Quantcast
Environmental News for a Healthier Planet and Life

Johnson & Johnson Pauses COVID-19 Vaccine Trial After Mystery Illness

Health + Wellness
Johnson & Johnson Pauses COVID-19 Vaccine Trial After Mystery Illness
Pharmaceutical giant Johnson & Johnson is pausing its COVID-19 vaccine trials after a study participant fell ill. Lubo Ivanko / Getty Images

Pharmaceutical giant Johnson & Johnson (J&J) announced that it is pausing COVID-19 vaccine trials after a study participant fell ill. The announcement comes just weeks after the company said trials were in the final stages, NBC News reported.


J&J told STAT that the pause was due to "an unexplained illness in a study participant," but would not provide more details citing the patient's privacy. The company added that it needs to gather more information before sharing any details. J&J does not yet know if the participant received the vaccine-candidate or the placebo.

"Following our guidelines, the participant's illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board as well as our internal clinical and safety physicians," the company 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."

Pauses are not uncommon, NBC News reported, but rather a testament to upholding regulatory standards. AstraZeneca paused its vaccine trial last month when a study participant in the UK also fell ill with an unexplained illness.

While the 60,000-patient trial is paused, it's different from a clinical hold, which is a longer regulatory procedure. In fact, it is rare for J&J to disclose study pauses to the public, STAT reported.

"A study pause, in which recruitment or dosing is paused by the study sponsor, is a standard component of a clinical trial protocol," J&J said in the statement. "A regulatory hold of a clinical trial is a requirement by a regulatory health authority, such as the U.S. Food and Drug Administration. As outlined in our transparency commitments, we proactively disclose any regulatory hold of a pivotal clinical trial."

J&J CFO Joseph Wolk told CNBC that the company was acting responsibly. "We're letting safety protocol follow proper procedure here," he said. "What it should also do is reassure the public that every scientific, medical and ethical standard is being applied here."

Experts also pointed out the importance of study pauses.

"This is completely expected, and it's just a reminder how ridiculous it is to try and meet a political timeline of having a vaccine before Nov. 3," Ashish Jha, dean of the Brown University School of Public Health, told CNN.

J&J is the fourth pharmaceutical company receiving funding under Operation Warp Speed to enter late-stage testing of its vaccine candidate. Moderna, AstraZeneca and Pfizer are all in the process of evaluating safety and efficacy data of their clinical trials, CNBC reported.

David Attenborough narrates "The Year Earth Changed," premiering globally April 16 on Apple TV+. Apple

Next week marks the second Earth Day of the coronavirus pandemic. While a year of lockdowns and travel restrictions has limited our ability to explore the natural world and gather with others for its defense, it is still possible to experience the wonder and inspiration from the safety of your home.

Read More Show Less
EcoWatch Daily Newsletter

By Michael Svoboda

For April's bookshelf we take a cue from Earth Day and step back to look at the bigger picture. It wasn't climate change that motivated people to attend the teach-ins and protests that marked that first observance in 1970; it was pollution, the destruction of wild lands and habitats, and the consequent deaths of species.

Read More Show Less
Trending
An Amazon.com Inc. worker walks past a row of vans outside a distribution facility on Feb. 2, 2021 in Hawthorne, California. PATRICK T. FALLON / AFP via Getty Images

Over the past year, Amazon has significantly expanded its warehouses in Southern California, employing residents in communities that have suffered from high unemployment rates, The Guardian reports. But a new report shows the negative environmental impacts of the boom, highlighting its impact on low-income communities of color across Southern California.

Read More Show Less
Xiulin Ruan, a Purdue University professor of mechanical engineering, holds up his lab's sample of the whitest paint on record. Purdue University / Jared Pike

Scientists at the University of Purdue have developed the whitest and coolest paint on record.

Read More Show Less

Less than three years after California governor Jerry Brown said the state would launch "our own damn satellite" to track pollution in the face of the Trump administration's climate denial, California, NASA, and a constellation of private companies, nonprofits, and foundations are teaming up to do just that.

Read More Show Less