Astra is likely to run an additional global vaccination test, the CEO says

AstraZeneca Plc is likely to conduct a further global study to assess the effectiveness of the Covid-19 vaccine, according to the company’s CEO, after current studies have raised questions about the level of protection.

Instead of adding an arm, the new trial would be run instead of an experiment in the U.S. and would evaluate a lower dose that performs better than the total volume. The company acknowledging that the lower level was given by mistake has fueled concerns, and the new study is being used to confirm whether or not a higher 90% efficacy rate exists.

“Now that we have found better efficiency, we need to confirm this, so we need to do more research,” said CEO Pascal Soriot of data were disclosed. There will probably be another “international study, but it could be faster because we know that efficiency is high, so we need fewer patients”.

Soriot said he did not expect further negotiations in the UK and the European Union to approve official approvals. Authorization by the U.S. Food and Drug Administration may take longer because the regulator is unlikely to approve the vaccine based on studies elsewhere, especially considering issues over the results. In some countries, licensing is expected before the end of the year, he said.

“The question for us was whether we would need U.S. data to get approval in the U.S. or get approval in the U.S. with international data, and that was never clear,” said Soriot, who is in quarantine. after arriving in Australia. “With these results, it is more likely that we will need data from the United States.”

Astra and its CEO are under scrutiny as the drug manufacturer responds to the growing disruption caused by the vaccine. The company’s late-stage data initially boosted confidence that there would soon be more shots in the world to fight the pathogen, based on a positive report from the leaders Pfizer Inc. and Moderna Inc. But the lack of publication and manufacturing discrepancies have raised doubts among scientists and investors.

Different prices

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