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 Thursday, the US Food and Drug Administration (FDA) granted emergency use authorization to the first COVID-19 test to detect the disease through breath. The InspectIR COVID-19 Breathalyzer is able to identify five volatile organic compounds associated with COVID-19 infection in breath samples and delivers results in less than three minutes. In a study of 2,409 individuals both with and without symptoms, the test had a 99.3 percent specificity rate, which measures the percent of correctly identified negative test samples, and a 91.2 percent sensitivity rate, which measures the percent of correctly identified positive test samples. The breathalyzer device—about the size of a piece of carry-on luggage—will be used in mobile testing sites, hospitals, doctor’s offices, and other locations where samples are both collected and analyzed.An experimental drug halved the death rate among critically ill COVID-19 patients receiving supplemental oxygen and at high risk for serious lung disease and death, the drug’s developer announced last week. Sabizabulin, which works by disrupting the transport of the virus through microtubules in cells, is given in a capsule taken once a day and has no refrigeration requirements. A clinical trial of the drug, the results of which have not yet been published or peer reviewed, was halted early at the recommendation of independent safety monitors after the treatment was shown to drastically reduce deaths among hospitalized COVID-19 patients. Developers plan to meet with the FDA later this month and will be applying for emergency use authorization for sabizabulin.An anti-HIV strategy called vectored immunoprophylaxis—in which an adeno-associated viral (AAV) vector delivers instructions to muscle cells to pump out antibodies that block the virus—showed promising results in a phase 1 clinical trial conducted by the National Institutes of Health. The AAV therapy is able to block HIV’s ability to bind to an immune cell’s receptor that the virus targets before infecting the cell, therefore shutting down the virus’s entry. The phase 1 clinical trial enrolled eight adults with HIV who were on stable antiretroviral therapy for at least three months and found that intramuscular injection of the therapy was safe and well-tolerated. Researchers are continuing to develop this technology, which they say could have wide-ranging clinical implications for preventing or treating HIV and other infections.

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 week, advisers to the US Food and Drug Administration convened to assess the country’s COVID-19 vaccine policy, including guidance on updated vaccines to offer increased protection against variants. Some health officials believe revised vaccines will be needed by the fall, when the virus could resurge in force. Researchers developing modified vaccines would need to settle on a formula as early as June to have a vaccine ready for use this fall, according to the panel, though several trials are just now getting underway—including a National Institutes of Health study analyzing a Moderna vaccine revised to target three different variants, for which results are expected this summer. Once regulators decide on a reconfigured vaccine, manufacturers would need several months to produce doses, according to one expert, and several others underscored the uncertainty and difficulty of the highly compressed timeline.Moderna and IAVI will collaborate to develop vaccines and antibodies for HIV/AIDS, tuberculosis, antimicrobial-resistant enteric infections, and COVID-19 using mRNA technology, the organizations announced Thursday. The partnership aims to accelerate the research and development process, as Moderna’s mRNA platform can help develop material for clinical testing more quickly than traditional recombinant protein synthesis or cell systems can. If candidates are successful, they can also be manufactured quickly and at large scale, according to Moderna. The first candidate the partnership will work on is HIV vaccine antigens delivered by mRNA, for which a phase 1 trial was initiated in January. Preclinical efforts in the collaboration include candidates for tuberculosis, COVID-19, and HIV.The world needs to invest $15 billion this year, and $10 billion annually in future years, to establish and maintain an adequate toolkit to respond to COVID-19 and future pandemic threats, according to a working paper released by the International Monetary Fund last week. The paper, published in partnership with the Coalition for Epidemic Preparedness Innovations, the Global Fund, and Wellcome Trust, outlines the funding estimate while asserting that ending the pandemic everywhere remains an urgent economic, health, and moral priority for the world. Countries need vaccines, tests, treatments, and an improved health infrastructure to tackle COVID-19 and other deadly diseases, as well as investments in global surveillance, research and development, manufacturing, and health systems, global leaders said.

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 World Health Organization launched a new global initiative to combat arboviruses—fast-growing and poorly understood viral diseases carried by insects that have future pandemic potential. The Global Arbovirus Initiative aims to tackle diseases like dengue, yellow fever, chikungunya, and Zika, which currently have limited effective treatments and vaccines. The initiative will better link the various research, surveillance, and vector control efforts around the world in a more formal network of collaboration. Research innovation and partnerships are also key to the new strategy, which is the culmination of a series of consultations among a broad network of partners to enable efficient and successful collaboration across a range of pathogens and disciplines and ensure a more integrated approach to this family of viruses.The US Food and Drug Administration on Tuesday approved HIV treatment Cabenuva for adolescents, the first long-acting injectable regimen for the age group. The treatment, which includes shots of cabotegravir and rilpivirine, was approved for adults last year as a monthly regimen and more recently as a bimonthly regimen, meaning it can be administered as few as six times per year. Both timing options will now be available to virologically suppressed adolescents aged 12 years or older who weigh at least 35 kg, are on a stable antiretroviral therapy regimen, and have no history of treatment failure or resistance to either drug. The approval for adolescents is supported by evidence from studies conducted among adults as well as from interim analysis of an ongoing trial among adolescents.Ahead of a World Health Assembly (WHA) meeting in May, the United Kingdom is circulating a resolution to improve the quality of clinical trials by boosting funding, adding more trial sites, and fully reporting study results. The proposal, which comes amid increased concerns about meeting global health needs in the wake of COVID-19, promotes steps to generate “high-quality research” that can help develop medical products to provide routine care, especially in lower- and middle-income countries, for any global health priority. These steps include coordinating research, ensuring funding, and creating mechanisms to register trials and report results. If the resolution proceeds after member state debate, revisions are expected between now and the WHA session in early May.

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. Moderna plans to ask the US Food and Drug Administration to authorize its COVID-19 vaccine for emergency use in children aged 6 months to 6 years, the company announced Wednesday. Interim data from two clinical trials among children under 6 showed the vaccine generated similar immune responses to those seen in adults aged 18 to 25 who received two doses of Moderna’s adult formulation. The two-dose vaccine was, however, less effective at preventing symptomatic infection in the young children than seen in previous trials for older age groups. The decreased efficacy was on par with what would be expected of a vaccine in adults against the omicron variant, which predominated during the trial, according to Moderna. There were no severe cases, hospitalizations, or deaths in the studies.Pfizer will supply nearly 4 million courses of its oral COVID-19 treatment, Paxlovid, to UNICEF for use in 95 low- and middle-income countries. The two-drug treatment, which has emergency use authorization in the United States and is currently under assessment by the World Health Organization, will be allocated among the target countries depending on demand, clinical recommendation, and necessary approvals. Paxlovid was shown to be 89 percent effective at reducing the risk of hospitalization or death due to COVID-19 in clinical trials, and early studies indicate the treatment has some efficacy against the newer BA.2 variant that has caused cases to increase across Europe and Asia. Pfizer expects to be able to begin supplying orders to UNICEF in April and continue throughout 2022.A new “mosquito-grounding” insecticide that causes mosquitos’ wings to spasm and wither could bolster the fight against malaria, according to trial results published in The Lancet last week. In a two-year trial in Tanzania, lacing bednets with a combination of the new substance—chlorfenapyr—and a widely used insecticide—pyrethroid—significantly reduced malaria prevalence, including in regions where insecticide resistance is widespread. Insecticide-treated bednets have been central in efforts to reduce the spread of malaria, but rising insecticide resistance among mosquitos has hampered progress. Chlorfenapyr is the first new insecticide to be deemed safe and effective in about 40 years, and an ongoing study in Benin will continue to evaluate whether the substance reduces malaria transmission.