A PUBLISHED STUDY about Serious adverse events post Pfizer and Moderna vaccines

https://www.sciencedirect.com/science/article/pii/S0264410X22010283

WHOA DOGGIES!  We have a study done on this that was published!  The findings here were quite interesting.

Pfizer and Moderna mRNA COVID-19 vaccines were associated with an excess risk of serious adverse events of special interest of 10.1 and 15.1 per 10,000 vaccinated over placebo.  Combined, the mRNA vaccines were associated with an excess risk of serious adverse events of special interest of 12.5 per 10,000 vaccinated (95 % CI 2.1 to 22.9); risk ratio 1.43 (95 % CI 1.07 to 1.92). The Pfizer trial exhibited a 36 % higher risk of serious adverse events in the vaccine group.  The Moderna trial exhibited a 6 % higher risk of serious adverse events in the vaccine group: risk difference 7.1 per 10,000.  Combined, there was a 16 % higher risk of serious adverse events in mRNA vaccine recipients.

“The excess risk of serious adverse events found in our study points to the need for formal harm-benefit analyses, particularly those that are stratified according to risk of serious COVID-19 outcomes. These analyses will require public release of participant level datasets.”  THIS IS CALLING FOR PUBLIC RELEASE OF ALL TRIAL DATA so that INFORMED CONSENT can be given.  This is huge.

In the Pfizer trial, 52 serious AESI (27.7 per 10,000) were reported in the vaccine group and 33 (17.6 per 10,000) in the placebo group. This difference corresponds to a 57 % higher risk of serious AESI and a risk difference of 10.1 serious AESI per 10,000 vaccinated participants.

Read that again.  IN THE VACCINE TRIAL, 52 vaxxed had a serious AESI versus only 33 placebo patients………the vaccinated trial participants did WORSE than placebo!  Moderna was the same…….see below.

In the Moderna trial, 87 serious AESI (57.3 per 10,000) were reported in the vaccine group and 64 (42.2 per 10,000) in the placebo group. This difference corresponds to a 36 % higher risk of serious AESI and a risk difference of 15.1 serious AESI per 10,000 vaccinated participants .

Combining the trials, there was a 43 % higher risk of serious and a risk difference of 12.5 serious AESI per 10,000 vaccinated participants.  Cardiac disorders have been of central concern for mRNA vaccines; in the Pfizer trial more cardiovascular AESIs occurred in the vaccine group than in the placebo group, but in the Moderna trial the groups differed by only 1 case.

Our study has several important limitations. First, Pfizer’s trial did not report SAEs occurring past 1 month after dose 2. This reporting threshold may have led to an undercounting of serious AESIs in the Pfizer trial. Second, for both studies, the limited follow up time prevented an analysis of harm-benefit over a longer period. Third, all SAEs in our analysis met the regulatory definition of a serious adverse event, but many adverse event types which a patient may themselves judge as serious may not meet this regulatory threshold. Fourth, decisions about which SAEs to include or exclude as AESIs requires subjective, clinical judgements in the absence of detailed clinical information about the actual SAEs. We encourage third party replication of our study, with access to complete SAE case narratives, to determine the degree to which these decisions affected our findings.

A fifth important limitation is our lack of access to individual participant data, which forced us to use a conservative adjustment to the standard errors.  AESI’s  calculated are therefore only approximate because we do not know which patients had multiple events. Finally, as described above, in the Moderna analysis, the SAEs that were sequelae of serious COVID-19 could not be identified and therefore remain included in our calculations. Because the vaccines prevent SAEs from COVID-19 while adding SAE risks of their own, this inclusion makes it impossible to separately estimate SAEs due to the vaccine from SAEs due to COVID-19 in the available Moderna data, as must be done to extrapolate harm-benefit to other populations. These study limitations all stem from the fact that the raw data from COVID-19 vaccine clinical trials are not publicly available.

Take home message here:  The data is not publicly available, raw data is not available for research, the trial data terms were brief (1-2 months) and long term data was either not collected or it is not released.

Drip Drip Drip as the fraud begins to trickle out………..