Posted onJuly 28, 2021|Comments Off on EudraVigilance Tracks COVID-19 Vaccine Adverse Events in Europe
The various available vaccines likely have different adverse effect profiles
The European Medicines Agency publishes reports of adverse reactions to medications at EudraVigilance. This is the closest European equivalent of the U.S. VAERS (vaccine adverse events reporting system) except it covers more than just vaccines. Click here for their European experience, scroll down to letter C then find your favorite COVID-19 vaccine.
Caveats:
The information on this website relates tosuspected side effects , i.e. medical events that have been observed following the use of a medicine, but which are not necessarily related to or caused by the medicine.
Information on suspected side effects should not be interpreted as meaning that the medicine or the active substance causes the observed effect or is unsafe to use. Only a detailed evaluation and scientific assessment of all available data allows for robust conclusions to be drawn on the benefits and risks of a medicine. [If this hasn’t been done yet, why not?]
The European Medicines Agency publishes these data so that its stakeholders, including the general public, can access information that European regulatory authorities use to review the safety of a medicine or active substance. Transparency is a key guiding principle of the Agency.
Visit Bayou Renaissance Man for a table of various types of adverse effects reported after the individual vaccines. (I haven’t verified the accuracy of the figures.) To put the numbers in perspective, I’d want to know the total number of Europeans vaccinated.
The six-man team burst through my door on a no-knock raid at 3 AM.
I was soon blinded and deafened by the flash-bang grenade. No time to reach my gun, which probably saved my life. Fortunately my dogs weren’t with me, or they’d have been shot.
Two of the men pointed AR-15s at me while three held me down and their leader yelled, “Parker, this is your last chance to take the vaccine voluntarily. Will you submit?” My foggy mind raced through the options: take the jab, lose my medical license and livelihood, go to prison, fight and die here now….
“PARKER, THIS YOUR LAST CHANCE. WILL YOU SUBMIT TO THE VAX?”
No….never, you sons’o’bitches!”
A thug immediately stabbed my buttock with a rusty #16 needle and injected the toxic brew.
Posted onJuly 19, 2021|Comments Off on The 1976 Swine Flu Vaccine Debacle
To vaccinate or not vaccinate, that is the question…
Most of you don’t remember the 1976 flu epidemic. Early on, it appeared to be on track to equal the 1918 Spanish Flu death rates. Politicians and public health authorities felt like they better do something, anything, to avert disaster. Their response didn’t work out too well. COVID-19 isn’t the flu, but it’s a viral illness that often looks like the flu clinically.
From Discover magazine:
Vaccines were once thought of as an axiomatic good, a longed-for salvation in the form of a syringe, banishing crippling and deadly infections like polio, smallpox and tetanus. But within the past few decades we have seen the emergence of anti-vaccination movements and a rise in cases of childhood diseases that are entirely preventable with a quick jab to the arm.
Over the past five years, outbreaks of mumps, measles and whooping cough have cropped up throughout the country. And then, of course, there is widespread skepticism among the general public on influenza and the merits of a seasonal flu shot. Even as outbreaks of avian and swine flu have periodically emerged in this country, there are still people who resist vaccination against the flu. This seemingly pervasive opposition to flu vaccination is not without its historical and sociological roots.
Some of the American public’s hesitance to embrace vaccines — the flu vaccine in particular — can be attributed to the long-lasting effects of a failed 1976 political campaign to mass-vaccinate the public against a strain of the swine flu virus. This government-led campaign was widely viewed as a debacle and put an irreparable dent in future public health initiatives, as well as negatively influenced the public’s perception of both the flu and the flu shot in this country.
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But while the World Health Organization adopted a cautious “wait and see” policy to monitor the virus’s pattern of disease and to track the number of emerging infections, President Gerald Ford’s administration embarked on a zealous campaign to vaccinate every American with brisk efficiency. In late March, President Ford announced in a press conference the government’s plan to vaccinate “every man, woman, and child in the United States” (1). Emergency legislation for the “National Swine Flu Immunization Program” was signed shortly thereafter on April 15th, 1976 and six months later high profile photos of celebrities and political figures receiving the flu jab appeared in the media. Even President Ford himself was photographed in his office receiving his shot from the White House doctor.
* * *
The American public can be notably skeptical of forceful government enterprises in public health, whether involving vaccine advocacy or limitations on the size of soft drinks sold in fast food chains or even information campaigns against emerging outbreaks. The events of 1976 “triggered an enduring public backlash against flu vaccination, embarrassed the federal government and cost the director of the U.S. Center for Disease Control his job.”
One aspect of the fiasco was that of the 45 million U.S. residents hastily vaccinated against Swine Flu, 450 developed a severe neurological disorder called Guillain-Barre syndrome.
She’s at little risk of serious illness if she’s generally healthy
Children can indeed contract COVID-19. But it is rarely deadly. The infection fatality rate in children between ages 5 and 14 is 0.001%. This means that of every 100,000 children that age who get infected, one will die.
Most schools in the U.S. start back up in about a month. Some school systems will be mandating that children wear face masks, hoping to reduce infections, but not realizing the adverse effects. See the end of this post for the list of bothersome effects. Here’s a study that advises against forced mask-wearing in children:
Many governments have made nose and mouth covering or face masks compulsory for schoolchildren. The evidence base for this is weak.1,2 The question whether nose and mouth covering increases carbon dioxide in inhaled air is crucial. A large-scale survey3 in Germany of adverse effects in parents and children using data of 25 930 children has shown that 68% of the participating children had problems when wearing nose and mouth coverings.
The normal content of carbon dioxide in the open is about 0.04% by volume (ie, 400 ppm). A level of 0.2% by volume or 2000 ppm is the limit for closed rooms according to the German Federal Environmental Office, and everything beyond this level is unacceptable.4Methods
We measured carbon dioxide content in inhaled air with and without 2 types of nose and mouth coverings in a well-controlled, counterbalanced, short-term experimental study in volunteer children in good health (details are in the eMethods in Supplement 1). The study was conducted according to the Declaration of Helsinki and submitted to the ethics committee of the University Witten/Herdecke. All children gave written informed consent, and parents also gave written informed consent for children younger than 16 years. A 3-minute continuous measurement was taken for baseline carbon dioxide levels without a face mask. A 9-minute measurement for each type of mask was allowed: 3 minutes for measuring the carbon dioxide content in joint inhaled and exhaled air, 3 minutes for measuring the carbon dioxide content during inhalation, and 3 minutes for measuring the carbon dioxide content during exhalation. The carbon dioxide content of ambient air was always kept well under 0.1% by volume through multiple ventilations. The sequence of masks was randomized, and randomization was blinded and stratified by age of children. We analyzed data using a linear model for repeated measurements with P < .05 as the significance threshold. The measurement protocol (trial protocol in Supplement 2) is available online.5 Data were collected on April 9 and 10, 2021, and analyzed using Statistica version 13.3 (TIBCO).Results
The mean (SD) age of the children was 10.7 (2.6) years (range, 6-17 years), and there were 20 girls and 25 boys. Measurement results are presented in the Table. We checked potential associations with outcome. Only age was associated with carbon dioxide content in inhaled air (y = 1.9867 – 0.0555 × x; r = –0.39; P = .008; Figure). Hence, we added age as a continuous covariate to the model. This revealed an association (partial η2 = 0.43; P < .001). Contrasts showed that this was attributable to the difference between the baseline value and the values of both masks jointly. Contrasts between the 2 types of masks were not significant. We measured means (SDs) between 13 120 (384) and 13 910 (374) ppm of carbon dioxide in inhaled air under surgical and filtering facepiece 2 (FFP2) masks, which is higher than what is already deemed unacceptable by the German Federal Environmental Office by a factor of 6. This was a value reached after 3 minutes of measurement. Children under normal conditions in schools wear such masks for a mean of 270 (interquartile range, 120-390) minutes.3 The Figure shows that the value of the child with the lowest carbon dioxide level was 3-fold greater than the limit of 0.2 % by volume.4 The youngest children had the highest values, with one 7-year-old child’s carbon dioxide level measured at 25 000 ppm.Discussion
The limitations of the study were its short-term nature in a laboratory-like setting and the fact that children were not occupied during measurements and might have been apprehensive. Most of the complaints reported by children3 can be understood as consequences of elevated carbon dioxide levels in inhaled air. This is because of the dead-space volume of the masks, which collects exhaled carbon dioxide quickly after a short time. This carbon dioxide mixes with fresh air and elevates the carbon dioxide content of inhaled air under the mask, and this was more pronounced in this study for younger children.
This leads in turn to impairments attributable to hypercapnia. A recent review6 concluded that there was ample evidence for adverse effects of wearing such masks. We suggest that decision-makers weigh the hard evidence produced by these experimental measurements accordingly, which suggest that children should not be forced to wear face masks.
Impairments caused by wearing the mask were reported by 68% of the parents. These included irritability (60%), headache (53%), difficulty concentrating (50%), less happiness (49%), reluctance to go to school/kindergarten (44%), malaise (42%) impaired learning (38%) and drowsiness or fatigue (37%).
I hope this is effective ammunition for you when you go the the school board meeting to protest forced masking of your child.
A couple of months ago Scott Gavura explained why the veterinary deworming drug ivermectin is the new hydroxychloroquine, a repurposed drug touted as a “miracle cure” for COVID-19 despite evidence that is, at best, very weak and, at worst, supportive of the conclusion that ivermectin is ineffective against COVID-19. Then, two weeks ago, I posted a typically lengthy, detailed, and snarky article about how ivermectin is the new hydroxychloroquine. What I meant was that, just as 12-15 months ago the antimalarial drug hydroxychloroquine was the repurposed drug touted as a “miracle cure” for COVID-19 that fizzled when tested with rigorous clinical trials, over the first half of 2021 ivermectin has become the repurposed drug touted as a “miracle cure” for COVID-19. Like hydroxychloroquine, which by the end of last summer I was describing as the Black Knight of COVID-19 treatments, an homage to (of course) the Black Knight in Monty Python and the Holy Grail, belief in ivermectin as a highly effective treatment for COVID-19—that will eliminate the need for vaccines, too!—seems similarly immune to having its limbs hacked off by science, the way that they were for hydroxychloroquine. This post won’t be as long—although it might be as snarky—and will deal more with the conspiracy theories that have cropped up around ivermectin. Unsurprisingly, they’re very similar to the conspiracy theories that cropped up around hydroxychloroquine. Many of these conspiracy theories are being promoted by a group of doctors who bill themselves as the Front Line COVID-19 Critical Care Alliance (FLCCC).
I don’t recall Gorski in the article addressing the reasons that physicians and scientists would be promoting ivermectin if it doesn’t work. Dr Joseph Mercola’s in it for the money. Probably Mike Adams, too. But for legitimate practicing physicians and scientists, I can’t see any financial pay-off. Could they be motivated simply by fame, notoriety, or drama? How about a straightforward difference of opinion on how to interpret the data, which happens routinely among scientists and physicians?
We’re in a situation where we have a wildly effective vaccine, multiple choices, lots available, free of charge, and we have folks who are just saying I won’t do it. I think that it’s time to say to those folks, it’s fine if you don’t choose to get vaccinated. You may not come to work. You may not have access to a situation where you’re going to put my grandchildren in jeopardy. Where you might kill them, or you might put them in a situation where they’re going to carry the virus to someone in a high-risk position.
– July 2021: Former Obama administration Secretary of Health and Human Services Administration
I was skeptical, so confirmed it at The Irish Times. The 66-year-old “criminal” was a repeat offender. The article never said she was infected with COVID-19 and spewing germs like a fire hose.
“Don’t you dare get near me!”
I doubt this type of action is coming to the U.S. but you never know. Here, we have enough civil disobedience that the jails would be overwhelmed. And rightfully so.
Steve Parker, M.D.
PS: If she’s not taken the vaccine, will they hold her down and force it on her?
The delta variant of covid-19 was previously called the Indian variant. I guess some of the latter were triggered, so the name was changed to delta. It’s the predominant variant in the U.K. now, and is 15-20% of the cases in Arizona, where I live.
Ivor Cummins says the delta variant is not a big deal:
A couple studies in the medical literature tend to support the use of fluvoxamine for early treatment of COVID-19. Click the links below for specific results of the research.
Fluvoxamine is available as a generic and is also sold in the the U.S. as brand name Luvox. It is FDA-approved for obsessive-compulsive disorder (OCD). It’s also used off-label for several other psychiatric disorders. The usual starting dose for OCD is 50 mg/day, increasing gradually to 100-300 mg/day if needed. The most common side effects are headache (30% of users), insomnia (30%), drowsiness (25%), nausea (35%), and weakness (20%). It is significantly less well-tolerated than ivermectin.
Participants received a dose of 50 mg of fluvoxamine (or matching placebo) in the evening immediately after the baseline assessment and confirmation of eligibility, then for 2 days at a dose of 100 mg twice daily as tolerated, and then increasing to a dose of 100 mg 3 times daily as tolerated through day 15 then stopped. That’s a much more rapid dose escalation than the manufacturer recommends for OCD.
Click for the Seftel study of fluvoxamine if interested. This research was less cleanly-designed compared to Lenze. For instance, a fair number of study subjects didn’t even have symptoms at the time of “diagnosis,” just a positive SARS-CoV-2 antigen test (PCR?). The dose of fluvoxamine was a 50-100 mg loading dose on day 1 followed by 50 mg twice daily for 14 days.
Emergency Use Authorization
All the available U.S. vaccines against COVID-19 are under Emergency Use Authorization. What does this mean? From the FDA:
An Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives.
So if there are adequate, approved, and available alternatives to the vaccines, the vaccinations must halt for now. Until they pass the usual multi-year tests that prove adequate safety.
If you think the FDA is immune to pressure from politicians and Big Pharma, think again.