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Pascal Soriot
Photographer: Simon Dawson / Bloomberg
Photographer: Simon Dawson / Bloomberg
AstraZeneca Plc is likely to conduct an additional global trial to assess the effectiveness of its Covid-19 vaccine, according to the company’s CEO, after current studies have raised questions about its level of protection.
The new trial would run instead of adding an arm to an ongoing US trial and assess a lower dose that worked better than a full amount in Astra’s studies. Of the society the recognition that the lower level was being given in error fueled concerns.
“Now that we have found what appears to be better efficiency, we need to validate this, so we need to do further study,” CEO Pascal Soriot said in his first interview since the data was 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”.
Astra shares continued their decline, falling 0.8% in London.
Astra’s Covid-19 vaccine needs another trial to assess its effectiveness
Soriot said he did not expect the additional testing to delay regulatory approvals in the UK and the European Union. US Food and Drug Administration approval may take longer because the regulator is unlikely to approve the vaccine based on studies conducted elsewhere, especially given questions about the results, he said. . Authorization in some countries is still expected before the end of the year, he said.
Astra and its CEO come under close scrutiny as the drugmaker reacts to growing confusion over the vaccine. Late-stage company data initially raised confidence that the world would soon have multiple injections to combat the pathogen, following positive reports from pioneers. Pfizer Inc. and Moderna Inc. But the lack of disclosure and manufacturing discrepancies have raised doubts among scientists and investors.
Different rates
Astra and its partner, the University of Oxford, reported on Monday that a lower initial dose of the vaccine, followed by a full dose, produced an efficacy rate of 90%, compared to 62% for two full doses.
A day after the data came to light, the head of the U.S. vaccination program known as Operation Warp Speed said the regimen with the highest level of effectiveness had been tested in a younger population. He also said that the half-dose was given to some people due to an error in the amount of vaccine placed in some vials. None of these details were disclosed in the original statements from Astra or Oxford.
The company previously said it was considering adding a new arm to its US trial to test for the lower dosage.
Astra and the researchers declined to provide further data ahead of a peer-reviewed analysis expected to be published in the coming weeks. The results were submitted to an undisclosed review, Astra said in a statement.
Astra is one of three vaccines that could be approved before the end of the year. Pfizer and Moderna, who both created vaccines using messenger RNA, released data earlier this month that showed their vaccines to be around 95% effective, and Pfizer has applied to US regulators for emergency approval.
There is added pressure on the Astra blow to be successful because it is easier to store and the company is selling it at cost during the pandemic, which means many low and middle income countries. rely on it.
(Updates with shares in the fourth paragraph)
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