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 Wednesday, the US Food and Drug Administration (FDA) authorized Novavax’s COVID-19 vaccine for individuals 18 and over, making it the fourth COVID-19 shot recommended by the agency for use in the United States. The Novavax vaccine is also the first authorized protein-based COVID-19 shot, which works by delivering a protein present on the virus’s service, along with a chemical adjuvant that spurs the immune system to recognize it. The new authorization is for a series of two shots, separated by three weeks; it does not cover use of the Novavax vaccine as a booster shot, which the agency will need to evaluate separately. The vaccine must still be recommended by the Centers for Disease Control and Prevention (CDC) before becoming widely available; the United States has acquired 3.2 million doses of the vaccine to be shipped to states once authorized by the CDC director.The National Institutes of Health has launched a clinical trial of an mRNA vaccine candidate to prevent Nipah virus infection, a zoonotic disease with no currently authorized vaccine or treatment. The phase 1 clinical trial will test an mRNA-based vaccine developed by Moderna and the National Institute of Allergy and Infectious Diseases (NIAID) to evaluate its safety, tolerability, and ability to generate an immune response in 40 healthy adults. NIAID’s Pandemic Preparedness Plan, published earlier this year, established a framework to study viruses of pandemic potential, like Nipah, and prioritize research on prototype pathogens. The newly launched study is the first clinical trial to use the prototype pathogen approach since the plan’s publication.In a new report, the World Health Organization outlines the pipeline of bacterial vaccine candidates and emphasizes the urgent need to step up investment and research into vaccines that can help combat antimicrobial resistance (AMR). The analysis is the first to provide detailed analysis of the pipeline of vaccines with potential to address drug resistance from priority pathogens, identifying 61 vaccine candidates in various stages of clinical development and 94 candidates in preclinical development. While highlighting existing vaccines and the promising candidates in late-stage development, the report also notes a critical need to accelerate trials of vaccines to address AMR and makes a case for bolstered investment that can lead to increased global health equity.

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 Bank on Thursday approved the creation of a prevention, preparedness, and response financial intermediary fund, or FIF, intended to strengthen national, regional, and global capacities to prevent and prepare for future pandemics. The FIF will pool dedicated resources for pandemic preparedness and response, starting with initial pledges of $1.1 billion—though this represents only around 10 percent of the $10.5 billion the fund will need annually, according to the World Bank and World Health Organization (WHO). WHO will provide technical leadership for the FIF in close collaboration with the World Bank; the scope and structure of its operations and board, however, have not yet been determined. The FIF will also incentivize increased investments from countries, enhance partner coordination, and serve as a platform for advocacy.The US Food and Drug Administration is advising vaccine makes to reformulate their COVID-19 shots to target the BA.4 and BA.5 omicron subvariants, which now account for the majority of US infections and have been growing in prevalence globally, alongside the original strain of the virus. The updated recommendation, announced last week following a vote by a panel of outside experts, is meant to leave enough time for vaccine makers to adapt their formulas and manufacture updated shots to provide broader protection against the virus amid potential fall and winter booster campaigns. The newer forms of the shots will only be offered as boosters, while the primary series of shots will continue to use the original vaccines given their maintained effectiveness against severe outcomes of the virus.The National Institutes of Health has begun testing a universal influenza vaccine that could provide long-lasting protection against a wide range of seasonal flu viruses as well as those with pandemic potential. The vaccine candidate, BPL-1357, is composed of four strains of non-infectious, chemically inactivated, low-pathogenicity avian flu virus. The phase 1 trial, which follows successful preclinical studies, will evaluate BPL-1357 delivered both intranasally and intramuscularly for safety and ability to induce immune responses among up to 100 volunteers. With this new vaccine candidate, scientists are attempting to induce a comprehensive immune response closely mimicking immunity from natural flu infection, as opposed to focusing on inducing immunity to a single viral antigen.

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 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.