(Not so) "Safe and Effective"

September 21, 2022 Dr.s Jill and Robert W. Malone

Politics and COVID-19/Vaccine Policy

I am starting off this compilation of articles with a new peer reviewed study, published in Vaccine - which is a well respected journal.

Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults

Vaccine, Aug 31, 2022

This publication covers a re-analysis of the original Pfizer and Moderna clinical trial data by a very experienced team of investigator/authors. By using more traditional methods of calculating the clinical trial data, the study authors found that the mRNA vaccines were associated with an excess risk of serious adverse events of special interest of 12.5 per 10,000 vaccinated.

What does this mean? A simple calculation shows that

10,000 vaccinated people divided by 12.5 people with serious adverse events =(10,000/12.5 = 800)

That means 1 in 800 young adults in the original clinical trial suffered a serious adverse event.

What is a serious adverse event?

Per the CDC: Serious adverse event report ― These reports meet the definition of “serious” specified by the Code of Federal Regulations because one of the following is reported: death, life-threatening illness, hospitalization or prolongation of hospitalization, permanent disability, congenital anomaly, or birth defect.

Abstract

In 2020, prior to COVID-19 vaccine rollout, the Brighton Collaboration created a priority list, endorsed by the World Health Organization, of potential adverse events relevant to COVID-19 vaccines. We adapted the Brighton Collaboration list to evaluate serious adverse events of special interest observed in mRNA COVID-19 vaccine trials.

Methods

Secondary analysis of serious adverse events reported in the placebo-controlled, phase III randomized clinical trials of Pfizer and Moderna mRNA COVID-19 vaccines in adults (NCT04368728 and NCT04470427), focusing analysis on Brighton Collaboration adverse events of special interest.

Results

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 baselines of 17.6 and 42.2 (95 % CI −0.4 to 20.6 and −3.6 to 33.8), respectively. 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; risk difference 18.0 per 10,000 vaccinated (95 % CI 1.2 to 34.9); risk ratio 1.36 (95 % CI 1.02 to 1.83). The Moderna trial exhibited a 6 % higher risk of serious adverse events in the vaccine group: risk difference 7.1 per 10,000 (95 % CI –23.2 to 37.4); risk ratio 1.06 (95 % CI 0.84 to 1.33). Combined, there was a 16 % higher risk of serious adverse events in mRNA vaccine recipients: risk difference 13.2 (95 % CI −3.2 to 29.6); risk ratio 1.16 (95 % CI 0.97 to 1.39).

Discussion

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.

To conclude: This is a serious re-analysis of the original clinical trials data that had a number of limitations. 1) adverse events are rare, so the original trial data probably didn’t pick up as many as there actually were and 2) the study authors did not have access to the individual level data.

The study authors mention that there have been no post-marketing studies conducted as is usually required by the government. They also mention that two years into the vaccine roll-out and the government has not performed a serious analysis of the vaccine adverse events in the generation population. Also of interest is that the serious adverse event rate appears related to the dose, as the Moderna mRNA dose is significantly higher than the Pfizer mRNA dose.

The next article is still in the peer review process, but I have spoken with the authors who believe that it will get through the peer review process soon.

Note that this is a very straight forward analyses - there is nothing here that should stop this paper from being published in a good scientific journal. Well, nothing but politics.

COVID-19 Vaccine Boosters for Young Adults: A Risk-Benefit Assessment and Five Ethical Arguments against Mandates at Universities

SSRN, Sept 12, 2022

Students at North American universities risk disenrollment due to third dose COVID-19 vaccine mandates. We present a risk-benefit assessment of boosters in this age group and provide five ethical arguments against mandates.

We estimate that 22,000 - 30,000 previously uninfected adults aged 18-29 must be boosted with an mRNA vaccine to prevent one COVID-19 hospitalisation. Using CDC and sponsor-reported adverse event data, we find that booster mandates may cause a net expected harm: per COVID-19 hospitalisation prevented in previously uninfected young adults, we anticipate 18 to 98 serious adverse events, including 1.7 to 3.0 booster-associated myocarditis cases in males, and 1,373 to 3,234 cases of grade ≥3 reactogenicity which interferes with daily activities. Given the high prevalence of post-infection immunity, this risk-benefit profile is even less favourable. University booster mandates are unethical because: 1) no formal risk-benefit assessment exists for this age group; 2) vaccine mandates may result in a net expected harm to individual young people; 3) mandates are not proportionate: expected harms are not outweighed by public health benefits given the modest and transient effectiveness of vaccines against transmission; 4) US mandates violate the reciprocity principle because rare serious vaccine-related harms will not be reliably compensated due to gaps in current vaccine injury schemes; and 5) mandates create wider social harms. We consider counter-arguments such as a desire for socialisation and safety and show that such arguments lack scientific and/or ethical support. Finally, we discuss the relevance of our analysis for current 2-dose CCOVIDovid-19 vaccine mandates in North America.

Read that again- for each young adult who is prevented from hospitalization for COVID-19 previously uninfected young adults, we anticipate 18 to 98 serious adverse events, including 1.7 to 3.0 booster-associated myocarditis cases in males, and 1,373 to 3,234 cases of grade ≥3 reactogenicity which interferes with daily activities.

Most young adults have already been infected with COVID-19, but this paper uses uninfected young adults as its baseline. This means that the adverse event ratio cause by the vaccines to prevent one hospitalization is even higher than this analysis. These vaccines are clearly causing more harm than good - as this paper concludes.

This next article worth your attention is massive in scope and length.

How four private groups used their clout to control the global Covid response — with little oversight

Politco, Sept 14, 2022

Four health organizations, working closely together, spent almost $10 billion on responding to Covid across the world. But they lacked the scrutiny of governments, and fell short of their own goals, a POLITICO and WELT investigation found.

What followed was a steady, almost inexorable shift in power from the overwhelmed governments to a group of non-governmental organizations, according to a seven-month investigation by POLITICO journalists based in the U.S. and Europe and the German newspaper WELT. Armed with expertise, bolstered by contacts at the highest levels of Western nations and empowered by well-grooved relationships with drug makers, the four organizations took on roles often played by governments — but without the accountability of governments.

While nations were still debating the seriousness of the pandemic, the groups identified potential vaccine makers and targeted investments in the development of tests, treatments and shots. And they used their clout with the World Health Organization to help create an ambitious worldwide distribution plan for the dissemination of those Covid tools to needy nations, though it would ultimately fail to live up to its original promises.

The four organizations had worked together in the past, and three of them shared a common history. The largest and most powerful was the Bill & Melinda Gates Foundation, one of the largest philanthropies in the world. Then there was Gavi, the global vaccine organization that Gates helped to found to inoculate people in low-income nations, and the Wellcome Trust, a British research foundation with a multibillion dollar endowment that had worked with the Gates Foundation in previous years. Finally, there was the Coalition for Epidemic Preparedness Innovations, or CEPI, the international vaccine research and development group that Gates and Wellcome both helped to create in 2017.

Civil society organizations active in poorer nations, including Doctors Without Borders, expressed discomfort with the notion that Western-dominated groups, staffed by elite teams of experts, would be helping guide life-and-death decisions affecting people in poorer nations. Those tensions only increased when the Gates Foundation opposed efforts to waive intellectual property rights, a move that critics saw as protecting the interests of pharmaceutical giants over people living poorer nations.

“What makes Bill Gates qualified to be giving advice and advising the U.S. government on where they should be putting the tremendous resources?” asked Kate Elder, senior vaccines policy adviser for the Doctors Without Borders’ Access Campaign.

Beyond the main stream political spin that this article incorporates and regurgitates (these vaccine are safe and effective, etc), what this article does do is expose some of the malfeasance and corruption that went on in this pandemic. It exposes how governments have given up their sovereignty and their laws over to non governmental organizations.

The organizations that have run the world-wide response to this pandemic are the Bill & Melinda Gates Foundation, Gavi, Wellcome Trust, and CEPI. They have superceded governments. They all have strong ties to the World Economic Forum and the United Nations. These organizations have pivoted to linking climate change legislation and investment with future pandemic responses. This is all about big money and power.

Here’s How Big Tech Plans To Rig The 2022 Midterms

The Federalist, Sept 14, 2022

The bulk of this article discusses at length how each of the big tech platforms has both historically suppressed and censored conservative news media, and how they have ramped up those efforts for the 2022 elections.

As the 2022 midterms loom, big tech companies are again announcing their plans to meddle in U.S. elections by censoring news and information. Social media censorship ramped up dramatically following President Donald Trump’s 2016 victory, leading to companies such as Twitter and Facebook colluding with Democrat operatives in intelligence agencies to censor and suppress factual stories that harmed then-candidate Joe Biden during his 2020 campaign.

Two years later, following heavy documentation of the meddling, big tech companies are intent on using the same strategy. And they’re openly admitting as much.

Through its censorship, Big Tech controls the flow of information that informs voters and impacts elections.

Much like in 2020, Big Tech companies are actively censoring information they deem harmful to their official narrative or preferred candidates. By falsely labeling factual information from conservatives “misinformation,” such companies have the power to control the flow of information that informs voters and rig elections in their favor.

It’s been heavily reported that companies like Facebook and Twitter have colluded with the Biden administration to censor information related to Covid-19. As the Biden administration already has plans to massively influence the 2022 midterms, they and other Democrats will continue to collude with big tech to swing high-stakes congressional races come November.Metro Health offering $100 H-E-B gift cards for all COVID-19 vaccinations/boosters

An update on the situation in Belgium shows some cracks in the policy of universal vaccination.

Belgium, at least for now, is only using boosters for immunocompromised people, those aged 65 and over, and health professionals in hospitals and nursing homes. Then they will move the campaign down to those 50-64 later. However, it does not appear that they will be backing a universal boosting campaign at this time.

Belgium starts Omicron booster campaign

Source: Xinhua, Sept 12, 2022

The current campaign is primarily aimed at immunocompromised people, those aged 65 and over, and health professionals in hospitals and nursing homes.

People in the 50-64 age group will receive their invitation later.

Coronavirus indicators remain stable in Belgium. According to the Sciensano Scientific Institute of Public Health, 1,489 new COVID-19 infections on average were recorded per day between Aug. 29 and Sept. 4, a decrease of 2 percent compared to the previous week.

As of Sept. 5, 25,800,728 COVID-19 vaccine doses had been administered in Belgium. The vaccination coverage for the second booster dose is 5.2 percent of the total population, and that of people aged 85 and over is 48.2 percent, according to Sciensano.

Lastly, what is happening with those vaccines and boosters in the USA?

I bet you thought bribes for jabs had ended? That this type of behavior by state and local governments was “all behind us?” Well…. , NOT SO FAST!

Local new stations across America are crowing about special deals whereby people can get their baby/child vaccinated and get a $100 gift card or maybe get your name put into a lottery! I

I kid you not. It is happening all over the USA.

It seems like any state I search for with the terms vaccine, gift card or incentive come up POSITIVE for bribing parents, bribing people to get vaccinated.

There is nothing in any of these articles about the adverse events of these vaccines. I have to wonder, if the federal government, vaccine manufacturers or state are governments funding these programs?

This is sickening!

Metro Health offering $100 H-E-B gift cards for all COVID-19 vaccinations/boosters

(H-E-B is a grocery store chain)

NEWS4SA, Sept 13, 2022

Metro Health Clinics and some pop-up vaccination sites are offering a $100 H-E-B gift card to each person who receives any COVID-19 vaccination, including the bivalent vaccines.

Vaccination clinic in Boston offers $75 gift card for getting a shot

Mass Live, Sept 14, 2022

The Boston Public Health Commission plans to hold a free vaccination event Saturday in Boston where anyone who gets a shot will be eligible to receive a $75 gift card, regardless of their age.

The event, pinned on students’ return to classrooms and dubbed “B Healthy Back-to-School,” will run from 11 a.m. to 3 p.m. at White Stadium in Franklin Park. Health officials say they are hoping to encourage pediatric vaccination, support a safe school year, and improve equitable access to COVID-19 vaccines and boosters.

THE MALONE INSTITUTE