- World Health Organization
We are deeply concerned that possible data manipulations during clinical trials by AstraZeneca can reduce worldwide confidence in vaccines and jeopardize lives around the world. We believe that only full transparency and detailed answers to the following questions can reduce the damage already done through manipulative and inaccurate clinical trial disclosures from AstraZeneca:
1. The original protocol of clinical trials do not mention any half dose regimen. Executive Vice President of AstraZeneca Mene Pangalos told Reuters “It was a mistake.” When and how did the mistake occur? Did 2,741 patients receive a half dose regimen by mistake? Were there any other dosing mistakes?
2. The dose of AstraZeneca Plc’s Covid vaccine that showed the highest level of effectiveness was tested in a younger population than a bigger dose that showed less efficacy, according to the head of the U.S. Operation Warp Speed program Moncef Slaoui. Why was this not disclosed in the AstraZeneca release? Were there other differences in the demographic characteristics of half dose and full dose cohorts?
3. Why would a half dose regimen produce better results than a full dose? Why were the dosing studies not finalized as they should have been in the standard practices of Phase 2 clinical trials?
4. “I don’t believe that the FDA will look positively at any trial where the dose, or the age cohorts, or any other variable were changed mid-trial, inadvertently or deliberately,” said Geoffrey Porges, an SVB Leerink analyst who predicted Monday that the U.S. Food and Drug administration would not clear the vaccine. So, will AstraZeneca apply for the approval of a half dose or full dose regimen? If full dose, then the current efficacy of 62% is the only one that can be disclosed? If a half dose, then new clinical trials will need to be started. When will they start and how many volunteers will it involve?
5. There is no mention of chimpanzee adenoviral vectors in the AstraZeneca release. The world needs to know that AstraZeneca is the only company in the world that is using animal viruses in its vaccines and no long term studies of the safety of such approaches have been conducted. "This is a unique situation where we as a company simply cannot take the risk if in ... four years the vaccine is showing side effects," Ruud Dobber, a member of Astra's senior executive team, told Reuters. When will long term effects of the chimpanzee adenoviral vaccine be studied and presented to the public?
6. AstraZeneca shifted all of the legal risks of the vaccine on purchasing countries by forcing them to ensure full compensation of AstraZeneca for all damages. Will AstraZeneca agree to share legal risks if obvious mistakes in clinical trials lead to negative consequences and human lives lost?
7. There have been at least two severe cases of possible autoimmune diseases during AstraZeneca clinical trials. When will the full information of these cases be disclosed to regulators all over the world? When will this information be disclosed to the public?
With this petition, we all demand to Suspend the tests of the AD 1222 vaccine by the AstraZeneca pharmaceutical company, which has already led to human casualties. The company has been found guilty of frauds and systematic non-disclosure of data on their research progress in the past.
The We want to live! petition to World Health Organization was written by Hariti Sastry and is in the category Human Rights at GoPetition.