Anna Kovacevich

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.Pharmaceutical company Merck has announced an agreement to share its license for the oral COVID-19 drug molnupiravir with the United Nations–backed Medicines Patent Pool to expand access to the treatment in more than 100 countries. Molnupiravir, an easy-to-take pill, reduced hospitalizations and deaths by half among higher-risk COVID-19 patients diagnosed with mild to moderate illness in a global clinical trial. The agreement is the first public health license for a COVID-19 treatment or vaccine, allowing the medicine to be produced by all capable manufacturers—once the drug receives regulatory approval—to expand the drug’s availability, widen its manufacturing base, and potentially push down the price. Merck has applied to the US Food and Drug Administration for emergency use authorization, and the European Medicines Agency recently began a rolling review of the drug.The Access to COVID-19 Tools Accelerator (ACT-A) on Thursday launched its new strategic plan outlining a focus on addressing access inequities to tools in underserved areas. Over the next year, ACT-A—a global partnership set up to accelerate the development and delivery of COVID-19 tests, treatments, and vaccines—will aim to support low- and middle-income countries in vaccinating 70 percent of their populations, increasing their testing rates to at least 1 per 1,000 people per day, and treating up to 120 million COVID-19 cases through deployment of existing treatments and enabling access to new therapies. The plan outlines a required budget of $23.4 billion between now and September 2022, including $840 million for research and development.Inexpensive drug fluvoxamine could reduce hospitalization in adults with severe COVID-19, according to research published Wednesday in The Lancet Global Health. The findings, based on a clinical trial in Brazil evaluating high-risk, symptomatic adults who had recently contracted COVID-19, showed participants were less likely to require hospitalization or an extended emergency room stay when given a 100-milligram dose of fluvoxamine twice daily for ten days. Fluvoxamine is commonly prescribed to treat depression and obsessive-compulsive disorder and is known to reduce inflammation, which COVID-19 can cause throughout the body. The study findings, part of the larger TOGETHER Trial aiming to identify repurposed therapies effective against COVID-19 disease progression, have been shared with the World Health Organization and the US National Institutes of Health.

President Joe Biden has made clear that addressing climate change is a top priority for his administration. Since January, the president has issued executive actions in pursuit of tackling the climate crisis; opened a new federal office for climate change, health, and equity; and convened two meetings of the Major Economies Forum on Energy and Climate, one of which was part of a larger leaders summit intended to rally world leaders to strengthen climate ambition in the lead-up to the 26th United Nations Climate Change Conference of the Parties (COP26) in early November, during which countries hope to negotiate shared climate commitments.Amid these ongoing and vital conversations, GHTC is taking stock of how global health and climate are intertwined and how innovation can address these twin issues and mitigate the impact of climate change on human health. As the Unites States prepares to engage in COP26, we hope to see continued commitments and concrete actions to combat the climate crisis, including climate-related global health challenges.Climate-related global health risksClimate and global health are inextricably linked: Climate change could put billions more people worldwide at risk of vector-borne and zoonotic diseases like malaria and dengue. Changing temperatures have been described as a “threat multiplier” of antimicrobial resistance, due to warm conditions being more favorable for bacterial reproduction. The climate crisis exacerbates food instability and malnutrition as a result of droughts and other extreme weather events—circumstances which also prove opportune for disease outbreaks. The threat of a “Disease X” outbreak occurring, and spreading globally, is greater than ever before due to deforestation and other climate-related risk factors.These risks will not be felt equally around the world. Children are among the most vulnerable—and will be exposed for the longest—to health risks resulting from climate change, given their physical and cognitive immaturity. Health effects are also expected to be worse for people who are older, have preexisting medical conditions, or are living in poverty or in low- and middle-income countries. These populations are less able to insulate themselves through technology, housing, social networks, health services, and other infrastructure. Food insecurity is likely to particularly affect Indigenous communities, many of which rely on local food sources, such as fish. Women and girls, too, are often underprioritized in responses to climate-induced disasters, which can inhibit their agency and access to sexual and reproductive health services, from contraception to HIV prevention and treatment.Existing efforts by US agenciesThe US government is beginning to recognize and take on the interconnected fight against climate change and global health crises through programs at the Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), and US Agency for International Development (USAID).For example, CDC’s Climate and Health Program assists states, cities, territories, and tribes in the United States with protecting human health from a changing climate by providing data, tools, and technical guidance to reduce vulnerability and increase resilience.NIH has launched a Working Group on Climate Change and Health aimed at addressing climate change and its health effects through research and innovation, and its National Institute of Environmental Health Services Climate Change and Human Health Program funds research aimed at understanding the health effects of climate change.USAID conducts a breadth of climate-related work, playing a crucial role in mitigating climate change and supporting resilience against its global impact—including by strengthening resilient food systems. USAID-supported programs have worked to develop and distribute disease-, heat-, and drought-tolerant seeds as well as nutrient-dense foods. For example, to support response to climate change–induced droughts and dry climates, USAID has invested in a public-private partnership to develop a variety of drought-tolerant maize, which was used by 6 million farmers in 2016 when the El Niño drought hit Southern and Eastern Africa.Looking ahead: What more should the US government do?In line with its expressed priorities, the US administration should continue to sustain and expand investment in climate change innovation—embracing a comprehensive agenda that recognizes the need to not only directly improve climate health, but also mitigate its impact on human health. While US health agencies have demonstrated some capacity to take on climate action for health, there is much more to be done.US agencies addressing climate change should consistently consider its ripple effect on global health and integrate a broad range of health-related climate innovation into their work—for instance, through emerging infectious disease surveillance, health and environmental systems capacity strengthening, or research to further understand both threats and the ways they interact.We will never achieve global health goals without also protecting our environment, and we won’t succeed in preventing the climate crisis’s worst impacts without bolstering investments in global health. GHTC looks forward to seeing continued commitment and global leadership from the US government to advance innovation to address these deeply intertwined challenges.

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 six-month oral treatment regimen for rifampicin-resistant tuberculosis (TB) is substantially more effective than the current standard of care, according to preliminary trial results presented at the 52nd Union World Conference on Lung Health on Wednesday. The TB-Practecal trial tested a six-month regimen of bedaquiline, pretomanid, linezolid, and moxifloxacin (BPaLM) among 552 patients against the locally accepted standard of care at seven trial sites across Belarus, South Africa, and Uzbekistan. Findings showed around 89 percent of patients in the BPaLM group were cured, compared to 52 percent in the standard of care group. Current standard care for rifampicin-resistant TB can require up to 20 pills daily, along with injections, for up to 20 months.A new fingerstick blood test could be a promising tool for screening TB patients, interim study results indicate. The test, developed by Cepheid, gives results in under one hour using a few drops of blood. The new results, from a study of 195 participants in Gambia, Uganda, South Africa, and Vietnam, show an overall sensitivity of 91 percent and specificity of 86 percent, regardless of HIV status or geographical location, which meets the World Health Organization’s minimum specifications for a TB triage test. Researchers plan to expand trials to further test the technology’s accuracy, including among people who have other risk factors for TB, as well for people who have both TB and COVID-19.On Friday, the US Food and Drug Administration (FDA) released a briefing document indicating the Pfizer-BioNTech COVID-19 vaccine is more than 90 percent effective against symptomatic COVID-19 among children ages 5 to 11. The data is based on a 10-microgram vaccine dose, a third of the dose used for adults and older children, which minimizes side effects but still induces a strong immune response. The antibody response was comparable to the one seen in individuals 16 to 25 years old, and no new safety problems were identified in the companies' studies. The FDA also released an analysis later Friday showing the protection “would clearly outweigh” the risks of the shot. FDA advisers will meet Tuesday to discuss expanding authorization of the vaccine, currently greenlit for people over 12, to those ages 5 to 11.

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 US Food and Drug Administration (FDA) advisory panel voted late last week to recommend booster shots of the Moderna and Johnson & Johnson (J&J) COVID-19 vaccines. The committee voted unanimously Thursday in favor of the FDA granting emergency authorization of a half-dose booster of Moderna’s vaccine, at least six months after the second dose, among people 65 and older, those 18 to 64 with risk factors for severe COVID-19, and those whose jobs put them at high risk for serious complications of COVID-19. The following day, the same panel also recommended a second dose of the J&J vaccine given at least two months after the first shot for individuals 18 years and older. Final FDA authorization rulings on boosters are expected in the coming days.The COVID-19 pandemic has reversed years of progress against tuberculosis (TB), according to the World Health Organization’s (WHO) 2021 Global TB Report, released last week. The report, which includes data from more than 200 countries, reveals that global TB deaths increased in 2020, for the first time in more than a decade, and the number of people newly diagnosed with TB and reported to national governments fell from 7.1 million in 2019 to 5.8 million in 2020. WHO estimates an additional 4.1 million people infected with TB were not diagnosed or reported. The increase in deaths and decline in diagnoses is attributable to reduced capacity of countries to provide TB services, including diagnosis and treatment, according to WHO. The report also highlights the inadequate global funding for TB diagnostic, treatment, and prevention services, which fell from $5.8 billion in 2019 to $5.3 billion in 2020.On Wednesday, WHO announced a new team, the Scientific Advisory Group on the Origins of Novel Pathogens (SAGO), to investigate the origins of the COVID-19 pandemic, study origins of future outbreaks and epidemics, and guide studies of emerging pathogens more generally. The proposed list of SAGO team members includes 26 researchers, from 26 countries, six of whom were part of the international team that traveled to China earlier this year to study the pandemic’s origins. SAGO will conduct an independent evaluation of the available evidence on the pandemic’s origins and advise WHO about the next series of COVID-19 origin studies, as well as, beyond the current pandemic, advise WHO on the development of a global framework to define and guide studies into the origins of emerging and re-emerging pathogens of epidemic and pandemic potential.

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. On Wednesday, the World Health Organization recommended broad rollout of the world’s first malaria vaccine, known as RTS,S, among children in sub-Saharan Africa and in other regions with moderate to high P. falciparum malaria transmission. The recommendation is based on results from an ongoing pilot program—which has reached more than 800,000 children in Ghana, Kenya, and Malawi since 2019—showing the vaccine’s safety and effectiveness in remote and rural settings. Clinical trials of RTS,S, which was developed by GSK and PATH with funding from the Bill & Melinda Gates Foundation, indicated it reduces the risk of contracting malaria by 40 percent and risk of hospitalization for severe malaria by 30 percent. The vaccine will now face funding decisions from the global health community for broader rollout and country decision-making on whether to adopt the vaccine as part of national malaria control strategies.A new study has identified a compound able to block dengue virus replication in test tube experiments and in mice, researchers reported in Nature last week. There are currently no specific medicines to treat dengue, which infects more than 400 million people annually and can lead to fevers, rashes, and muscle and joint aches. Researchers behind the new study screened tens of thousands of small molecules for anti-dengue activity using an automated high-throughput testing process, then tweaked several molecules to produce more than 2,000 compounds for further testing. One of those drugs, JNJ-A07, proved equally potent against all four dengue serotypes in test tube experiments. In subsequent testing in mice, the compound was highly effective in reducing viral loads and viral-induced disease. The drug will be further tested in clinical trials for safety and efficacy in humans, according to developer Janssen Pharmaceutical Companies of Johnson & Johnson.The African Medicines Agency (AMA) treaty was ratified by its 15th African Union (AU) member country last week, meeting the threshold for the agency to be officially set up. The treaty was adopted by the AU in February 2019, though it required ratification and formal notification from 15 countries to launch implementation. Following Cameroon’s ratification on Tuesday, the AU now has 30 days, or until November 5, to begin setting up the agency, which is intended to support African countries in improving and harmonizing the regulation of medicines across the continent in order to improve access to quality, safe, and efficacious products. The AMA will be Africa’s second continental health agency, joining the Africa Centers for Disease Control and Prevention.

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. Merck plans to seek authorization for its COVID-19 antiviral pill after clinical trial results showed the drug, molnupiravir, cut the risk of hospitalization or death in half among high-risk individuals early in their infections. An independent board of experts monitoring the study data had recommended that the trial be stopped early because the drug’s benefit to patients had proved so convincing, and the US Food and Drug Administration agreed, according to Merck. The drug, designed to stop the virus from replicating, is taken as four capsules twice a day for five days. As an oral antiviral treatment, the pill could be a crucial new tool in combating COVID-19 by reaching more people than the antibody treatments being widely used in the United States.COVID Moonshot, an open-source effort to design a COVID-19 pill, has won US$11 million, or GBP£8 million, from the Wellcome Trust to develop a low-cost, broadly available antiviral to fight the pandemic. The project, coordinated by the Drugs for Neglected Diseases initiative, is a nonprofit consortium of scientists that began in March 2020 and led to around 250 people submitting more than 4,500 potential molecular designs intended to block the key protein that helps the virus replicate. The new funding, through Wellcome on behalf of the COVID-19 Therapeutics Accelerator, will help pay for the expensive last step of research needed to bring the project into human clinical trials. Moonshot hopes to have a compound able to be tested in humans by next year.Sanofi’s mRNA-based COVID-19 vaccine showed positive results in a phase 1/2 clinical trial, the company announced last week, providing confidence in its mRNA program that will now be used to pursue vaccines against other pathogens, including influenza. Sanofi will not be continuing to develop its mRNA COVID-19 vaccine, as the market will have been saturated by the time it would be authorized, the company said. In the preliminary phase 1/2 trial results, 91 percent of people who received the lowest tested dose saw their neutralizing antibody levels increase four-fold, a measure thought to equate to a protective level of antibodies, confirming that the mRNA platform is potent, can generate a strong immune response, and has no safety signal. Sanofi will now turn to accelerating its work on a vaccines “center of excellence” intended to be ready to produce vaccines when the next pandemic hits.