US activists ensure people living with HIV can enrol in COVID-19 vaccine studies
28 August 2020. Related: COVID-19: vaccine research, COVID-19.
Simon Collins, HIV i-Base
The last issue of HTB reported on the launch of large randomised placebo controlled phase 3 COVID-19 vaccine studies, that will be used to prove safety and efficacy of vaccine candidates that already have shown promising results in smaller phase 1 and 2 studies.
We reported this with an assumption that enrolment would be open to people living with HIV, certainly if on affective ART and without other complicated health issues. [1]
This expectation turned out to be wrong – at least for US studies. Although the Moderna vaccine was supported by US public funding and planned the phase 3 study using HIV research sites, the company ignored requests for actively allow HIV positive people to be enrolled.
In response, a dozen high profile HIV organisations, led by Lynda Dee from AIDS Action Baltimore, engaged the leadership of the US National Institues of Health (NIH) and challenged Moderna. Exclusion from these key studies risk HIV positive people do not have insurance cover and access to the final vaccine if it proves to be effective.
The activist challenge was successful for both the Moderna and upcoming Pfizer studies and as a result, HIV positive people on effective ART are now to be included in these studies. [2, 3]
References
- Vaccine candidates report phase 3 studies after early safety and immune responses in phase 1/2 studies. HTB (22 July 2020).
https://i-base.info/htb/38589 - Murphy T. Moderna reverses decision to exclude people with HIV from their COVID-19 vaccine trial. TheBody.com. (6 August 2020).
https://www.thebody.com/article/joe-biden-strongest-option-to-end-hiv-epidemic - Guasco R. HIV activists win fight for includion in major COVID-19 vaccine trial. (10 August 2020).
https://www.positivelyaware.com/articles/hiv-activists-win-fight-inclusion-major-covid-19-vaccine-trial