Moderna, Pfizer to Include HIV-Positive Volunteers in Phase 3 COVID Trials – 19 Vaccines
–
After promising results from preliminary trials of two main coronavirus vaccine candidates, Moderna-NIAID and Oxford-AstraZeneca entered its final phase of human trials in August. Now Moderna and Pfizer (which has partnered with German biotech company BioNTech to develop a COVID – 19 vaccine) have announced that they will include a limited number of HIV-positive volunteers in the final phase of trials.
So far, all human trials for a COVID – 19 vaccine have excluded participants with pre-existing conditions and co-morbidities. The NIAID-Moderna vaccine protocol, for example, excludes people with an “immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection”. The Oxford-AstraZeneca trial protocol excludes people with “a confirmed or suspected immunosuppressive or immunodeficient condition” without specifying HIV, Firstpost reported.
“ Decades of research have proven that people living with HIV with undetectable viral loads and safe CD4 counts respond to vaccines and are encouraged to receive all recommended vaccinations, “Said Jeff Taylor of the HIV Aging Research Project POZ. “It should give us a break to see an inexperienced company with a lack of basic scientific knowledge in charge of an extremely important vaccine trial – at enormous cost to taxpayers,” he added.
However, advocates argued that with modern antiretroviral therapy, most people with HIV 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 greater risk of infection with SARS-CoV-2, nor are they more likely to develop severe COVID-19 or die of it.
On August 5, Moderna tweeted that its Phase 3 COVID – 19 vaccine trials would be adapted to “include people living with controlled HIV who are not otherwise immunosuppressed.” The company had planned to test the vaccine in HIV-positive patients in a separate study, but “heard the community preference,” she said, to be part of the ongoing trial.
Today we are sharing an important update on our protocol for the Phase 3 mRNA COVE Study – 1273, our COVID vaccine candidate – 19. pic.twitter.com/jigTXUi9v2
– Moderna (@moderna_tx) August 5, 2020
Latest news on the coronavirus
Fight against coronavirus: full coverage
–
