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 develop unrelated diseases and symptoms. However, it is interesting that there have now been two cases of demyelinating conditions with AZD1222. Thus, It will be prudent to continue to watch these trials carefully, and worth investigation of these vaccines in people already diagnosed with demyelinating diseases to evaluate if COVID-19 vaccines may contribute to relapses. Overall, the incidence has been extremely low and the quick response from AstraZeneca reflects their concern and attention to these trials.
The ACTIV-4 antithrombotic trials are part of the NIH’s Operation Warp Speed and consist of three Phase III trials evaluating different blood thinners in COVID-19 adult patients. Many patients who have died from COVID-19 have been noted to have numerous clots, and many ICU patients also have clotting requiring antithrombotic treatment. The NIH has now announced that two of three trials are underway. These two trials, ACTIV-4 Antithrombotics Inpatient and ACTIV-4 Antithrombotics Outpatient, will respectively evaluate heparin and apixaban/aspirin.
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