalized patients who received the treatment had a 79 percent lower risk of developing more debilitating symptoms and were twice as likely to recover without limitations compared to those receiving a placebo. The preliminary double-blind placebo-controlled study will be followed up with larger clinical trials.