Johnson & Johnson said its Covid-1
The New Brunswick, New Jersey based company said in a Statement late Monday that the participant’s illness will be assessed and that they would provide more information after further investigation. J & J’s testimony confirmed an earlier report by health news provider STAT that the study had been suspended.
“We are committed to providing transparent updates throughout the clinical development process of our vaccine candidate,” said J&J in its statement. “Adverse events – illnesses, accidents, etc. – even those that are serious are an expected part of any clinical trial, especially large trials.”
While pauses in late-stage testing are routine in the pharmaceutical industry, J & J’s interruption may raise safety concerns as research on Covid-19 vaccines advances at an unprecedented rate this year. British drug maker AstraZeneca Plc temporarily stopped testing its own vaccine candidate last month after a study participant fell ill. This study was resumed in a number of countries, however remains stopped in the US
J&J executives are likely to have questions about the Tuesday morning litigation in the US when they present their third quarter results. US Food and Drug Administration representatives could not be immediately reached by phone or email for comment outside of business hours.
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J & J’s setback is the latest reality check for a world eagerly awaiting a vaccine against the virus that has sickened more than 37 million people worldwide. It’s a reminder of how long it takes to get a successful shot to market despite politicians and governments having promised that a Covid-19 fix is around the corner.
The pursuit of a vaccine has become a political issue. Some observers fear that US President Donald Trump’s eagerness to see a pre-election shot could jeopardize the scientific process.
While hundreds of Covid-19 vaccines are being developed around the world, J&J is one of a small group of vaccine manufacturers who have already conducted end-stage human studies. The company doses up to 60,000 volunteers in the first major study of a Covid-19 vaccination that can work after just one shot.
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AstraZeneca is awaiting a decision from US regulators on whether testing can resume in the country after global trials were halted on September 6th amid concerns about a sick UK participant. This experimental vaccine was developed with Oxford University and has resumed studies outside of the US in places like the UK and South Africa.
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