Breakthroughs Blog: HIV/AIDS

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. On Wednesday, Moderna released preliminary results on its updated COVID-19 vaccine booster targeting omicron showing a significantly stronger immune response against the variant than the existing vaccine. The results come from a clinical trial among 814 volunteers testing a booster dose that combines the original vaccine with one that specifically targets omicron. The updated booster shot followed three earlier doses of Moderna’s vaccine. Among individuals with no evidence of prior COVID-19 infection, the new combination produced 1.75 times the level of neutralizing antibodies against omicron as the existing vaccine did alone. While the updated booster is promising against the omicron variant, some experts noted the evolving virus continues to lead to new variants and subvariants, potentially outpacing the ability to modify vaccines. US Food and Drug Administration advisers are set to meet June 28 to discuss which vaccine formulation would work best as a booster in the fall.The World Health Organization (WHO) published new guidelines last week for the treatment of people coinfected with visceral leishmaniasis and HIV, recommending better treatments based on studies conducted by the Drugs for Neglected Diseases initiative (DNDi), Médecins Sans Frontières, and partners in Ethiopia and India. In the Indian study, the new recommended treatment—a combination of injectable liposomal amphotericin B and oral miltefosine—demonstrated 96 percent efficacy after 210 days, compared to 88 percent for the current standard treatment. In the Ethiopian study, the new treatment demonstrated 88 percent efficacy after 58 days, compared to 55 percent for the standard treatment. The new regimen also reduces the use of injectable drugs and shortens the duration of treatment. Researchers plan to continue efforts to develop an even better treatment that will be completely oral, safe, and efficacious.The first participants have been vaccinated in a phase 3 study of an influenza vaccine developed by Moderna based on mRNA technology used in its COVID-19 vaccine. The vaccine, mRNA-1010, encodes for hemagglutinin glycoproteins of the four influenza strains recommended by WHO for the prevention of influenza. mRNA-1010 is the first of several influenza vaccine candidates intended to improve upon traditional vaccines, according to Moderna, by inducing broad, robust immune responses and employing the flexibility and speed of the mRNA platform manufacturing process. The trial will enroll around 6,000 adults in the southern hemisphere to evaluate the safety and immunological efficacy of the vaccine in comparison to a licensed seasonal flu vaccine. The company plans to run a confirmatory efficacy study for the vaccine as early as the 2022-23 northern hemisphere flu season.

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. IAVI and Moderna are preparing to launch the first in-Africa trial for an mRNA HIV vaccine candidate, the organizations announced last week. The phase 1 vaccine trial will take place at the Center for Family Health Research in Kigali, Rwanda, and The Aurum Institute in Tembisa, South Africa. The vaccine candidate, mRNA-1644, uses Moderna’s mRNA technology to deliver a specific class of B cells needed to develop broadly neutralizing antibodies to fight HIV infection. mRNA technology could accelerate the development of a safe, effective, affordable, and durable HIV vaccine, according to IAVI, and the trial will build on progress in HIV vaccine research using the combination of Moderna's proven mRNA vaccine technology and a novel HIV vaccine approach developed by IAVI and Scripps Research, and draw on more than two decades of collaboration with scientific centers of excellence in sub-Saharan Africa, supported by the US Agency for International Development.A US Centers for Disease Control and Prevention (CDC) advisory panel on Thursday voted to recommend children between the age of 5 and 11 should be offered a third dose of the Pfizer-BioNTech COVID-19 vaccine at least five months after receiving their second dose. CDC Director Dr. Rochelle Walensky then endorsed the panel’s recommendation, which followed authorization by the Food and Drug Administration earlier that week. In making their decision, the CDC advisors reviewed data indicating a third dose increases the antibody response from the vaccine, which should protect recipients better, at least temporarily. CDC also now recommends those who are 12 and older and immunocompromised and all people over the age of 50 should receive a second booster, at least four months after their first dose.Clinical research in the United States faces a “critical shortcoming” when it comes to diversity, a new report from the National Academies of Science, Engineering, and Medicine stresses. While diversity has become an increasingly important priority, racial and ethnic minority populations continue to be left behind in research, leaving a large portion of the US population—and those that often face the greatest health challenges—less able to benefit from discoveries, because they are not adequately represented in clinical studies. Members of the LGBTQIA+ community, older adults, pregnant and lactating individuals, and people with disabilities are also among the populations frequently left out. The report offers recommendations to increase the inclusion of these groups in order to advance equitable research—described as a clinical trial population that matches the demographics of the disease being studied.