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November 23, 2020, AstraZeneta UK published interim data on population protection in the COV002/COV003 study of Phase 3 clinical trials developed by Oxford University in the UK and Brazil, showing that the population protection of its adenovirus vector vaccine AZD1222 (ChAdOx1) was 70.4%.Of the 8,895 subjects who completed all two full doses, the vaccine was 62 per cent protected. Of the 2,741 subjects who were vaccinated twice but only half the dose for the first time, the vaccine was 90 per cent protected.AstraZeneta/Oxford University's vaccine results have left scientists wondering why there is still a half-dose, and AstraZeneta has not given an explanation. For why the first dose of half-time, the protection of the population of the vaccine is 90%, while the full dose of the vaccine of the population protection of only 62%, the researchers also said: can not explain the results.The New York Times published a weighty article on November 25th revealing the secrets behind the two issues;The article begins by pointing out that astraZenecon's COVID-19 vaccine, AZD1222, works better in half the dose of the inoculation group, which is the unintended result of mistakes made by the company in clinical trials, rather than intentionally.Menelas Pangalos, manager of AstraZeneta's research and development division, told Reuters on Monday that AstraZeneta had no plans to give any subjects only half the dose. But british research institutions and clinical trial contracting agencies miscalculated the dose, resulting in some subjects receiving only half the dose. After the agency discovered the error, the clinical trial agency conducted two doses of vaccination.In an interview with the New York Times on Wednesday, Pangalos said the mistake was not put at anyone's risk, but rather "blessed by disaster". Upon discovery of this error, the company quickly corrected the error and consulted with the Pharmacy to conduct a summary analysis of all results (half dose/full dose).He also noted that the company did not disclose the error in the trial because it felt it was "inno-free".Then, John Moore of Wellill Cornell, a prominent HIV vaccine expert, pointed out that AstraZeneta's announcement was vague and actually raised far more questions than it answered, and that it was now their responsibility to retest doses in clinical trials.Natalie Dean, a biostatist at the University of Florida, says the company's clinical trials lack transparency and strictness.For the second question, why the low-dose group is more effective than the high-dose group, Oxford University and AstraZenecom, the institutions that developed the vaccine, did not give an answer.But on Tuesday, American vaccine advocacy group Opera Warp Speed found that all of those who received half the dose of AstraZeneta were under the age of 55, the New York Times revealed.Pangalos acknowledges this. This may explain why half the dose group is better protected.It should be noted that AstraZeneta lacks experience in vaccine production and clinical trials. The clinical trial was called off in September after a subject had a serious adverse event in a vaccine clinical trial.The New York Times revealed a series of problems that could hamper FDA approval of the vaccine.Hanson explains:The New York Times has finally uncovered two confusing questions: 1, low doses in clinical trials, miscalculations by AstraZenecon and research and development institutions. 2, the low dose showed good results only because the subjects were younger; The point is, none of these issues were voluntarily disclosed by AstraZeneta! The news was a great surprise. For a big Company like AstraZeneta, it's just too bad! First of all, the calculation of the wrong dose, even as a blessing due to disaster. This time it's half the amount, what if it's double? Will it cause serious adverse events in the subjects? Then, found to give the wrong dose, but can think of this as "inno-free." This is a serious violation of the basic rules of clinical trials that are open and transparent and cannot be changed at will. AstraZeneta really doesn't take the rigours of clinical trials seriously. Finally, publicize bad things as good things and hide them deliberately. AstraZeneta's boasting of its unexpected 90 per cent high-prevention effect was false; AstraZeneta did not voluntarily disclose the results due to the younger results of the group of subjects until they were discovered by a third party. Such obvious basic information is not disclosed, whether the level of scientific research is not good, or deliberate deception. The most basic requirements of clinical trials are: the protection of subjects' ethics and the science of verifying effectiveness. The vaccine incident reflects AstraZeneta's disregard for the ethics of subjects at risk and for the rigorous and transparent science of clinical trials. That's disappointing! (
Hanson Clinical Research
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