Breakthroughs Blog: Medicines

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. The World Health Assembly (WHA) convened last week and concluded with several decisions affecting the global health architecture. The Assembly adopted a decision to bolster sustainable financing at the World Health Organization (WHO) by raising “assessed contributions,” or mandatory member fees, to cover 50 percent of the organization’s base budget by 2030, alongside steps to increase the agency’s efficiency. Proposals to immediately reform the International Health Regulations—which govern countries’ obligations to report and respond to pathogens that could lead to global public health emergencies—were not adopted due to member state disagreement, but the Assembly established an extended consultation process for future reforms and set a timeline for their implementation. Member states also discussed the ongoing negotiations around a pandemic instrument, which are being driven by an intergovernmental negotiating body formed last year, but any specific decisions will likely be at next year’s WHA at the earliest.Rising cases of monkeypox—confirmed in 19 countries since early May—have driven interest in the existing range of vaccines and treatments that could be used to offer protection against the outbreak. The monkeypox virus, which causes a usually mild infection, is closely related to the smallpox virus—and smallpox vaccines appear up to 85 percent effective in preventing monkeypox, according to WHO. There are two available smallpox vaccines: Bavarian Nordic’s Jynneos, also known as Imvamune or Imvanex, which has US approval for prevention of smallpox and monkeypox and European Union approval for smallpox but ability to be prescribed off-label for monkeypox, and Emergent Biosolutions’ ACAM2000, which has US approval for people at high risk for smallpox infection and no European Union authorization. While symptoms of monkeypox often resolve on their own within two to four weeks, there are also smallpox antivirals that may be considered for use.On Wednesday, Pfizer committed to provide its patented medicines and vaccines already available in the United States and Europe at a not-for-profit price to 45 lower-income countries. The deal, announced during last week’s World Economic Forum, includes 23 medicines and vaccines for infectious diseases, some cancers, and rare and inflammatory diseases, as well as future products. The initiative also includes Paxlovid, Pfizer’s oral antiviral treatment for COVID-19. Rwanda, Ghana, Malawi, Senegal, and Uganda are the first five countries to commit to join the accord, which will help inform rollout in all 27 low-income countries and 18 lower-middle-income countries that have transitioned from low to lower-middle-income classification in the past ten years. Pfizer says the initiative will be paired with improvements in diagnostics capacity and distribution infrastructure to improve access, as well as technical assistance for health worker training and expedited regulatory processes for entry of the new medicines.

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 Thursday, the US Senate confirmed Dr. John Nkengasong as US global AIDS coordinator to head the President's Emergency Plan for AIDS Relief, or PEPFAR. Dr. Nkengasong, a Cameroonian virologist who currently serves as director of the Africa Centres for Disease Control and Prevention (CDC), is the first person born on the African continent to take on the global AIDS coordinator role. President Joe Biden nominated him for the position last September, following a gap in permanent leadership since Dr. Deborah Birx departed in 2020. Prior to his position at Africa CDC, Dr. Nkengasong worked at PEPFAR on strengthening laboratory capacity across Africa. Africa CDC Deputy Director Dr. Ahmed Ogwell Ouma will head the agency in the interim while the African Union Commission selects a new director.The World Health Organization (WHO) last week released a rapid communication stating that patients 15 and older with multidrug-resistant tuberculosis (TB) or rifampicin-resistant TB can take a six-month, all-oral treatment regimen—comprising the drugs bedaquiline, pretomanid, linezolid, and moxifloxacin (BPaLM)—instead of a regimen lasting nine months or longer. The guidance also indicates that patients with multidrug-resistant TB or rifampicin-resistant TB who have developed resistance to fluoroquinolones can subscribe to the same six-month treatment regimen, but without moxifloxacin—known as BPaL. WHO has previously recommended the BPaL and BPaLM treatment regimens, but only under operational research conditions; the new recommendation will allow programmatic implementation of treating almost all forms of drug-resistant TB with either of the shorter regimens.Two novel COVID-19 vaccine platforms—a plant-based coronavirus-like particle vaccine and a receptor-binding domain (RBD)–dimer-based vaccine—showed promising results, according to studies published last week based on phase 3 clinical trials. The two-dose, plant-based particle vaccine, developed by Medicago and GlaxoSmithKline, showed 69.5 percent efficacy against symptomatic COVID-19 caused by five variants identified in sequencing, and no severe cases or deaths were recorded. The RBD-dimer-based vaccine, developed by Anhui Zhifei Longcom, is a three-dose shot that showed 75.7 percent efficacy against infection and 87.6 percent efficacy against severe to critical disease. Neither vaccine requires extreme cold chain storage, which makes them appealing candidates for global COVID-19 vaccination efforts.