UK regulator gives all-clear after brief pause following illness of test subject
LONDON: British clinical trials for the AstraZeneca and Oxford University coronavirus vaccine have resumed following confirmation by a regulator that it was safe to do so, the company said on Saturday.
The late-stage trials of the experimental vaccine, one of the most advanced in development, were suspended earlier this week after an illness in a study subject in Britain.
“The standard review process triggered a voluntary pause to vaccination across all global trials to allow review of safety data by independent committees and international regulators,” AstraZeneca said.
“The UK committee has concluded its investigations and recommended to the Medicines Health Regulatory Authority (MHRA) that trials in the UK are safe to resume.”
The company said it could not disclose further medical information.
“All trial investigators and participants will be updated with the relevant information and this will be disclosed on global clinical registries, according to the clinical trial and regulatory standards.”
AstraZeneca’s vaccine candidate is one of nine around the world currently in late-stage Phase 3 human trials.
In the United States, the company began enrolling 30,000 volunteers across dozens of sites on Aug 31, and the inoculation is being tested on smaller groups in Brazil and elsewhere in South America.
The AZD1222 vaccine uses a weakened version of a common cold-causing adenovirus engineered to code for the spike protein that the Covid-19 coronavirus uses to invade cells.
After vaccination, this protein is produced inside the human body, which primes the immune system to attack the coronavirus if the person is later infected.
According to a World Health Organization site that tracks vaccine progress, there are currently 169 Covid-19 vaccine candidates under development, with 26 in the human trial phase.
REUTERS / AFP