CEO Says AstraZeneca Likely to Lead New Global COVID-19 Vaccine Trial: Bloomberg News By Reuters

(Reuters) – AstraZeneca (NASDAQ 🙂 is likely to conduct an additional global trial to assess the effectiveness of its COVID-19 vaccine using a lower dose, its chief executive said on Thursday amid questions about the results of his delay. stage study.

Instead of adding the trial to an ongoing US process, AstraZeneca could launch a new study to assess a lower dosage of its vaccine that worked better than a full dosage, Pascal Soriot said in a Bloomberg News report. .

“Now that we have found what appears to be better efficacy, we need to validate that, so we need to do further study,” he said.

Soriot said it would likely be another “international study, but this one could be faster because we know the efficacy is high and therefore we need a smaller number of patients.”

The news comes as AstraZeneca faces questions over its pass rate that some experts say could hamper its chances of getting early regulatory approval from the US and EU.

Several scientists have questioned the robustness of results released Monday showing the experimental vaccine to be 90% effective in a subset of trial participants who initially mistakenly received a half dose followed by a full dose.

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

When asked about the Bloomberg report, a spokesperson for AstraZeneca said there was “great interest in continuing to further study the half-dose / full-dose regimen.”

“We are still evaluating the data and will work with regulators on the best approach for a more in-depth assessment,” he said.

“This would add to the data from existing trials that are currently in preparation for regulatory submission.

AstraZeneca told Reuters earlier Thursday that the administration of the half-dose had been reviewed and approved by independent data security monitors and the UK regulator, adding that the regulator had publicly confirmed that there was ” no worries “.

US Food and Drug Administration (FDA) approval may take longer, however, as the agency is unlikely to approve the vaccine based on studies conducted elsewhere, especially given questions about the results, Soriot said.

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

AstraZeneca chief research officer Mene Pangalos told Reuters on Monday that researchers stumbled upon the half-dose regimen by accident, saying a subgroup of the trial received an initial dose smaller by mistake.

Previously, he said the company would enter into discussions with the FDA to change the design of its COVID-19 vaccine investigational trial to add the most effective dosing regimen.

Organizing an additional trial may not be too complicated for the British drugmaker in the race to develop an effective vaccine to help tame the pandemic, which has killed more than a million people and rocked the world. Mondial economy.

Helen Fletcher, professor of immunology at the London School of Hygiene & Tropical Medicine, said another trial would not necessarily delay getting a green light because the effectiveness of the higher dose regimen still reached the goal of the World Health Organization, and it was not unusual to run new studies on approved vaccines.

“It’s entirely possible that AZ and Oxford could license the high dose and then quickly apply for an amendment to use the low dose when they have sufficient data,” she said.

The vaccine is one of three vaccines that could be approved before the end of the year. Earlier this month, Pfizer (NYSE 🙂 and Modern (NASDAQ 🙂 reported that their vaccines were about 95% effective in preventing disease, setting the bar very high.

Even so, the AstraZeneca photo developed with the University of Oxford is cheaper to make, easier to distribute, and faster to scale than its rivals.

A peer-reviewed analysis of the trial data will be published in a medical journal in the coming weeks.

The UK Medicines and Health Products Regulatory Agency (MHRA) is continuing its ongoing review of the vaccine, the regulator’s chief executive June Raine said in an email on Thursday.

“Any vaccine must go through robust clinical trials to international standards, under the supervision of the Medicines and Health Products Regulatory Agency (MHRA), and no vaccine would be allowed to be supplied in the UK. Uni unless the expected standards of safety, quality and efficiency are met. are satisfied, ”she said.

The European Medicines Agency did not immediately respond to requests for comment on the possibility of another study.