FDA authorized problematic COVID-19 tests due to agency's EUA approach, HHS OIG finds
360Dx (9/22)
Additional coverage from Reuters (9/22) and Fierce Biotech (9/22)
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 to increase the availability of COVID-19 tests, possibly leading to the authorization of substandard assays, 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.
WHO’s Africa hub starts work on mRNA tuberculosis vaccine
Bloomberg (9/21)
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.
Uganda declares outbreak of rare Ebola strain with no approved vaccine
Devex (9/20)
Additional coverage from Reuters (9/25) and Health Policy Watch (9/23)
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.
