UPDATE 8/6/20: Pfizer has informed advocates that its Phase III COVID-19 vaccine trial will include people living with HIV, hepatitis B or hepatitis C.
UPDATE 8/5/20: Moderna, which is developing a COVID-19 vaccine in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), has agreed to include people with stable HIV in its newly opened Phase III clinical trial, according to advocates. A sign-on letter demanding removal of the exclusion collected more than 1,000 signatures in a week.
Other companies developing COVID-19 vaccines, including Sanofi, NovaVax and J&J, will also include HIV-positive people in their trials, according to longtime advocate Lynda Dee of AIDS Action Baltimore. U.K. advocate Gus Cairns of NAM/aidsmap reports that a Phase III study of a vaccine from the University of Oxford and AstraZeneca will also include people with HIV. That leaves Pfizer, which is jointly developing a vaccine with BioNTech, as a holdout that still may exclude people with HIV or hepatitis B or C. But activists are working to get these exclusions removed as well.
“What an amazing community victory, harkening back to the old days! This was a concerted HIV community effort, once again working with NIAID in the best interests of people with HIV,” Dee told POZ. “Every COVID-19 vaccine company with current trials in the U.S. has agreed to include people with HIV, except Pfizer, which is next on our list.”
UPDATE 7/31/20: Responding to a question from POZ on an International AIDS Society-USA virtual dialogue on COVID-19 on July 31, Michael Saag, MD, of the University of Alabama at Birmingham, and Robert Schooley, MD, of the University of California San Diego, agreed that there is no reason to exclude HIV-positive people from coronavirus vaccine trials.
“We need to test this broadly,” Schooley said. “If we’re going to be using a vaccine in the general population, you need to test it in the general population.”
“I think trials ought to be open to as many different types of people as possible,” Saag concurred. “The worst case would be to enroll mostly young and middle-aged white people without comorbid conditions. What if it works and you’ve excluded an entire population? What are you going to tell them? We’ve got to have data.”
UPDATE 7/30/20: POZ has learned that Pfizer and BioNTech also plan to exclude people with HIV from their late-stage coronavirus vaccine trial, as well as those with hepatitis B or C.
This article was originally published on July 28, 2020.
As the world waits with bated breath for a safe and effective vaccine to prevent SARS-CoV-2, the new coronavirus that causes COVID-19, people living with HIV are concerned that they may be excluded from clinical trials testing these vaccines.
Following the publication this month of promising data from early-stage trials, two vaccine candidates—one being developed by the National Institute of Allergy and Infectious Diseases (NIAID) and the biotechnology company Moderna, the other by the University of Oxford and AstraZeneca—entered the final stage of testing this week.
But the trial protocol for the NIAID-Moderna vaccine, available on ClinicalTrials.gov (study number NCT04470427), excludes people with an “immunosuppressive or immunodeficient state, including human immunodeficiency virus (HIV) infection.” Read more via POZ