Although they were developed very quickly, the clinical trials of COVID-19 vaccine candidates have been carried out to the same standards, including safety standards, as other clinical trials. All COVID-19 vaccines authorized for use have completed the Phase 3 study stage and shown to be safe and effective. Stringent regulatory bodies have approved them for use in the general population.
People living with HIV have taken part in trials of most COVID-19 vaccine candidates, including those developed by Pfizer-BioNTech, Moderna and the National Institutes of Health, AstraZeneca and the University of Oxford, Johnson & Johnson, and Novavax and Sanofi-GlaxoSmithKline. Most trials that have not included people living with HIV as participants are studying similar vaccines to ones that have been tested in people living with HIV already. They are therefore assumed to be safe for people living with HIV.
The currently approved vaccines have been shown to be safe and effective at preventing disease. This means that the vast majority of vaccinated people did not become ill with COVID-19. However, no vaccine is 100% efficacious, and efficacy levels have varied in the clinical trials of the different vaccines. Most vaccines also require two doses to achieve this effectiveness and to ensure longer durability of vaccine-induced immunity. Some vaccines under review currently use one dose.
People living with HIV being treated effectively with ARV therapies may have subtle immune deficiencies and chronic inflammation that could affect susceptibility to SARS-CoV-2, risk of severe disease from COVID-19 and response to SARS-CoV-2 vaccines.
The British HIV Association (BHIVA) says that people with HIV, whether being treated with ARVs or not, might not respond as well to COVID-19 vaccines, possibly because people living with HIV might have a weaker immune response than people who are HIV negative. BHIVA is monitoring all evidence around COVID-19 and HIV and will update its advice if needed.
There are no safety concerns with COVID-19 vaccines interacting with ARVs or around ARVs affecting COVID-19 vaccines.