CEO says AstraZeneca likely to run new global Covid vaccine trial: Report

In a surprise, the group of volunteers that got a lower dose seemed to be much better protected than the volunteers who got two full doses.

 

AstraZeneca is likely to run an additional global trial to assess the efficacy of its Covid-19 vaccine, its chief executive Pascal Soriot was quoted as saying on Thursday after questions over the results from its late-stage study.

Instead of adding the trial arm to an ongoing U.S. process, a new study would be run to evaluate a lower dosage that performed better than a full amount in AstraZeneca's studies, Soriot was quoted as saying in a Bloomberg News report.

"Now that we've found what looks like a better efficacy we have to validate this, so we need to do an additional study," Soriot was quoted as saying.

Soriot said it would 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".

The news comes as AstraZeneca faces questions about its success rate that some experts say could hinder its chances of getting speedy U.S. and EU regulatory approval.

Several scientists have raised doubts about the robustness of results released on Monday showing the experimental vaccine was 90% effective in a sub-group of trial participants who, by error initially, received a half dose followed by a full dose.

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

Clearance from the U.S. Food and Drug Administration (FDA) may take longer though because the agency is unlikely to approve the vaccine based on studies carried out elsewhere, especially given the questions over the results, he said.

Authorisation in some countries is still expected before the end of the year, he added.

AstraZeneca research chief Mene Pangalos told Reuters on Monday that researchers had stumbled upon the half-dose regime by accident, saying a sub-group of the trial was given a smaller initial dose by mistake.

Earlier he had said that the firm would start discussions with the FDA to change the design of its experimental COVID-19 vaccine trial to add the more-effective dosage regime.

Earlier,AstraZeneca and Oxford University have acknowledged a manufacturing error that is raising questions about preliminary results of their experimental COVID-19 vaccine.

A statement describing the error on Wednesday came days after the company and the university described the shots as "highly effective" and made no mention of why some study participants didn't receive as much vaccine in the first of two shots as expected.

In a surprise, the group of volunteers that got a lower dose seemed to be much better protected than the volunteers who got two full doses.

In the low-dose group, AstraZeneca said, the vaccine appeared to be 90 per cent effective. In the group that got two full doses, the vaccine appeared to be 62 per cent effective. Combined, the drugmakers said the vaccine appeared to be 70 per cent effective.

But the way in which the results were arrived at and reported by the companies has led to pointed questions from experts.

The partial results announced on Monday are from large ongoing studies in the UK and Brazil designed to determine the optimal dose of vaccine, as well as examine safety and effectiveness. Multiple combinations and doses were tried in the volunteers. They were compared to others who were given a meningitis vaccine or a saline shot.


Comments