Surprised to learn that Kamala Harris who is asymptomatic, healthy, and quadruple vaccinated is getting Paxlovid, a drug reserved for high-risk patients per the FDA label.
It appears the FDA no longer requires clinical trial data
Pfizer&Moderna's new Omicron vax(tested in 8 mice) was authorized today for children, who are at the highest risk of vaccine-induced myocarditis
FDA bypassed their expert advisers
The most political FDA&CDC in U.S. history
Dear President Biden,
FDA is bypassing it's scientific advisors to authorize boosters for all kids 12-15 next week. This is unconscionable--undermines the integrity of the FDA's standard process! Please require FDA to put this authoriz before the VRBPAC advisory comm for a vote!
The CDC's problem is not "messaging". Its bad policy. Ignoring nat imm, not releasing data, pushing boosters on healthy kids, quarantining low-risk immune students, closing schools last yr & using flawed Maricopa mask study are not messaging problems. They're flawed data problems
“immune function among vaccinated individuals 8mo. after the administration of two doses of COVID vaccine was lower than that among the unvaccinated”.
According to European Med Agency, “frequent booster shots could adversely affect the immune response”
Is this following the science?? FDA will authorize 4th doses this week by bypassing the typical voting process of their external experts. FDA will then convene them after the authoriz to "discuss". It's like a judge issuing a verdict and then having lawyers make their arguments.
Starbucks, Boeing, &Delta are hiring back staff they fired under vax mand. Its time to re-instate American workers with an apology. Nat Imm data are in--when employers fired those w/nat imm, they got rid of those LEAST likely to spread the virus! My latest:
Evergrande, a company with close ties to the Chinese Communist Party, donated $115M to Harvard Med Sch. Days after the donation, Harvard-linked experts (some who had proposed a lab leak origin) suddenly changed their position, condemning the lab leak idea
Watching all the drama around
@AaronRodgers12
... How many professional athletes have ever died of Covid in any sport in any country in the last 2 years?
0 (zero)
They are the lowest-risk people on earth.
Let's channel this energy to talk about obesity as a leading risk factor.
At this point, there should be a unanimous consensus to forever ban gain-of-function research. History had proven it to have catastrophic risks and zero clinical benefit.
CDC dir told abc "no adverse events among vax recipients, & denied seeing any cases of myocarditis among vax'd kids 5-11. On that same day, however, data from her own agency showed the CDC was aware of at least 8 cases of myocarditis within that age group"
Moderna's vaccine had a 4 (four) percent efficacy against asymp Covid in kids 6mo-2yrs of age. I admire the many health experts within the NIH & CDC who are outraged and spoke to me. Our liberty as physicians to speak up should always be sacred & protected
I'm looking forward to testifying before congress this week on how Covid policies are no longer based on clinical data.
Nothing captures the problem more than this--requiring a booster in a young healthy low-risk student who already has natural imm. Omicron inaccurately cited...
CDC has a civic duty to do rigorously study the long-term effects of vaccine-induced myocarditis. New follow-up study 3-8 months after myocarditis shows the MRI heart abnormality of late gadolinium enhancement seen in 63% of children. Merits further study.
FDA will likely authorize the Omicron vaccine later today/tomorrow based on data from 8 mice and no human clinical data avail to the public. Americans deserve to see the data. Why is the White House/Dr. Jha pushing it so hard & universally w/o public data?
Over the last few weeks, meta-analysis studies from highly-respected researchers found that:
1. Masks has NO impact on the epidemic trajectory (Cochran)
2. Natural Immunity >> Vax Immunity (or ~the same) (Lancet)
3. Vax mandates did NOT increase vaccination rates (GMU)
4.…
Huge news: While California decided the state won’t mandate COVID vaccines for school, state Supreme Court now ruled that school DISTRICTS may NOT impose mandates on their own either. This is a big win for kids/parents/science/common sense. @
New Study: "cardiac autopsy findings in five persons who have died unexpectedly within seven days following anti-SARS-CoV-2-vaccination... Our findings establish the histological phenotype of lethal vaccination-associated myocarditis."
CDC: "You do not need to get the chickenpox vaccine if you have evidence of immunity against the disease."
It's time for the CDC to recognize the power of natural immunity against Covid-19, affirmed in an Israeli study of 700K+ people posted this week.
A snapshot into America's uncanny booster enthusiasm: Pfizer applied for a 4th dose for people >65, but the FDA granted them an authorization for people >50. In other words, the FDA gave Pfizer more than what they asked for. And bypassed their own expert advisors voting to do it.
Dr. Jha just said “it's going to be really important that people this fall and winter, get the new shot.”
But we’ve seen ZERO data on this new vaccine.
I’d love to see the data.
Pushing hard a new medication with zero data is not good medicine, policy, or following the science
My Johns Hopkins research team is leading a long-term study of natural immunity because the NIH and CDC are not doing it. They have $50 billion and 30,000 employees and yet can't seen to conduct one of the most important studies we need done to inform the public.
Our Natural Immunity Study out today in JAMA:
👍🏼816 people
👍🏼99.3% with prior Covid had circulating antibodies (unvax)
👍🏼Durable for ~2yrs studied
👍🏼Lexicon of immune/non-imm >> vax/unvax
👍🏼Don't try to get Cov. But if you had it, imm more durable than vax
@MartyMakary
et al in JAMA on enduring SARS-CoV-2 natch immunity: “Anti-spike SARS-CoV-2 RBD levels were observed after a positive COVID-19 test result up to 20mos, extending previous 6mo durability data” in 293/295 (99.3%) with confirmed covid-19
Why are we doing trials if when a trial shows no clinical benefit in babies & toddlers (i.e. no statistical significance) the FDA & CDC authorizes a vaccine anyway?? This is a very concerning precedent.
Well CDC just did it, as I predicted. They changed their language from "Get a booster" to "Are you up to date?"
This manipulation or words implies that low-risk people without a booster are out-of-date. Also sets the stage for freq boosters
Covid vaccinations are not software
Listening now to FDA deliberate on mRNA vaccines for kids 6-23 months old, I'm very concerned they are using very little primary data in that age group. Instead they are extrapolating, assuming data from older people apply to 6-month-old babies. What they call "immunobridging" /4
The data are now abundantly clear. Natural imm is more effective than vax imm.
Sadly, tens of thousands Americans lost their job & livelihood because the Ab circulating in their blood are Ab the govt does not recognize. Sci group think ruined their careers. Agree to Re-instate👇🏼
How many times was this denied by “experts.” And how many fired nurses, police, fire fighters, Marines, etc, whose natural immunity was superior to the vaccinated deserve to be reinstated!
I really hope Biden recognizes natural immunity tomorrow in his Covid announcements. Israeli study found it is 27x more effective than vaccines in preventing symptomatic infections.
10% of my flight is wearing a mask + 1/4 flight attendants. We should all respect any person’s decision to mask. No one should taunt them or treat them differently. Civility has always been an American value.
FDA asked a court for 75yrs to release documents related to the Pfizer vax. Today, a smart judge rejected their request. This is the same
@US_FDA
that bypassed experts to authorize boosters for young ppl. Thank u
@AaronSiriSG
for bringing public accountability to a broken agency.
I am pleased to report a federal judge rejected the FDA's request to produce the Pfizer Covid vaccine data at 500 pages per month and instead ordered a rate of 55,000 pages per month! Everyone should read the Judge's excellent 3-page decision available at
A more honest announcement would have been:
"We approved the vax for babies &toddlers based on very little data. While we believe its safe in this population, the study sample size was too low to make a concl about safety. Note that studies were done in kids w/o natural immunity"
Today, I endorsed ACIP’s recommendation that all children 6 months through 5 years of age should receive a
#COVID19
vaccine.
Parents, I strongly encourage you to get your children vaccinated against COVID-19.
More:
Public health officials changing their position on natural immunity, after so much hostility toward the idea, would go a long way in rebuilding the public trust, as I explain in today's
@washingtonpost
Natural Immunity wins again. New England Journal Study: Natural immunity “protection was higher than that conferred after the same time had elapsed since receipt of a second dose of vaccine among previously uninfected persons.”
Big tech was not happy about our JAMA study on natural immunity. LinkedIn took it down (censored my post below). The data doesn’t fit the narrative.
Li re-instated my post after a friend compl to the CEO. Sorry if Silicon Valley did not *like* the results:
our JAMA paper on natural immunity prevalence and durability has the 7th highest altmetric score of all 31,154 JAMA papers ever published since altmetric began -- wow!! guess we identified an important topic to study :)
Based on the data: We should not be giving healthy kids a 2nd vax dose at a 3wk interval, esp boys where 1/7K get myocarditis and 1/136 of them died, i.e. from the vax itself(NEJM study). Vax deaths could approximate Covid deaths in boys 5-11 w/no comorbid
Masking did nothing for the 276,000 participants in randomized trials or cluster RCTs. The Cochrane review is now being criticized simply because some people do not like the results--but that's not how science works. 1/2
The 'natural immunity is unreliable' theory has done a lot of damage. It's OK to have a wrong hypothesis but public health leaders have pushed their theory way too long after data became overwhelmingly clear,yet remarkably clinging to their outdated theory
I’ve heard these concerns from academic physicians in the U.S. There’s a modern day McCarthyism in science whereby researchers who question certain “sacred cow”assumptions using the scientific method are bullied by their universities and worry about their future NIH funding.
'They aren't going to publish their findings, they are concerned about losing research money'
Dr Aseem Malhotra reveals a cardiology researcher found similar results to a new report showing an increase in risk of heart attack following the mRNA COVID vaccine.
At a time when the country needed Fauci’s NIAID to work, it didn't. The agency failed to pivot its mammoth research infrastructure to give doctors &policymakers the medical evidence they needed in real time. In the absence of evidence, dogma ruled the day.
FDA should have rejected these data:
▪️Pfizer's new vaccine was approved based on 10 mice (no human data)
▪️Moderna's new vax was tested in 50 people tracked for just 2wks. One person had an adverse event requiring med attention-Moderna provided no details
1 in 3 Americans had Covid last year (Columbia Univ). I'm constantly amazed how unvax people are being fired despite having circulating antibodies to Covid. They HAVE antibodies that neutralize the virus.. but the antibodies are not recognized by the gov't
Yale is banning students from eating OUTDOORS at local restaurants for spring semester--a public health over-reach on defenseless population. The good news is that students are rising up, demanding data, and challenging martial law against mild illness.
T-Cell immunity is strong and effective against Omicron. This is the most significant (and overlooked) scientific paper of the entire Omicron saga. The fixation on antibody levels has diverted attention away from comprehensive immunity, including cellular
Interesting that people are 100% certain that a new drug with complex drug interactions, only studied in 1,120 people worldwide is 100% safe enough to give off-label to a popul it's never been shown to help-asymp low-risk people. Do folks know it can cause hypertension &diarrhea?
There was NO STATISTICAL SIGNIFICANCE in the vaccine study cited by FDA &CDC to recommend the vax in babies through kids<5. Any respected medical journal would normally reject this study for publication. How does the CDC so vigorously recommend this with such strong language?
It is a slap in the face to science for
@US_FDA
to circumvent the standard convening of the expert advisory board... FDA is quietly doing this because their experts previously voted it down, voicing concerns about medical harms.
@POTUS
@DrWoodcockFDA
We are living in a new era: billions of NIH dollars spent on long Covid research (which has yielded nothing) and almost no money allocated to basic studies of heart injury in children like this one…
"The fact the US, CDC, NIAID, FDA, etc etc. have to rely on a Thailand preprint for the first prospective study of cardiac biomarkers is mind-boggling negligence. "
Powerful video of a nurse who spoke out on vax-induced myocarditis in children, which could have been markedly reduced if FDA/CDC did their job and tracked cases, spaced out interval between doses, recognized natural immunity, allowed 1 dose, &banned Moderna age<30yrs like Europe
Interesting timing for CDC to announce eliminating their masking & distancing orders for children & the “vast majority” of Americans— a new war, hrs after a Supreme Court pick is named, late on a Friday afternoon, and 2 business days before a SOTU speech🤔
This clip is infuriating. It is an admission of public health malpractice by the
@CDCDirector
.
The main clinical endpoint of the vaccine trials was symptomatic infection at 3-4 months post vax, not infection or disease transmission:
[1/4]
Last week I testified before Congress that many Covid policies are no longer based in science. Data are misrepresented to fit agendas, like boosting young healthy people, while nat imm is ignored and life-saving therapies are sidelined. My newest oped
@WSJ
The data on natural immunity protecting against severe disease was there all along, as I wrote in the WSJ over a year ago.
The recent lancet article simply reviewed every major study done on the topic and reached the same conclusion: …
FDA PLEASE STOP: nyt reporting
@fda
is about to authorize boosters for 12-15 yr-olds WITHOUT convening their VRBPAC expert advisory committee. We are in uncharted territory.
Who's calling the shots
@US_FDA
?? Experts (standard process) or The White House?
The 'natural immunity is unreliable' hypothesis was wrong. It should be abandoned. The latest study shows it's 27X more effective than vax immunity against symptomatic Covid. That's not a subtle signal in the data. Cherry-picking science is disingenuous.
FDA should explain their erratic behavior:
💉Bypassed experts to authorize 4th dose
💉Gave Pharma more than they asked for (application for >65yo, but EUA for >50)
💉Months delinquent on Covaxin application (better vax for variants)
💉I explain more here:
Dr. Fauci's primary job is to fund research. I'm disappointed he did not fund a rapid randomized controlled trial of the new bivalent vaccine. In his last WH press conf today, he pushed it for everyone, incl young & healthy +those with Omicron natural imm. Where's the trial data?
Well folks, the answer is a clear "NO". FDA just authorized 4th doses for everyone >50 despite a lack of data that 4th doses reduce hospitalization risk and strong opposition from their own FDA experts--experts who did not get to vote as they normally do before authorizations.
Is this following the science?? FDA will authorize 4th doses this week by bypassing the typical voting process of their external experts. FDA will then convene them after the authoriz to "discuss". It's like a judge issuing a verdict and then having lawyers make their arguments.
Today, Biden/Jha demanding $22.5B in additional Covid funding. A lot will go to:
🔹Another vax that has not been disclosed, studied or FDA authorized
🔹The testing-industrial complex to over-test immune students
🔹Off-label use of Paxlovid in asymp, low-risk ppl who don't need it
"Supplementation of vitamin D3 was related to a 33% decreased incidence of COVID-19 infection resulting in 30-day death." But why is this study published now? Would have been good for Dr. Fauci/NIH with its $45 Billion budget in 2020 to do this study then.
The shocking convo @ CDC that resulted in the rec to boost 5yr-olds. From the mtg: "if we say 'should' more people will get boosted (vs 'may') then we may have more data that helps us really define where we're going." A clin trial w/o informed consent??👇👇
The immediate reflex to give young healthy people a 3rd vaccine dose to protect against Omicron is not supported by data, nor is it necessary for anyone who has natural immunity based on the studies we have to date.
What if I told you 1 in 50 people who took a new medication had a "medically-attended adverse event" and the manufacturer refused to disclose what the complication was, would you take it? And what if the theoretical benefit only lasted for a 3-mo window after which time the…
Worth pointing out👇
Of the 50 study participants that got the Moderna monovalent vax
@CDCgov
universally recommended today, 1/50 (2%) had a medically-attended adverse event related to the vax
W/unknown clinical benefits how can CDC say w certainty benefits outweigh risks 4 all?
All Omicron cases for which there is available information on severity were either asymptomatic or mild (EU report). There have been no Omicron-related deaths reported.
CDC is quietly reversing many of their recs while no one is paying attention. I went out to dinner and felt bad seeing so many young healthy waiters &waitresses still holding on to outdated CDC recs, believing that a cloth mask is protecting them.
There is zero clinical data that a 4th dose reduces hospitalization risk. There isn't even any evidence that a 3rd dose reduces hospitalization risk in young people.
I'm concerned the White House annual Covid vax announcement is not data-driven and ignores nat imm & concerns of immune imprinting from a multi-dose vax strategy. Omicron vax authoriz was based on 8mice, non-public data & bypassed the usual FDA expert vote
Hospitals not allowing people to visit their critically ill loved ones because of covid is a human rights violation. There are things worse than dying, like dying alone.
CDC just revised down U.S. child Covid deaths by 25%. CDC, with 21K employees, still can't tell us how many were healthy, if any (Germany reported zero 5-17y.o.) or how many had nat imm? Studies suggest zero. How can anyone quantify risk in healthy kids with nat imm without data?
The CDC has failed miserably in data collection and is finally beginning to correct a few of their errors that inflated Covid deaths in all ages, including kids.
An ancient trait of the medical profession is to speak up when we believe something is not in the best interest of our patients. Less absolutism and more humility by health agencies would go a long way in rebuilding public trust. My piece w/
@TracyBethHoeg
Here's the article I discussed this evening. The good news is since it was published 4 days ago, hundreds of university students, parents, alumni, & donors have told me they reached out to their school administrators to talk to them about these issues.
Brilliant re-analysis of the data the CDC used justify school masking. This new elegant study, using a larger population & longer study period, found that school masking was NOT associated with pediatric case rates.
@TracyBethHoeg
@aChandra_TO
1/3
More studies revealing how the Covid vaccine affects the heart of children. This is why many of us called for more humility and less dogma when vax &booster mandates were pushed hard on ultra-low risk healthy children. Some European countries did not even rec the vax for children
Great summary of Thailand study by
@anish_koka
"there are no cardiologists who want to see their child have a cardiac troponin that is 2x normal or 40x normal after administration of some therapeutic"
Honestly, this study should have been done in USA 👇
BIG new Israeli study: Natural immunity "offers considerably more of a shield against the Delta variant of the pandemic coronavirus than two doses of the Pfizer-BioNTech vaccine"
Affirms what i've been saying for a year in 5 opeds
CDC &NIH have not prioritized studying vax complications. J Peds study just found 69% of kids pres w/ myocarditis had a heart abnorm on MRI 3-8mo later. When pressed, CDC points to the limitations of their own sloppy method of tracking complications(VAERS)
The omicron vaccine, which was authorized based on public data from 8 mice, is now mandatory for students at Fordham. If a student (with pre-existing natural imm to omicron) develops vaccine-induced myocarditis, it will be another tragic case of politically-induced avoidable harm
Why make policies that burden people and don't stop transmission? Fordham is a special place that can turn 8 mice into a mandate. An evidence based miracle!
Dear President Biden,
Your
@CMSGov
is ordering struggling rural hospitals to fire nurses with nat immunity. Amidst a staffing crisis, some rural hosp now asking Cov+ staff to work despite active infection. This is illogical--firing unvax staff with nat imm while Cov+ staff work?
No surprise to learn that the White House is “running the CDC”. At least, he’s honest. Certainly explains why many CDC policies go against the current data and instead serve the interests of big Pharma, teachers unions, and the medical-industrial complex.
According to POTUS, Dr. Jha is “basically running the CDC” these days. If the WH advisor controls the CDC, what role does Dr. Walensky have? Does the CDC have any apolitical leadership anymore? FYI, lowering the facemask negates any effect it may have.
The rest of the world has accepted the endemic nature of Covid and moved on, but the U.S. is an int'l outlier, still pushing mass testing & chasing down every case. The admin is now hinting they will renew the Covid state of emergency later this week.
Hospitals not allowing people to visit and hold the hand of their dying loved one was one of the greatest human rights violations of the Covid response--a groupthink policy that 'experts' instituted and rigidly stuck to for most of the pandemic. There are things worse than dying.
FDA &CDC pushing the new XBB Covid booster on 300M Americans with zero human outcomes data makes a mockery of the scientific method and our regulatory process.
My latest oped..
Swapping out experienced nurses with nat guard who are not familiar with a hospital's systems, local ways of doing things & emerg protocols has risks.
Recognize natural imm, instead of demonizing our heroes who put their lives on the line and got Covid.
The NIH should be doing a long-term study of natural immunity instead of torturing thousands of beagle puppies, including cutting their voice box to avoid barking sounds (sick). All taxpayer funded. All our health agencies need fresh new leadership.
Agree Dr. Prasad. I will say it again... If anyone knows of any data showing that boosters reduce Covid hospitalizations/deaths in young healthy people, please let me know.
#followthescience
Every organization mandating boosters in young healthy people knowing the data on omicron's breakthrough rate despite boosting is making a big error.
It is ethically bankrupt, it is scientifically bankrupt, and it is going to cause serious damage to future vaccination efforts.
If Dr. Fauci, with his platform, would have ever mentioned this treatment once, many hospitalizations could have been prevented.
2 favorable trials reported in JAMA & Lancet in the spring & fall (one showing a 91% reduction in Covid deaths). No study to the contrary.
More honesty and less absolutism by health officials would have served us better. My testimony before congress today with
@DrJBhattacharya
@MartinKulldorff
Dr.
@MartyMakary
: The CDC, FDA & the NIH Decided to Vaccinate Babies Before the Trials Were Completed
"They decided babies were going to get vaccines before the study was done. And when it came out, it found no statistically significant difference in efficacy between the two…
The FDA is now trying to get the public to accept the idea of an annual mRNA Covid vaccine, with no good data. FDA leaders are in a bubble. How much longer will the FDA (18,000-employees) continue to work remotely? Its mid-day on a weekday and the parking lot is essentially empty
Amazing to see these universities clinging to their booster requirement for young healthy students.
If anyone has any data showing that boosting teenagers reduces hospitalizations, please share it. I've been on the hunt for it for over 6 months now.