Side Effects and Data Gaps Raise Questions on COVID Vaccine

STORY AT-A-GLANCE

  • Reports of serious side effects to the COVID-19 vaccines have started emerging. Examples include persistent malaise and extreme exhaustion, anaphylactic reactions, multisystem inflammatory syndrome, chronic seizures and convulsions, paralysis and sudden death within hours or days
  • By December 18, 2020, 112,807 Americans had received their first dose of COVID-19 vaccine. Of those, 3,150 suffered one or more “health impact events.” That’s a side effect rate of 2.79%
  • While Pfizer claims its vaccine is 95% effective, this is the relative risk reduction. The absolute risk reduction is actually less than 1%
  • Analysis of recently released data suggests the relative risk reduction for Pfizer’s vaccine may actually be between 19% and 29% — far lower than the required licensing threshold of 50%
  • Studies have warned COVID-19 vaccines may result in more serious disease when exposed to the virus, either through antibody-dependent immune enhancement or pathogen priming that triggers an autoimmune response

While many have hitched their hope for a return to normalcy and a sense of safety to the rollout of COVID-19 vaccines, early reports are cause for concern. It didn’t take long before reports of serious side effects started emerging in popular media and on social media networks. Examples include:

Persistent malaise1,2 and extreme exhaustion3 Anaphylactic reactions4,5,6
Multisystem inflammatory syndrome7 Chronic seizures and convulsions8,9,10
Paralysis,11 including cases of Bell’s Palsy12 Sudden death within hours or days13,14,15

High Rate of Side Effects

According to the U.S. Centers for Disease Control and Prevention,16 by December 18, 2020, 112,807 Americans had received their first dose of COVID-19 vaccine. Of those, 3,150 suffered one or more “health impact events,” defined as being “unable to perform normal daily activities, unable to work, required care from doctor or health care professional.”

That gives us a side effect rate of 2.79%. Extrapolated to the total U.S. population of 328.2 million, we may then expect 9,156,780 Americans to be injured by the vaccine if every single man, woman and child is vaccinated.

When I checked the Vaccine Adverse Event Reporting System (VAERS) January 13, 2021, the total number of reported adverse events for the COVID-19 vaccine (any manufacturer) stood at 3,920.

v-safe active surveillance covid vaccine

Effectiveness Questioned

In a January 4, 2021, article17 in The BMJ Opinion, Peter Doshi, associate editor of The BMJ, again raised questions about the stated efficacy rate of Pfizer’s and Moderna’s COVID-19 vaccines, saying “we need more details and the raw data.”

Previously, in a November 26, 2020, BMJ article,18 Doshi had pointed out that while Pfizer claims its vaccine is 95% effective, this is the relative risk reduction. The absolute risk reduction is actually less than 1%. This is the typical Big Pharma trick: confusing absolute and relative risks. They played this card in spades with the statin drugs and made tens if not hundreds of billions in profits. He also stressed that severe side effects appear commonplace:

“Moderna’s press release states that 9% experienced grade 3 myalgia and 10% grade 3 fatigue; Pfizer’s statement reported 3.8% experienced grade 3 fatigue and 2% grade 3 headache. Grade 3 adverse events are considered severe, defined as preventing daily activity. Mild and moderate severity reactions are bound to be far more common.”

In his January 4 article,19 Doshi delves into recently released summary data20 given to the Food and Drug Administration. “While some of the additional details are reassuring, some are not,” he says. In fact, his article outlines yet additional concerns “about the trustworthiness and meaningfulness of the reported efficacy results” of these two vaccines based on that data.

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Relative Risk Reduction May Be Far Below Required Threshold

For starters, Doshi points out that Pfizer did not consistently confirm whether test subjects who showed symptoms of COVID-19 were actually PCR positive. Instead, a large portion of them were simply marked as “suspected COVID-19.”

In all, there were 3,410 cases of “suspected but not confirmed” COVID-19 in the total study population (vaccine group and controls), 1,594 of which occurred in the vaccine group. Only eight cases in the vaccine group were actually confirmed with PCR testing. The problem with this is that the 95% effectiveness rating is based on PCR confirmed cases only. Doshi writes:21

“With 20 times more suspected than confirmed cases, this category of disease cannot be ignored simply because there was no positive PCR test result. Indeed, this makes it all the more urgent to understand.

A rough estimate of vaccine efficacy against developing COVID-19 symptoms, with or without a positive PCR test result, would be a relative risk reduction of 19% — far below the 50% effectiveness threshold for authorization set by regulators.

Even after removing cases occurring within 7 days of vaccination (409 on Pfizer’s vaccine vs. 287 on placebo), which should include the majority of symptoms due to short-term vaccine reactogenicity, vaccine efficacy remains low: 29%.”

It’s worth noting that, for some reason, far more people in the vaccine group ended up with COVID-19 symptoms within that first week than did those in the placebo group.

Doshi goes on to state that if suspected cases occurred in people who had false negative PCR test results, then the vaccine’s efficacy would be lowered even further. He also stresses that “average clinical severity” is not really all that important. What really matters is the “incidence of severe disease that affects hospital admissions.”

Unfortunately, and this is really shocking, the trials were not designed to assess whether the vaccines prevent transmission of the infection. Since they don’t, “an analysis of severe disease irrespective of etiologic agent — namely, rates of hospitalizations, ICU cases, and deaths amongst trial participants — seems warranted, and is the only way to assess the vaccines’ real ability to take the edge off the pandemic,” Doshi writes.

Why Were so Many in Vaccine Group Excluded?

Another concern brought forth in Doshi’s article is the exclusion of 371 participants from Pfizer’s efficacy analysis due to “important protocol deviations on or prior to seven days after Dose 2.” Of those, 311 were from the vaccine group while only 60 were in the placebo group.

This marked imbalance is cause for concern. Why were five times as many in the vaccine group excluded from the efficacy analysis than in the placebo group? And what exactly were these “protocol deviations” that caused them to be excluded? This is called stacking the deck so the results can be manipulated in the desired direction to “prove” effectiveness, when it is merely a statistical manipulation.

Confounding Factors

Doshi is also concerned about the confounding role of pain and fever medications. These kinds of medications can mask symptoms, resulting in mild cases of COVID-19 going undetected, especially since all participants were not tested. They can also mask side effects of the vaccine.

The data suggest that in the Pfizer trial, pain and fever medication was taken three to four times more often by vaccine recipients than among those in the placebo group though, and according to Doshi:

Their use was presumably concentrated in the first week after vaccine use, taken to relieve post-injection local and systemic adverse events. But the cumulative incidence curves suggest a fairly constant rate of confirmed COVID-19 cases over time, with symptom onset dates extending well beyond a week after dosing.

That said, the higher rate of medication use in the vaccine arm provides further reason to worry about unofficial unblinding. Given the vaccines’ reactogenicity, it’s hard to imagine participants and investigators could not make educated guesses about which group they were in. The primary endpoint in the trials is relatively subjective making unblinding an important concern.”

He also questions Pfizer’s use of an “adjudication committee” to count COVID-19 cases. “Were they blinded to antibody data and information on patients’ symptoms in the first week after vaccination?” he asks.

“What criteria did they employ, and why, with a primary event consisting of a patient-reported outcome (COVID-19 symptoms) and PCR test result, was such a committee even necessary?” Furthermore, the committee consisted not of licensed doctors but of Pfizer staff members, which makes one wonder whether they had the appropriate qualifications to determine whether someone might have COVID-19 or not.

Does Vaccine Work in Those Who Already Had COVID-19?

Lastly, it’s important to ascertain how the vaccine works for those who have already had COVID-19, seeing how the vaccine is recommended for everyone, regardless of whether or not you’ve already recovered from the infection. Here, the data reveal something rather odd. Doshi writes:22

“Individuals with a known history of SARS-CoV-2 infection … were excluded from Moderna’s and Pfizer’s trials. But still 1,125 (3.0%) and 675 (2.2%) of participants in Pfizer’s and Moderna’s trials, respectively, were deemed to be positive for SARS-CoV-2 at baseline …

By my count, Pfizer apparently reported 8 cases of confirmed, symptomatic COVID-19 in people positive for SARS-CoV-2 at baseline (1 in the vaccine group, 7 in the placebo group …) and Moderna, 1 case (placebo group …)

But with only around four to 31 reinfections documented globally, how, in trials of tens of thousands, with median follow-up of two months, could there be nine confirmed covid-19 cases among those with SARS-CoV-2 infection at baseline?

Is this representative of meaningful vaccine efficacy, as CDC seems to have endorsed? Or could it be something else, like prevention of COVID-19 symptoms, possibly by the vaccine or by the use of medicines which suppress symptoms, and nothing to do with reinfection?”

Vaccine Rollout Coincides With Outbreak

Whether or not the vaccine is helpful or harmful in people who either had COVID-19 before, or are currently positive for SARS-CoV-2 or ill with COVID-19 symptoms, is an important question now that these vaccines are being rolled out.

Case in point: In Auburn, New York, a COVID-19 outbreak began December 21, 2020, in a Cayuga County nursing home.23,24 Before this outbreak, no one in the nursing home had died from COVID-19.

The next day, December 22, they started vaccinating residents and staff. The first death was reported December 29, 2020. Between December 22, 2020, and January 9, 2021, 193 residents (80%) received the vaccine, as did 113 staff members.

As of January 9, 2021, 137 residents had been infected and 24 had died. Forty-seven staff members had also tested positive for SARS-CoV-2 and one was on life-support. Considering we’re seeing cases in which healthy young and middle-aged individuals die within days of receiving the vaccine, it’s not inconceivable that the vaccine might have something to do with this dramatic rise in deaths among the elderly. In fact, I’d expect it.

You can rest assured that the public health authorities and media will never report on these observations. Anything that conflicts with vaccine safety and effectiveness will be intentionally and universally buried. This is precisely their modus operandi of the past three decades. If anything, the suppression of the facts will only be amplified.

One of the Most Powerful Videos I’ve Ever Seen

The following video from Barbara Loe Fisher is one of the most powerful videos that I have ever seen. I am hopeful that watching this video will inspire you to take up the cause and join the fight for vaccine freedom and independence.

There is a cultural war and collusion between many industries and federal regulatory agencies that results in a suppression of the truth about vital important health issues. If this suppression continues we will gradually and progressively erode our private individual rights that our ancestors fought so hard to achieve. Please take a few minutes to watch this video.

Protect Your Right to Informed Consent and Defend Vaccine Exemptions

With all the uncertainty surrounding the safety and efficacy of vaccines, it’s critical to protect your right to make independent health choices and exercise voluntary informed consent to vaccination. It is urgent that everyone in America stand up and fight to protect and expand vaccine informed consent protections in state public health and employment laws. The best way to do this is to get personally involved with your state legislators and educate the leaders in your community.

Think Globally, Act Locally

National vaccine policy recommendations are made at the federal level but vaccine laws are made at the state level. It is at the state level where your action to protect your vaccine choice rights can have the greatest impact.

It is critical for EVERYONE to get involved now in standing up for the legal right to make voluntary vaccine choices in America because those choices are being threatened by lobbyists representing drug companies, medical trade associations and public health officials, who are trying to persuade legislators to strip all vaccine exemptions from public health laws.

Signing up for NVIC’s free Advocacy Portal at www.NVICAdvocacy.org gives you immediate, easy access to your own state legislators on your smartphone or computer so you can make your voice heard. You will be kept up to date on the latest state bills threatening your vaccine choice rights and will get practical, useful information to help you become an effective vaccine choice advocate in your own community.

Also, when national vaccine issues come up, you will have the up-to-date information and call-to-action items you need at your fingertips. So, please, as your first step, sign up for the NVIC Advocacy Portal.

JOIN THE NVIC ADVOCACY PORTAL

Share Your Story With the Media and People You Know

If you or a family member has suffered a serious vaccine reaction, injury or death, please talk about it. If we don’t share information and experiences with one another, everybody feels alone and afraid to speak up. Write a letter to the editor if you have a different perspective on a vaccine story that appears in your local newspaper. Make a call in to a radio talk show that is presenting only one side of the vaccine story.

I must be frank with you: You have to be brave because you might be strongly criticized for daring to talk about the “other side” of the vaccine story. Be prepared for it and have the courage to not back down. Only by sharing our perspective and what we know to be true about vaccination will the public conversation about vaccination open up so people are not afraid to talk about it.

We cannot allow the drug companies and medical trade associations funded by drug companies or public health officials promoting forced use of a growing list of vaccines to dominate the conversation about vaccination.

The vaccine injured cannot be swept under the carpet and treated like nothing more than “statistically acceptable collateral damage” of national one-size-fits-all mandatory vaccination policies that put way too many people at risk for injury and death. We shouldn’t be treating people like guinea pigs instead of human beings.

Internet Resources Where You Can Learn More

I encourage you to visit the website of the nonprofit charity, the National Vaccine Information Center (NVIC), at www.NVIC.org:

  • Vaccine Requirements and Exemptions by State — Vaccine laws vary from one U.S. state to another. By knowing the specific policies where you live, you’ll learn how you can get exemptions and better protect your right to make informed vaccine choices.
  • NVIC Memorial for Vaccine Victims — View descriptions and photos of children and adults who have suffered vaccine reactions, injuries and deaths. If you or your child experiences an adverse vaccine event, please consider posting and sharing your story here.
  • If You Vaccinate, Ask 8 Questions — Learn how to recognize vaccine reaction symptoms and prevent vaccine injuries.
  • Vaccine Freedom Wall — View or post descriptions of harassment and sanctions by doctors, employers and school and health officials for making independent vaccine choices.
  • Vaccine Failure Wall — View or post descriptions about vaccines that have failed to work and protect the vaccinated from disease

Source for Story:

https://articles.mercola.com/sites/articles/archive/2021/01/26/covid-vaccine-side-effects.aspx?ui=24d05926a9ffbfc76c628dd0db2baa6df4df6984b212087ab0a7ccef25640f15&cid_source=dnl&cid_medium=email&cid_content=art1ReadMore&cid=20210126&mid=DM785944&rid=1068553037

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