After an adverse effect was reported on a candidate Johnson & Johnson paused its COVID-19 vaccine trial on Monday. An immediate investigation has been initiated on the participant’s “unexplained illness” by the company, said a statement issued by it.
Such incidents and other adverse events “are an expected part of any clinical study, especially large studies,” said the company statement. Their doctors and safety monitoring panel are trying to ascertain the reason behind the illness of the individual.
The trial was stopped because a woman developed severe neurological symptoms consistent with transverse myelitis. It is a rare inflammation of the spinal cord, the company said in a statement.
Although such momentary halts are part and parcel of such large studies and very few of them are made public, the trials of COVID-19 vaccine trial is at a different level as the whole world is grappling with the pandemic.
Even AstraZeneca and Oxford University’s vaccine testing is on hold in the US as officials examine whether an illness in its trial poses a safety risk. However, it has resumed in other parts of the world.
Infections across the world have crossed 37 million and over 1 million people have lost their lives due to the virus. J&J was looking to enroll 60,000 volunteers to prove if its single-dose approach is safe and protects against COVID-19. Meanwhile, other vaccine candidates in the US require two shots.