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Germany and France have decided that because of the excess risk of myocarditis the Moderna vaccination should not be given to people less than 30 years old. News reports suggest that myocarditis is 5 times more common with Moderna than Pfizer at these ages. Given that Pfizer is available, tolerating the excess harms of Moderna for people in this age group is obviously unsound policy. Accordingly, Germany and France have made the right decision.
There are immediate policy implications for the United States, if we have the courage to heed them.
First, the USA has to grapple with the question: Are we truly committed to maximizing the benefit and minimizing the harms of vaccination? Throughout this pandemic, I struggled to understand US decision making. When we learned that J&J vaccination was linked to thrombosis (VITT) preferentially in women <40, and given that alternative vaccines were available, I argued we should suspend vaccination in that age group for that product, but this was notably not pursued by regulators. We should not make the same error here.
For that reasons, the USA must immediately follow suit with Germany and France. It is unjustified to continue administering Moderna for people < 30 when the excess risk is known, and a safer alternative exists. Drug safety expert and Professor of Medicine Walid Gellad concurs:
https://twitter.com/walidgellad/status/1458817064173453318
This decision shows that it is possible to learn additional safety information after product launch that can better tailor the use of vaccines to maximize benefit and minimize harm. Now reconcile this fact with the language used by many professionals when products are debuted, which are unequivocal and fail to acknowledge uncertainty. I would strongly suggest we temper our comments about vaccines among kids 5 to 11 until further data comes forward.
The decision has immediate implications for ongoing vaccination efforts. We should be randomizing people, who have elected to undergo vaccination, to variations in dose and timing of dose 2 for the Pfizer vaccine. This should happen for anyone under the age of 40, and particularly for kids aged 5 to 11.
Ongoing studies should attempt to see if toxicity can be mitigated with reduced dose or prolonged interval between doses. It makes little sense to scale up a suboptimal dosing regimen, and post-market RCTs are possible here. With kids 5 to 11, there remains massive uncertainty as to the harms (there may be harms, but there might also not be— we simply don’t know).
Testing variations in dose and schedule is logical. Already 1 million children (5 to 11) have gotten dose 1. A trial can be run among willing participants and randomize some people to get dose 2 on schedule (21 days), some on day 60, some on day 180, and some can forgo dose 2 entirely, and within months we will know which strategy is best.
Ironically, not conducting a trial like this is a real experiment. It means we will continue a massive vaccination campaign with little idea if our dosing and timing is optimized for benefit/ harm balance.
We need to see troponin levels and cardiac MR performed on 10,000 random recipients of vaccination at all ages to document if subclinical myocarditis exists. We urgently need long term follow up on patients with myocarditis to see if a fraction (even a tiny one) develops long term sequelae.
Europe has made fewer unforced errors than the USA. They did not mask 2 year olds without data; They were (and still are) more reluctant to vaccinate younger individuals, and they take myocarditis seriously. We have a lot to learn from them on how to balance drug efficacy with safety.
Image via DW. Adapted from the author’s blog.
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by Michael Snyder
(End of the American Dream)—What is causing the extremely loud “booms” that people are hearing in the sky all over the world? We are being told that “skyquakes” are responsible, but scientists have no idea why these “skyquakes” are occurring. In some cases, the “skyquakes” cause such powerful shaking that…
The Biggest Sale on Long-Term Storage Beef EVER
by Sponsored Post
Let’s cut to the chase. Prepper All-Naturals is offering an unprecedented 40% off for it’s “Beef Steak” survival bags with promo code “steak40”. With a 25-year shelf life and a single ingredient (beef, of course), our most popular product is available for a very limited time with the biggest discount…
Seattle Is Ordered to Stop Blocking Illegal Alien Deportations in the Most Hilarious Court Decision Ever
by PJ Media
A federal court has just pooped in the oatmeal of the West Coast, Messed Coast™governors and local election officials suffering from acute cases of Trump Derangement Syndrome who think they can stop illegal alien deportations. And after this hilarious and thorough legal takedown from the 9th Circuit Court of Appeals,…
Illegal Alien Terror Suspect Found Dead in Cook County Jail Cell
by Slay News
An Islamic illegal alien has been found dead in his jail cell after being arrested on terrorism charges. According to CWBChicago, 22-year-old Sidi Mohamed Abdallahi was found dead at the Cook County jail in Illinois on Saturday. Abdallahi was arrested on felony terrorism and hate crime charges in October. He…
Trump’s Wild Bunch Is Ready for Action
by Frank Miele
If for no other reason than that it will elicit fear in the hearts of autocracy-phobics, I propose that Donald Trump’s second-term Cabinet be known as “The Wild Bunch.” The name is best known as the title of Sam Peckinpah’s classic 1969 western featuring a colorful cast of aging outlaws…
FAA Issues Flight Restrictions Over Questionable Drone Activity Near Trump’s Bedminster Golf Course
by Just The News
The Federal Aviation Administration (FAA) on Tuesday said that it has issued two flight restrictions on the area surrounding President-elect Donald Trump’s Bedminster golf club in New Jersey, following questionable drone activity. The drone sightings were first reported on Nov. 18, but have continued into this week, according to Fox…
Ex-FBI Agent Convicted for Stealing From Jan 6 Defendant During Raid
by Trending Politics
A former Houston-based FBI agent has been convicted of stealing valuables and cash while conducting searches. In one instance, the agent stole cash and silver bars from a non-violent January 6 defendant’s home. Nicholas Anthony Williams, 36, was indicted on January 31 in the Southern District of Texas. Williams, who…
Democrats, Media Elite Urge Biden to Pardon Trump’s Alleged ‘Enemies List’
by Breitbart
President Joe Biden should issue preemptive pardons to his political allies and those deemed to be on President-elect Donald Trump’s alleged “enemies list,” Democrats and their media allies believe. Delivering a preemptive pardon indicates an admission of guilt, although Democrats claim a preemptive pardon would only be intended to block…
Fani Willis Forced to Release All Communications With Jack Smith, J6 Committee
by Trending Politics
The Fulton County Superior Court has ruled against District Attorney Fani Willis, ordering her to disclose communications with Special Counsel Jack Smith and the House January 6 Committee. The decision, announced on Tuesday, follows a lawsuit brought by Judicial Watch, a conservative watchdog group, which accused Willis of violating Georgia’s…
Lindsey Graham Is the Warmongering NeoCon Leading the Charge to Upend Pete Hegseth
by JD Rucker
Pete Hegseth represents a shift away from the wokeness that has infected the United States military. This is possibly the biggest reason President-Elect Donald Trump tapped him to be the next Secretary of Defense and the vast majority of Republicans on Capitol Hill can support this, at least for the…
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by Nicole Silverio, DCNF
(DCNF)—Fox Business host Charles Payne called out the alleged “huge double standard” of President Joe Biden’s family Tuesday by revealing that his brother, who struggles with a crack addiction, is currently serving a jail sentence. Payne said his brother, who is getting out of jail on Friday, is likely one…
Zelensky Admits Ukraine Can’t Retake All Its Land: ‘We Must Seek Diplomatic Means’
by Breitbart
Ukrainian President Volodymyr Zelensky conceded in an interview on Tuesday that Ukraine does not have “enough forces” to restore sovereignty over Russian-occupied Crimea and “must seek diplomatic means” to end the Russian invasion and regain its land. The state-run Ukrinform outlet reported that Zelensky described Crimea – which Russia colonized…
Ultra-Processed Foods: How Bad Are They for Your Health?
by Olivia Cook
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by Tyler Durden, Zero Hedge
(Zero Hedge)—As the retail apocalypse that started with Amazon and e-commerce continues, the latest victim is The Container Store. The retail giant could file for bankruptcy as soon as next year, according to the New York Post, who said the retailer is blaming its recent descent on “a weak housing…
Mysterious ‘Car-Sized Drones’ Over New Jersey Prompt FBI Investigation
by Zero Hedge
Several weeks of mysterious drone swarms over the skies of one New Jersey county near the military research and manufacturing facility Picatinny Arsenal have sparked concerns among residents and prompted an FBI investigation. “It’s kind of unsettling,” Mike Walsh, a Morris County resident who has spotted the drones on numerous…
UNESCO’s New Mission: Train Influencers About Combatting Online “Misinformation”
by Reclaim the Net
The UN Educational, Scientific and Cultural Organization (UNESCO) is now incorporating teaching influencers how to “fact check” into its activities. UNESCO claims that influencers have become “primary sources of news and cultural information” around the world – which prompted it to carry out a survey into how these online personalities…
