Contact: Natalie Shure, natalie.shure@treatmentactiongroup.org

October 6, 2023 — TAG is appalled by the revelations set forth in Anna Marie Barry-Jester’s deeply reported investigation for ProPublica, “How a Big Pharma Company Stalled a Potentially Lifesaving Vaccine in Pursuit of Bigger Profits,” published online October 4. Barry-Jester’s detailed portrait of how GSK’s financial interests have – and will likely continue to – set back progress against the world’s deadliest infectious disease lays bare just how egregiously large pharmaceutical companies bilk the global public, and makes an urgent case for government and philanthropic funders to take action and demand better.

The article walks readers through the history of a promising TB vaccine candidate called M72/AS01E originally owned by GSK. In 2018, results from a phase IIb proof-of-concept trial suggested the vaccine merited study in a larger phase III trial to confirm the vaccine’s safety and efficacy. If successful there, M72/AS01E could be the first new TB vaccine developed in over 100 years. Despite this promising breakthrough, GSK elected not to invest in further R&D on M72/AS01E, instead striking a 2020 deal with the Gates Medical Research Institute (Gates MRI) to license M72 to Gates MRI while retaining rights over a key vaccine ingredient, the lucrative AS01 adjuvant.

Now we have learned that the early, foundational research on the adjuvant originated in U.S. government labs through research on malaria vaccines sponsored by the U.S. Army, who brought GSK into the project as a potential manufacturing partner in the 1980s. The company went on to patent the Army-developed technology themselves, as well as to obtain control over smaller companies supplying ingredients necessary to make the adjuvant including “a lion’s share of the supply” of the only known source of a particular tree bark extract from Chile. In other words, even though GSK no longer owns the vaccine borne out of years of publicly funded research, it still maintains a chokehold over the eventual manufacturing process and will therefore determine available access and supply

Even with Gates MRI and the Wellcome Trust set to co-sponsor a $550 million phase III trial on M72/AS01E starting in early 2024, emerging details regarding the terms of the deal between Gates MRI and GSK are concerning. Should the vaccine be approved, GSK will retain control over sales in many countries including in high-income countries and countries in Latin America and Eastern Europe with significant TB burdens, as well as adjuvant supplies – all but guaranteeing future bottlenecks in TB vaccine production and dissemination. In exchange for this deal, ProPublica inferred Gates MRI paid GSK a one-time licensing fee of $10 million. GSK described this to ProPublica as “a small incentive to invest in the company’s global health endeavors,” but in actuality GSK has clearly scaled down its global health ambitions since then.

Put simply, there is a lot here that warrants deep concern. In the near term, TAG urges relevant actors to take the following corrective actions to best situate M72/AS01E to benefit communities at risk of TB:

GSK:
The company must take immediate action to make the AS01 adjuvant available to meet potential demand for a new TB vaccine by facilitating technology transfer and knowledge sharing with local manufacturers in low- and middle-income countries, and commit to not stand in the way of R&D and production efforts happening elsewhere or undertaken by other stakeholders.

GSK, Gates MRI:
GSK and Gates MRI must both be transparent about the terms of the secret agreement they made, including details on agreed quantities of adjuvant supply, cost-of-goods, geographic scope, and pricing/affordability. They should renegotiate better terms for adjuvant access and geographic scope, and ensure that there is adequate adjuvant available to meet demand beyond the period of initial introduction covered by the existing terms. The new agreement must be made public in full.

US Government:
Public funders should place access safeguards on public investments. Given Army contributions and other public funding behind this vaccine, officials must explore every available tool for obtaining rights to manufacture AS01 adjuvant for TB, malaria, and other deadly pandemics for which vaccines have benefitted from significant public funding.

In particular, the Federal Trade Commission (FTC) and the Department of Justice should work together to update antitrust policies and regulations, adapted from examples used for telecommunications and other industries, to apply to pharmaceutical and health technology industries. Such regulations should exercise FTC’s existing authority to prohibit companies from acquiring competitors with patents that may lend them an effective monopoly over certain critical health technologies, as was the case in several of GSK’s mergers and acquisitions of smaller companies that make and supply adjuvant ingredients (e.g., Corixa Corp and Agenus). This regulation is crucial to ensure that anticompetitive practices do not inhibit public access to lifesaving health technologies like TB vaccines.

WHO:
The World Health Organization must make solving the M72/AS01E adjuvant access problem a top priority of the newly formed TB Vaccine Accelerator Council, which is co-chaired by the Ministers of Health of Brazil and Indonesia with a mission to accelerate the development, licensure, and equitable and affordable use of new TB vaccines.

It is distressing to learn from the ProPublica report that representatives from the government of Brazil who attended a series of meetings on the vaccine the WHO organized in 2019 were “authorized to spend significant government funds on a tuberculosis vaccine trial,” but that GSK’s unwillingness to transfer technology and intellectual property in exchange for governments paying for the trial stood in the way.

Beyond these actions, we must demand a better system for generating socially necessary medicines. For-profit companies simply shouldn’t have the unilateral power that they do over lives of people affected by TB and other diseases. We urge public officials to step up and play a greater role in ensuring publicly-funded science serves the public interest, by making use of existing legal mechanisms to counteract pharmaceutical monopolies on public goods – potentially including investigations, lawsuits, or even by pursuing novel legislation to facilitate public pharmaceutical manufacturing.

Everyone on earth has the human right to benefit from scientific progress. ProPublica’s investigation makes clear that current arrangements with GSK stand in the way of that right being realized for people at risk of TB.

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