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

Who would have ever thought?

They'll have to work on the faulty reporting mechanism to fix this.

Copied and pasted. Notice the initial statements and also the post statements that seem an attempt to explain away or at least minimize the main message, which I've bolded:

Transparency and vaccine safety are top priorities for the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). U.S. government agencies use multiple, complementary safety monitoring systems to help detect possible safety signals for vaccines and other medical countermeasures as early as possible and to facilitate further investigation, as appropriate. Often these safety systems detect signals that could be due to factors other than the vaccine itself.

All signals require further investigation and confirmation from formal epidemiologic studies. When one system detects a signal, the other safety monitoring systems are checked to validate whether the signal represents an actual concern with the vaccine or if it can be determined to be of no clinical relevance.

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.

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:

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

Although the totality of the data currently suggests that it is very unlikely that the signal in VSD represents a true clinical risk, we believe it is important to share this information with the public, as we have in the past, when one of our safety monitoring systems detects a signal. CDC and FDA will continue to evaluate additional data from these and other vaccine safety systems. These data and additional analyses will be discussed at the upcoming January 26 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.

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:

Data have shown an updated COVID-19 vaccine reduces the risk of hospitalization from COVID-19 by nearly 3-fold compared to those who were previously vaccinated but have not yet received the updated vaccine.
Data have shown that the updated COVID-19 vaccine also reduces the risk of death from COVID-19 by nearly 19-fold compared to those who are unvaccinated.
Other preliminary data from outside the U.S. have demonstrated more than 80% protection against severe disease and death from the bivalent vaccine compared to those who have not received the bivalent vaccine.

Overall safety data for the bivalent COVID-19 vaccines are available here.

Once again, no change is recommended in COVID-19 vaccination practice, which can be found here.

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.

Hell! Weirdly they're still pushing their all-new-improved vaccine. I wonder if they're taking it themselves?

Apart from the Safety Signal for 65-year-olds, strokes are like earthquakes - they happen suddenly but they're the result of a gradual build-up. Have under 65 year-olds also taken a large step towards their first stroke?

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.

Guess the Aussie money-making machine managers didn't get the memo:

News: Australians will be able to get a fifth Covid vaccine within a fortnight.

The Australian Technical Advisory Group on Immunisation (ATAGI) has recommended that everyone .. who has not received a vaccine within the last six months should get a fifth shot.

ATAGI made it clear that those over the age of 65 remain at severe risk of death or becoming seriously unwell if they catch Covid.

Of course not a word in the article about the Safety Signal for over-65s, or the fact that Australian deaths mysteriously leapt by 17% last year, or that the current version of Covid is much less severe than normal flu, or vaccines cause long-Covid, or Japan launching an investigation into the numbers of Covid vaccine deaths ...

(note: Fact Check is claiming the story below is a hoax - i'm not able to verify it one way or another - i do know Fact Check has spread an awful lot of disinformation re Covid origin & vaccines. Dan, don't know how good your Japanese is but you may be able to verify the translation on the video at least.)

Oklahoma City Sentinel: Japan has launched an official investigation into the unprecedented numbers of people dying after receiving the Covid-19 vaccination.

Japanese researchers have been instructed to investigate the mechanisms by which experimental mRNA jabs could be causing deaths and severe adverse reactions.

Hiroshima University School of Medicine Prof. Masataka Nagao highlighted how the bodies of vaccinated persons he performed autopsies on were abnormally warm, with upwards of 100 degree F body temperatures.

Prof. Shigetoshi Sano, Kochi University School of Medicine: I don’t know if I should say this, but it has been found that vaccinated people are more likely to get coronavirus than unvaccinated people.

Sometimes, things that are not good are introduced into the human body. Vaccination may cause our overall immune system to fail to fight against such bad things. Spike proteins are locally suppressing the immune system. The function of the spike proteins to produce adverse reactions is formation of blood clots. And even worse, spike proteins can also locally induce inflammation.

Kyoto Univerisity Prof. Emeritus Dr. Masanori Fukushima: Japan’s prestige is at stake. You have vaccinated so many people. And yet, only 10% of the members of the Ministry of Health, Labor and Welfare, who are leading members of the vaccine campaign have been vaccinated. Is this a f__king joke?

That last one is interesting if it's true. Are all these experts who are insisting people line up for their fifth jab actually taking it themselves? I don't think they are. There have been a lot of vax-mandates in Australia, there definitely needs to be one for any expert recommending jabs to the populous. Show us the proof that you've taken five jabs before you use the immense power of your position to force it onto others.

Video of Dr Fukushima scolding Ministry of Health officials: https://youtu.be/zbmB19tp5aU

Glad to see Robert Kennedy Jr is running for President, even though he won't win. He's a voice questioning the origin of Covid & tthe whole vaccine regime it unleashed - which apparently makes him unelectable, but his name alone will give it some publicity.

Interesting how the demonization machine, including some of the Kennedy clan, has cranked up against him:

Robert F. Kennedy Jr. is part of this campaign to attack the institutions committed to reducing the tragedy of preventable infectious diseases. He has helped to spread dangerous misinformation over social media and is complicit in sowing distrust of the science behind vaccines.

Always about the trust in science - never about actual details. Scientists themselves have killed off faith in science by lying about Covid. You can't blame people for pointing that out. Well you can blame them, i guess, coz we see it time after time.

Epoch Times: The Pfizer and Moderna COVID-19 vaccines did not impact overall mortality, a reanalysis of clinical trial data found.

The two vaccines, both based on messenger RNA (mRNA) technology, protected against deaths from COVID-19 but that effect was offset by vaccinated trial participants being more likely to die from cardiovascular problems, Christine Stabell Benn, a health professor at the University of Southern Denmark, and other researchers reported in April in the Cell journal.

That's astounding if true, which it appears to be. It means all that jackboot coercion, all that money spent ... was for ... nothing. Well, not nothing - big-pharma got a lot richer/more powerful & govts got to help themselves to the world's greatest ever data grab, but in terms of health benefits ... ? Nothing.

Interestingly, the study (from Denmark) says J&J (adenovirus vaccines) did achieve a reduction in mortality. Given the study was looking at historical data, it's damning that with that knowledge out there, adenovirus vaccines were sidelined in preference to Pfizer & Moderna. Clearly a big-money power-play - that bore no concern whatsoever for health outcomes.

Meanwhile, Epoch Times appears to be the only newspaper left on the planet that still reports vax or Covid origin news.

News: British cardiologist, Dr Aseem Malhotra, has called for the Pfizer and Moderna Covid shots to be suspended in Australia until the risk of heart complications is better understood, saying prior vaccines “have been pulled for much less”.
(He) accused the medicines regulator, the Therapeutic Goods Administration (TGA), of ignoring the clear safety signal from its own reporting system once the rollout was well under way.

Malhotra: People can be forgiven if new information comes in, we know people make mistakes — but once you get that information back, them not acting on it … the problem is the cover-up is worse than the crime.

Same can be said for the origin of Covid. If those responsible had 'fessed up in the beginning, said, 'whoops, sorry, we've accidentally released a super contagious virus that we engineered in the lab', then at least the world could have taken appropriate action to nip it in the bud. Instead the messaging from WHO was: no human-to-human transmission, don't close borders, don't wear masks, it's not as bad as SARS, CCP is "open & transparent". This is where real culpability comes in.

Professor Marc Dweck, chair of clinical cardiology, University of Edinburgh, told The Guardian .. Dr Malhotra’s opinions were “misguided and in fact dangerous”.

Dweck: The vast majority of cardiologists do not agree with his views and they are not based upon robust science. I would strongly urge patients to disregard his comments, which seem to be more concerned with furthering his profile … rather than the wellbeing of the public.

Again, the vast majority of scientists also said: no human-to-human transmission, don't close borders, don't wear masks, it's not as bad as SARS, CCP is "open & transparent", Covid is from pangolin at a wet-market, anyone who questions that is a conspiracy theorist.

So we can safely say, the vast majority of scientist will say whatever they consider to be in their own personal financial interests in order to further their own profiles … rather than the wellbeing of the public.

In fact, any scientist who did question the vast majority was vilified, ostracized, & risked trashing their own careers. Every single one that opposed THE Science cabal has spoken about the intense blow-back they received from the establishment for their troubles.

Malhotra started out promoting Covid vaccines, but then his father (also an eminent physician) died of a heart attack.

Malhotra: At the time people were trolling me, saying it was the vaccine, and I got really angry and blocked them, because that was not my mindset — but then I started to notice increased incidences in cardiac deaths and I started to wonder.

Basically, all patients with unexpected heart attacks or cardiac arrests have to be seen as being caused by the vaccine until proven otherwise — even several months later, so even, I would say, up to two years since having the vax.

As a cardiologist, it is unusual to see sudden cardiac death. We have a mechanism of action, it would be unscientific not to include it as a potential cause. What the vaccine does is it accelerates the progress of coronary artery disease, so someone who otherwise wouldn’t have is going to present several months or a year later.

News: Despite speaking at a series of sold-out events in Sydney, Melbourne, Canberra, Adelaide, Perth and the Gold Coast, Dr Malhotra’s Australian tour has been met with a virtual media blackout.

Remember, this is 3 & half years in! Still MSM is censoring vital info. Obviously they will keep doing that permanently. There are many MSM orgs that still have not written even one article on the origin of Covid.

Malhotra: What’s really interesting is everyone comes up to me and is aware, and doctors are seeing stuff, but they are generally afraid to say anything. You could argue I’m speaking to an echo chamber … [but] the professionals are very supportive — they’re horrified, sad. When you speak to people on the ground, taxi drivers, shopkeepers, everyone is aware of someone they know, either a family member or friend, who suffered a serious adverse event.

I'm aware of 3 or 4.

Malhotra: The objective evidence to support the fact there is a disconnect between the public and the establishment is people are not turning up (for boosters).

Which is true. Despite massive amounts of tax-payer money being spent (at a time when normal people are doing it tough) on advertising campaigns to promote boosters (as well as the billions spent on vaccines), the vast majority of people are avoiding it like the plague.

82% of Australians have ignored the pleas of THE Experts/Government to get boosted. It's closer to 90% in the US. This represents the death of trust in scientists.

So why on earth are scientists/gov officials doubling down on their disinformation about Covid/vaccines? Malhotra reached the same conclusions that we did:

Think about it from a psychological perspective — they are responsible in a way for approving and the mandating of these vaccines for all Australian citizens — it’s not easy to suddenly acknowledge what they’ve done is harm people to such a significant degree.

It’s much easier to bury your head in the sand. I would be mortified to know what I’d done, even accidentally. But having said that, it is their job — there has to be accountability.

As with many so called anti-vax whistleblowers, he's not anti-vax. In fact he sees this distrust of scientists & vaccines in general as one of the worst fallouts

Historically, traditional vaccines have a serious adverse event rate of one in one million — other vaccines have been pulled for much less

He cited the 1976 swine flu vaccine which carried a one in 100,000 risk of Guillain-Barré Syndrome, and the 1999 rotavirus vaccine which was linked to bowel obstruction at a rate of one in 10,000.

As for the full-court vilification press, Malhotra says it's a normal part of the playbook for those with power.

One of the ways is through opposition fragmentation — it involves smearing and deplatforming those who are countering their narrative

This is not unusual. This is deliberate. If there are people who are in opposition, this is how we discredit them, this is how we frame them to other people in society. Big tobacco did it for many years — this is not new.