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[Reuters]— Sorio, CEO of the British pharmaceutical giant AstraZeneca, added worldwide on the 26th to evaluate the efficacy of the new coronavirus vaccine, which is being developed jointly with the University of Oxford in the United Kingdom. A clinical trial is very likely to take place. Bloomberg reported.
Based on interim results of the clinical trial (clinical study) of the new corona vaccine announced by AstraZeneca on day 23, the efficacy rate is 90% when half the amount is administered first and the full amount is administered with at least one month difference. , The effective rate exceeded 62% when the total amount was administered twice as planned. According to a person involved in the development of the vaccine, it was “coincidence” that he was given half the dose the first time.
In response, some scientists questioned the reliability of the trial results.
According to media reports, CEO Sorio has announced that he will conduct a new test to further evaluate the efficacy of half the dose. “We have found a case that may be more effective and needs to be verified and requires additional testing,” he said. It will probably “be an international study, but we know it will be more effective.” This test can be done quickly with a small number of participants. “
Additionally, while we do not expect this 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. made outside the United States. He noted 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, professor of experimental medicine at Imperial College London, who said he had to wait for full data and regulatory opinions. US and European regulators “may have different points of view,” he said.
Experts are concerned that subgroup analysis (specific layer) showed the most promising 90% efficacy in the trial. “Subgroup analysis in randomized controlled trials is always difficult,” said Paul Hunter, professor of medicine at the University of East Anglia.
Others have pointed to significant gaps in the data AstraZeneca has published so far. “We are trying to evaluate a very complex clinical trial design based on some press releases,” said Danny Altman, professor of immunology at Imperial College London.
The data published by AstraZeneca has little to be evaluated by scientists other than the main efficacy rate, for example, how many infections occurred in the subgroup, two full dose groups, and the placebo group (fake). It is not clear how many people were infected.
“I have the impression that Astra Zeneca is choosing the data,” said Morganne Bonsel of the French National Center for Scientific Research.
Meanwhile, AstraZeneca said the half-dose administration was reviewed and approved by the Safety and Efficacy Evaluation Committee (Independent Data Monitoring Committee) and the UK regulator, with the regulator publicly confirming that there was “no concern” . explained.
The company spokesperson 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 “to present to authorities.” It will be added to the existing clinical trial data that we are preparing. “
No comments were received from the University of Oxford.
The US FDA has not commented on the AstraZeneca vaccine trial. The European Pharmaceutical Agency (EMA) announced on the 26th that “if the data on the efficacy and safety of the vaccine come from the company, it will be evaluated within a few weeks.”
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