Safety of mRNA vaccines administered during the initial 6 months of the US COVID-19 vaccination programme: an observational study of reports to the Vaccine Adverse Event Reporting System and v-safe The Lancet, March 7, 2022.
The CDC published the above paper in The Lancet on March 7, 2022. The legacy media immediately promoted the study as documenting that the vaccines are safe and effective. With severe side effects being of short duration and rare.
I began reading this paper with my usual wary eye, and what jumped out at me was that the conclusions reached by the legacy media did not match what I, as a trained physician and scientist, found important. As is often the case. Because they are journalists, not scientists. Please remind me, why are we relying on/allowing them to interpret science when they are not trained for this?. In any case, here are some of the headlines from the main stream media:
THE LANCET INFECTIOUS DISEASES: Large U.S. study confirms most mRNA COVID-19 vaccine side effects are mild and temporary
Huge study finds most COVID-19 vaccine side effects were mild for Pfizer-BioNTech and Moderna (USA Today)
Side Effects of COVID mRNA Vaccines Are Mild and Short, Large Study Confirms (Medscape)
No link between Covid vaccine and deaths, says major US study Just 4,500 people died out of the 298 million vaccines considered in the study (Evening Standard)
Wait, let’s back up a bit here and do our own due diligence and thinking! The Lancet paper documents the percent of severe adverse events (6.6%), compared to non-severe adverse events (92.1%). BTW - death was a separate category determined to be around 1.3% of all adverse events. So, what does this mean? A severe event ratio (including death) of 7.9% of all reported adverse events is high - very high! That means that about 1 in 13 people has a severe adverse event out of all adverse events reported, as defined by the VAERS system (quote from the Lancet paper below):
“VAERS reports were classified as serious if any of the following outcomes were documented: inpatient hospitalisation, prolongation of hospitalisation, permanent disability, life-threatening illness, congenital anomaly or birth defect, or death.”
One out of every eight reported adverse events were classified as serious! But “somehow” what the Medscape Headline concludes is that the side effects are “mild and short.” This is just not accurate.
But let’s dig deeper. One has to look at the actual numbers of people affected by adverse events. Not just at the percentage points of the various adverse events. So, let’s take a look under the hood and figure out what this all means.
First there are many caveats to this paper. This data is only for the first six months after the vaccine roll out, so no children and almost no teens were vaccinated during this period (the 15-18 year old age range began to get vaccinated around May, 2021, but the data analysis started January and ends June 2021). Why the cut-off at six months? There are now data that extend for 14 months, and those data include children.
There is an issue with the literature search as presented. By using too many search words, highly technical and long phrases, the search did not yield many papers that discus the health impact they were searching for (“BNT162b2” OR “mRNA-1273” OR “mRNA COVID-19 vaccine”) AND (“reactogenicity” OR “side-effects” OR “adverse effects” OR “health impact”). For instance, a search done in January, 2022 by my team had many peer reviewed papers that discussed the health impacts of these vaccines that the authors evidently did not discover, based on their following statement:
Among 429 results, few publications described health impacts following vaccination by BNT162b2 (Pfizer-BioNTech) or mRNA-1273 (Moderna). Available literature included reports of manufacturer-sponsored phase 1–3 clinical trials, observational and cross-sectional studies among specific groups (eg, transplant recipients or employees of a specific health-care system), and reviews or society recommendations that discussed reactogenicity and adverse events following mRNA vaccination
Then, there are issues regarding conflict of interest of the authors. The authors are CDC employees. As we have recently been warned from the New York Times, the CDC is now a political organization that has been hiding data from physicians, public health officers, and the public. They have been supporting what the executive branch wants to hear, by publishing that which they feel fits that narrative that vaccines are “safe and effective”. You know, not publishing data - so as to avoid “vaccine hesitancy.” As such, each and every author on the publication has a significant conflict of interest. This is a big red flag.
Next, we have very good documentation that the VAERS system, which is the vaccine injuries national system for tracking injuries, traditionally undercounts the actual adverse events by a wide range, depending on vaccine type and/or adverse event. this is because the VAERS system is not a mandatory reporting system. I found one study of various vaccine adverse events using the VAERS system that showed a rate of about 50% of vaccines adverse events are under reported, with a large variability range. Other studies report a much higher under-reporting rate, but going with 50% is probably a good, conservative number. This means that whatever data is presented by the VAERS system, most likely represents an undercount of at least half of the cases.
Or… at least that is what would have been my estimate until the Cell paper titled Immune imprinting, breadth of variant recognition, and germinal center response in human SARS-CoV-2 infection and vaccination, came out showing that the synthetic mRNA hangs around in the lymph node germinal centers for at least 60 days – and continue to produce spike protein as well as spike protein antigen, for at least that duration of time. Physicians and medical professions have been informed by the CDC and the FDA that the side effects of the vaccine occur within a short time frame after vaccination. The FDA has stated that the mRNA degrades rapidly. So, adverse events (such as myocarditis) outside of the time limits imposed by the VAERS reporting system do not get recorded. There is a good likelihood that the adverse events and deaths reported to the VAERS system grossly under estimates these events, as event reporting is time limited. More studies will have to be conducted, but clearly the VAERS system only works if adverse events are reported. If vaccine related events are happening two months out, as the data from the Cell paper suggest may well be the case, we really don’t have any idea of what the adverse event rate is.
So, what are some of the highlights from Lancet paper, using the VAERs data for the first six months of vaccine administration:
Frequency of reports of death are 1 in 66,666 for EACH dose administered. That is, 15 deaths per one million doses administered. For two doses, the risk is much higher - as risk actually increases with each dose. The risk would be at least doubled, IMO. By three doses, the risk would be much higher. At least tripled, IMO.
Frequency of adverse events: 1 in 953 for EACH dose administered. For two doses, the risk is much higher - as risk actually increases with each dose. The risk would be at least doubled, IMO. By three doses, the risk would be much higher. At least tripled, IMO.
Frequency of severe adverse events (“inpatient hospitalisation, prolongation of hospitalisation, permanent disability, life-threatening illness, congenital anomaly or birth defect, or death”) is 1 in 11,056 for EACH dose administered. For two doses, the risk is much higher - as risk actually increases with each dose. The risk would be at least doubled, IMO. By three doses, the risk would be much higher. At least tripled, IMO.
Because this vaccine is being administered to hundreds of millions of people, this is an unacceptable risk for the young and healthy, as this is a disease of those with co-morbidities and elderly. The USA is still discussing mandating the vaccine to school aged children, please stop and think about these adverse event numbers.
BTW - for brevity, I am skipping data from many of the tables- data which show percentage and types of adverse events. Please go to the paper and read it. The adverse event list is quite varied.
This data for the first six months of the vaccine roll-out are skewed, as this manuscript doesn’t report all age cohorts, and the adverse events reported in the VAERS are grossly under reported, as discussed above.
Next the paper sought to use the V-safe survey system to determine quality of life issues after vaccination. The V-safe survey system revealed that 26% were unable to do normal activities and 16% were unable to work after vaccination.
Again, we now have Omicron. So, vaccinating for a mild cold in the healthy, young person versus loss of significant quality of life issues, even in the short term, is unacceptable. 99.5% of the cases in the USA are now the Omicron variant, per the CDC. We know that for most healthy people, Omicron is nothing more than a cold and for the young, is usually very mild cold – or often asymptomatic. To use a gene therapy technology-based vaccine with a high-risk profile and uncharacterized long term effects against a mild variant is the height of scientific ignorance and arrogance. It is time to stop.
Finally, the discussion at the end of the paper is misleading at best. The authors state that there is no pattern to heart related deaths after analysis by the authors. The methodology or data from that analysis, if there was actually such an analysis, is not presented in the paper. THERE IS NO ANALYSIS PRESENTED. THIS ANALYSIS DOES NOT INCLUDE CHILDREN or adolescents. The risk of myocarditis to young men is much higher – we know this. The Hong Kong data shows 1 in 2700 in boys.
Frankly, the CDC is again obfuscating the data to suit their own political agenda. And “The Lancet” is letting the CDC get away with yet more propaganda cloaked as semi-science. This is unacceptable.
Is there not ONE reporter in MSM that is aware of this? I'd like to see just one of these prominent reporters go off on their own and do a piece uncovering all of this. They might just get a Pulitzer Prize. Is there not just one that has the courage? I always tell you this, Dr. Malone - God bless you for your courageous fight to tell the truth. I am in awe of you and pray that one day, I will be blessed enough to shake your hand.
Dr. Malone, with all due respect, the time to have stopped this was before it started. The orginal trial results screamed STOP! But the FDA and CDC colluded to hide that data until it was recently revealed.
Second, the Lancet reviewers are not letting the CDC "get away" with anything. THEY'RE COMPLICIT! Don't forget the paper that miraculously got past what is supposed to be a rigorous review process and smashed HCQ as an early treatment game changer. No Sir! This is not turning a blind eye. It is willful. It is criminal. It is accessory after the fact and It's a cover up! And they're doing it because to do anything else would be an admission of guilt!