The Johnson & Johnson company
paused its clinical studies of its experimental vaccine against COVID-19,
while investigating whether the emergence of an "unexplained" disease in one of the participants is related to the injection he received.
The company's decision to stop testing comes within weeks of announcing that it was in the final phase of clinical trials, involving thousands of people in various countries.
The company said in a statement late Monday that illness, accidents and other alleged adverse events "are an expected part of any clinical trial, especially large studies."
His doctors and a safety monitoring panel will
try to determine what could have caused the disease, he
added.
[The White House accepts FDA rules that will delay approval of the vaccine until after the election]
It is the second pause of this type
that one of the pharmaceutical companies that seeks to develop a vaccine against COVID-19 must carry out.
Archive image of Johnson & Johnson's experimental COVID-19 vaccine.AP
When AstraZeneca and the University of Oxford announced a hiatus in their clinical studies due to the emergence of a potentially unexplained disease a month ago, medical experts praised the move because it reflected the scientific rigor that must be maintained, despite the enormous public interest in it. produce a vaccine.
Johnson & Johnson did not disclose further details about the illness that led to the suspension
of the trials, citing the privacy of the participant.
[Trump says the COVID-19 vaccine will be ready in October. But this is unlikely]
Temporary pauses in phase three of clinical trials of a vaccine are relatively common and rarely made public.
However, the interest in obtaining a vaccine against the coronavirus has raised the level of public scrutiny.
Companies should investigate any serious or unexpected reactions
that occur during trials to study the drug.
As these involve thousands of participants in phase three, the last one, some medical problems can occur by coincidence.
In fact, one of the first steps the company said it will take is determining whether the person received the vaccine or a placebo.
Johnson & Johnson's COVID-19 Vaccine Kicks Off Phase Three of U.S. Clinical Trials
Sept.
23,202000: 25
While AstraZeneca and the University of Oxford have already resumed their clinical studies in the UK and other countries, in the US they remain on hiatus, awaiting continued approval from the Food and Drug Administration (FDA).
The AstraZeneca trials were paused when a woman in the UK developed severe neurological symptoms consistent with transverse myelitis, a rare inflammation of the spinal cord, the company said at the time.
More than 30,000 people are participating in its trials
, some with placebos.
Johnson & Johnson aimed to enroll 60,000 volunteers to demonstrate whether its single-dose approach is safe and protects against coronavirus.
Other candidate vaccines in the United States require two injections.
With information from The Associated Press and NBC News.
