J&J pauses Covid vaccine clinical trial
Johnson & Johnson halted clinical trials of its Covid-19 vaccine after a participant fell ill, the second time that a front-runner developer has paused testing in the race to create a viable immunisation against the virus.
The participant’s illness is being evaluated, the New Brunswick, New Jersey-based company said late Monday, adding that it would share information after further investigation. J&J shares fell 2.4% in trading before US exchanges opened. The vaccine is undergoing tests in as many as 60,000 volunteers from Peru to South Africa.
J&J is racing along with rivals such as Moderna Inc., Pfizer Inc. and AstraZeneca Plc to deliver a shot to help blunt the pandemic. Drugmakers must balance time pressures— especially as coronavirus cases set new records— with safety considerations in the crucial last stage of testing.
“We’re going to have to get used to hearing these sorts of reports of pauses,” Hassan Vally, an associate professor in epidemiology at La Trobe University in Melbourne, said by email. “As you vaccinate more people in these trials the chances are that there will be some illnesses in participants. The only difference here is that in the world that we live in right now, the progress of these trials are in the public eye, and so we are riding every bump.”
British drugmaker Astra last month temporarily stopped tests of its own vaccine candidate after a trial participant fell ill. That study has resumed in a number of countries, but
halted in the US.
While such pauses are routine in the pharmaceutical industry, J&J’s interruption may contribute to concerns over safety with vaccine research progressing at an unprecedented pace. Developmental processes that usually take years have been compressed into months, egged on by politicians wanting a solution to a pandemic that has killed over 1 million people and scuppered economic growth.
“We are committed to providing transparent updates throughout the clinical development process of our vaccine candidate,” J&J said in a statement. “Adverse events—illnesses, accidents, etc.—even those that are serious, are an expected part of any clinical study, especially large studies.”
J&J executives will likely face questions about the trial pause Tuesday morning when they present third-quarter earnings. Representatives for the FDA could not immediately be reached by phone or email for comment after business hours.