While the committee got nowhere on the choice of next boosters, there were a few very important reveals
By Meryl Nass, MD | April 10, 2022
Authorizing vaccine for the 6 months to 5 year old group was never mentioned. Can it be that FDA is finally grappling with the awful data, the longterm risks of vaccination, and will turn away from unleashing these vaccines on our youngest kids? Or is there simply too much money at stake, too many promised school mandates, too many done deals behind closed doors?
Important takeaways
1. Many members and presenters agreed that antibody levels (aka titers) are not a valid measure of immunity (they are not a correlate of protection, and there is currently NOTHING measurable in the blood that is considered a valid reflection of immunity). This admission is HUGE, as it reveals that neutralizing antibody titers can no longer be used to authorize or approve COVID vaccines.
2. Therefore the only way to determine vaccine effectiveness is a clinical trial.
3. No one at the meeting (nearly 30 people) ventured a guess as to what strain might cause the next COVID wave. All seemed to agree there would be another wave, but this was just a guess. However, without a variant you can’t make a vaccine and you can’t conduct a clinical trial to see if the vaccine works. And you can’t possibly do this by June, to make vaccine available for the fall, when FDA and the VRBPAC expect it will be needed.
4. Dr. Peter Marks, the director of the FDA’s vaccine division, CBER, admitted that the 4th booster dose authorized last week was a “stopgap measure”– in other words, he claims it was to kick the waning vaccine efficacy can down the road.
5. Claims were repeatedly made that vaccine still protects against severe outcomes and death, but FDA’s lead scientist for this presentation, Doran Fink, admitted that efficacy is also waning for severe outcomes. I’ll say it is.
6. NO data was presented at all regarding strain choice/prediction of what to use as the antigen(s) for a newer vaccine. It was as if everyone just got the idea to begin thinking about this yesterday.
7. It appeared that neither CDC, FDA nor the VRBPAC advisors wanted to take any initiative or responsibility in figuring out what kind of a vaccine comes next (with the exception of Dr. Kim, who did show initiative about prescribing a way forward). I am not sure any of them wanted to find a way forward.
8. Was everyone dancing around the strain/variant choice because in fact no one really wants a newer vaccine, or because no one wanted to be responsible for picking a loser? I could not tell whether this was a deliberate slow-roll as a means of squeezing out of the COVID vaccine disaster, or whether we were watching an agency and advisors who are highly risk-averse but have no problems with the vaccines.
9. The Public Comments from about 1:30 pm to 2:30 pm (about 5 hours into the meeting) were evidence of outstanding work by independent scientists and heart-rending testimonies by the vaccine injured. There were only 2 people who favored vaccines in the group, one a top Moderna scientist (Dr. Rita Das) who did not actually belong there… had FDA begged Moderna to find someone to speak in favor of boosters?
10. The word transparency was used a lot. Which was peculiar since FDA’s COVID vaccine data, deliberations and decisions have been anything but transparent. Even the reason for today’s meeting is murky.
The link below is to my live blog of the all day meeting.
https://live.childrenshealthdefense.org/admin/fda-advisory-committee/fullscreen-chat
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Of course, what the FDA needs to say, no doubt in some slowly unrolling, self-serving fashion, is that:
What they won’t way is that these vaccines sickened many thousands, or millions, and the US will now establish clinics to evaluate and treat the injured Americans who did what their government asked of them, cover their medical expenses and pay them disability.
PS. When the Japanese found that the HPV vaccines caused similar severe injuries, about 8 or 10 years ago, clinics were established to take care of the injured.
Liberty Counsel | April 8, 2022
The Fifth U.S. Circuit Court of Appeals ruled 2-1 yesterday to overturn the January injunction issued by a federal judge in Texas that blocked Joe Biden’s shot mandate that required all federal employees to receive the COVID shot or face termination.
Biden announced last September that more than 3.5 million federal workers were required to undergo vaccination, with no option to get regularly tested instead, unless they secured approved medical or religious exemptions.
Feds for Medical Freedom, which represents more than 700 border patrol agents, pilots, diplomats, firefighters, contractors, and other Americans, filed a lawsuit against the Biden administration on December 21, 2021, seeking preliminary and permanent injunctive relief from “enforcing or implementing the Federal Employee Mandate and the Contractor Mandate.”
In Feds for Medical Freedom v. Biden, U.S. District Court Judge Jeffrey Vincent Brown previously granted a preliminary injunction and wrote that the mandate would pose a substantial threat of irreparable harm over the “liberty interests of employees who must choose between violating a mandate of doubtful validity or consenting to an unwanted medical procedure that cannot be undone.”
Yesterday, the Court of Appeals said that Judge Brown did not have jurisdiction to block the mandate. The appeals court ruled that the parties failed to exhaust administrative remedies because they did not raise their claims through the Civil Service Reform Act of 1978. Federal workers facing adverse actions may appeal to an entity called the Merit Systems Protection Board, which decides whether the worker was properly disciplined. If the worker prevails, the board can order an agency to reinstate the worker or undertake other measures. The Court of Appeals noted that federal employees can then appeal to the District of Columbia Court of Appeals.
This case did not raise the Religious Freedom Restoration Act (RFRA), which does not require the exhaustion of administrative remedies and which allows litigation in any federal court. Liberty Counsel’s case involving federal employees, Federal Civilian Contractor Employer v. Carnahan, does raise RFRA. RFRA provides a powerful remedy and protection for federal employees who object to the COVID shots based on their religious beliefs. In fact, the mandate itself acknowledges that federal employees may request a religious accommodation from the shots.
Now Feds for Medical Freedom can ask the full Court of Appeals to review the matter and also request the Supreme Court to intervene. The case is far from over.
Liberty Counsel Founder and Chairman Mat Staver said, “This court decision by no means ends the case for federal employees. The case has a long way to go. While the Court of Appeals dodged the legal issues of the federal employee mandate, federal employees have a clear right to religious accommodation under the Religious Freedom Restoration Act. The mandate even acknowledges the fact that federal employees have religious free exercise rights. Under the mandate, and in accordance with the federal law, employees have the right to religious accommodation from the COVID shots.”
By Amanuensis | The Daily Sceptic | April 9, 2022
New Zealand is a fascinating country – amazing geography, likeable population, and, unlike its neighbour Australia, most of its wildlife isn’t planning on killing you at the slightest opportunity. It is also fascinating with respect to Covid because its population has a very high vaccination rate across all age groups (well, down to five), but up until recently there has been negligible natural immunity to Covid. Because of these two factors, New Zealand was always going to be of interest as soon as Covid arrived properly, if only to see how its vaccination efforts had protected its population.
For those who missed it, since the end of last year New Zealand has had a succession of Covid waves. These started small, but in the most recent wave, taking place during February and March, infection rates were enormous – if we had these infection rates in the U.K. we’d have peaked at approximately 350,000 cases per day (rather than around 200,000). What’s more, it looks like New Zealand exceeded its testing capacity during that wave, suggesting that peak infections were probably even higher. It is relevant to note that during February and March, New Zealand had over 90% of all the cases it has ever had and most of the rest occurred in January – prior to 2022 New Zealand reported very few Covid infections.
So much for the Covid vaccines protecting against infection – but what do the data look like in detail?
Cases
New Zealand is somewhat helpful in that it does publish daily cases, hospitalisations and deaths by vaccine status; somewhat because it doesn’t allow easy access to anything other than the current day’s report. Thankfully, the Wayback Machine ensures that at least some web pages aren’t forever lost to history. These data were collated for dates since mid February 2022 and smoothed with a seven-day moving average to create a time series of Covid cases by vaccine status.
The first time the above graph popped up on my computer screen I had to go and double check all the data sources – and then I triple checked them. The data shown on the graph are notable for several reasons:
The infections data from New Zealand allow us to estimate the vaccine effectiveness for the Covid vaccines in the absence of natural immunity.
These data are in contrast to recent data from the U.K., which show one and two doses of vaccine to have a VE of minus-50% to minus-100%, and the booster to have a VE of around minus-300%. While this sounds counterintuitive, it is possible that we’re seeing a complex interplay between a waning of the impact of the vaccine and the impact of additional vaccine doses:
In New Zealand, the timescales are very different: those given the booster dose will still be in the two-three month period where short-lived immune responses dominate; those given two doses will be in the proposed period of maximal vaccine negative impact; while those that chose not to accept the offer of a second vaccine dose will be in the period where vaccine effects are waning.
There’s one more point to add for cases in New Zealand, and it relates to the U.K. For months, the UKHSA has been telling us that one possible reason for us seeing far fewer cases in the unvaccinated compared with the vaccinated is because the unvaccinated have natural immunity following high infection rates previously (presumably because the unvaccinated are reckless and didn’t follow lockdown rules – I imagine that they also ride motorcycles too quickly, set off fireworks indoors and play with matches while filling up the car). These data from New Zealand, which at the time had very few individuals previously infected with Covid, show lower case rates in the unvaccinated without any significant levels of natural immunity, contradicting the claim of the UKHSA and eliminating one of its reasons for ignoring the alarming data.
Hospitalisations
Analysis of the hospitalisations data offered by the New Zealand authorities is made complex by there being no stratification of the hospitalisations by age group, and the lack of complete vaccinations data by age. However, U.K. data show that in recent weeks approximately 95% of hospitalisations were in those aged over 60; assuming that this will also hold true for the New Zealand population allows us to offer a indicative analysis of the likely impact for that age group of the vaccines on hospitalisations in the country.
The analysis is also hindered by the data on vaccine coverage for those aged over 60 not differentiating between those that have had only one dose of vaccine and those that are unvaccinated. This might in isolation from other data appear to be ‘sensible’ – after all, the single dosed have the ‘least protection’ as well as ‘the longest time for protection to wane’. However, the data shown in the previous section suggest that the unvaccinated and those having taken a single dose of vaccine are in no way comparable, and that considering them as a single group could lead to misleading conclusions. Nevertheless, that’s the hand that’s been dealt for us.
The data are somewhat surprising. While those given a booster dose of vaccine seem to have lower levels of hospitalisations than found in the group containing the unvaccinated and those given only one dose of vaccine – as might be expected – the double dosed have significantly higher hospitalisation rates.
Also interesting is the trend in the data:
It was not possible to properly disentangle the hospitalisations data for the unvaccinated, but the data suggest that in aggregate those having taken two or three doses of vaccine (when the two groups are put together) have approximately 45% lower risk of hospitalisation than the unvaccinated/single-dosed. It is worth noting that in the U.K. data we see higher hospitalisation rates in the single vaccinated in those aged over 60, compared with the unvaccinated. It is possible that the same pattern is found in New Zealand, only ‘covered up’ by the co-mingling of the data. If this is the case then the apparent protection offered by the vaccine in the two or three dose individuals will be somewhat lower than 45%.
Deaths
The mortality data from New Zealand are also complicated because the health authorities lump together into one group all the unvaccinated and those having taken a single dose of vaccine. Beyond that complication, deaths data can be tricky to analyse, because there are such huge differences in death rates from (or with) Covid by age. Fortunately, the mortality data offered by the New Zealand authorities do include deaths by age group, which allows a finer analysis than was possible with the infections and hospitalisations data.
The above table suggests that while those given three doses of vaccine have a decreased risk of death from (or with) Covid compared with the mortality rate in the strange group called ‘unvaccinated or one dose’, the risk of death is greatest in those given two doses of vaccine.
However, it is possible that New Zealand’s data have a similar pattern to that seen in the U.K. (and elsewhere), where dose effects are complicated by the health of those given each vaccine, namely that those closest to death were spared a dose of vaccine, and thus concentrated deaths into the very small number left in the prior dose group. A comparison of the data for ‘unvaccinated or one dose’ with ‘two or three doses’ suggests that the vaccines do still protect against death, but only to a very low degree in younger age groups.
The data above support the use of vaccination to protect against death from (or with) Covid for those aged over 80. On the other hand, the mortality rate in those aged under 60 is very low, and the estimated vaccine effectiveness in protecting against death for those aged under 80 is only approximately 30% – once again, the real-world vaccine effectiveness estimate is rather low. It is also of note that these rather poor figures for the protection offered by the vaccines against mortality come from a country that started vaccination rather late (summer 2021) and where most of the population were only given their booster doses two to three months ago. These data suggest that the vaccines simply do not offer substantive protection against death for newer Covid variants, rather than it simply being a case of waning vaccine protection.
It is also important to note that the data on the benefits of the vaccine in protecting against death shown above should be treated with caution:
Overall mortality
One other aspect of the data coming from New Zealand that is of interest relating to Covid is excess mortality. These data are of interest because New Zealand managed to keep itself more-or-less clear of Covid until the last few months of 2021, and even then case numbers were very low until 2022, with the result that Covid deaths were negligible prior to 2022. With that in mind, its excess death data between the start of 2020 and the end of 2021 are very interesting.
Many countries around the world had a peak in excess deaths in the first quarter of 2020, followed by a significant reduction in deaths into mid 2020. There has been speculation that this pattern was seen because Covid infections in early 2020 killed the most vulnerable, leaving a period in which there were fewer people left to die. However, New Zealand also has this pattern of excess deaths in the first half of 2020 (black data points in the graph above) without Covid infections, suggesting that the reduction in deaths seen in mid 2020 were a result of lockdown. The reason for the excess deaths in New Zealand in the first quarter of 2020 are not at all clear.
Most countries then saw an increase in deaths towards the end of 2020; this has been explained by a resurgence in Covid cases. However, New Zealand saw a similar pattern without Covid infections (red data points). It is possible that this increase was caused by the impact of the reduced healthcare provision during the extreme lockdown – though there are no data to support this supposition. There are reports that the New Zealand healthcare system experienced its busiest summer (January and February) on record with hospitals across the country reaching ‘crisis point’ and several emergency departments at capacity. The cause of this healthcare pressure is unclear, however.
Perhaps the most interesting data in the graph above are seen in 2021. During the first half of 2021 excess deaths slowly reduced from the high seen at the start of 2021 (green data points), perhaps a result of healthcare provision returning to normal. However, around mid-year the trend reversed and excess deaths started to climb again (purple data points). Again, it must be pointed out that there were very few Covid cases in New Zealand at this time, and negligible deaths. Just about the only unusual things occurring in the country at that time were a lack of international travel, restrictions in day-to-day activities for the population and an enormous mass vaccination campaign using novel, under-tested vaccines.
During 2020-2022, there were approximately 2,000 excess deaths in New Zealand, a significant number in a country with a population of five million. We don’t know the proportion that occurred because of lockdown, vaccines or something else; all that we do know is that they weren’t a result of Covid.
Note on data analysis methods. Infection, hospitalisation and mortality data were obtained from the New Zealand Ministry for Health (using Wayback Machine for historical data). Vaccination data were also obtained from the NZ Ministry for Health. Population data were obtained from Stats.govt.nz. Vaccination data were offset by seven days for the infections analysis to account for the Ministry for Health’s definition of vaccine status at infection. An additional seven days offset was applied for hospitalisation, and 14 days for death, to account for the typical timescales of disease progression.
Amanuensis is an ex-academic and senior Government scientist. He blogs at Bartram’s Folly.
By Megan Redshaw | The Defender | April 8, 2022
The Centers for Disease Control and Prevention (CDC) today released new data showing a total of 1,217,333 reports of adverse events following COVID vaccines were submitted between Dec. 14, 2020, and April 1, 2022, to the Vaccine Adverse Event Reporting System (VAERS). VAERS is the primary government-funded system for reporting adverse vaccine reactions in the U.S.
The data included a total of 26,699 reports of deaths — an increase of 303 over the previous week — and 217,301 of serious injuries, including deaths, during the same time period — up 2,780 compared with the previous week.
Excluding “foreign reports” to VAERS, 803,613 adverse events, including 12,304 deaths and 79,094 serious injuries, were reported in the U.S. between Dec. 14, 2020, and April 1, 2022.
Foreign reports are reports foreign subsidiaries send to U.S. vaccine manufacturers. Under U.S. Food and Drug Administration (FDA) regulations, if a manufacturer is notified of a foreign case report that describes an event that is both serious and does not appear on the product’s labeling, the manufacturer is required to submit the report to VAERS.
Of the 12,304 U.S. deaths reported as of April 1, 17% occurred within 24 hours of vaccination, 21% occurred within 48 hours of vaccination and 59% occurred in people who experienced an onset of symptoms within 48 hours of being vaccinated.
In the U.S., 561 million COVID vaccine doses had been administered as of April 1, including 331 million doses of Pfizer, 211 million doses of Moderna and 19 million doses of Johnson & Johnson (J&J).
Every Friday, VAERS publishes vaccine injury reports received as of a specified date. Reports submitted to VAERS require further investigation before a causal relationship can be confirmed.
Historically, VAERS has been shown to report only 1% of actual vaccine adverse events.
U.S. VAERS data from Dec. 14, 2020, to April 1, 2022, for 5- to 11-year-olds show:
U.S. VAERS data from Dec. 14, 2020, to April 1, 2022, for 12- to 17-year-olds show:
U.S. VAERS data from Dec. 14, 2020, to April 1, 2022, for all age groups combined, show:
… and they are lying about the reason why
By Alex Berenson | April 7, 2022
Until last week, the British government offered the best source of raw data on the efficacy of the Covid vaccines. Each Thursday, the UK Health Security Agency reported the number of new infections, hospitalizations, and deaths by vaccine status.
Since last fall, and especially since the Omicron variant hit, the reports have presented an increasingly dismal picture of vaccine efficacy. Last week’s report showed that in March, nearly 90 percent of adults hospitalized for Covid were vaccinated. And OVER 90 percent of deaths were in the vaccinated:
The importance of these reports is hard to overstate.
They were the single best source of raw data about how well the Covid vaccines were or were not working anywhere in the world. It was a long-running sequential series with clearly defined rules from a large country with high vaccine coverage.
Plus, because the British have national health insurance, the government could determine with near-certainty who had been vaccinated. As you can see, fewer than 1 percent of the people in the reports are called “unlinked” – meaning their vaccine status was undetermined.
AS OF THIS WEEK’S REPORT THE BRITISH GOVERNMENT IS NO LONGER PROVIDING THESE CHARTS.
The British government is offering the nonsensical excuse that it can no longer provide the figures because it has ended free universal testing for Covid: Such changes in testing policies affect the ability to robustly monitor COVID-19 cases by vaccination status, therefore, from the week 14 report onwards this section of the report will no longer be published.
The British government is lying.
Even if the end of free testing somehow affected its ability to provide “robust” data about infections, it would make no difference to the hospitalization or death figures, which are far more important. Unless Covid patients are going to be hospitalized anonymously, the Health Security Agency will still be able to match their names (and the names on death certificates) against vaccination records.
In fact the British government would be derelict not to continue to collect the data, and it surely will. But the public will no longer see it.
Why?
One reason and one reason only. Ever since I mentioned the existence of these reports to Joe Rogan in October, they have become an embarrassment. They are impossible to spin, and the clearest possible signal of vaccine failure.
But hiding the numbers won’t make the vaccines work better. It will just make people less likely to believe anything else public health authorities tell them about Covid and the vaccines – if that’s even possible at this point.
The Naked Emperor’s Newsletter | April 7, 2022
In my recent article on heart attacks in youngsters I focussed on the Scottish data. I have since looked at the English data and it follows a similar pattern.
The UK Health Security Agency (UKHSA) produce a weekly Ambulance Syndromic Surveillance System Bulletin for England. Page 8 looks at Cardiac or respiratory arrest, specifically the daily number of cardiac or respiratory arrest ambulance service calls.
Similar to the Scottish data, during mid 2021 the 7 day average closely followed the black dotted baseline. However, from June it began to rise and stayed higher than average until December. Since February 2022 it has taken off again and is currently much higher than the baseline.
This is data for all ages and as we saw with the Scottish data, when broken down by age, the figures were much worse for the younger age groups. It would be interesting to see this English data also broken down by age.
By Meryl Nass, MD | April 7, 2022
I don’t write enough about the adverse events from COVID vaccines. The reason is that I like to be accurate, but most of the data on vaccine side effects is hidden from us. So while I have pointed out the many databases that FDA and CDC have available and are supposed to be using to assess vaccine safety, only 1 is publicly available: VAERS. Officially, it is the joint FDA-CDC Vaccine Adverse Event Reporting System. Steve Kirsch and Jessica Rose have done the best job analyzing the VAERS data, so I suggest you go to their substacks and read what they have to say.
Both FDA and CDC each have about ten other databases that taxpayers pay for, but most of them we never hear about. Here are the FDA databases:
Below, then-head of Immunizations at CDC, Dr. Nancy Messonier, told the public about the databases that would be used to assess COVID vaccines’ safety just before the rollout, on December 10, 2020.
Both agencies provided the public with promises of what these vaccine safety databases could provide. The databases FDA rents include more than 100 million Americans, for example. But since the rollout, the federal agencies have been almost silent on what they reveal.
However, yesterday I came across 3 very important items about COVID vaccine safety that I had not seen mentioned until now. Each one is an important, though limited, piece of the COVID vaccine safety puzzle–but together, they give you a very good idea of what we are all dealing with as we traverse this data desert, touching small bits of the elephant like the blind men, but never being able to grasp the picture in its entirety.
Item 1 was posted on the FDA website on July 12, 2021 with no fanfare. It revealed that yes, FDA was using its Medicare beneficiary database to look for potential vaccine adverse reactions, and it found four related to Pfizer’s vaccine, which is the most widely used COVID vaccine. FDA writes:
FDA has routinely been using screening methods to monitor the safety of COVID-19 vaccines and to evaluate potential adverse events of interest (AEI) related to these vaccines. One of these methods, called near real-time surveillance, detected four potential AEIs in the Medicare healthcare claims database of persons aged 65 years and older who had received the Pfizer/BioNTech COVID-19 vaccine. The four potential AEI are pulmonary embolism, acute myocardial infarction, immune thrombocytopenia, and disseminated intravascular coagulation. The screening methods have not identified these AEI after vaccination in persons 65 years and older who received the two other authorized COVID-19 vaccines…
These events have not been identified as safety concerns or signals in the CDC Vaccine Safety Datalink (VSD) or the Veterans Administration (VA) Healthcare data systems screening methods. The Vaccine Adverse Event Reporting System (VAERS), another government monitoring system, also has not identified any association between any COVID-19 vaccine and these AEI.
FDA continues to closely monitor the safety of the COVID-19 vaccines and will further investigate these findings by conducting more rigorous epidemiological studies. FDA will share further updates and information with the public as they become available.
If the vaccine caused blood clots and bleeding, as is suspected, these are exactly four diagnoses I would expect to see indicating vaccine injuries. The claim that FDA has not seen them in its other databases, including VAERS, is curious, because people who independently study VAERS have in fact reported higher rates of myocardial infarctions and pulmonary emboli.
Six weeks after FDA posted about these very serious warning signs, FDA issued a full, unrestricted license for Pfizer’s vaccine, the very one they were warning about. The FDA website where the above information is posted has never been updated, and FDA has not revealed what the last 8 months of “more rigorous epidemiological studies” show.
Item 2 is an academic paper published by the CDC in its own, non peer reviewed journal, the Morbidity and Mortality Weekly Report. It was written by CDC scientists with researchers at various sites that participate in a CDC-funded data collection on COVID.
The paper concludes that while myocarditis is known to occur after COVID vaccinations, it is more common after getting the disease COVID. This is an unusual claim, since myocarditis rates as high as 1 in 2000 males aged 18-24 have been reported after the second Covid shot, and no one has claimed that such rates apply after getting the disease.
So what did CDC do? It chose to examine this issue using a database that admittedly misattributed most vaccinations! CDC has access to everyone’s vaccination data and could easily have have used an accurate dataset, but chose not to. Instead, CDC admitted in the paper’s fine print that while 82% of Americans over age 5 have reportedly received at least one COVID vaccine, in the 15 million person dataset it used, only 28% were recorded as vaccinated. The only reasonable interpretation is that a large number of vaccinated individuals were incorrectly assigned to the unvaccinated category. It seems a case could be made that this is scientific fraud.
Item 3 came from the Pfizer documents that were released on April 1. Huge thanks to all the volunteers who have been digging through these documents to piece together the truth about the vaccines. Huge thanks also to the scientists and attorneys who had to file suit and win in court to force FDA to release them.
This information, I think, could be a gamechanger. It turns out that Pfizer had to hire 600 new full-time employees simply to process the adverse event reports that were coming in regarding vaccine injuries and deaths: 600 new hires in the first 2 1/2 months of the vaccine rollout. And Pfizer further said it planned to hire another 1800. Eighteen hundred more! Just to manage the paperwork resulting from its vaccine-caused carnage.
FDA knew. But FDA wanted it buttoned up for 75 years. CDC knew also, since the reports of deaths to VAERS for COVID vaccines exceed all death reports for the past 30 years, for all other vaccines, put together. Both agencies hid what they knew. CDC even played tricks with data to mislead us. Pfizer knew. DHHS must have known.
There is no Public Health without public honesty. Our public health agencies have become public trickery agencies. Why should anyone believe anything they say now? Why would anyone do what they recommend?
By Michael Nevradakis, Ph.D. | The Defender | April 5, 2022
Pfizer hired about 600 additional full-time employees to process adverse event reports during the three months following the Emergency Use Authorization (EUA) of its COVID-19 vaccine, newly released documents reveal.
According to the documents, Pfizer said, “More are joining each month with an expected total of more than 1,800 additional resources by the end of June 2021.”
The information was contained in a 10,000-page document cache released April 1 by the U.S. Food and Drug Administration (FDA) and made public as part of a court-ordered disclosure schedule stemming from an expedited Freedom of Information Act (FOIA) request.
The latest revelations appeared in a document, “Cumulative analysis of post-authorization adverse event reports” of the Pfizer-BioNTech vaccine, highlighting such adverse events identified through Feb. 28, 2021.
The document was previously released in November 2021, but was partially redacted. The redactions included the number of employees Pfizer hired and/or was planning to hire.
According to the unredacted document released April 1:
“Pfizer has also taken a multiple actions [sic] to help alleviate the large increase of adverse event reports. This includes significant technology enhancements, and process and workflow solutions, as well as increasing the number of data entry and case processing colleagues.
“To date, Pfizer has onboarded approximately 600 additional full-time employees (FTEs).
“More are joining each month with an expected total of more than 1,800 additional resources by the end of June 2021.”
The unredacted version also revealed the number of Pfizer-BioNTech vaccine doses shipped worldwide between December 2020 and February 2021:
“It is estimated that approximately 126,212,580 doses of BNT162b2 [the Pfizer EUA vaccine] were shipped worldwide from the receipt of the first temporary authorisation for emergency supply on 01 December 2020 through 28 February 2021.”
The number of shipped doses previously was redacted.
Remarking upon this newly revealed information, Brian Hooker, chief scientific officer of Children’s Health Defense, told The Defender :
“The rollout of the Pfizer vaccine has led to an unprecedented number of adverse events reported — 158,000 adverse events in the first two-plus months of the rollout means that the rate of reported AE [adverse events] was approximately 1:1000, with many of the AEs graded as serious. This is based on a denominator of 125,000,000 vaccines distributed.
“It is no wonder that an army of 1,800 individuals was needed to process all of the information.”
Hooker noted the total number (1,205,755) of COVID vaccine adverse events reported to the Vaccine Adverse Event Reporting System between Dec. 14, 2020 and March 25, 2022, now eclipses the total number (930,952) of adverse events reported in the 32-year history of the database.
Dr. Madhava Setty, a board-certified anesthesiologist and senior science editor for The Defender, previously reported on the same Pfizer document, before the unredacted version was released.
“In that piece, I alluded to Pfizer’s admission that they needed more staff to process all of the adverse events being reported to them,” Setty said.
“It seems this document has now been updated. 600 FTEs [full-time employees]! … I wonder how many extra people the CDC [U.S. Centers for Disease Control and Protection] has hired? Given how they are operating, I would say zero.”
Pfizer downplayed adverse reactions in request for full FDA license
The April 1 document release also included “request for priority review” — the documentation Pfizer in May 2021 submitted to the FDA for full licensure of its Comirnaty COVID vaccine.
In this document, Pfizer described its vaccine as fulfilling an “unmet medical need,” claiming:
“Mass immunization with a safe and effective vaccine against COVID-19 can dramatically alter the trajectory of the pandemic.
“According to policy briefing by the Institute for Health Metrics and Evaluation published on 31 March 2021, COVID-19 remains a leading cause of death in the US with up to 100,000 additional deaths projected in the US between March and July 2021, many of which can likely be prevented with COVID-19 vaccination.”
Pfizer expressed “concerns” about lifting COVID-related measures, such as lockdowns, on the basis that the lifting of such restrictions would “counteract the impacts of this vaccination effort.”
The document states:
“Vaccination against COVID-19 began with EUA/conditional approvals in December 2020, in a phased rollout defined by national/regional guidance.
- “However, there continue to be concerning trends that may counteract the impacts of this vaccination effort, including:
- “[L]imitations in access to obtaining a vaccine due to infrastructure challenges (ie, clinic and appointment capacity and systems)
- “[I]ncreasing viral transmission fueled by relaxed compliance with mitigations as the pandemic surpasses the 1-year mark (ie, masks, physical distancing, limiting travel)
- “[I]ncreasing circulation of emerging variants of concern (which are currently driving continued spread of viral infection in Europe despite extensive mitigation mandates).”
Pfizer justified its request for full licensure of its COVID vaccine on the following basis:
“A vaccine program must be implemented expediently and rapidly expanded to have a significant impact on the pandemic course.
“Licensure of BNT162b2 is likely to enhance vaccine uptake by facilitating supply of vaccine from Pfizer/BioNTech directly to pharmacies and healthcare providers/facilities.
“The greatest impact of BNT162b2 licensure may be direct supply to healthcare providers who serve vulnerable populations such as elderly patients and those who live in rural and underserved communities (ie, individuals who might be unable to navigate the challenges of securing vaccine access using the systems in place for EUA).
“Expansion of vaccine via licensure would ultimately improve the prospect of achieving population herd immunity to bring the pandemic under control.”
The same document glossed over the adverse effects for which the company previously admitted it hired a significant number of new employees to process, claiming:
“Based on Phase 1 data from the FIH Study BNT162-01, BNT162b1 and BNT162b2 [various vaccines tested during the trial period] were safe and well-tolerated in healthy adults 18 to 55 years of age, with no unanticipated safety findings.
“Phase 2/3 safety data were generally concordant with safety data in Phase 1 of the study, both overall and with regard to younger and older participants.”
This is despite hard figures regarding adverse reactions provided later in the document:
“Through 28 February 2021 (data lock point aligned with Pharmacovigilance Plan), there were a total of 42,086 case reports (25,379 medically confirmed and 16,707 non-medically confirmed) containing 158,893 events. Cases were received from 63 countries.
“Consistent with what was seen in Phase 2/3 of Study C4591001, most reported AEs were in System Organ Classes (SOCs) with reactogenicity events: general disorders and administration site conditions (51,335), nervous system disorders (25,957), musculoskeletal and connective tissue disorders (17,283), and gastrointestinal disorders (14,096).
“Post-authorization data have also informed the addition of adverse drug reactions (ADRs) related to the experience of reactogenicity to the product labeling.”
Release of Pfizer vaccine documents still in progress
Many of the documents released as part of the April 1 tranche appear to include more mundane information and data related to the Pfizer COVID vaccine trials.
These documents include:
The next set of documents — an expected 80,000 pages — is scheduled to be released on or before May 1.
Michael Nevradakis, Ph.D., is an independent journalist and researcher based in Athens, Greece.
Swiss Policy Research | April 3, 2022
A Brazilian investigator may have identified the mechanism driving mRNA vaccine myocarditis. And the US CDC finally acknowledges the strongly increased risk in young males.
What is causing vaccine myocarditis?
What is causing post-vaccination myocarditis, and why does it affect primarily young adults, especially young males and athletes? It has been speculated that in young males, muscle blood flow may be higher, which may cause higher biodistribution of vaccine mRNA or spike protein. The mRNA or spike protein may then be absorbed by the heart muscle and cause inflammation.
But Brazilian investigator Flavio Cadegiani, who previously looked into the role of androgens (male sexual hormones) in covid, recently proposed a new and highly intriguing theory: Based on autopsy findings, Cadegiani noted that post-vaccination myocarditis appears to be very similar not to typical myocarditis (e.g. viral myocarditis), but rather to adrenergic myocarditis or catecholamine-mediated stress cardiomyopathy (i.e. heart muscle injury caused by catecholamines).
Catecholamines are a group of hormones that include, most notably, dopamine, adrenaline and noradrenaline. These hormones drive the “fight-or-flight response”, and their concentration is highest in young adults, especially in young males and athletes. Cadegiani notes that the adrenal glands (located on top of the kidneys) are amongst the tissues with highest production of spike protein from mRNA covid vaccines, which can cause local inflammation and may lead to a “catecholamine storm”, which is known to have a toxic stress effect on heart muscle cells.
Prior to covid mRNA vaccinations, this type of heart injury was seen almost exclusively in patients with a rare tumor of the adrenal gland (called pheo-chromo-cytoma). Cadegiani suspects that mRNA vaccination is more likely to affect adrenal glands than a mild coronavirus infection, especially in young and healthy adults.
Cadegiani (February 2022): Catecholamines are the key trigger of mRNA SARS-CoV-2 and mRNA COVID-19 vaccine-induced myocarditis and sudden deaths. (ResearchGate)
New CDC study on myocarditis
In a newly published study covering data from 40 US health care systems and about 15 million people, the US CDC purports to show that “the risk for cardiac complications was significantly higher after SARS-CoV-2 infection than after mRNA COVID-19 vaccination for both males and females in all age groups”, which “supports the continued use of recommended mRNA COVID-19 vaccines among all eligible persons aged ≥5 years.”
But the actual data provided by the CDC tells a very different story.
First, the US CDC confirms that among males aged 12 to 17, the rate of diagnosed myocarditis or pericarditis after the second vaccine dose is 1 in 4,500 to 1 in 2,700, and in males aged 18 to 29, the rate is 1 in 15,000 to 1 in 6,600.
These values are significantly higher than anything previously acknowledged by the CDC, but they still only include cases diagnosed by a doctor or in a hospital. If undiagnosed and unrecognized (subclinical) cases of myocarditis and pericarditis are taken into acccount, the rate will likely reach about 1 in 1,000 in young males. Even an undiagnosed case of myocarditis can turn out to be fatal, as the many recent cases of athletes with sudden cardiac arrest have shown.
However, the CDC argues that the risk of diagnosed myocarditis and pericarditis is still higher after SARS-CoV-2 infection, viz. 1 in 2,000 to 1 in 1,500 in males aged 12 to 17, and 1 in 1,800 to 1 in 1,000 in males aged 18 to 29. But previous studies, both in the US and in Europe, have already shown that the incidence of myocarditis remained normal or even below average during major covid waves in 2020 and early 2021 and only increased during vaccination campaigns in 2021 (see chart below).
So what did the CDC get wrong? It’s a classic mistake (or trick): while the CDC speaks of “SARS-CoV-2 infections”, they in fact only captured positive tests and only within the health care system (i.e. at a doctor’s office or in a hospital). SARS-CoV-2 infections were not captured “if testing occurred in homes, schools, community sites, or pharmacies”, or, one may add, if no testing at all occurred. Thus, the CDC captured only a fraction of actual infections (perhaps 10% or even less), and they likely captured only the most severe infections (i.e. young adults who visited a doctor or a hospital).
(In a somewhat related development, the CDC recently reduced US child covid deaths by 25%, as these deaths, while testing positive, had nothing at all to do with covid.)
But the CDC made another basic mistake: not only is the risk of myocarditis/pericarditis after vaccination in young males higher than after infection (as already shown by several other studies), but vaccination doesn’t prevent infection, either, and there is still no evidence that vaccination reduces the risk of post-infection myocarditis in young adults. In other words, the risk after vaccination simply increases the already existing risk after infection.
To make matters even worse, the CDC study considered only the first two doses of covid vaccination, whereas some US colleges and universities have already mandated a third dose for their students, adding even more risk. In fact, a booster dose may well increase the total risk of myocarditis and pericarditis to more than 1 in 1,000 in otherwise perfectly healthy young males. And as a recently published cardiac MRI study has shown, heart abnormalities in adolescents with mRNA vaccine myopericarditis may persist for at least several months.
In conclusion, the forced covid vaccination of young and healthy adults and children may constitute the largest medical scandal, or medical crime, in modern history. Based on the currently available evidence, covid vaccination is only appropriate in people at significant risk of severe acute covid.
CDC (April 2022): Cardiac Complications After SARS-CoV-2 Infection and mRNA COVID-19 Vaccination (CDC/MMWR)
Figure: Myocarditis and Covid Vaccination in the Western US
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Review by Marilyn Langlois | November 10, 2023
If you regard the United States as perhaps flawed but overall a force for good in the world . . .
If you scoff at the notion that the US, a republic founded on principles of freedom and democracy, has morphed into a world empire, perpetrating assassinations, coups d’état, acts of terror and illegal warfare . . .
If you want to promote peace but haven’t yet explored deceptive events that precipitate US warmongering . . .
. . . here is a volume that will clear the air and paint an honest picture of the significant, not-so-rosy impact US foreign policy and actions have had in the world around us.
USA: The Ruthless Empire, by Swiss historian and peace researcher Daniele Ganser, is the newly published English language translation of his book Imperium USA, originally written in German and published in 2020. Here is a summary of key points — including some lesser-known ones — along with remedies for a more peaceful future, that are covered in the book. … continue
Aletho News If Americans Knew No Tricks Zone
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