AstraZeneca wants to repeat vaccine study

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Restart

: The vaccine from the laboratories at

is to be tested again.

Photo: John Cairns / AP

AstraZeneca is likely to conduct an entirely new global study to evaluate the effectiveness of the Covid-19 vaccine developed in collaboration with Oxford University.

For example, CEO

(61) was quoted

on Thursday

after the irritation to the interim results of the study published on Monday had increased.

Instead of completing the ongoing mass study, a new study will be set up to test the vaccine in what appears to be a better-working lower dose, Soriot told Bloomberg news agency.

This is a setback for the British-Swedish pharmaceutical company.

After the biotech companies BioNTech and Moderna, the researchers went public with interim results of their study at the beginning of the week.

While the competition had indicated an effectiveness of around 95 percent for their vaccine, AstraZeneca spoke in a statement of 62 to 90 percent.

The high level of effectiveness only related to subjects who had incorrectly not received the full dose of active ingredient in the study.

After the initial joy about the results, this had increasingly led to fundamental doubts about the study, which could also jeopardize its rapid approval in Europe and the USA.

Soriot now wants to have the effectiveness of the vaccine tested again separately in the low dosage.

"Now that we've found something that looks like it is more effective, we need to validate that, so we need to do an additional study," he said.

There would probably be another "international study", but it could be completed more quickly "because we know that the effectiveness is high, so we need a smaller number of subjects".

Pascal Soriot hopes for quick approval in the EU

In the EU and Great Britain, however, the group continues to hope for rapid approval before the end of the year.

Soriot said he doesn't expect the additional study to delay approvals here.

However, US FDA approval could take longer as it is unlikely to approve the vaccine based on data collected overseas, especially given questions about the results, Soriot said.

The European approval authority EMA said on Thursday, regardless of the announcement of a new study, that the data on the efficacy and safety of the vaccine would be checked as soon as the company had submitted it.

The US authority has not yet commented on the interim results.

AstraZeneca originally announced that it would contact the FDA to change the design of the study and add the new, more effective dosing regimen.

lhy / Reuters