AstraZeneca US Vaccine Trial to Resume
AstraZeneca’s paused Phase 3 US clinical trial with its Covid-19 adenovirus vaccine candidate could resume as early as this week, sources have told both Reuters and the Wall Street Journal. The drugmaker initially paused all global trials in early September, after a participant in the UK Phase 3 test suffered a spinal inflammatory disorder. The purported diagnosis of transverse myelitis was never officially confirmed.
While the trials quickly resumed in other countries including Brazil, India, South Africa and the UK, the US Food and Drug Administration (FDA) had held back up to now. The agency has now confirmed US tests are on track to proceed.
A letter from the UK Medicines and Healthcare products Regulatory Agency MHRA seen by Reuters reportedly supports the resumption of the Covid-19 vaccine clinical trial as it has found “insufficient evidence” to link the vaccine to transverse myelitis. The disorder can be triggered by physical trauma and virus, which can complicate the task of determining a causal relationship to the vaccine, experts say.
While the FDA has never explained its reluctance to resume the testing activity, reports said the agency wanted to see data from other trials of vaccines based on the same viral vector platform. The US National Institutes of Health also called for AstraZeneca to provide more data.
AstraZeneca’s study, which had only just begun when it was halted, is expected to include 30,000 patients.
Author: Dede Williams, Freelance Journalist
