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.Last week, Pfizer announced promising results from their late-stage clinical trial for an experimental vaccine candidate for respiratory syncytial virus (RSV), which has been causing serious concern in recent weeks. The vaccine was administered to pregnant individuals with the goal of protecting infants upon their birth. The trial found that the vaccine candidate was 82 percent effective against severe illness for infants in their first 90 days and 69 percent effective through their first six months. The Pfizer vaccine is one of several candidates that are expected to undergo review from the US Food and Drug Administration later this year.As the Ebola outbreak in Uganda continues, three experimental vaccine candidates aimed at protecting against the Sudan strain of the virus (for which there are no approved vaccines) have been sent to Uganda to be administered to people and to help generate more data for clinical trials. The candidates include one vaccine developed by Oxford University and manufactured by the Serum Institute, one developed by the National Institute of Allergy and Infectious Diseases and licensed to the Sabin Vaccine Institute, and one candidate from Merck. Doses of all three vaccines will be deployed to Uganda through a joint effort with the World Health Organization and the United States Centers for Disease Control and Prevention in the coming weeks and months.A new study conducted in Mali showed that a single dose of monoclonal antibodies provided protection from malaria infection for up to six months. While monoclonal antibodies are notoriously expensive to produce and complex to administrate, the lab-made antibodies employed in the study could prove to be a key tool to protect children and pregnant individuals in the fight against malaria, at least in the short-to-medium term. This study follows another last year, which showed that intravenous administration of the antibody prevented infection in all nine participants.

At GHTC, we get to read stories every day about incredible innovations in global health. Most of the technologies we see are inventive, some are revolutionary, and a few are so unusual, one might think they were ripped from the pages of a science fiction novel. Now, we’re testing how well you know these global health technologies with our annual Halloween game: the TRICK or TREATment quiz.For each question, we will present a description of a global health technology. Choose TREATment if you believe this innovation exists. Choose TRICK if you think we are trying to pull one over on you and, instead, the product is still in development or is just a figment of our imagination. 

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. In a new report, the US Department of Health and Human Services’ (HHS’) Office of the Inspector General (OIG) analyzed the US Food and Drug Administration’s (FDA’s) policies during the COVID-19 pandemic response and made recommendations for improving responses to future health emergencies. The report recognized several strong practices including the creation of templates for emergency use authorization (EUA) submissions and communication forums for the agency and developers. However, continual policy shifts and the decision to ease EUA requirements, possibly leading to the authorization of substandard assays, to increase the availability of COVID-19 tests were among the challenges identified. The report’s six recommendations include a revised device-tracking platform to facilitate the EUA submission process, formal communication channels with the lab community, and a national testing strategy.The messenger RNA (mRNA) hub, established last year in South Africa with support from the World Health Organization (WHO), began development of an mRNA vaccine for tuberculosis. The hub’s objective is to develop inoculations to address high-burden diseases in low- and middle-income countries. It is also working on developing a local mRNA vaccine candidate for COVID-19 (which will enter human trials in the coming months) after low- and middle-income countries faced major challenges accessing COVID-19 vaccines during the pandemic. The first approved mRNA vaccines were developed for the COVID-19 pandemic, but the technology has potential to accelerate vaccine development for other diseases as well, including tuberculosis.Last week, the government of Uganda declared an outbreak of a relatively rare strain of Ebola. The Sudan strain has not been reported globally in a decade and there is no approved vaccine to use against it. The rVSV-ZEBOV vaccine, or Ervebo, is currently used across Africa to limit the spread of Ebola outbreaks but it is only approved for the Zaire strain, which is responsible for the majority of outbreaks. However, WHO has pointed to a different Johnson & Johnson vaccine that has potential in targeting the Sudan strain, which could be confirmed through testing.

The ability of women to choose whether, when, and how many children to have is essential to advancing the health and well-being of women and their families. In fact, research shows that expanding global access to contraception could reduce maternal deaths by nearly one-third and child deaths by one-quarter. Yet today, 218 million women in low- and middle-income countries have an unmet need for modern contraceptives. New contraceptive innovations are urgently needed to help close this contraceptive gap, including tools that are suitable and convenient for women who live far from health care settings and multipurpose products that combine contraception with HIV prevention. In recognition of World Contraception Day, GHTC is testing our readers’ knowledge of the history of contraceptive innovation. Your challenge for each question below: Name that contraceptive method.