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.
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.
One day after the data was released, the head of a U.S. vaccine program known as the Warp Speed Operation said the system, which showed higher efficacy, was tested in a younger population. He also said that half the dose was given to some people because of a mistake in the amount of vaccine placed in each vial. None of these details were disclosed in the original statements of Astra or Oxford.
Astra may need a new Covid-19 vaccination trial outside the United States: React
Soriot disputed the idea that the half-dose dosing was a mistake, saying that after researchers noticed the dosing error, the test protocol was officially changed with the blessing of regulators.
“I’m not saying we expected more efficiency,” Soriot said. “People call it a mistake – it’s not a mistake.”
Astra shares fell 0.7% lower in London. They dropped about 7% this week amid questions about test results.
The company previously said it would consider adding a new arm to the U.S. experiment to test the lower dose.
Astra and the researchers declined to submit additional data before the peer-reviewed analysis, which is expected to be published in the coming weeks. The results were published in an unpublished journal, Astra said in a statement.
Astra is one of three vaccines that can be approved before the end of the year. Pfizer and Moderna, both of which created vaccines using messenger RNA, data released earlier this month showing that their vaccines were about 95% effective, and Pfizer applied to the U.S. regulatory authorities for urgent approval.
The Astra shot is under further pressure to succeed because it is easier to store and the company sells costly in a pandemic, which means many low- and middle-income countries they rely on it.
(Updates from the company commenting on the confirmation in the second paragraph)