Clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, have resumed in the UK following confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so, communicated both organizations this Saturday.
In a statement, AstraZeneca recalled that on 6 September, the standard review process triggered a voluntary pause to vaccination across all global late-stage trials to allow a review of safety data by independent committees and international regulators.
The patient involved in the study had been reportedly suffering from neurological symptoms associated with a rare spinal inflammatory disorder called transverse myelitis.
AstraZeneca and the University of Oxford, as the trial sponsor, stated that they cannot disclose further medical information.
The Serum Institute of India said it would restart its trials once it had permission from the Drugs Controller General of India.
Brazil’s health regulator Anvisa said it was waiting for notice from the British MHRA confirming that resumption of trials has been authorized before resuming in Brazil.
The Federal University of Sao Paulo, which is conducting the paused trials, said in a statement that 4,600 of the planned 5,000 volunteers have been recruited and vaccinated without any of them reporting any serious health issues.
The vaccine is in late-stage clinical trials in the United States, Britain, Brazil and South Africa and additional trials are planned in Japan and Russia.