AstraZeneca has resumed the US Phase III clinical trial of its COVID-19 vaccine candidate after approval by regulators, the company said on Friday.
AstraZeneca’s vaccine is being developed along with scientists at Oxford University.
Meanwhile, Johnson & Johnson is preparing to resume its clinical trial by next week after getting suspended earlier, the company announced on Friday.
The US trial of AstraZeneca was halted on September 6 after UK researchers found a participant who developed a serious neurological disorder, called transverse myelitis.
Johnson & Johnson has to suspend its late-stage clinical trial last week after a participant became sick, with the company announcing an independent safety panel that was investigating the case.
On Friday, Johnson & Johnson said that the safety panel, known as a Data and Safety Monitoring Board, has advised the drugmaker to resume trial recruitment because the panel found no evidence of the vaccine making the participant sick.
The New Jersey-based pharmaceutical company is expected to resume its trial in the US from next week. Johnson & Johnson Chief Scientific Officer Paul Stoffels said the company “remains on track to produce data from the trial on the vaccines’ effectiveness by the end of 2020 or early 2021.”
The company also said that it discussing with other drug regulatory bodies to resume a trial outside of the United States.
The medical board has not mentioned a clear cause for the participant’s illness. Stoffels said, “Johnson & Johnson cannot reveal any details about the patient’s sickness because of patient privacy rules.”
AstraZeneca explained that it is not uncommon for some participants to fall sick during a large-scale vaccine trial. And the U.S. Food and Drug Administration (FDA) reviews all safety data from the trials and deems it safe to continue testing the coronavirus vaccine.
Last month, AstraZeneca resumed trials in the United Kingdom, Brazil, and South Africa even as the FDA continued its investigation into the case. Earlier this week, Reuters said, “The FDA had completed its review and that the AstraZeneca U.S. trial was set to resume as early as this week, citing four sources familiar with the situation,” according to Medscape Medical News.
