(The Defender) The Bill & Melinda Gates Foundation and Wellcome Trust on Wednesday announced plans to fund a phase 3 clinical trial for a tuberculosis (TB) vaccine that will be tested on 26,000 people at 50 sites in Africa and Southeast Asia over the next four to six years.
Gates committed $400 million to the trial and Wellcome — the largest funder of medical research in the U.K. and one of the largest in the world — committed an additional $150 million.
The trials will test the M72/AS01 vaccine, developed by pharmaceutical giant GSK (formerly GlaxoSmithKline) with partial funding from the Gates Foundation.
Experts told The Washington Post the news was “huge.” The Guardian heralded the announcement as “gamechanging,” while STAT called it “promising.”
But Brian Hooker, Ph.D., P.E., senior director of science and research for Children’s Health Defense told The Defender that the planned trials for the TB vaccine raised red flags.
“I’m concerned that they’re planning on conducting the trial in underdeveloped nations,” Hooker said. “It seems almost prototypical that the underserved have to be guinea pigs for the rest of the world.”
He added, “Fifty percent is incredibly low efficacy for such an ‘important’ intervention to go to essentially everyone in the developing world.”
TB more common among poor
GSK developed the vaccine and ran smaller, “proof-of-concept” phase 2b trials on it in 2018, reporting a 54% efficacy rate. But the vaccine maker didn’t move forward with the large-scale trials needed for a license.
Instead, it passed the license to the Gates Medical Research Institute, a nonprofit biotech spinoff of the Gates Foundation dedicated to developing “novel biomedical interventions” to treat global health problems.
The existing vaccine for TB, the BCG (bacille Calmette-Guérin) vaccine, was developed in 1921 and is effective at stopping TB infection among children but has limited efficacy in adults.
Recent estimates suggest up to 25% of the global population carries a latent (asymptomatic) TB infection, which may later become active among 5-15% of latent carriers. People with latent infection cannot spread the disease.
TB kills 1.6 million people per year, primarily in low and middle-income countries. It is treatable and curable with antibiotics. Drug-resistant strains have emerged, but those also are treatable and curable using second-line drugs.
TB is more common among poor people, who are more likely to work in poorly ventilated and overcrowded conditions, suffer from malnutrition and have more limited access to healthcare.
The funded trial will test whether the experimental vaccine can prevent adolescents and adults with latent tuberculosis from developing symptoms.
Maziar Divangahi, Ph.D., associate director of the McGill International TB Centre — a WHO collaborating research center and recipient of large-scale Gates Foundation grants — told STAT the vaccine was “really a big deal.”
But he also cautioned against putting too much faith in the earlier GSK trial. In that trial, 39 people — 26 in the placebo group and 13 in the vaccine group — became sick, so the sample size was “extremely low,” he said. And no one knows how long protection might last, he said.
In the earlier trial, 67% of people in the group that received the drug made unsolicited reports of adverse events within 30 days after injection, compared with 45% in the placebo group.
Gates Foundation funding like working in a ‘cartel’
The Gates Foundation is one of the largest funders of global health initiatives and “its influence on international health policy and the design of global health programmes and initiatives is profound,” The Lancet reported in 2009.
Since then its influence has grown substantially.
According to Anne-Emanuelle Birn, Sc.D., professor and chair of the Dalla Lana School of Public Health at the University of Toronto, this is a problem:
“The BMGF [Gates Foundation], emblematic of elite interests in contemporary society, disregards the underlying causes of ill health in the first place, overlooks what role the unprecedented accumulation of wealth in the hands of a few has played therein, and remains fiercely proud (staking a moral high ground) of its generosity and technical savoir-faire, all the while remaining underscrutinized by scientists and the wider public alike.”
Her research outlined how the Gates Foundation’s “profit-making principles as drivers of policy” have given business interests “an enormous and unprecedented role” in driving international policy-making.
“Despite the manifold shortcomings of a technology-focused, disease-by-disease approach to global health, this model prevails at present, abetted by the BMGF’s prime sway at formal global health decision-making bodies,” she wrote.
In a recent article examining the role of the Gates Foundation in global health, University of London professor Gwilym David Blunt, Ph.D., wrote that the foundation has been widely criticized for not following data-driven policies. “Its preference for technology and new vaccines” fails to acknowledge that mortality is often driven by “lack of basic resources such as sanitation, housing and nutrition,” Blunt wrote.
While people may benefit from clinical solutions, he wrote “a public health intervention such as ensuring access to clean water and sanitation may reduce deaths more quickly and with less expense.”
Instead, he wrote, the Gates Foundation’s influence “has helped move global health towards high-tech, vaccine-focused initiatives.”
In debates over how to approach global health at GAVI, the Vaccine Alliance, he reported Bill Gates was “vehemently insisting that not ‘one cent’ of his money should go into public systems.”
Arata Kochi, Ph.D., former head of the WHO’s malaria program, compared the Gates Foundation’s funding to working in a “cartel,” with researchers locked into the agenda of a foundation with “a closed internal process, and as far as can be seen accountable to none other than itself.”
Even The Lancet published a similar critique of Gates back in 2009.
“Important health programmes are being distorted by large grants from the Gates Foundation,” Dr. Richard Horton, editor-in-chief wrote in an editorial.
