Moderna, Pfizer to include HIV-positive volunteers in Phase 3 trials of COVID-19 vaccines
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.
