AstraZeneca is likely to conduct an additional global trial to assess the efficacy of its Covid-19 vaccine, Bloomberg reported. According to the company's chief executive officer, the new trial would be run instead of adding an arm to an ongoing US trial and would evaluate a lower dosage that performed better than a full amount in Astra's studies.
“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.”
Pascal also mentioned that he didn’t expect the additional trial to hold up regulatory approvals in the UK and European Union. As per reports, clearance from the US 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.
Authorisation in some countries is still expected before the end of the year, Pascal added.
This did not go well with the drug makers, as they are considering it as a confusing move by Astra and its CEO. The company's late-stage data initially increased confidence that the world would soon have multiple shots to combat the pathogen, following positive reports from front-runners Pfizer Inc. and Moderna Inc. But scant disclosures and the manufacturing discrepancy have sparked doubts among scientists and investors.
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