CDC: "safety of vaccines reinforced": UNPACKED

8 Nov 2021

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Unpacked

On 28 Oct 2021 a brand new pre-print paper was released by the CDC response team. The CDC themselves advertise it stating "it reinforces the safety of Covid vaccines". The pre-print paper has not yet been peer-reviewed.

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The CDC used VAERS data to make the claim that "the safety of Covid vaccines is reinforced". 

The CDC also advise that VAERS reports cannot be used to determine if a vaccine caused or contributed to an adverse event. That is, VAERS data can't infer causation. The CDC have however, used used VAERS data in this study to infer safety.

The CDC used the VAERS data to make the claim that the safety of Covid vaccines is reinforced. Their claim appears counter-intuitive when their VAERS data is graphed (see below graph for deaths reported after vaccinations). The CDC study ended in June '21. However the data till the end of '21 year, along with all reports from all other years from all vaccines, is compared below.

There have been over 18,000 vaccine death reports during 2021 which is orders of magnitude above previous years.

OpenVAERSdataNov21.png

Why is there such a discrepancy between the CDC safety claim and the 18,000 deaths reported following vaccination?

The reason, says the CDC, is that "during the study period, all Covid vaccines were administered under emergency use authorisations (EUAs), which require vaccine providers to report serious safety events that follow vaccination to VAERS. Heightened public awareness of the Covid vaccination program, outreach and education to healthcare providers and hospitals about Covid EUA adverse event reporting requirements, and adherence to EUA reporting requirements by providers and health systems, are likely contributing to the high volume of VAERS reports following mRNA vaccination."

The paper used VAERS* data to assess mortality rates to ascertain vaccine safety. When we visually view the data CDC used, it does not appear safe.  

*VAERS = Vaccine Adverse Event Reporting System.  The data collected in VAERS is presented more clearly at OpenVAERS.com.

 This contrasts visually with the raw OpenVAERS data of vaccine deaths p.a. plotted below.

** UNPACKED **

a) The paper is a pre-print and has not yet undergone peer-review so should "not be used to guide clinical practise". I personally have no objection to giving some weight to pre-prints. However, the hypocrisy starts when other pre-print papers written by CDC scientists are shot down in flames because they do not espouse the same world view as the reader. For example, this paper which shows that both infected vaccinated and unvaccinated people shed the same viral load has been ridiculed. https://www.medrxiv.org/.../2021.09.28.21264262v2.full-text

b) The paper uses the same VAERs data that we are told cannot be used to infer causation due to bias. Yet, the CDC uses it to reinforce the safety profile of vaccines. They can't have it both ways. I personally have no objection to analysing VAERs data as it is a good for detecting safety signals and in fact, that is the purpose of VAERs. It is VAERS that detected the huge number in post-vaccine deaths. However, every time raw VAERS data is shared a fact-checker pops up. It says there is no solid proof of injury or death and that the purpose of it is for the FDA to hope to spot groups of similar reports. The agencies can then investigate them to sort out coincidences from real side effects. (https://leadstories.com/.../fact-check-vaers-reports-are...)

No such investigation has been done by the FDA, nor in this science paper. It simply re-uses VAERS data. There is no randomised controlled trial. There is no observational trials. *Only* VAERS data was used. If this is good for the goose, it is good for the gander and the hypocrisy is blatant.

(VAERS = The American Vaccine Adverse Event Reporting System).

c) The CDC summary says most reports were not serious and side effects were mild and short-lived. Nobody is denying that. Most reports are just a sore arm. However, their statement is sweeping and misleading as it downplays the seriousness of the adverse reactions that are reported, including nearly 18,000 deaths reported.

d) The CDC states that vaccines are the most effective tool to prevent severe illness. This is true on an individual basis for 3-6 months after being fully vaccinated. On a population level, it is suggested vaccinations increase the amount of cases in the population ref https://link.springer.com/.../10.1007%2Fs10654-021-00808-7

e) In the paper's review of VAERS death reports, no unusual patterns in cause of death were found.

Yet, to the ordinary eye, there is a clear signal of death reports compared to previous years (shown in the VAERS graph in main image).

The number of doses given at six months was almost the same as the number of total annual doses of other vaccines given: about 300,000. So in the sense of dose numbers given, the visual signal is in proportion.

The paper however, did not use the comparison of death reports to previous years. They explain that the reason is that for the Covid vaccine, deaths following vaccination are REQUIRED to be reported whether it seems likely the death was related to the vaccine or not. Therefore, a higher reporting rate of deaths is expected.

Dismissing this signal bears several flaws:

First and foremost, if deaths from previous years are much higher because they are not required to be reported, this should raise concerns about other vaccines' safety rather than reassuring us about the Covid vaccine. It is already established that less than 1%-13% of serious drug adverse events are reported to the FDA (https://openvaers.com/.../r18hs017045-lazarus-final...) (the number is 5% in NZ).

It is quite possible that not every post vaccine Covid death is being reported and we may in fact be seeing under-reporting rather than over-reporting.

Most European countries, the UK and many other countries have similar patterns of deaths being reported following vaccinations. These countries have no such legal requirement to make a report.

There is no evidence that all US authorities report all deaths after vaccination to VAERS despite this being a federally mandated procedure. To think all physicians spend at least half an hour filling in death reports for every deceased patient, for an undefined period of time after death, even if they do not suspect the death is related to the vaccine, is naive at best. Statistics alone tell us this is not happening.

The all cause mortality rate in America is approximately 0.86%. The number of people receiving two doses was at least 150,000,000 (assuming a two dose course totalling 300,000,000 doses). We would expect an all cause mortality total of approximately 1,290,000 death reports in this six month period if the rules were strictly adhered to. Yet the actual reported deaths at six months (in this study) was 4,472. Clearly, the mandated reporting regardless of cause of death or time period was not at all being adhered to. Therefore the claim that reports were over-reported is baseless.

Instead of using previous years' data to make a comparison of death rates, the paper estimated normal all cause mortality rates to see if the number of reported deaths exceeds that.

In order for reported deaths to exceed that in a statistically significant and meaningful way, *every single* post vaccine death would need to have been reliably collected. Then we could compare the number of deaths reported with previous years.

We have already ascertained that the reported death rate of 4,472 is woefully short of the normal all cause mortality of 1,290,000. Under-reporting is obvious. With this data, we cannot measure if the vaccine is causing extra deaths. We would actually need.

It's a case of these researchers getting so lost in their data they can no longer see the big picture. They can't see the woods for the trees.

If we assume that each of these 4,472 deaths was caused by the vaccine, then out of 150,000,000 people, the death rate is rare: (.003% or one death in 3,333 fully dosed people).

Yet, the results of the study clearly says "Analysis of deaths reported to VAERS demonstrated lower than expected reported mortality rates compared with background mortality rates."

What did they expect? They don't say what they expected. Given their guidelines, that all deaths are to be reported, it sounds like they expected 1,290,000 death reports to be filed. What they are saying is that 4,472 deaths is less than 1,290,000 expected deaths, so there is nothing to see here. Move along.

It doesn't take a rocket scientist to see that this proves nothing.

What they should do is look at the signal of deaths compared to previous years and declare a safety signal, just as they did for the Swine Flu vaccine - which they pulled from the market after just 50 deaths.

The paper refers back to the clinical trials that showed the vaccine had an acceptable safety profile. The (Pfizer) clinical trials had about 18,000 vaccine recipients (in the experimental group). If death was going to be detected as a rare adverse event, it would only be detected if the deaths numbers were with a 95% confidence interval, statistically significant.

If all 4,472 deaths were a genuine vaccine-related death, then out of 1,290,000 people, that is a death rate of .003% or one person in 3,333.

If the actual vaccine death rate was, say, 1:33,000, a trial with 18,000 would not detect it. It would only be about .54 of a person more than the control group. It would need a much larger sample size to be statistically significant. (In the trial there were three deaths in the placebo group and two in the vaccine group https://www.nejm.org/doi/full/10.1056/nejmoa2035389)

ASIDE

*** I would be grateful if any enthusiastic or retired statistician (teacher or otherwise) is able to do the exact calculations on this. The exact question is this: Assuming an all cause mortality rate of .86%, what population sample size would be necessary in a randomised controlled trial to detect if an excess death rate of 0.003% is statistically significant? *** I bet it is more than 18,000.

The question that should be asked, is if a very small chance of an event occurring, what sample size would be needed to detect whether the anomaly was significant.

In the paper, the temporal relationship between time after vaccination and death is apparent. It says it may represent a bias of reporting. But that is inconclusive because there has been no randomised controlled trial big enough to test it.

Finally, the paper says this "This study has several strengths, including the large population under surveillance and comprehensive capture of national data from two complementary surveillance systems." (it also looked at v-safe but there appeared no deaths in that data).

The point is, the population are under surveillance and we are the data. This is indeed an experimental vaccine.

CDC fb link: https://www.facebook.com/cdc/posts/247687184059394

Refs: CDC paper (https://www.medrxiv.org/.../2021.10.26.21265261v2.full-text)

VAERS data and graph: See "openvaers" dot com. Click on covid vaccine events reports and scroll down.