Johnson & Johnson Halts COVID-19 Vaccine Trials As Participant Falls Mysteriously ILL
By: Sneha Chaudhary
- Johnson & Johnson temporarily paused its COVID-19 vaccine trials
- Candidate’s Clinical trials were different from “regulatory hold”.
- The current pause has occurred in the vaccine due to unexplained illness in the Candidate.
On Monday, Johnson & Johnson said that due to an unidentified disease in a research sample, it had briefly suspended its COVID-19 vaccine trials.
“The unexplained condition of the participant is being checked and is being examined by an impartial data and health monitoring board as well as the clinical and safety doctors of the Company”, the company said in a statement. (source from ET)
On Tuesday morning, Johnson & Johnson published the quarterly financial results, and it said that in massive trials, which can involve tens of thousands of persons, such pauses are common. It claimed that the “research delay” was different from the “regulatory hold” mandated by health authorities in giving doses to the vaccine candidate; a delay is a present situation.
J&J’s move follows a similar one by AstraZeneca Plc. However, AstraZeneca suspended the late-stage trials of its novel coronavirus vaccine, developed with the University of Oxford, in a UK research participant in September due to an unknown disorder.
Although trials have continued in the UK, Brazil, South Africa, and India, following a regulatory review, the US trial is still on hold.
“Because of what happened to AstraZeneca, everyone is on alert”, Dr. William Schaffner, a professor of infectious diseases at the Vanderbilt University School of Medicine, said by email, adding that it might take a week to compile information.
“It would have to be a significant adverse event. They would not avoid it for all of those reasons if it were anything like breast cancer, untreated diabetes, or a heart attack. This is likely to be a neurological event,” he said.
Last month, in an early to mid-stage clinical trial after which the company conducted a final 60,000-person trial, the findings of which were due by the end of this year or early 2021, J&J announced that its experimental COVID-19 vaccine developed an excellent immune response against the novel coronavirus.
Because of the health considerations, Johnson & Johnson declined to comment about the illness. It was believed that some research subjects were given a placebo. However, it was not always clear if a person suffering from a severe adverse effect was given a placebo or medication in a clinical trial.
The delay in the day was started by Stat News citing a document sent to independent researchers claiming that a “delay law” had been followed, the online portal used to enroll patients in the study had been closed, and the data and safety control board will be convened.
