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NEW JERSEY (BLOOMBERG) – Johnson & Johnson said its study of the Covid-19 vaccine was temporarily halted due to an unexplained illness in a trial participant, the second time a leading developer has encountered this situation in the race each time. more intense by immunization.
The New Brunswick, NJ-based company said in a statement Monday night that it was evaluating the participant’s illness and would share more information after the investigation. J & J’s statement confirmed an earlier report by health news provider Stat that the study was on hiatus.
“We are committed to providing transparent updates throughout the clinical development process for our vaccine candidate,” J&J said in its statement.
“Adverse events (illnesses, accidents, etc.), even those that are serious, are an expected part of any clinical trial, especially large studies.”
While late-stage testing breaks are a routine event for the pharmaceutical industry, the J&J outage raises concerns about safety concerns, as Covid-19 vaccine candidates have progressed at unprecedented speed this year. .
Last month, AstraZeneca Plc temporarily stopped testing its vaccine after one trial participant fell ill. That study has been resumed in several countries, but is still on hold in the US.
J&J executives will likely face questions about the suspension of the lawsuit Tuesday morning during their third-quarter earnings presentation.
Representatives from the US Food and Drug Administration could not be immediately reached by phone or email after business hours.
The J&J setback is the latest reality check of a world eagerly awaiting a vaccine against the pandemic that has sickened more than 37 million.
It is a reminder of how long it takes to bring a successful injection to market, despite promises by politicians and governments that a Covid-19 solution is just around the corner.
The search for a vaccine has become a political issue, and some observers are concerned that US President Donald Trump’s enthusiasm to see a licensed vaccine before the election could run counter to the scientific process.
While hundreds of Covid-19 vaccines are in development around the world, Johnson & Johnson is among a short list of vaccine manufacturers that have progressed toward end-stage human studies.
The company is dosing up to 60,000 volunteers in the first large trial of a Covid-19 inoculation that can work after a single injection.
AstraZeneca is still awaiting a decision from US regulators on whether it can resume testing in the country after halting global testing on September 6 due to concerns about a UK participant falling ill.
Developed with the University of Oxford, that experimental vaccine has seen trials resumed outside of the US in places like the UK and South Africa.
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