M72/ AS01E Works: Now What?

We recently discussed M72/AS01E and the exciting data suggesting its efficacy in preventing progression of TB disease after people had already been exposed to TB. Today, we will put these findings into context. Some of the excitement regarding this trial stems from the novelty of its findings. Dr. Ann Ginsberg is a TB researcher working for the Bill & Melinda Gates Foundation who helped author the study.  She was particularly impressed by the novel characteristics of M72/AS01E.

“This is the first time any vaccine has protected people who were already infected with the bacteria that cause TB but not yet symptomatic. This is the first time it was demonstrated that protecting already infected peoples was even possible. There were certainly doubters that a TB vaccine could ever do that,” she said.

And the composition of M72/AS01E as a “subunit” vaccine is also unique for a TB vaccine that protects in people. As Dr. Ginsberg put it, TB bacteria expresses over 4000 proteins, but this vaccine only has two of them incorporated into it. Yet the trial demonstrated that a subunit vaccine can offer protection from TB disease.  Dr. Ginsberg’s impression overall was that this trial is a “fantastic and a very exciting result that could have a major impact”, estimating that millions of lives could be saved and that tens of millions of cases of TB could be averted over time were it to be broadly implemented.

 The results of the trial were certainly welcome good news to Mike Frick, Co-Director of the TB Project at Treatment Action Group. “Vaccine research is the lynchpin to prevention and the global elimination agenda,” he said.

“Despite the fact it is one of the largest killers in the world most TB patients are found in impoverished areas and LMICs [Low- and Middle-Income Countries] so it is not a vaccine that has a market, essentially. This vaccine does not have potential for a ‘for profit’ company to make a substantial profit and they would have to invest many more millions of dollars to complete development and implement it,” Dr. Ginsberg said.

One solution to this problem has been philanthropic investment. In January 2020, GlaxoSmithKline (GSK), the pharmaceutical company that originally developed and owned M72/AS01E, entered into a licensing agreement with the Bill and Melinda Gates Research Institute to increase production capacity.

Mr. Frick argues that another way to overcome barriers of financial risk is to have governments take a leading role in funding development. He points out that for TB research at large, “65% of available funding comes from public sector” with the result that the effort to eliminate TB is already “a public driven agenda.” Through advocacy, the public has leverage to influence government to take on the financial risks associated with TB vaccine development and production. Dr. Ginsberg lays out a simple case for the American public’s investment in TB elimination: as a disease spread via airborne transmission, much like COVID-19, “TB anywhere is TB everywhere.”

While the COVID-19 pandemic has diverted attention and resources from the effort to eliminate TB over the past year, the response to vaccine development for COVID-19 has demonstrated the incredible power of effective partnerships between private, philanthropic and public investors. The recently approved COVID-19 vaccines demonstrate the unprecedented progress we can make when acting together. Hopefully, the lessons learned can be applied to the rapid testing, production, distribution and implementation of M72/AS01E. as well. Millions of lives are depending on it.

Hunter C. Spencer, DO
Oregon Health & Science University
Department of Geriatrics and Internal Medicine

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