AstraZeneca will Conduct A New Clinical Trial

Sorio, CEO of AstraZeneca, a major British pharmaceutical company, added to the global assessment on the 26th to evaluate the efficacy of the new coronavirus vaccine jointly developed with Oxford University in the UK. He said he is likely to conduct clinical trials. Bloomberg reported.

Sorio, CEO of AstraZeneca, a major British pharmaceutical company, said yesterday in an additional global clinical trial to evaluate the efficacy of the new coronavirus vaccine, which is being jointly developed with Oxford University in the UK. Said that it is likely to be implemented. Bloomberg reported.

According to the interim results of the clinical trial (clinical trial) of the new corona vaccine announced by AstraZeneca on the 23rd, the efficacy rate is 90% when half the dose is administered first and the full dose is administered at least one month apart. The effective rate of 62% was exceeded when the total dose was administered twice as planned. According to vaccine developers, it was “serendipity” that gave half the dose the first time.

In response, some scientists have questioned the reliability of clinical trial results.

According to media reports, Solio CEO has announced that it will conduct a new clinical trial to further evaluate the efficacy of half the dose. “We have found a case that may be more effective and must be validated and require additional testing,” he said. Probably “it will be an international study, but we know it will be more effective. , This test can be conducted quickly with a small number of participants. ”

And while we don’t expect the additional study to delay approval by UK and European regulators, the US Food and Drug Administration (FDA) may approve the vaccine based on the results of clinical trials conducted outside the United States. He pointed out that approval in the United States may take some time due to its low level. Approval is expected within the year in some countries.

“There is only limited data release,” said Peter Openshaw, a professor of experimental medicine at Imperial College London, who said he had to wait for complete data and regulatory views. US and European regulators “may take different views,” he said

Experts are concerned that subgroup (specific layer) analysis showed the most promising 90% efficacy in clinical trials. “Subgroup analysis in randomized controlled trials is always difficult,” said Paul Hunter, a professor of medicine at the University of East Anglia.

Others have pointed out significant gaps in the data AstraZeneca has released so far. “We are trying to evaluate a very complex clinical trial design based on a few press releases,” said Danny Altman, a professor of immunology at Imperial College London.

The data released by AstraZeneca have little to be evaluated by scientists other than the featured efficacy rate, for example, how many infections occurred in the subgroup, two full-dose groups or a placebo (placebo) group. It is not clear how many people were infected.

“I get the impression that AstraZeneca is choosing the data,” said Morganne Bonsel of the Center National de la Recherche Scientifique.

Meanwhile, AstraZeneca said the half-dose dose was reviewed and approved by the Efficacy and Safety Assessment Committee (Independent Data Monitoring Committee) and the UK regulator, and the regulator publicly confirmed that there was no concern. explained.

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A spokeswoman for the company said in a press question, “We are evaluating the data and will discuss with the regulator the best approach for further evaluation,” and additional data “for submission to the authorities.” It will be added to the existing clinical trial data that we are preparing. ”

No comment was received from Oxford University.

The US FDA has not commented on AstraZeneca‘s vaccine trial. The European Medicines Agency (EMA) announced on the 26th that “if data on the efficacy and safety of vaccines are received from the company, we will evaluate them within a few weeks.”

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