Source: Baxter Dmitry
One of the leading coronavirus vaccine clinical trials has been put on hold to investigate a “potentially unexplained illness” in one of the participants, the company announced Tuesday.
“As part of the ongoing randomised, controlled global trials of the Oxford coronavirus vaccine, our standard review process triggered a pause to vaccination to allow review of safety data,” AstraZeneca said in a statement.
“This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials.”
“In large trials illnesses will happen by chance but must be independently reviewed to check this carefully,” the company said. “We are working to expedite the review of the single event to minimise any potential impact on the trial timeline.”
300 million of the doses of the Oxford vaccine are planned to be distributed through a $750 million agreement with two charities backed by the Bill and Melinda Gates Foundation and the WHO, among others.
Stat, which first reported the pause in the trial, reported that the participant who had the “suspected serious adverse reaction” is in the United Kingdom.
TheHill report: AstraZeneca is one of three companies that have phase three coronavirus vaccine trials ongoing in the United States. Two other trials are being conducted for potential vaccines from Pfizer and Moderna.
This is the first time any of those three trials have been known to have been paused for a safety investigation.
The announcement illustrates the importance of a careful vaccine process to check safety and efficacy, and comes on the same day that AstraZeneca, as well as eight other drug companies, issued a rare joint statement pledging to follow the science and avoid politics, amid President Trump floating the idea of a pre-election approval of a vaccine.
“We will need more information but obviously this is concerning,” tweeted Carlos del Rio, a vaccine expert at Emory University.