Breakthroughs Blog: FDA

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.

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.Experts are increasingly concerned about connections between Paxlovid, Pfizer’s COVID-19 antiviral drug, and COVID rebound in patients who complete the five-day regimen, especially as Paxlovid use has grown dramatically in recent months. The US Food and Drug Administration (FDA) has asked Pfizer to investigate whether a second course will prevent rebound. A large study previously showed that Paxlovid significantly reduced hospitalizations and deaths in those 65 years and older, but uncertainty remains over the drug’s effectiveness in younger people as well as the link between the drug and COVID rebound. Rebound has also been observed in people who have not taken Paxlovid as well.A new study investigating the effectiveness of the BPaL drug regimen (a combination of bedaquiline, pretomanid, and linezolid) with linezolid at lower doses found that the treatment was still highly effective in patients with drug-resistant tuberculosis (TB) and the number of patients who experienced side effects related to linezolid dropped significantly. BPaL was approved by the FDA in 2019. Although studies showed the drug to be highly effective in drug-resistant TB patients, there was also a high rate of side effects found to be linked to linezolid. The new study, supported by TB Alliance, published in the New England Journal of Medicine indicated that the dosage of linezolid can be halved while maintaining similar efficacy, making the six-month regimen easier and more tolerable for patients.On Wednesday, August 31, the FDA gave emergency use authorizations to Moderna and Pfizer-BioNTech’s Omicron-updated COVID-19 booster shots to be used as single-dose inoculations at least two months after the first booster vaccination. Both vaccines are aimed at targeting both the original COVID-19 and B.A.4 and B.A.4 Omicron subvariants. Whereas Moderna’s booster is approved for all adults 18 years and older, the Pfizer-BioNTech booster is approved for all people 12 years and older. The CDC endorsed the vaccines on Thursday, clearing the way for a quick rollout in the coming weeks.