Research Roundup: Vaccine candidate for gestational malaria, FDA fast-tracks coronavirus diagnostic, and Zika vaccine induces potent Zika and dengue antibodies

With the global health emergency of the novel coronavirus looming large, last week the global health community gathered in Geneva to kick off the World Health Organization (WHO) Executive Board (EB) meeting. In his opening remarks, WHO Director-General Dr. Tedros Adhanom Ghebreyesus highlighted the agency’s new Science Division and underscored WHO’s commitment to “being at the forefront of science,” signaling the importance of research and development (R&D) to achieve the agency’s goals. GHTC was on the scene following the official agenda and delivering statements. Here are our top three takeaways from this year’s EB:1. Coronavirus and public health emergency preparedness take center stageWith the coronavirus [COVID-19] crisis dominating the attention of the world, the global response to this health emergency was a clear priority for WHO during the EB. Throughout the week, WHO held daily briefings to update member states on the evolving situation and ongoing response efforts. While plenty of the discussions were mired in the ongoing political controversies around travel and trade restrictions, a good portion also encouragingly centered around the need to fast-track the R&D response. Delegates highlighted the development and evaluation of effective diagnostic tests, vaccines, and medicines, as part of the R&D priorities and called for establishing mechanisms that ensure access to these new treatments and technologies for the most vulnerable populations. Data sharing, public-private partnerships, and collaboration were also highlighted as key elements to be strengthened as part of emergency preparedness activities.A global research and innovation forum specifically on the coronavirus was convened by WHO in the days following the EB in line with the WHO R&D Blueprint strategy and preparedness plan to rapidly activate R&D activities during epidemics. Its aim is to fast-track the availability of effective tests, vaccines, and medicines that can be used to save lives and avert large-scale crises.The theme of rapid response capabilities also dovetailed into the dialogue at the EB around the Nagoya Protocol, a legal framework that regulates the sharing of genetic resources across borders to ensure any benefits derived are fairly and equitably shared. China was continuously praised at the EB for its rapid sharing of genetic sequence data on the virus, which has helped accelerate the R&D response. However, this action was not in line with the Protocol, which calls for this type of genetic data sharing to be negotiated individually with each country. In a session on the public health implications of the Nagoya  Protocol, member states called on WHO to continue to gather intelligence and provide a review of the current impact of the Protocol. Several members also highlighted the need for a new international framework to specifically govern pathogen sharing, modeled on the Pandemic Influenza Preparedness (PIP) framework, a non-binding mechanism that seeks to strengthen global influenza surveillance and response systems. WHO Chief Scientist Dr. Soumya Swaminathan promised that her team would continue its efforts to study the issue and hold additional consultations to provide more clarity to all stakeholders.2. R&D features prominently in Global Vaccine Action Plan and Ending TB agendaWith sessions on the Global Vaccine Action Plan, intellectual property, ending tuberculosis (TB), and neglected tropical diseases, it is not surprising that this year’s EB featured an agenda with significant implications for R&D.In particular, the session on ending TB generated critical momentum for R&D, as member states called for increased investment in developing new technologies, including shorter, high-quality treatment regimens and diagnostic tools. The need to enhance data sharing and strengthen enabling environments for R&D was also discussed by country delegates.Member states also unanimously approved two decisions that set the stage for global vaccine policy in the next decade—a draft resolution on “strengthening global immunization efforts to leave no one behind” and the first-ever draft resolution on “eliminating meningitis by 2030”—after reviewing a report prepared by the Director-General on lessons learned from the Global Vaccine Action Plan 2011–2020. Member states were urged to continue working with R&D stakeholders to support immunization supply chain innovations and vaccine administration technologies to increase the efficiency of vaccine delivery. Countries were also encouraged to improve and increase vaccine production capacity and develop new products, services, and practices, including those addressing emerging infectious diseases.3. Civil society engagement at WHO remains strainedCivil society engagement with WHO continues to be a challenging process and this year’s EB strained relations between stakeholders even further. In a surprising move, the EB Chairman, took fairly drastic actions to further curtail civil society participation during the official proceedings. Non-state actors’ (NSAs) statements were reduced to one minute, which has occurred at EB meetings in the past, often as a way to protect time allocated for other agenda items. However, this time, some organizations were also prohibited from delivering statements if they had already made previous interventions during the EB, and the Chair aggressively admonished those who wished to speak on multiple topics.This came amidst the backdrop of a proposal that member states were set to consider that could considerably hamper civil society’s ability to provide input to important fora like the EB and the World Health Assembly (WHA). The proposal called for streamlining the statement process by compelling NSAs to deliver joint interventions, limiting the overall size of civil society delegations, and possibly introducing an altogether new process for dialogue between member states and NSAs at a separate forum. Member states supported the idea of joint statements and a constituency approach, while civil society pushed back against these measures that they believe would restrict meaningful contributions and silence important voices. All stakeholders agreed that the idea of a forum for NSAs required additional dialogue and was too premature for this year’s process. WHO is looking to pilot some of the new procedures, at least in part, during the next WHA, though details are not yet available. With many items still up in the air and further discussion needed to implement and advance programs, the WHA in May promises to be quite the roller-coaster. GHTC will be present and look forward to advancing these conversations with our partners as well as continuing to strategically drive the innovation agenda heading into the Assembly. 

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email. A broad study of a promising HIV vaccine has ended in failure after an interim analysis showed it was no more effective than placebo in preventing infection. Vaccinations for the Uhambo study in South Africa were halted following the determination on January 23 that 129 people who received the vaccine developed HIV while 123 people who were given placebo also contracted the infection. The trial began in 2016 following testing of a modified version of a vaccine that had proven to be modestly effective in a trial in Thailand four years earlier, thus warranting further study. The Uhambo study was only the seventh large-scale human trial of a vaccine for HIV, a virus that infected 1.7 million people worldwide in 2018, according to the Joint United Nations Program on HIV and AIDS. Two other large human trials of another HIV vaccine candidate, designed by Janssen Pharmaceuticals, part of the health care giant Johnson & Johnson, are currently underway. Funding to develop new technologies for some of the world’s leading infectious disease killers, such as HIV and AIDS, tuberculosis, and malaria, reached a record high of US$4 billion in 2018 with strong increases from the private sector, according to the 2019 G-FINDER report. This marks both the largest real annual funding increase on record and the first time that funding has grown for three consecutive years. However, investments in research and development (R&D) for neglected tropical diseases (NTDs)—a subset of debilitating but lesser-known parasitic, viral, and bacterial infections—have plateaued in the past two years and even declined by $34 million over the last decade, according to the report, which was released on the first World NTD Day. The G-FINDER report provides a comprehensive annual look at investments in neglected disease R&D, including how investments are allocated across diseases and product types, funding trends over time, and potential gaps in funding. People showing no symptoms of the novel coronavirus appear to be able to spread it, according to a report in the New England Journal of Medicine. If this finding is confirmed, it will make it much harder to contain the coronavirus, which has caused an outbreak in China and has led the World Health Organization to declare a global health emergency. Some viruses can only be passed when a person is exhibiting symptoms, while others can be spread a day or two before the onset of symptoms—meaning people who are contagious but are asymptomatic can unknowingly spread the virus, complicating containment efforts. According to the report, a woman from Shanghai flew to Germany where she appeared to have passed on the virus to a German colleague a day or two before being symptomatic herself. As of Thursday, the coronavirus was reported to have infected nearly 9,700 people in China, killing 213. Approximately 100 more infections but no deaths have been reported in 18 other countries.