According to recent reports, the U.S. Food and Drug Administration (FDA) gave the green light to AstraZeneca and Johnson & Johnson to resume their respective clinical trials testing Covid-19 vaccines. Both drugmakers received the go-ahead on Friday. The AstraZeneca study (AZD1222) was halted in the U.K. due to a severe neurological-based adverse event. A participant in the study was afflicted with transverse myelitis. Johnson & Johnson also reported a safety incident but didn’t disclose details, but apparently, there is no evidence at all that the investigational vaccine triggered the incident.
Recently reported by Linda A. Johnson with Associated Press, the two vaccine makers are among the frontrunners conducting Phase 3 clinical trials, the last step before submitting requests to the FDA for either formal registration or emergency use authorization.
TrialSite has reported that testing for the AstraZeneca vaccine (AZD1222, or ‘Oxford’ vaccine) has resumed in the UK, India, South Africa, and Brazil. A recent Phase 2 study in India, nearly complete, reports no adverse events associated with AZD1222 thus far.
AstraZeneca’s CEO Pascal Soriot declared in a statement, “The restart of clinical trials across the world is great news as it allows us to continue our efforts to develop this vaccine to help defeat this terrible pandemic.”
AstraZeneca’s study (NCT04516746) involves up to 30,000 participants testing the Oxford vaccine, now known as AZD1222. TrialSite reported that the sponsor had established an unprecedented timeline with a duration of only 3.5 months between Estimated Study Start Date (Aug. 17, 2020) and Estimated Primary Completion Date (Dec. 2, 2020).
The Johnson & Johnson study (NCT04505722) investigates the safety and efficacy of Janssen’s Ad26.COV2.S in up to 60,000 participants.