Over the past two weeks, the AstraZeneca/Oxford AZD1222 phase III vaccine trials have had a bumpy road. The phase III trials were temporarily halted after a participant developed neurological symptoms and was later diagnosed with transverse myelitis. This is the second temporary halt of AZD1222 trials, after a similar incidence with a participant having neurological symptoms in phase II who was diagnosed with Multiple Sclerosis. Since this halt, the AstraZeneca AZD1222 trial has resumed in the UK only as of 9/12/20. In these large trials there is an expected number of participants who may …
NIH Uncertain about Convalescent Plasma, Sanofi’s anti-IL6 Receptor mAb phase III trials show no results, and AstraZeneca bring their Adenovirus vaccine to the US
Last week, there were several interesting updates on the front of COVID-19 clinical trials. The first one is a statement released by the NIH which expresses disapproval of the recent emergency use authorization (EUA) granted by the Food and Drug Administration for convalescent plasma. The NIH raised concerns about the lack of data, particularly from double blinded studies. At this point in time, many questions remain about the safety and efficacy of convalescent plasma, which the NIH believes should have prevented the release of the EUA. As a result, the NIH has recommended against using this …
The FDA’s latest EUA for Convalescent Plasma, AstraZeneca’s new antibody cocktail, and new mRNA vaccine storage details
The FDA has now given an emergency use authorization (EUA) to the use of convalescent plasma in treating severe COVID-19. Convalescent plasma contains antibodies from patients who have recovered from COVID-19 and is a common therapy tested in any novel infection. However, convalescent plasma has many limitations that monoclonal antibodies seek to solve (check out the post from two weeks ago!). The EUA came on the heels of a pre-print article that followed 35,322 patients who received convalescent plasma therapy across the US (Joyner MJ et al., 2020). However, the data and paper have yet to …