AstraZeneca could lead a new global vaccine trial

It is likely that AstraZeneca Plc to conduct a new global trial to assess the effectiveness of its COVID-19 vaccine, according to the chief executive of the company, after recently published studies raised questions about its level of protection.

The trial would be conducted as an entirely new study, rather than a section of an ongoing US trial, and would assess a lower dose that worked better than a full dose in the Astra studies. There were concerns that the company admitted that the lower dose of the drug was administered in error, and the new trial would be used to confirm whether the higher efficiency rate of 90% is maintained or not.

“Now that we have found what appears to be better efficacy, we need to validate it, so we need to do further study,” said the CEO of the pharmaceutical company, Pascal Soriot, in his first interview since the data was released. This is probably another “international study, but it could be faster because we know the efficacy is high, so we need fewer patients.”

Astra stock closed 0.7% lower in London and they’re down about 7% this week amid questions about test results.

Soriot said he did not expect the new trial to delay regulatory approvals in the UK and the European Union. US Food and Drug Administration (FDA) approval it might take longer because the regulator is unlikely to approve the vaccine based on studies done elsewhere, especially given questions about the results, he said. Authorization is still expected in some countries before the end of the year, he said.

Astra and its CEO face close scrutiny Pharmaceutical Company Responds to Growing Vaccine Confusion. The company’s late-stage data initially boosted confidence that the world would soon have multiple vaccines to combat the pathogen following positive reports from Pfizer Inc. and Moderna Inc., which are among the favorites in the race. at launch. a vaccine. But the lack of information and the divergence around manufacturing have raised doubts among scientists and investors.

Different efficiency rates

Astra and its partner, the University of Oxford, reported on Monday that their vaccine was 90% effective when only half a dose was given before a full-dose booster, and that two full doses showed 62% efficacy.

But the title of the American show Operation Warp Speed He said the next day that the dose which showed the highest level of effectiveness had been tested on a younger population and that half the dose had been given to some people due to an error in the amount of medicine placed. in some vials. None of this was revealed in the original AstraZeneca announcement.

The company said earlier that it was considering adding a new section to its U.S. trial to test for the lower dose.

Astra and the researchers declined to provide more data ahead of a peer-reviewed analysis expected to be published in the coming weeks. The results were sent to an unidentified newspaper, Astra reported in a statement.

Astra’s vaccine is one of three vaccines that could be approved before the end of the year. Pfizer and Moderna, which have developed vaccines using messenger RNA, this month released data showing their vaccines to be around 95% effective, and Pfizer has asked U.S. regulators to approve emergency use. .

There is additional pressure on Astra’s success because it is easier to store and the company will sell it at cost during the pandemic, meaning many low- and middle-income countries will depend on it.