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J&J Halts Covid-19 Vaccine Trial Due to Unexplained Illness Oct 13, 2020
 

Johnson & Johnson said its Covid-19 vaccine study was 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 virus. 

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. 

“We are committed to providing transparent updates throughout the clinical development process of our vaccine candidate,” J&J said. “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. Developmental processes that usually take years have been compressed into months, egged on by politicians wanting a quick fix to the pandemic, which has scuppered economic growth and disrupted everyday life.

British drugmaker AstraZeneca Plc 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 remains halted in the U.S.

J&J executives will likely face questions about the trial pause Tuesday morning U.S. time 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.

The J&J pause “is good news in that it demonstrates that the regulatory safeguards to protect the public are still in place,” said Michael Kinch, a vaccine specialist and professor at Washington University in St. Louis. He said more information is needed to determine whether the issues with J&J’s vaccine are related to the illness experienced by AstraZeneca’s trial participant.

In the AstraZeneca incident, a trial subject who received the vaccine saw unexplained neurological symptoms, prompting a temporary halt in early September. Though trials have since resumed in the U.K., Brazil and South Africa, work remains paused in the U.S., raising questions over whether regulators there have lingering safety concerns.

J&J’s setback will add to these worries, delivering another reality check for a world anxiously awaiting a vaccine against a 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 U.S. President Donald Trump’s eagerness to see a shot authorized before the election could compromise the scientific process. Trump has repeatedly announced the goal in contradiction to top science officials in his administration.

The U.S. FDA has been working for months to hammer out clear standards for vaccines seeking to be fast-tracked to market. The agency said in early October it would demand two months of safety data before it would review any application for a vaccine emergency-use authorization.

Higher Bar

An inoculation must clear a higher bar than a treatment because it’s injected into healthy individuals. Public trust in a vaccine will be crucial as health authorities try to convince millions around the world to take it. Drugmakers have condensed the development timeline for their vaccines substantially, but are eager to avoid the perception that they are bending to political interference and have pledged to avoid scientific shortcuts.

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

Besides in the U.S, it’s also recruiting trial participants in Argentina, Brazil, Chile, Colombia, Mexico, Peru and South Africa.

J&J Chief Executive Officer Alex Gorsky joked in an interview earlier this month that he’s asked “almost every 15 minutes” when a vaccine will be available. At the time, he reaffirmed J&J’s expectation that by “late this year, early next year,” the company could begin reviews with regulators for possible emergency use authorization. That timeline may now be in question depending on how long the trial is paused for.

AstraZeneca, Pfizer Inc. and Moderna Inc. are among other western developers with late-stage clinical trials. Pfizer has said it could have the data to support an application for an emergency authorization as soon as this month. Moderna doesn’t expect to have such data until late November.

Russia has tried to leapfrog the process in the race to be first with a Covid-19 shot, approving its Sputnik V product before it’s undergone full testing, drawing widespread skepticism. China also has several candidates in the works and the country’s top bio-safety scientist said last month that shots will be ready for public use as early as November or December.



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Source: www.bloomberg.com
 
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