Corona Virus Vaccine Trial Paused Due to Unexplained Illness
Corona Virus vaccine trial could take a few days to resume. Johnson & Johnson said the review of illness led to the pause. On Tuesday, October 13th, Johnson & Johnson said it would need to hear from a safety monitoring panel regarding the review of the company’s late-stage COVID-19 vaccine trial. The large study has been paused due to an unknown illness in one participant.
AstraZeneca Plc also suspended trials of its experimental Corona Virus vaccine. They use similar technology. It was due to a participant falling ill. That trial remains on pause. The Johnson & Johnson pause comes around a month after the AstraZeneca Plc suspended their trials.
High Profile Attempt to Fight the Corona Virus Pandemic
U.S.-based J&J’s vaccine effort is among the high profile attempts to fight the Corona Virus pandemic. On Monday, October 13th, the company said the vaccine effort will involve an independent data and safety monitoring board and their own clinical and safety team. Next, the data board will submit its findings to the U.S. Food and Drug Administration. Then, the study can then restart.
Sick Trial Participant
The company informed the safety board about the ill trial participant on Sunday, October 11th. The board has asked for more information. The company is also collecting information to answer its questions. Mathai Mammen, head of research & development at J&J’s Drug business, said giving the above statement.
“It will be a few days at minimum for the right set of information to be gathered and evaluated,” Mammen said during a conference call to discuss the company’s quarterly results.
It’s Not Known Whether the Trial Participant Got the Vaccine or Placebo
He said because the study is blind, the company did not yet know if the ill person got the vaccine or a placebo.
Big Trials Include Tens of Thousands of People
According to J&J, pauses are normal in big trials. They can include tens of thousands of people. However, the company said the trial is still on track to continue adding patients over the coming months.