Posted on 10/21/2020 3:19:07 PM PDT by Diana in Wisconsin
A volunteer in AstraZeneca’s COVID-19 vaccine trial died in Brazil, the country’s health authority confirmed Wednesday.
Anvisa, the authority, said it wouldn’t stop the CCP (Chinese Communist Party) virus vaccine trials for now and is investigating the death.
The volunteer died on Oct. 15 but Anvisa was informed of the death on Monday, the health authority said in a news release. In a statement, Anvisa said that “based on the ethical confidentiality commitments provided for in the protocol, the regulatory agencies involved received partial data related to the investigation carried out by this committee [and] they suggested to continue the study.”
An investigation is currently ongoing. No information was provided about the volunteer.
The health authority noted that “data on clinical research volunteers must be kept confidential, in accordance with the principles of confidentiality, human dignity, and protection of participants,” according to a news release.
The Federal University of Sao Paulo, which is helping coordinate trials in Brazil, told Reuters the volunteer was a Brazilian national.
It’s not clear whether the volunteer received the placebo shot or the vaccine.
AstraZeneca told news outlets on Wednesday that the vaccine trial would continue.
“We cannot comment on individual cases in an ongoing trial of the Oxford vaccine as we adhere strictly to medical confidentiality and clinical trial regulations, but we can confirm that all required review processes have been followed,” the statement said. “All significant medical events are carefully assessed by trial investigators, an independent safety monitoring committee and the regulatory authorities. These assessments have not led to any concerns about continuation of the ongoing study.”
Oxford University, which is also helping with the trial, confirmed the plan to keep testing, saying “there have been no concerns about [the] safety of the clinical trial,” Reuters reported. “The independent review in addition to the Brazilian regulator have recommended that the trial should continue,” Oxford spokesperson Alexander Buxton added, according to CNBC.
Brazil has reported that more than 154,000 people were killed by COVID-19, and more than 5.2 million people have been infected.
The Food and Drug Administration placed a late-stage clinical trial from AstraZeneca on hold in the United States, which means the pharmaceutical giant cannot administer second doses of its two-dose vaccine regimen to American volunteers.
It came after AstraZeneca said on Sept. 8 that its vaccine trial was placed on hold due to an illness in a patient in the United Kingdom. The trial has since resumed in the UK and other countries.
AstraZeneca is one of four companies backed by the United States to carry out late-stage testing for a possible vaccine.
So it may end up being worse than the disease itself?
That’s not good.
I’m reading elsewhere that the person who died was taking the placebo.
“””the regulatory agencies involved received partial data related to the investigation carried out by this committee”””
When a ‘committee’ is in charge we all know a coverup is happening.
OK, put poison in the ‘placebo’, and kill them.
Now the results are: Everyone who did not get the real stuff died.
“It’s not clear whether the volunteer received the placebo shot or the vaccine.”
Any time a subject dies or has a serious health event in a clinical trial, the trial will be put on what’s called clinical hold. That includes even control group. It includes anything, for example death in a car crash.
If it is determined the death or serious event is not associated with the test drug, generally the trial can continue.
Based on other things I have read, and this article it does appear that this patient received the placebo. And a placebo is nothing more than sterile saline — no poisons in that.
Not sure. It is, however, a dandy pretext for continuing the various lockdowns and the idiotic mask mandates for an indefinite period of time -- in other words, forever.
They might as well give up on the vaccine now.
I would expect them to say that.
Brazil...3rd world country, enough said
Everybody dies.
When A Drug Trial Goes Wrong: Emergency At The Hospital (Medical Documentary) | Real Stories
https://www.youtube.com/watch?v=a9_sX93RHOk
One out of 30,000 trial participants. Even if the person was in the vaccine group, unrelated illnesses or even deaths are quite possible in such a large group. Meanwhile one out 1,500 Americans have died of COVID. It’s good that trials are so critical of adverse events. But folks should keep them in perspective.
It's also not clear from the article what the volunteer died from (unless I missed that). Maybe he died from an auto accident or influenza.
In a town of 30,000 people, on average, 1 person will die every day. That equates to an 82 year life expectancy. This trial included 30,000 people and has been going on for over 2 months and has had 1 death. Even in a generally healthy population, that’s not unexpected. People die. All of us.
Source: CDC National Center for Health Statistics
Is this the trial you are referring to? "Phase III Double-blind, Placebo-controlled Study of AZD1222 for the Prevention of COVID-19 in Adults."
It says "Not yet recruiting," but it also says 30,000 participants age 18 and older with these key dates:
Estimated Study Start Date: August 17, 2020
Estimated Primary Completion Date: December 2, 2020
Estimated Study Completion Date: October 5, 2022
If it started on schedule, they are about two months into it.
If you exclude U.S. infant mortality, the overall mortality rate would be less than the 863.8 cited above. Even at that mortality rate for all ages, one death in two months in a population of 30,000 is WAY below the 43 that would be expected for all causes. (did I goof up my calculations?)
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