Covid-19 vaccines and vaccinations

CDC / FDA Statement on possibility of small increased risk of stroke following Pfizer bivalent booster.

CDC & FDA Identify Preliminary COVID-19 Vaccine Safety Signal for Persons Aged 65 Years and Older

Following the availability and use of the updated (bivalent) COVID-19 vaccines, CDC’s Vaccine Safety Datalink (VSD), a near real-time surveillance system, met the statistical criteria to prompt additional investigation into whether there was a safety concern for ischemic stroke in people ages 65 and older who received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. Rapid-response investigation of the signal in the VSD raised a question of whether people 65 and older who have received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent were more likely to have an ischemic stroke in the 21 days following vaccination compared with days 22-42 following vaccination.
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This preliminary signal has not been identified with the Moderna COVID-19 Vaccine, Bivalent. There also may be other confounding factors contributing to the signal identified in the VSD that merit further investigation. Furthermore, it is important to note that, to date, no other safety systems have shown a similar signal and multiple subsequent analyses have not validated this signal:
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From the related CNN article:

Of about 550,000 seniors who got Pfizer bivalent boosters and were tracked by the VSD, 130 had strokes in the three weeks after the shot, according to a CDC official who spoke to CNN on condition of anonymity because they weren’t authorized to share the data. None of the 130 people died.
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The same safety signal has not been detected with the bivalent Moderna booster, the CDC said in its notice.
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Interesting, sort of a tiny little red flag, not even a formal watch but not one I would be overly concerned with compared to getting covid and all it’s brain effects, ischaemic or otherwise from multiple pathological processes - further info from paper
  • A large study of updated (bivalent) vaccines (from Pfizer-BioNTech and Moderna) using the Centers for Medicare and Medicaid Services database revealed no increased risk of ischemic stroke
  • A preliminary study using the Veterans Affairs database did not indicate an increased risk of ischemic stroke following an updated (bivalent) vaccine
  • The Vaccine Adverse Event Reporting System (VAERS) managed by CDC and FDA has not seen an increase in reporting of ischemic strokes following the updated (bivalent) vaccine
  • Pfizer-BioNTech’s global safety database has not indicated a signal for ischemic stroke with the updated (bivalent) vaccine
  • Other countries have not observed an increased risk for ischemic stroke with updated (bivalent) vaccines
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and don’t advise change to vaccination schedule

No change in vaccination practice is recommended. CDC continues to recommend that everyone ages 6 months of age and older stay up-to-date with COVID-19 vaccination; this includes individuals who are currently eligible to receive an updated (bivalent) vaccine. Staying up-to-date with vaccines is the most effective tool we have for reducing death, hospitalization, and severe disease from COVID-19, as has now been demonstrated in multiple studies conducted in the United States and other countries:
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Tara Green said:
Does anyone think it worth doing an outline of some of the latest videos of Dr J Campbell? I've watched them and they look sound to me.
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I don't know if they are sound or not. He is a relatable character but I don't have the science to assess his work. I have read a critique of his talk on the Swindon data by an Australian researcher which is hard on him. I have read other critiques which say his earlier reports were very sound but that more recently, that isn't the case.
I was directed to looking at his work by an acquaintance, a Ph. D researcher who has spent the whole of his career on medical research and who valued John Campbell's work.

I do think that there is more to look at than the formal narrative that has enveloped us.
 
I watched one of John Campbell's videos and wasn't impressed. He was showing cumulative graphs on excess deaths which if you don't understand how these graphs work can give the impression that excess deaths are accelerating. He also claimed that 'none of this is down to Covid' which is frankly untrue - there's still a lot of Covid about, as well as flu - both causing deaths. I would expect this to mean there are excess deaths still compared to pre pandemic. And he just dropped hints that nobody knows the cause, clearly implying it is something to do with vaccines.

Here's what it says on Wikipedia;
https://en.wikipedia.org/wiki/John_Campbell_(YouTuber)
John Lorimer Campbell is an English YouTuber and retired nurse educator known for his videos about the COVID-19 pandemic. Initially, the videos received praise, but they later veered into misinformation.[2] He has been criticised for suggesting COVID-19 deaths have been over-counted, repeating false claims about the use of ivermectin as a COVID-19 treatment, and providing misleading commentary about the safety of COVID-19 vaccines.[3][4][5] As of December 2022, his YouTube channel had 2.6 million subscribers and over 581 million views.
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In August 2022 David Gorski wrote for Science-Based Medicine that while at the beginning of the pandemic Campbell had "seemed semi-reasonable", he later became a "total COVID-19 crank".[2]
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There's a lot more detail there about his misuse of information and factually incorrect claims.


He's a retired nurse who makes millions from his poorly researched and presented videos with limited understanding of statistics. I'm not impressed.
 
Trish said:
I watched one of John Campbell's videos and wasn't impressed. He was showing cumulative graphs on excess deaths which if you don't understand how these graphs work can give the impression that excess deaths are accelerating. He also claimed that 'none of this is down to Covid' which is frankly untrue - there's still a lot of Covid about, as well as flu - both causing deaths.
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Reinforcing just how bad Campbell's false analysis of excess death data is, I watched the Indie Sage on the subject yesterday. Here's my comment:
https://www.s4me.info/threads/united-kingdom-independent-sage.24432/page-4#post-458132
 
CDC Director of Vaccine Task Force, Tom Shimabukuro , acknowledges that the CDC is aware of reports of the vaccines causing debilitating illnesses. They recognise the distress the ilhealth causes especially in these circumstances ( presumably mandating them)and will continue to monitor adverse events.





Edit: he didn't actually say there was a causal relationship but that there were reports of vaccine causing illhealth. Let's see what monitoring adverse events shows up.
edit2) But aren't they doing this already?
 
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The text of the Tweet is misleading. Here's what the CDC vaccines director actually said:
We take vaccine safety very seriously. With respect to reports of people experiencing debilitating illnesses, we are aware of these reports of people experiencing long-lasting health problems following Covid vaccination. In some cases, the clinical presentation of people suffering these health problems is variable and no medical cause for the symptoms have been found. We understand that illness is disruptive and stressful, especially under those circumstances and we acknowledge these health problems have substantially impacted the quality of life for people and have also affected those around them. And we hope for improvement and recovery and we will continue to monitor the safety of these vaccines and work with partners to try to better understand these types of adverse events.
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Again, he never said there was a causal relationship between the vaccines and health problems.

However, the way he spoke is concerning. It's all non-action. We need to determine:
  • Are these health problems causally related to the vaccine?
  • How many reports have been received?
  • Which vaccines are they associated with?
  • What's your odds of the vaccine causing you chronic health problems?
  • Is the rate higher than well-established vaccines or the background rate of disease incidence?
  • Who is at risk?
  • What is the prognosis?
Why wasn't this caught in the phase 3 trial? is perhaps the most concerning. If the reason is because the vaccines aren't the actual cause or the rate is extremely low, that's reassuring. If it's because people in the trial did get POTS/ME/etc. and their doctors failed to diagnose them, it will require changes to future studies.

The possible, unconfirmed presence of rare and severe adverse reactions isn't a good reason to not get vaccinated. But it's the CDC's duty to thoroughly investigate it.
 
RedFox said:
The possible, unconfirmed presence of rare and severe adverse reactions isn't a good reason to not get vaccinated. But it's the CDC's duty to thoroughly investigate it.
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It's easy to say that if you were lucky enough not to have any adverse reaction(s) to the covid vaccines. I haven't been able to work for the past 16 months thanks to the vaccines. I'm tired of people denying that the vaccines are responsible. I've had adverse reactions with all three shots and each time the symptoms have become progressively worse and take longer to partially recover from. It's bad enough having ME, but this on top of it has robbed me of most of the past two years of my life. It's also made it so that I can no longer have the flu vaccine as I had side-effects from that within hours of having the shot in December. In all my years of getting the flu vaccine I've never had a reaction before.

I am one of 33,000 people registered in British Columbia as having long term adverse reactions to the covid shots. It's real. It's happening.
 
Really sorry you have reacted so badly and are so ill@TigerLilea. I too reacted badly to all 3 vaccinations. The third was terrifying, worse than anything I've ever experienced. I haven't taken v4 and 5 and was strongly advised not to. One doctor at least recognised the link.
I wonder if the formal narrative will ever change from rare adverse effects. There are a lot of people out there with grave concerns.
 
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RedFox said:
Why wasn't this caught in the phase 3 trial? is perhaps the most concerning. If the reason is because the vaccines aren't the actual cause or the rate is extremely low, that's reassuring. If it's because people in the trial did get POTS/ME/etc. and their doctors failed to diagnose them, it will require changes to future studies.
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The cardinal example is Maddie de Garay, who was the 12 year old on the Pfizer trial. She was devastated by severe ME/CFS, but she was taken off-trial and deemed not a vaccine-related adverse event.

Googling for a basic summary of that case, I am linking to Fox News and Tucker Carlson. Most other links I could find were not suitable, but I think this illustrates one of the problems when people's concerns and even basic scientific data are dismissed - they are forced to go others who will listen even when their agenda can be highly problematic.

Stephanie De Garay told "Tucker Carlson Tonight" Thursday that after reaching out to multiple physicians they claimed her daughter, Maddie De Garay, couldn’t have become gravely ill from the vaccine.

"The only diagnosis we've gotten for her is that it's conversion disorder or functional neurologic symptom disorder, and they are blaming it on anxiety," De Garay told Tucker Carlson. "Ironically, she did not have anxiety before the vaccine."
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vEidence that the time of the day of vaccine administration influences the adaptive immune response

Influence of circadian clocks and adaptive immunity and vaccination responses, 2023, Louise Madeleine Ince et al

Abstract
The adaptive immune response is under circadian control, yet, why adaptive immune reactions continue to exhibit circadian changes over long periods of time is unknown. Using a combination of experimental and mathematical modeling approaches, we show here that dendritic cells migrate from the skin to the draining lymph node in a time-of-day-dependent manner, which provides an enhanced likelihood for functional interactions with T cells. Rhythmic expression of TNF in the draining lymph node enhances BMAL1-controlled ICAM-1 expression in high endothelial venules, resulting in lymphocyte infiltration and lymph node expansion. Lymph node cellularity continues to be different for weeks after the initial time-of-day-dependent challenge, which governs the immune response to vaccinations directed against Hepatitis A virus as well as SARS-CoV-2.

In this work, we present a mechanistic understanding of the time-of-day dependent development and maintenance of an adaptive immune response, providing a strategy for using time-of-day to optimize vaccination regimes.

https://www.nature.com/articles/s41467-023-35979-2






 
Mij said:
vEidence that the time of the day of vaccine administration influences the adaptive immune response

Influence of circadian clocks and adaptive immunity and vaccination responses, 2023, Louise Madeleine Ince et al

Abstract
The adaptive immune response is under circadian control, yet, why adaptive immune reactions continue to exhibit circadian changes over long periods of time is unknown. Using a combination of experimental and mathematical modeling approaches, we show here that dendritic cells migrate from the skin to the draining lymph node in a time-of-day-dependent manner, which provides an enhanced likelihood for functional interactions with T cells. Rhythmic expression of TNF in the draining lymph node enhances BMAL1-controlled ICAM-1 expression in high endothelial venules, resulting in lymphocyte infiltration and lymph node expansion. Lymph node cellularity continues to be different for weeks after the initial time-of-day-dependent challenge, which governs the immune response to vaccinations directed against Hepatitis A virus as well as SARS-CoV-2.

In this work, we present a mechanistic understanding of the time-of-day dependent development and maintenance of an adaptive immune response, providing a strategy for using time-of-day to optimize vaccination regimes.

https://www.nature.com/articles/s41467-023-35979-2
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So what time of day is it saying is best to get vaccinated? i cant pick out the key point through all that information
 
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