AstraZeneca Resumes UK Covid Vaccine Trials
AstraZeneca has resumed Phase 2/3 clinical trials with Oxford University’s Covid-19 vaccine candidate in the UK, days after halting the tests due to an “adverse neurological event” that CEO Pascal Soriot said occurred in the UK trial and involved an inflammatory spinal cord disorder.
The Anglo-Swedish drugmaker said in a statement it had received confirmation from the UK’s Medicines Health Regulatory Authority that it was safe to resume the trial there. Studies in other countries have not been resumed, due to the need to work with national health authorities on the terms.
“The company will continue to work with health authorities across the world and be guided as to when other clinical trials can resume to provide the vaccine broadly, equitably and at no profit during this pandemic,” AstraZeneca said.
News reports, citing sources familiar with the details, said the illness in the UK had been diagnosed as transverse myelitis, which roughly fits the description presented by the company. In a conference call with investors, Soriot also revealed that another adverse event had been seen during a trial earlier this summer; however, the participant was found to be suffering from multiple sclerosis.
Both AstraZeneca and the university said they were prohibited from disclosing further medical information. The drugmaker said that “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.”
Despite the brief setback, the CEO said he still expects to be in a position to present a set of data from the trials to regulators for approval by the end of this year. According to Oxford University, some 18,000 people have so far received the vaccination in trials worldwide.
Commenting on the current state of play, Soumya Swaminathan, chief scientist of the World Health Organization (WHO), said there was no need to be overly discouraged by the news of the trial’s interruption, adding that it could be seen as a” wake-up call or a lesson that there are ups and downs in research and clinical development.”
Author: Dede Williams, Freelance Journalist
