AstraZeneca Targets Extra Global Vaccine Trial As Questions Increase

AstraZeneca Plc’s COVID-19 vaccine appears to be heading for an additional global trial as the drugmaker tries to clear up the uncertainty and confusion surrounding the favorable results in its current study.

The company wants the new test to confirm the 90% efficacy rate the injection showed in one part of an existing test, CEO Pascal Soriot said. You’re favoring that option rather than adding an arm to a separate study that’s already underway in the US.

Questions mount about one of the faster feedings after the company acknowledged that a lower dosage level that seemed more effective resulted from a manufacturing discrepancy. The company and its partner, the University of Oxford, did not initially disclose the bug and other key details, raising concerns about its transparency.

“Now that we’ve found what looks like better efficacy, we have to validate this, so we need to do an additional study,” Soriot said in his first interview since the data was published. It will probably be another “international study, but this one could be faster because we know that the efficacy is high, so we need fewer patients.”

Soriot said he did not expect the additional testing to delay regulatory approvals in the UK and the European Union.

The UK government said on Friday it had asked the drug regulator to assess whether the Astra-Oxford vaccine was suitable for temporary authorization. The unusual step comes after the government amended legislation in light of the pandemic to allow the UK to approve a vaccine before the European regulator, to which Britain is still subject until January.

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, Soriot said. Authorization is still expected in some countries before the end of the year, he said.

“The question for us was, will we need the US data to get approval in the US or can we get approval in the US with international data, and it was never clear,” said Soriot, who is quarantined after arriving in Australia. “Now, with those results, we are more likely to need the US data.”

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.

Astra and Oxford reported Monday that a lower starting dose of the vaccine, followed by a full dose, produced a 90% efficacy rate in a smaller group of participants, compared with 62% for two full doses.

A day after the data was released, the head of Operation Warp Speed, the US vaccine program, said that the regimen showing the highest level of effectiveness was tested in a younger population. He also said that the average dose was given to some people due to an error in the amount of vaccine that was put into some vials. None of those details were revealed in the original statements from Astra or Oxford.

Soriot questioned the idea that the half-dose regimen was a mistake, saying that after the researchers realized the dosage discrepancy, they formally changed the testing protocol with the blessing of regulators.

“I won’t tell you that we expected the efficiency to be higher,” Soriot said. But “people call it a mistake, it is not a mistake.”

Astra shares closed 0.7% lower in London. They are down about 7% this week amid questions about the trial results.

The company has previously said that it could add a new arm to its US trial 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 injections using messenger RNA, released data earlier this month showing their vaccines were around 95% effective, and Pfizer applied to US regulators for emergency approval.

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.