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Questions are raised about the data on the experimental AstraZeneca coronavirus vaccine developed by the University of Oxford.
According to the Financial Times, the University of Oxford has acknowledged that an error inevitably led to different doses in a volunteer section. The latest development has sparked reactions to the way the university and pharmaceutical company managed and presented the first analysis of clinical trials.
The results were accepted as successful, showing an average efficiency of 70%, a number that was achieved by the pool the results of sets of two different dosing regimens. While one group of volunteers received two identical doses over a period of one month, the other group received half a dose and then a “full” dose.
On Wednesday, the University of Oxford recognized the difference in the construction and measurement process, which resulted in the accidental administration of half a dose to a percentage of volunteers. One of the volunteers who spoke to FT said that he had been informed of the error in July.
The company presented different percentages by subgroup, with the first group having the highest immunity at 62% and the second at 90%. As it turned out, administration of “half” doses started with an error. The “half” doses were given to fewer volunteers than those who received two full doses, “making the discovery of greater efficacy seem like a random result.”
Younger ages
Yesterday, however, Operation Warp Speed boss Moncef Slaoui revealed that the second subgroup with the highest efficiency rate included only volunteers up to 55 years of age that is, a demographic group with a lower risk of developing severe Covid-19.
Oxford University and AstraZeneca did not release age data on Monday when they released the results. “There are many variables that we must understand,” Slaoui said. It’s still possible that the efficiency difference was accidental, he adds.
Stock drop
Markets reacted to the latest development and AstraZeneca shares down 6%. On the other hand, the shares of Pfizer and BioNTech rose 6% and 14% respectively after the announcement of an effective vaccine of more than 90%. Moderna has also seen an 11% rise in stocks after its own shot.
Landscaping results? Difficult to pass in the US
SVB Leerink analyst Geoffrey Porges says the AstraZeneca product is unlikely to be approved in the United States after the company tried to “beautify” the results, emphasizing the increased efficiency in a “relatively small subset of test volunteers. “.
John LaMattina, former head of Pfizer’s global research and development division, said in a tweet that it was “hard to believe” that US regulators would briefly approve a vaccine. the “ideal dose” was administered to only 2300 people during clinical trials.
It is recalled that in mid-August, the European Union had agreed with AstraZeneca to supply up to 400 million doses of the vaccine, in case the clinical trials were completed successfully.
In vaccines, the general rule of thumb is to give the lowest possible dose that is effective, but the different effects in the case of the AstraZeneca vaccine have not yet been explained. Oxford University professor Sarah Gilbert estimated that a lower starting dose can help the immune system in a way that better mimics a “natural infection.” but nevertheless there is no precedent for other vaccines thus administered.
“We don’t have all the information we need to see if these results are reliable,” said Natalie Dean, assistant professor of biostatistics at the University of Florida. “We certainly don’t have enough information to decide if half the dose really works.”
Concerns about other variants are also expressed in clinical trials. of the vaccine in different countries. Besides the dose, there were other differences and variables for the volunteers in the control groups. In the UK, those who did not receive actual doses received a meningococcal vaccine, while in Brazil, saline placebo.
All of these discrepancies lead many to hypothesize that the data are too heterogeneous to combine into a single convincing result.
For his part, a representative for AstraZeneca defended the results, saying the tests meet the highest standards. The company adds that more and more data will be collected for further analysis.
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