Johnson & Johnson Pauses COVID-19 Vaccine Trial After Mystery Illness
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.
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Earth had its second-warmest year on record in 2020, just 0.02 degrees Celsius (0.04°F) behind the record set in 2016, and 0.98 degrees Celsius (1.76°F) above the 20th-century average, NOAA reported January 14.
Figure 1. Departure of temperature from average for 2020, the second-warmest year the globe has seen since record-keeping began in 1880, according to NOAA. Record-high annual temperatures over land and ocean surfaces were measured across parts of Europe, Asia, southern North America, South America, and across parts of the Atlantic, Indian, and Pacific oceans. No land or ocean areas were record cold for the year. NOAA National Centers for Environmental Information
Figure 2. Total ocean heat content (OHC) in the top 2000 meters from 1958-2020. Cheng et al., Upper Ocean Temperatures Hit Record High in 2020, Advances in Atmospheric Sciences
Figure 3. Departure of sea surface temperature from average in the benchmark Niño 3.4 region of the eastern tropical Pacific (5°N-5°S, 170°W-120°W). Sea surface temperature were approximately one degree Celsius below average over the past month, characteristic of moderate La Niña conditions. Tropical Tidbits
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