Home » Health » Moderna and Pfizer have decided to include HIV-positive volunteers in phase 3 trials of COVID-19 vaccines – L’Observateur de Troyes

Moderna and Pfizer have decided to include HIV-positive volunteers in phase 3 trials of COVID-19 vaccines – L’Observateur de Troyes

Health organizations, including the CDC, recommend routine immunization of people with HIV, who have been unilaterally excluded from vaccine trials so far.

After promising results preliminary testing of two key coronavirus vaccine candidates, vaccine candidates from Modern-NIAID and Oxford-AstraZeneca entered the final phase of human trials in August. Now Moderna and Pfizer (which has in partnership with the German biotechnology company BioNTech to develop a COVID-19 vaccine) announced that they would include a limited number of HIV-positive volunteers in the final phase of the trials, after initially excluding them.

So far, all human trials of a COVID-19 vaccine have excluded participants with pre-existing conditions and comorbidities. the protocol for the NIAID-Moderna vaccine, for example, excludes people with an “immunosuppressive or immunodeficient condition, including infection with human immunodeficiency virus (HIV)”. the Oxford-AstraZeneca trial protocol excludes people with “any confirmed or suspected immunosuppression or immunodeficiency state” without specifying HIV.

However, advocates have 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.

“Decades of research have proven that people living with HIV with an undetectable viral load and 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 a break to see an inexperienced company with a lack of basic scientific knowledge in charge of an extremely important vaccine trial – at a huge cost to taxpayers,” he added.

Decades of research have proven that people living with HIV with an undetectable viral load and safe CD4 counts respond to vaccines. AFP

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 director of AIDS of the US National Institute of Health, Francis Collins, citing that Moderna’s essay “excludes people with HIV without a scientific basis.”

In addition, many health organizations y compris le US Center for Disease Prevention and Control recommend routine vaccination of people with HIV. The only caveat, according to the CDC’s website, is with “live vaccines, if the CD4 T cell count is less than 200,” the petition pointed out.

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

Pfizer also in an August 7 letter to petition signatories, said he had changed his protocol to open the trial to HIV patients in phase II / III of his vaccine study, as well as to people who have been treated for hepatitis B and hepatitis C in the past.

In the same vein, a debate has emerged around pregnancy. Although the group of pregnant women is much less motivated by activists than the HIV community, they have also been excluded from safety and efficacy trials throughout. scientists and ethicists have recognized.

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