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HIV Vaccine Hopes Dashed

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The first Phase 3 trial for a potential HIV vaccine has ended in disappointment.

It’s back to the drawing board for a potential HIV vaccine, as Janssen Pharmaceuticals recently announced a Phase 3 investigational study into a potential regimen was not effective in preventing HIV infection.

The Janssen Pharmaceutical Companies of Johnson & Johnson announced in January that their independent Data and Safety Monitoring Board uncovered no safety issues with their Mosaico study, but also found it didn’t prevent HIV effectively, leading them to discontinue the trial.

“We are disappointed with this outcome and stand in solidarity with the people and communities vulnerable to and affected by HIV,” Penny Heaton, M.D., Global Therapeutic Area Head for Vaccines at Janssen, said in a statement. “1.5 million people acquired HIV in 2021 alone, underscoring the high unmet need for new options and why we have long worked to tackle this global health challenge. We remain steadfast in our commitment to advancing innovation in HIV.”

Dr. Anthony Fauci, former chief medical advisor to President Biden, countered the discouraging news by telling The New York Times that other strategic approaches, including an ongoing study called PrEPVacc in eastern and southern Africa, have gained some headway.

Although medications can suppress the virus and living with HIV is no longer a death sentence, the regimens are needed for life, with some patients developing side effects or drug resistance. Meanwhile, millions of people around the world cannot easily access the lifesaving medications.

“The ultimate prevention modality for any infection, particularly viral infection, is a vaccine that’s safe and effective,” said Dr. Fauci. “That’s the reason why the field is going to continue to pursue very active research in that area.”

Mosaico was a complimentary vaccine trial to the Imbokodo, study which was discontinued in 2021 after disappointing results among women in sub-Saharan Africa.

Mitchell Warren, executive direction of the HIV prevention organization AVAC, said, “It’s not that all hope is lost, it’s that we need to redirect our resources to greatest impact.”

Warren hopes the Mosaico news prompts policymakers and activists to ensure the existing tools for HIV prevention — like PrEP — be made more widely accessible.

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