Breakthroughs Blog: Child health

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 Friday, the US Food and Drug Administration (FDA) authorized Moderna’s and Pfizer’s COVID-19 vaccines for children as young as 6 months—making kids under 5 years old eligible for the first time. The decision followed a unanimous recommendation from a panel of independent advisers to the agency to authorize Pfizer’s three-dose vaccine for children 6 months to 4 years and Moderna’s two-dose vaccine for children 6 months to 5 years. The FDA also authorized on Friday Moderna’s vaccine, previously cleared in adults over 18, for children and adolescents ages 6 through 17 years old. Centers for Disease Control and Prevention Director Rochelle Walensky signed off on recommendation of the shots this past weekend, and vaccinations are beginning this week.The South African Health Products Regulatory Authority last week approved a sweet-tasting, heat-stable, “4-in-1” fixed-dose combination of four antiretroviral (ARV) treatments—abacavir, lamivudine, lopinavir, and ritonavir—specifically designed for infants and young children with HIV. The new formulation, developed by Cipla Limited and the Drugs for Neglected Diseases initiative (DNDi), does not require refrigeration, has a sweet taste, and is easy to administer to infants and children of different weights and ages, making it a significant improvement over existing pediatric ARV formulations. The accelerated review in South Africa is notable and encouraging for other countries with a high burden of HIV, according to DNDi, which also expressed hope that the necessary steps will be taken to ensure the broadest possible access to the treatment for children who need it.Japanese drugmaker Shionogi and the Global Antibiotic Research and Development Partnership (GARDP) announced Wednesday an agreement to expand access to a novel antibiotic for drug-resistant infections in lower-resource countries. The deal aims to provide access to cefiderocol, which is used to treat serious Gram-negative bacterial infections that may be resistant to other antibiotics, in countries that have experienced delayed or limited access to newer antibiotics. Under the agreement, GARDP will work with partners to manufacture and commercialize the antibiotic, developed by Shionogi, in up to 135 countries. The Clinton Health Access Initiative will also help navigate the technical, regulatory, legal, and economic barriers to getting the antibiotic to patients in these countries.

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.

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. More newborn babies with sepsis are dying because their infections are not responding to the usual antibiotics, according to the largest global study on the subject to date. The study, sponsored by the Global Antibiotic Research and Development Partnership (GARDP), which enrolled 3,200 newborns diagnosed with sepsis in 11 countries, found that 11 percent of newborns died over the course of the study and that 15 percent were prescribed last-line antibiotics due to the high degree of resistance to standard recommended antibiotics in treatment units. Antibiotic resistance is now one of the major threats to newborn health globally, according to researchers, with virtually no studies underway to develop novel antibiotic treatments for babies with sepsis caused by multidrug-resistant infections. GARDP is now designing an interventional trial to identify better treatment regimens to combat rising resistance.World Health Organization (WHO) member states reached a preliminary agreement this week to gradually increase mandatory fees, or “assessed contributions,” to cover 50 percent of the organization’s core budget needs. WHO currently relies heavily on voluntary contributions and private donors, which can leave its financing inflexible and unpredictable. The new funding reforms would be contingent upon certain conditions, such as increased transparency, with the funding linked to a member state review of WHO progress on promised internal reforms. The agreement will still need to be formally approved by governments at the World Health Assembly in May to take effect.COVID-19 diagnostic testing has fallen by 70–90 percent around the world, making it increasingly difficult to monitor the pandemic’s evolution, treat patients, and track variants, according to FIND, a co-convener of the Access to COVID-19 Tools Accelerator diagnostics pillar. While reported cases and deaths are declining globally, changes in testing strategies and reductions in the number of tests being used globally means there is little confidence in actual case trends. The testing decline also undermines the ability to treat patients with new therapeutics—like Pfizer’s antiviral Paxlovid, which requires early diagnosis to get the most benefit—and has led to a decrease in the number of genomic sequences submitted to global databases, which helps track emerging variants.

Malaria is one of the world’s oldest and deadliest diseases. Thanks to international efforts to develop and scale up prevention tools and treatments, significant gains have been made over the past few decades in fighting this dangerous disease. But challenges, such as growing drug and insecticide resistance and disruptions from COVID-19, have hampered control efforts. Unfortunately, in 2020, both malaria cases and deaths increased significantly from the prior year—indicating progress against the disease has stalled and underscoring the need for continued research and development of new tools.In recognition of #WorldMalariaDay, test your knowledge of this deadly disease and the innovations being advanced to #EndMalaria: