Research Roundup: Kid-friendly TB treatment, drug manufacturing on-the-go, diarrheal disease, and more

Each year, a new flu vaccine is developed, containing proteins from three to four strains of influenza. These proteins train the immune system to recognize different versions of the virus, enabling a rapid response in the case of infection. For the past eight years, the same strain of H1N1 (swine flu) has been included in flu vaccines globally, however, the World Health Organization has recommended this strain be replaced with a more recent version of the ever-changing virus. Normally, flu vaccines prompt the greatest immune response in healthy adults, however, since 2013, their efficacy has been decreasing in adults aged 30 to 60. The theory? Many of these adults were first exposed to H1N1 between 1977 and 1985, and the strains circulating at that time shared one critical component with those circulating between 2009 and 2013. Consequently, those who had been exposed to H1N1 between 1977 and 1985 responded to the flu vaccine as if it were a booster shot. Rather than producing entirely new antibodies tailored to the new version of the virus, their immune systems ramped up production of the existing antibodies tailored to the old version. In 2013, the virus mutated further, losing the component it shared with older strains, and thus, adults who experienced the booster shot phenomenon were no longer protected by the vaccine. Fortunately, experts have identified a new version of the virus, retrieved from a patient in Michigan, which should provide broader protection against H1N1 for future flu vaccines. A recent study out of South Africa suggests that one in ten children who are infected with HIV have no immune response to the virus and consequently experience none of the symptoms associated with HIV and AIDS. The researchers analyzed blood samples from 170 children who are HIV positive and have not received treatment, but nonetheless have not developed AIDS. The samples confirmed high volumes of the virus in the blood, and the lack of either an immune response or symptoms demonstrates, “HIV disease is not so much to do with HIV, but with the immune response to it,” according to Dr. Philip Goulder, an author of the study. This response—or lack thereof—has also been reported in more than 40 nonhuman primate species, but has not been seen in adults, who often have more aggressive immune reactions to pathogens. While limited, existing research indicates that some children with this protective attribute develop AIDS as they age, while others continue to display no symptoms. However, treatment may still be needed to prevent further transmission of the virus. SciDev.Net took an in-depth look at the European & Developing Countries Clinical Trials Partnership (EDCTP) and how its second iteration (EDCTP2) could be a catalyst for increased investments in health research and development (R&D) by African governments. EDCTP was launched in 2003 and ran through 2014, during which time it invested US$425 million into 254 collaborations between African and European scientists. The Partnership funded phase 2 and 3 clinical trials for HIV and AIDS, malaria, and tuberculosis. In 2014, EDCTP2 was established, expanding the scope to cover phase 1 and phase 4 (postmarketing surveillance) and to include other neglected infectious diseases. In just two years, EDCTP2 has mobilized nearly US$115 million. The role of the African member countries has been elevated in the second iteration—they have voting rights in the EDCTP General Assembly and have each pledged EUR€200,000 (US$224,000) to the Partnership.

As always at this time of year, the international diplomatic community is dealing with the adrenaline letdown following the conclusion of two weeks of mayhem in midtown for the United Nations General Assembly (UNGA). Attendees left with renewed inspiration, a few new political commitments, and for many, a nasty sinus infection that spread all too easily given the diplomatic necessity of copious hand-shaking. In our hyper-connected world where a single international event can spark a global outbreak of something far more deadly, it was apropos that two global health R&D topics received significant attention at this year’s assembly. Antimicrobial ResistanceAs GHTC has previously discussed, the assembly included a special High-Level Meeting on Antimicrobial Resistance (AMR), which was marked by an unusual level of agreement and commitment among member states and United Nations (UN) agencies on what actions are needed to address this challenge. The meeting concluded with the adoption of a political declaration, which among other priorities, acknowledges the importance of catalyzing R&D for the new diagnostics, vaccines, and antibiotics needed to combat AMR.The declaration specifically addresses R&D at three levels: National: Countries should include resources and policies to support R&D in their national AMR plans. Regional: Regional groups should develop regional AMR plans that leverage innovative partnership and incentive mechanisms to support R&D. Global: The UN system should include in its global AMR strategy sufficient policies to encourage global R&D efforts; the entire multilateral system (including development banks) should provide resources to support the above AMR plans, including for R&D; and the UN Secretary-General should establish an oversight group to ensure that all of these efforts are coordinated. We were pleased to see a dedicated call for all stakeholders in global health to ensure that R&D is a key part of addressing AMR and that sufficient resources are allocated to incentive mechanisms. Yet as one panelist rightly noted during the summit, “If I have three key points, they are implementation, implementation, implementation!” As the global community has seen far too frequently in the past, normative agreements reached at the UN require programming to translate them into progress on the ground. It will take civil society pressuring national governments to keep their commitments to this very progressive framework for it to have the impact it can and should. Access to Medicines TB medicines. Photo credit: PATH/Matthew DakinLess than one week before UNGA, the UN Secretary-General’s High-Level Panel on Access to Medicines (HLP) released its long-anticipated final report, which outlines dozens of recommendations from the panel in response to its mandate “to review and assess proposals and recommend solutions for remedying the policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies.”Both the mandate and the process of developing the report was controversial, as evidenced by the dissenting commentaries contained in an annex to the report. As outlined in the HLP cochairs’ letter to the Secretary-General, the dozens of agreed recommendations fall into four broad categories: Governments must urgently increase their current levels of investment in health technology innovation to meet unmet needs and should enter into negotiations for a binding global R&D treaty that delinks the costs of innovation from the end prices of health technologies in order to address issues that existing innovation mechanisms have failed to adequately remedy. There must be much greater transparency to ensure that the costs of R&D, production, marketing, and distribution, as well as the end prices of health technologies are clear to consumers and governments. Governments and the private sector must refrain from explicit or implicit threats, tactics, or strategies that undermine the right of World Trade Organization (WTO) members to use flexibilities as reaffirmed in the Doha Declaration on TRIPS [WTO Agreement on Trade-Related Aspects of Intellectual Property] and Public Health. WTO members must register complaints against undue political and economic pressure, and take punitive measures against offending members. The Secretary-General should establish an independent review body tasked with assessing progress on health technology innovation and access, and a High-Level meeting on Health Technology Innovation and Access should be convened by 2018.  In this environment, given the timing of the release of the report, the UN Development Programme convened at the last minute an invite-only panel discussion on the final day of UNGA. The session featured forceful remarks from the panelists and advocates, in addition to a lone dissenting statement from a member state government reiterating their concerns over the mandate of the panel.Ultimately, however, the takeaway from the event was the same as from the AMR meeting earlier in the week: the panelists unanimously agreed that the HLP’s work is done and that the Secretary-General now holds responsibility for moving the agenda forward. As a group convened without a member state mandate, the HLP had no binding authority to enact or enforce its recommendations and can only advise on what possible solutions might be. Advocates in the room noted that civil society activism can help hold governments to account and drive forward the recommendations to implementation.Overall, UNGA 2016 showed both the strength and the weakness of our multilateral governance structures. The UN can dream big, convene the world’s most senior leaders, and get them to agree to normative statements. However, implementing those norms requires the full support of its member states. This is not to minimize the importance of such a convening role; we would not have made the progress we have against HIV and AIDS, for example, without the UN’s forceful leadership. What remains to be seen, however, is whether the is a similar confluence of civil society, member state government, and multilateral organization support to move forward the AMR and access agendas over the coming years.