AstraZeneca is likely to conduct an additional global trial to assess the efficacy of its Covid-19 vaccine, according to the company’s chief executive officer, after current studies raised questions over its level of protection. From a report: The new trial would be run instead of adding an arm to an ongoing U.S. trial and would evaluate a lower dosage that performed better than a full amount in Astra’s studies. The company’s acknowledgment that the lower level was given in error fueled concerns.
“Now that we’ve found what looks like a better efficacy we have to validate this, so we need to do an additional study,” CEO Pascal Soriot said in his first interview since the data were released. It will probably be another “international study, but this one could be faster because we know the efficacy is high so we need a smaller number of patients.” Soriot said he didn’t expect the additional trial to hold up regulatory approvals in the U.K. and European Union. Clearance from the U.S. Food and Drug Administration may take longer because the regulator is unlikely to approve the vaccine on the basis of studies conducted elsewhere, especially given the questions over the results, he said. Authorization in some countries is still expected before the end of the year, he said.
of this story at Slashdot.
Source:: Slashdot