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

After  **promising results**  from early-stage trials of two key vaccine candidates against the coronavirus, vaccine candidates from **Moderna-NIAID** and **Oxford-AstraZeneca** entered 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, after initially having excluded them. 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. 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. “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. [caption id=“attachment_7620331” align=“alignnone” width=“1280”] Decades of research have proven that HIV-positive people with undetectable viral loads and a safe CD4 count respond to vaccines. AFP[/caption] The exclusion was overturned – first in the Moderna vaccine trial and later, in the Pfizer vaccine trials – after advocates submitted a Change.org petition to the US National Institute of Health AIDS Director Francis Collins, citing that Moderna’s trial “excludes people with HIV with no scientific basis.” Moreover, many health organizations including the US Centre for Disease Prevention and Control recommend routine immunizations for HIV-positive people. The only caveat, as per the CDC website, is for “live vaccines, if the CD4 T cell count is below 200”, the petition pointed out. 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

Pfizer, too, in a 7 August  letter to the petition signatories, said that is has amended its protocol to open up the trial to HIV patients in phase II/III of its vaccine study, as well as people who have been treated for hepatitis B and hepatitis C in the past. In the same vein, debate has emerged around pregnancy. While the pregnant women group is far less activist-driven than the HIV community, they too have been left out of safety and efficacy trials throughout, something  scientists and ethicists have acknowledged.