FDA seeks further information before allowing Phase III trial of AstraZeneca’s investigational Covid-19 vaccine to resume in the US
The study was paused after a patient was hospitalised with suspected transverse myelitis. The FDA is seeking further information from the Oxford University researchers regarding their trials of vaccines for other diseases, to determine whether or not similar events have occurred.
Source:
Biospace Inc.
SPS commentary:
The Phase III study has resumed testing in the UK, but the FDA is unlikely to allow studies to resume in the US until it is satisfied with the results of its investigation.
The European Medicines Agency has started a rolling review of the vaccine, which is a tool designed to speed up the assessment of a promising medicine or vaccine during a public health emergency. The CHMP has begun evaluating the first batch of data (non-clinical) on the vaccine, which is being developed by AstraZeneca and the University of Oxford.