Home / NewTech / Moderna, Pfizer will enroll HIV-positive volunteers in Phase 3 studies of COVID-19 vaccines

Moderna, Pfizer will enroll HIV-positive volunteers in Phase 3 studies of COVID-19 vaccines

Health organizations, including the CDC, recommend routine immunization for HIV-positive individuals who have previously been unilaterally excluded from vaccine trials.

After this promising results from early studies with two major vaccine candidates against the coronavirus, vaccine candidates Moderna-NIAID and Oxford-AstraZeneca entered the final stages of human experimentation in August. Well Moderna and Pfizer (which has Partnership with the German biotech company BioNTech on developing a COVID-19 vaccine) have announced that they will enroll a limited number of HIV-positive volunteers in the final stages of the trials after initially excluding them.

So far, all human studies with a COVID-1

9 vaccine have excluded participants with pre-existing medical conditions and comorbidities. The Protocol for the NIAID Moderna vaccineexcludes, for example, those with an “immunosuppressive or immunodeficient condition, including infection with human immunodeficiency virus (HIV)”. The Protocol for the Oxford-AstraZeneca study excludes persons with “a confirmed or suspected immunosuppressive or immunodeficient condition” without mentioning HIV.

However, proponents have argued that with modern antiretroviral therapy, most HIV-positive individuals undergoing treatment will not experience immunosuppression. Instead, it prevents the human immunodeficiency virus (HIV) from replicating and affecting immune cells, which are often at near normal levels. There are studies that show that people living with HIV are not at a higher risk of SARS-CoV-2 infection, nor are they more likely to have severe COVID-19 or die from it.

“Decades of research have shown that HIV-positive people 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 told POZ. “It should give us a break from seeing that an inexperienced company with a lack of basic science is responsible for an extremely important vaccine study – at a huge cost to taxpayers,” he added.

Moderna Pfizer will include HIV positive volunteers in Phase 3 studies of COVID19 vaccines

Decades of research have shown that HIV-positive people respond to vaccines with undetectable viral loads and safe CD4 counts. AFP

The exclusion was lifted – first in the Moderna vaccine study and later in the Pfizer vaccine trials – after proponents filed one Change.org petition to the AIDS director of the US National Institute of Health, Francis Collins, citing Moderna’s study “excludes people with HIV without a scientific basis”.

In addition, many health organizations including the US Center for Disease Prevention and Control recommend routine vaccinations for HIV positive people. The only restriction, according to the CDC website, is “live vaccines when CD4 T cell counts are below 200,” the petition said.

On August 5th Moderna tweeted that its Phase 3 COVID-19 vaccine studies would adjust to “include people with controlled HIV who are otherwise not immunocompromised”. The company had planned to test the vaccine in HIV patients in a separate study, but “heard the community preference” to be part of the ongoing study.

Also Pfizer in an August 7th Letter to the signatories of the petition, said it changed its protocol to open 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 way, a debate about pregnancy has arisen. While the group of pregnant women is far less activist than the HIV community, they too have been consistently excluded from safety and effectiveness studies Scientists and ethicists have recognized.

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