Monday, November 30, 2020

J&J halts covid-19 vaccine trial because of unexplained illness

Oct 13. 2020
The Johnson & Johnson logo. MUST CREDIT: Bloomberg photo by Scott Eells
The Johnson & Johnson logo. MUST CREDIT: Bloomberg photo by Scott Eells
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By Syndication Washington Post, Bloomberg · Riley Griffin · NATIONAL, BUSINESS, HEALTH, HEALTH-NEWS 

Johnson & Johnson said its covid-19 vaccine study has been temporarily halted after a clinical trial participant experienced an unexplained illness, the second time that a front-runner developer has paused a trial amid the intensifying race to create a viable immunization against the novel coronavirus.

The New Brunswick, New Jersey-based company said in a statement late Monday the participant's illness is being evaluated, and that it would share more information after further investigation. J&J's statement confirmed an earlier report by health-care news provider STAT that the study was paused.

"We are committed to providing transparent updates throughout the clinical development process of 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 study, especially large studies."

While pauses in late-stage testing are routine in the pharmaceutical industry, J&J's interruption may contribute to concerns over safety with covid-19 vaccine research progressing at an unprecedented speed this year. British drugmaker AstraZeneca 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 it remains halted in the U.S.

J&J executives probably will face questions about the trial halt Tuesday morning when they present third-quarter earnings. Representatives for the U.S. Food and Drug Administration could not immediately be reached by phone or email for comment after business hours.

J&J's setback is the latest reality check for a world anxiously awaiting a vaccine against the virus, which has sickened more than 37 million globally. It's a reminder of how long it takes to bring a successful shot to market, despite promises from politicians and governments that a covid-19 fix is around the corner.

The pursuit of a vaccine has become a political topic, with some observers concerned that President Donald Trump's eagerness to see a shot authorized before the election could compromise the scientific process.

While there are hundreds of covid-19 vaccines being developed around the world, J&J is among a small group of vaccine makers that have progressed into final-stage human studies. The company is dosing up to 60,000 volunteers in the first big trial of a covid-19 inoculation that may work after just one shot.

AstraZeneca is still waiting for a decision from U.S. regulators on whether it can resume tests in the country after halting global trials on Sept. 6 because of concerns about a U.K. participant who became ill. Developed with Oxford University, that experimental vaccine has seen trials resume outside the U.S. in locations including the U.K. and South Africa.

 

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