10-26-2020, 01:54 PM
https://www.wsj.com/articles/covid-19-va...1603476923
The FDA has lifted its clinical hold on trials from Astra Zeneca and Johnson and Johnson. In the AZ trial:
It is very hard to prove or disprove causality in single events. It is concerning that there were two neurological cases, though they must have been dissimilar enough for the agency not to have found a pattern (one sounds like a patient who developed MS, the other remains a mystery).
Based on the article, it sounds like the J&J was on a voluntary hold (not by the FDA), and the company was comfortable enough to resume.
BC
The FDA has lifted its clinical hold on trials from Astra Zeneca and Johnson and Johnson. In the AZ trial:
Quote:The AstraZeneca decision, which was first reported by The Wall Street Journal, came after the FDA didn’t find the vaccine was responsible for the two cases, though the agency couldn’t rule out a link either, a person familiar with the matter said.
The agency plans to require researchers to inform study subjects of the cases and monitor them for any related neurological events, such as numbness, the person said.
It is very hard to prove or disprove causality in single events. It is concerning that there were two neurological cases, though they must have been dissimilar enough for the agency not to have found a pattern (one sounds like a patient who developed MS, the other remains a mystery).
Based on the article, it sounds like the J&J was on a voluntary hold (not by the FDA), and the company was comfortable enough to resume.
BC