Moderna, Pfizer, Incorporate HIV-Positive Volunteers into Phase 3 Trial of COVID-19 Vaccine-Technology News, Firstpost

tech2 news staffAugust 10, 2020 15:32:12 AM

rear Promising results From early trials of two major vaccine candidates against coronavirus, Modern niad And Oxford Astra Zeneca In August, the final stage of human trial was entered. Moderna and Pfizer ( Partnership with German biotechnology company BioNTech COVID-19 Vaccine Development) announced the inclusion of a limited number of HIV-positive volunteers at the end of the trial, after initial exclusion.

So far, all human trials of the COVID-19 vaccine have excluded participants with pre-existing conditions and comorbidities. of NIAID-Moderna Vaccine ProtocolFor example, patients with an “immunosuppressed or immunodeficient condition that includes a human immunodeficiency virus (HIV) infection” are excluded. of Oxford-AstraZeneca test protocol Excludes individuals who have “confirmed or suspected immunosuppressed or immunodeficient status” without identifying HIV.

However, defenders argue that with modern antiretroviral therapy, most HIV-positive individuals undergoing treatment do not experience immunosuppression. Instead, the human immunodeficiency virus (HIV) is prevented from replicating and affecting immune cells. Immune cells are often close to normal levels. Studies show that people living with HIV are not at increased risk of SARS-CoV-2 infection and are less likely to develop severe COVID-19 or die of COVID-19.

“Decades of research have shown that HIV-positive people with undetectable viral load and safe CD4 counts respond to the vaccine and receive all recommended vaccinations. I am encouraged.” Said POZ.. “We should wait to see that an inexperienced company without basic scientific knowledge is responsible for a very important vaccine trial. It costs taxpayers a huge amount.”

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

The exclusion was overturned after supporters filed – first in the Moderna vaccine trial and then in the Pfizer vaccine trial – Change.org Petition Francis Collins, director of AIDS at the National Institutes of Health, said Moderna’s trial “excludes HIV patients who have no scientific basis.”

In addition, many health agencies Includes US Centers for Disease Control and Prevention Regular vaccination is recommended for people with HIV. The only warning, according to the CDC website, is “live vaccine, CD4 T cell counts below 200,” the petition noted.

August 5, Moderna Tweeted The Phase 3 COVID-19 vaccine trial will be adapted to “include people living with controlled HIV who are not otherwise immunosuppressed,” he said. The company was planning to test the vaccine in HIV patients in another study, but as part of an ongoing trial, “heard community preferences,” he said.

Today we would like to share important updates on the protocol for the Phase 3 COVE study of mRNA-1273, a vaccine candidate against COVID-19. pic.twitter.com/jigTXUi9v2

-Modern (@moderna_tx) August 5, 2020

Pfizer on August 7th Letter to petition signerIt states that it has modified the protocol to open the trial to HIV patients in Phase II/III of vaccine research, and to people who have been previously treated for hepatitis B and hepatitis C.

Similarly, debate is emerging before and after pregnancy. The group of pregnant women, although less activist-driven than the HIV community, has always been excluded from safety and efficacy trials. Scientists and ethicists admit..

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