Johnson & Johnson COVID-19 Vaccine Study Paused Due to Unexplained Illness in Participant

Johnson & Johnson COVID-19 Vaccine Study Paused Due to Unexplained Illness in Participant

Johnson & Johnson reported on Monday that it temporarily halted its clinical trial of the COVID-19 vaccine because one of its participants became ill.

“We have temporarily halted the administration of new doses in all of our clinical trials of the COVID-19 vaccine, including the phase 3 ENSEMBLE trial, due to unexplained illness in a study participant,” the company said in a statement.

The hiatus means that the online enrollment system has been closed for the 60,000-patient clinical trial, while the independent committee on patient safety is convened.

J&J said that serious adverse effects were “an expected part of any clinical trial, especially a large one.”. Based on company guidelines, they can stop a study to determine if the adverse effect was due to the drug in question and if the study can be resumed.

In the statement they issued, they explained that out of respect for the privacy of the participant who presented the disease, they will not issue more information about it while they study in depth what happened to him during the trials.

“Following our guidelines, the participant’s illness is being reviewed and evaluated by the data security monitoring board, as well as our internal safety and clinical physicians (…) We are learning more about this participant’s illness and it is It is important to have all the data before sharing additional information ”Johnson & Johnson added in a statement.

In September, the company started the third and final phase of testing required before requesting vaccine approval. The study has the largest number of volunteers for a process of this nature: double the number that participate in those carried out by other laboratories, and they are distributed in 215 locations throughout 8 countries: USA, South Africa, Argentina , Brazil, Chile, Colombia, Mexico and Peru.

Unlike other candidates, the possible Johnson & Johnson vaccine seeks to generate immunity with a single dose, which could facilitate its transportation and distribution if approved, in addition to reducing its cost.

There are currently 11 potential vaccines that are in the last stage of testing. Of those that are also being produced in the United States, in addition to Johnson & Johnson, there are those developed by Moderna and Pfizer and BioNtech. All companies put their signature on a document in which they agree not to seek approval until they have proven to be safe and effective.

“We, the undersigned biopharmaceutical companies, want to make clear our continued commitment to the development and testing of potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles,” the pharmaceutical companies say in the document.

They also express their hope that the signing of the commitment “will help ensure public confidence in the rigorous scientific and regulatory process with which COVID-19 vaccines are being evaluated and that they can eventually be approved.”

COMMENTS

WORDPRESS: 0
DISQUS: 0