Breakthroughs Blog: FDA

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 World Health Organization (WHO) released its updated Bacterial Priority Pathogens List 2024, which aims to guide investments and R&D in new antibiotics and promote international coordination to address the rising global threat of antimicrobial resistance (AMR). The updated list, which incorporates new evidence and expert insights, includes 15 families of antibiotic-resistant bacteria grouped into critical, high, and medium categories for prioritization based on their burden and ability to resist treatment and spread resistance to other bacteria. Five pathogen-antibiotic combinations were removed from the new list and four new combinations were added, reflecting the dynamic nature of AMR.Last week, WHO authorized a second vaccine for dengue, which will hopefully offer millions more worldwide protection against the mosquito-borne disease, which is currently behind a major outbreak in the Americas and rising cases globally. The two-dose vaccine, made by Takeda, protects against the four types of dengue and is recommended for use in children between six and sixteen years old in regions with high dengue rates. The decision opens the door for donors and other United Nations agencies to purchase the vaccine for high-burden countries.Last week, the US Food and Drug Administration approved the use of self-collected samples with Roche and BD’s HPV tests, a decision that hopefully will expand access and reduce barriers to HPV screening, allowing more people to detect and treat cervical cancer. Screening for HPV is used to identify those who may be at risk of developing cervical cancer, most cases of which are caused by persistent HPV infection. Traditional screening involves a speculum-involved pelvic exam to screen for cervical cancer, which can be painful or uncomfortable for many patients. Self-collection allows patients to collect their own vaginal samples for screening in a health care setting.

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. As the dengue outbreak in Latin America has continued to grow and the threat of dengue continues to rise globally due to climate change, better and cheaper vaccines are on the horizon but are unlikely to be available soon enough to address the current crises. Currently approved vaccines for dengue include one expensive two-shot regimen and one that can only be given to people who have already been infected. A new, single-dose vaccine designed to target all four strains of the dengue virus, which was created by the US National Institutes of Health and licensed for development by the Brazilian Instituto Butantan, provided strong protection in a Phase 3 trial. The institute plans to submit the vaccine to Brazil’s regulatory agency for approval within the next few months, and if approved, the institute could start producing tens of million doses next year. Merck also licensed the vaccine technology and is developing a related vaccine for the rest of the world but has yet to test it in a clinical trial. In the meantime, the Brazilian government bought global supply of Takeda’s Qdenga vaccine, which, at a steep per-dose price, will provide some protection during the current outbreak. Takeda’s vaccine has also been licensed to an Indian generic drugmaker, but a slow start-up process means that is unlikely to be available before 2030.Pfizer recently announced that its RSV vaccine demonstrated the potential to protect adults between 18 and 50 at high risk of severe illness in a late-stage clinical trial, offering the promise of a tool to protect a far broader population against the virus that not only causes thousands of hospitalizations and deaths among older Americans and hundreds among infants every year but also can also cause severe illness in younger adults with weakened immune systems or underlying chronic conditions. Abrysvo is currently approved in the United States and elsewhere for adults 60 and older and expectant mothers. Pfizer announced plans to submit the final results from the trial for expanded approval of Abrysvo, although a timeline for submission has not yet been disclosed. Last fall, GSK released late-stage trial data demonstrating that its RSV vaccine could protect adults between 50 and 59 years old, and the US Food and Drug Administration is expected to make its decision on that vaccine in June.A research team from the Centre for Clinical Microbiology at University College London has developed a new method for testing tuberculosis (TB) that would allow lower-resourced laboratories in low- and middle-income countries (LMICs) to process samples safely, with the method primarily aimed at use for monitoring drug treatment response and clinical trials. The World Health Organization recommends monthly treatment monitoring with sputum culture to ensure patients are adhering to treatment to reduce the emergence of multidrug- or rifampicin-resistant TB, but monitoring with culture is often unavailable or incredibly slow in LMICs. The new method cuts out the need for a culture; uses common instrumentation available in most laboratories, even in LMICS; does not have high energy requirements; and takes only three or four hours to return a result. The method is already being used in clinical studies.

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. Last Tuesday, Valneva announced the launch of a Phase 1 clinical trial to investigate the safety and immunogenicity of a vaccine against the Zika virus, for which there are currently no available preventable vaccines or treatments. The second-generation adjuvanted inactivated vaccine candidate, VLA1601, will be tested in 150 adult participants in the United States, with the first topline data from the trial expected as soon as early next year.  Numerous outbreaks of Zika have occurred around the world, but the virus is currently circulating in Mexico, Central and South America, the Caribbean region, and some areas of the continental United States.Moderna’s next-generation mRNA vaccine for COVID-19 elicited a higher immune response against most strains of omicron BA.4/BA.5 and the original virus than the company’s currently licensed vaccine and has a similar safety profile in Phase 3 trial. The vaccine candidate, mRNA-1283, demonstrated the highest benefits in patients over 65, who are at risk of more severe disease. The trial included over 11,000 patients from across the United States, the United Kingdom, and Canada. These results also point to the future promise of the company’s combination mRNA vaccines for COVID-19 and influenza, which are also currently in development and previously demonstrated a similar immune response to the company’s vaccines for COVID-19.The US Food and Drug Administration (FDA) recently announced the approval of Roche’s Cobas malaria test for screening blood, organ, and tissue donors, which could help reduce the risk of transfusion-transmitted malaria. The test is designed to qualitatively detect in whole-blood samples Plasmodium DNA and RNA from the five main species of Plasmodium parasite species known to cause human infection: P. falciparum, P. malariae, P. vivax, P. ovale, and P. knowlesi. Roche’s technology is now the first FDA-licensed test for screening blood donors for malaria.

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 Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) last week announced $467,000 in funding to GlyProVac to develop a maternal vaccine that targets Escherichia coli, the bacteria mainly responsible for neonatal sepsis, which is the leading cause of death among infants and a particular challenge in low- and middle-income countries. The funding will specifically support the development of the vaccine candidate GPV02, which offers protection to newborns through the antibodies passed on by vaccinated expectant mothers in utero and through breast milk after birth. GPV02 uses a unique approach compared to other attempted protein-based bacterial vaccines because it involves previously undiscovered natural sugar modifications and uses BEMAP technology to allow the vaccine to imitate E. coli, preparing the immune system to recognize the bacterium in the case of future infection.Last week, the Advisory Group on Immunization Practices at the US Centers for Disease Control and Prevention (CDC) recommended Valneva’s Ixchiq chikungunya vaccine for some travelers and laboratory researchers at risk of contracting the mosquito-borne virus. The United States records about 100 to 200 chikungunya cases a year in people infected abroad by the virus, which is mainly found in parts of Central and South America, Africa, and Asia. The vaccine was licensed by the Food and Drug Administration last fall for adults—the first vaccine approved for chikungunya. CDC has indicated that it may later expand the recommendation for people living in US territories where the virus may spread.A new extensive, long-term analysis from the Icahn School of Medicine at Mount Sinai found that COVID-19 vaccines induce long-lasting antibody responses, debunking previous claims that mRNA-based vaccine immunity wanes quickly. The researchers examined in over 8,000 samples collected over three years in New York City how antibody responses changed after infections, during the first series of vaccinations, during booster vaccinations, and during breakthrough infections. They concluded that the major reason for breakthrough infections is the virus evolving to evade immunity rather than waning immunity. The results will, hopefully, not only encourage people to continue to get vaccine boosters but also to continue research into new vaccines and viral variants.