After promising results from early-stage trials of two key coronavirus vaccine candidates, Moderna-NIAID and Oxford-AstraZeneca entered its final stage of human trials in August. Now, Moderna and Pfizer (which has partnered with German biotech firm BioNTech to develop a COVID-19 vaccine) have announced that they will be including a limited number of HIV-positive volunteers in the final stage of trials.
So far, all human trials for a COVID-19 vaccine have excluded participants with pre-existing conditions and co-morbidities. The protocol for the NIAID-Moderna vaccine, for instance, excludes those with an "immunosuppressive or immunodeficient state, including human immunodeficiency virus (HIV) infection." The protocol for the Oxford-AstraZeneca trial excludes people with "any confirmed or suspected immunosuppressive or immunodeficient state" without specifying HIV, Firstpost reported.
"Decades of research have proven that HIV-positive people with undetectable viral loads and a safe CD4 count respond to vaccines, and are encouraged to receive all recommended vaccinations," Jeff Taylor of the HIV+Aging Research Project told POZ. "It should give us pause to see an inexperienced company with a lack of basic scientific knowledge is in charge of a hugely important vaccine trial — at a huge cost to taxpayers," he added.
However, advocates have argued that with modern antiretroviral therapy, most HIV-positive people on treatment do not experience any immune suppression. Instead, the human immunodeficiency virus (HIV) is prevented from replicating and affecting immune cells, which are often at near-normal levels.
There are studies showing that people living with HIV are not at any greater a risk for SARS-CoV-2 infection, and neither are they more likely to develop severe COVID-19 or to die from it.
On 5 August, Moderna tweeted that its Phase 3 COVID-19 vaccine trials would adapt to "include people living with controlled HIV who are not otherwise immunosuppressed." The company had planned to test the vaccine in HIV patients in a separate study, but “heard the preference of the community,” it said, to be part of the ongoing trial.
Today, we are sharing an important update about our protocol for the Phase 3 COVE Study of mRNA-1273, our vaccine candidate against COVID-19. pic.twitter.com/jigTXUi9v2— Moderna (@moderna_tx) August 5, 2020