Health
Two companies resume virus testing in the U.S. after safety pauses
Incident Raised some concerns Among experts who pointed out that a similar adverse neurological event reported a few months ago occurred in another vaccinated volunteer. This early event prompted a suspension of itself in AstraZeneca’s trial, but an independent safety committee eventually decided it was unrelated to the vaccine and allowed the study to resume. Did.
After the second outage of AstraZeneca in September, overseas trials resumed rapidly in most countries. However, the US suspension continues, with few details on why.
The FDA did not directly link the vaccine to the two neurological disorders, but could not rule out, according to two vaccine experts familiar with the situation, which is not allowed to be publicly discussed. Experts advised the company to warn research volunteers about related symptoms such as weakness and numbness that may indicate mild cases of transverse myelitis.
Johnson & Johnson launched a Phase 3 trial in September with 60,000 volunteers. On October 12, the company announced its own suspension of trials due to concerns that one of its volunteers had the disease. The company was almost silent about the details of the case.
“There are many factors that could have triggered the event,” the company said. “Based on the information gathered so far and the opinion of independent experts, the company has not found evidence that the vaccine candidate caused the event.”
Adverse events are not uncommon in large-scale vaccine trials. In some cases, the vaccine is the cause. However, research usually reveals that they are coincidences — a simple coincidence issue.
Now that the trial has resumed, Dr. Borio said changes may need to be made “to strengthen safety measures,” at least in the case of AstraZeneca. Now there is precedent.
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