Clinical trials for AstraZeneca’s experimental COVID-19 vaccine, developed in partnership with researchers from the University of Oxford, were suspended globally after a suspected adverse reaction in a participant in the United Kingdom.
Now, a press release from the pharma giant stated that the clinical trials for their coronavirus vaccine, AZD1222, have resumed in the UK following approval by the Medicines Health Regulatory Authority (MHRA).
The trials’ suspension cast worldwide doubts not only on the progress of AstraZeneca’s vaccine but on all Covid-19 vaccines in development. Clinical holds are not uncommon, but the pause left many wondering if fast-track authorisation or approval of a vaccine before the end of the year will be possible.
After reviewing the safety data associated with the adverse event, a rare spinal inflammatory disorder called transverse myelitis, a UK independent committee has concluded its investigations and recommended to the MHRA that trials in the UK could resume.
The Serum Institute of India said it would restart its trials once it had permission from the Drugs Controller General of India, and Brazil’s health regulator ANVISA approved the trials’ resumption after reviewing data sent by the MHRA.