Research Roundup: Reform discussions at WHA, tools to combat monkeypox, and a not-for-profit deal for vaccines, drugs

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. COVID-19 vaccination during pregnancy appears to decrease newborns’ risk of infection with the virus, according to study results published Wednesday. The study, conducted in Norway, tracked 9,739 babies whose mothers received a second or third dose of a COVID-19 vaccine from Pfizer-BioNTech or Moderna while pregnant and 11,904 babies whose mothers were not vaccinated before or during pregnancy. COVID-19 infection was rare overall among the newborns, but risk of a positive PCR test during the first four months of life was 71 percent lower when the delta variant was dominant and 33 percent lower when omicron was dominant in babies whose mothers were vaccinated during pregnancy compared to babies whose mothers were unvaccinated. The findings could be in part a result of antibodies acquired from breastfeeding, according to a lead researcher, or due to vaccinated mothers being less likely to get COVID-19 and infect their infants.A team of researchers based at the University of Melbourne has discovered a new compound that could offer effective treatment against drug-resistant malaria. The compound, ML901, inhibits the malaria parasite by attacking the protein synthesis machinery from the inside and causing it to self-destruct, effectively making the parasite the agent of its own demise. During studies in both human blood cultures and an animal model, ML901 was able to kill malaria parasites that resisted currently used drugs and showed rapid and prolonged action. Based on the findings, the research team is now prepared to pursue the development of new antimalarial drug candidates.Individuals with HIV were able to achieve a lengthy period of virus suppression without antiretroviral therapy (ART) after receiving infusions of two broadly neutralizing antibodies (bNAbs), according to research conducted by the National Institute of Allergy and Infectious Diseases and partners. The research, published in Nature last week, indicates combination bNAb therapy can be highly effective in suppressing HIV in the absence of ART for extended periods, provided that antibody-resistant virus is not already present when individuals begin treatment. The authors suggest that infrequent infusions of combination bNAbs could offer a future alternative to daily ART for people living with HIV, though larger studies are needed to confirm the findings.

The 75th World Health Assembly (WHA) concluded on Saturday after seven intense days of debate and decision-making. While the Assembly took key actions to shape the leadership and financial future of the World Health Organization (WHO) and to strengthen coordinated regionally distributed clinical research, efforts to advance immediate substantive reforms to the world’s health preparedness framework sputtered, laying the grounds for a prolonged policy process ahead to make the world better prepared for future health threats.Here are our top takeaways from this year’s Assembly:1. WHA adopts landmark decision on sustainable financingIn a move many had anticipated leading into this year’s Assembly, member states adopted a landmark decision to gradually increase their assessed contributions, or membership dues, to WHO to reach 50 percent of the organization’s base budget by 2030. Today, assessed contributions represent just 16 percent of WHO’s budget, with the remainder of its funding derived from voluntary contributions that are often earmarked and unpredictable—a situation that has challenged the agency’s ability to plan strategically and respond effectively during crises. This decision means WHO will eventually receive a boost of roughly $600 million a year of predictable funds to its base budget, which in the words of its director-general will empower the agency to meet “expectations and truly fulfill our mandate as the world’s leading global health authority.” 2. WHO Director-General Dr. Tedros is reelected for second termWHA followed the old adage “don’t change horses in midstream,” voting to reelect Dr. Tedros Adhanom Ghebreyesus to serve another five-year term as WHO director-general. The former Ethiopian minister of health and foreign affairs, who has helmed the agency since July 2017, received the Assembly’s overwhelming endorsement, running unopposed. WHO director-generals can be reappointed only once, so Dr. Tedros should hold the position until August 2027, at which point the Assembly will need to choose a new agency leader. Under his leadership, WHO reshuffled the agency’s organizational structure, creating the Science Division, and GHTC will closely watch what other strategic shifts the director-general will make in his second term that could have implications on research and development (R&D).3. WHA fails to adopt immediate substantive reforms to preparedness framework, but establishes long-term processIn the meatiest of agenda items at this year’s Assembly, member states considered approaches to strengthen WHO and the world’s preparedness for health emergencies, including via potential changes to the International Health Regulations (IHR)—the current legal framework governing how countries are expected to respond to health threats. While going into the Assembly, a WHO working group had recommended that this year WHA establish a longer-term process for amending the IHR, while also immediately considering any proposed IHR amendments that were already tabled—and the United States came ready with a series of proposed IHR amendments that among other items would change requirements around countries notifying WHO of incidents—in the end, the Assembly decided not to adopt any immediate substantive changes to the IHR. Instead, it set in motion a long-term process, tasking the WHO working group with driving a two-year consultation and reform negotiation with member states, with the intent of having amendments voted upon at the 77th WHA in May 2024. Additionally, WHA also passed a companion resolution that halved from two years to one the time period for countries to implement IHR amendments, meaning if amendments are adopted in May 2024, then should be in force by May 2025. A separate but related process for countries to negotiate a new potential pandemic accord or instrument was not formally part of this year’s agenda but will continue via an Intergovernmental Negotiating Body, which will meet again next month.4. WHA passes resolution on strengthening clinical trialsMember states passed an important resolution, introduced by the United Kingdom and Argentina, to strengthen clinical trial research. The resolution urges countries to introduce grant conditions to encourage the use of standardized data protocols and mandate registration of trials via a WHO trial platform or other registry meeting its international standards. It also encourages measures to improve reporting of results, including negative results; promote sharing of prepublication results with regulatory bodies for rapid decision-making during health emergencies; and strengthen global coordination and clinical trial capacity in low- and middle-income countries. While it calls on individual member states to actually adopt the above changes at a local and regional level, it also requests that WHO convene stakeholders and provide guidance to facilitate implementation of the resolution principles.5. WHO takes small steps on other health issuesWhile much of the energy in Geneva was focused on WHO financing, IHR reforms, and pandemic preparedness, each year the Assembly addresses a huge range of agenda items from drug and alcohol abuse to nutrition, to progress on individual diseases and health conditions, and more. This year was no different. In addition to the headline-grabbing news, WHA also took other smaller actions of note and important to health R&D. It extended into 2030 its global strategy and plan of action on public health, innovation and intellectual property, a framework particularly relevant in the wake of COVID-19 that is intended to promote innovation and improve access to health technologies. In addition, it also heard progress reports on the global strategy for tuberculosis research and innovation, the road map on neglected tropical diseases, and implementation of the Immunization Agenda 2030 to improve global immunization coverage—all areas that, as GHTC emphasized in statements going into the Assembly, require enhanced investment in R&D. Unfortunately, these items did not come up until late in the Assembly, highlighting their lower priority in this year’s forum.