AstraZeneca Plc is likely to conduct an additional global trial to assess the efficacy of its Covid-19 vaccine, according to the company’s chief executive, after current studies raised questions about its level of protection.
The new trial would be conducted rather than adding an arm to an ongoing trial in the US and would evaluate a lower dose that worked better than a full amount in the Astra studies. The company’s recognition that the lower level was given in error raised concerns.
“Now that we have found what looks like 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 was published. It will probably be another “study, but this one could be faster because we know the efficacy is high, so we need fewer patients.”
Astra shares extended their declines, falling 0.8% in London.
Astra’s Covid-19 vaccine needs another trial to assess efficacy
Soriot said he did not expect the additional testing to delay regulatory approvals in the UK and the European Union. Approval from the US Food and Drug Administration 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 is still expected in some countries before the end of the year, he said.
Astra and its CEO face scrutiny as the drugmaker responds to growing confusion about the vaccine. The company’s late-stage data initially increased confidence that the world would soon have multiple opportunities to combat the pathogen, following positive reports from pioneers Pfizer Inc. and Moderna Inc. But poor disclosures and manufacturing discrepancy have raised doubts among scientists and investors.
Different rates
Astra and his partner, the University of Oxford, reported Monday that a lower starting dose of the vaccine, followed by a full dose, produced a 90% efficacy rate, compared with 62% for two full doses.
A day after the data was released, the director of the US vaccine program known as Operation Warp Speed said that the regimen showing the highest level of efficacy was tested in a younger population. He also said that some people were given half the dose due to an error in the amount of vaccine put in some vials. None of those details were revealed in the original statements from Astra or Oxford.
The company has previously said it was considering adding a new arm to its trial in the US to test the lower dose.
Astra and the researchers have declined to provide more data ahead of a peer-reviewed analysis that is expected to be published in the coming weeks. The results were sent to an undisclosed magazine, Astra said in a statement.
Astra’s is one of three vaccines that could be approved before the end of the year. Pfizer and Moderna, which have created vaccines using messenger RNA, released data earlier this month that showed their vaccines were around 95% effective, and Pfizer has applied for emergency approval from US regulators.
There is additional pressure on the Astra injection to be successful because it is easier to store and the company sells it at cost during the pandemic, which means that many low- and middle-income countries rely on it.
This story has been published from a news agency feed with no changes to the text. Only the title has been changed.
.
