Johnson and Johnson’s COVID-19 study is now on pause due to a mysterious illness that befell one of its participants, Stat News reported.
The more than a century company said in a document that everything related to the trial is now under a “pausing rule.”
According to the document obtained by Stat News, the online application for patients has been closed for its 60,000 patient clinical trials.
Moreover, the monitoring board for patients’ safety will also convene, which they have already done late Monday.
The company, however, refused to add more details about the participant’s unexplained illness.
According to the company’s statement, per Stat News, the company must have all the facts first before sharing more details.
Also, it must respect the participant’s privacy.
Recently, Oxford/AstraZeneca‘s vaccine research was also paused twice due to safety concerns.
Clinical Trial Pauses Are Not New
According to Johnson and Johnson’s, adverse events during clinical trials of a vaccine are usual parts of a clinical study.
However, due to the race for the first working COVID-19 vaccine, the attention is more magnified.
Moreover, most of the time, clinical pauses will only last for a few days, per Stat News.
Other experts also believe a study pause is normal, including Dr. Robert Redfield, director of CDC, per CNN.
However, other vaccine trial experts CNN interviewed do not think so.
Dr. Carl Fichtenbaum, an infectious disease expert from the University of Cincinnati, believes it’s unusual to pause during a Phase 3 trial due to safety.
According to Fichtenbaum, he only witnessed phase 3 trial pauses “a handful of times” in his experience.
Fichtenbaum is also a researcher for the AstraZeneca and Pfizer COVID-19 vaccine trials.
Details on J&J’s Phase 3 Trials
Johnson and Johnson’s, through its subsidiary, Janssen Pharmaceutical Companies, developed its own COVID-19 vaccine candidate.
Moreover, the company started its Phase 3 trials in the US in September.
According to experts in September, J&J’s vaccine prototype may have a substantial advantage against its other competitors.
According to experts, unlike other vaccines, Johnson and Johnson’s vaccines do not need to be stored in subzero temperatures.
Also, it may only require a single-dose instead of two, which can “expedite results” said Dr. Paul Stoffels, the company’s chief scientific officer per the New York Times.