Category: Vaccine

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2023 COVID-19 Testing Vaccine

Emergency Use Authorizations in a Post-Emergency World

According to the U.S. Department of Health and Human Services (HHS), the COVID-19 Public Health Emergency will expire in May, but Emergency Use Authorizations and liability protection will continue after the emergency ends.

Early in the pandemic, we were told that Emergency Use Authorizations were necessary to make unlicensed, unapproved tests, vaccines, and treatments available during an emergency.  On January 31, 2020, the Health and Human Services Secretary declared the COVID-19 pandemic a public health emergency, paving the way for these products.  The secretary even invoked the liability protection of the PREP Act to encourage manufacturing of countermeasures.  Soon, the FDA began issuing Emergency Use Authorization letters which close with a notice that the authorization will terminate when the emergency is over.

Last month, the HHS secretary signaled his intention to end the emergency on May 11, 2023.  At the same time, the secretary assured us that Emergency Use Authorizations will not be affected.  According to the statement, “Existing EUAs for COVID-19 products will remain in effect under Section 564 of the Federal Food, Drug, and Cosmetic Act, and the agency may continue to issue new EUAs going forward when criteria for issuance are met.”

The Federal Food, Drug, and Cosmetic Act was amended several times by the Consolidated Appropriations Act, 2023 (see page 1339, for example).  Did these amendments give FDA authority to issue EUAs without an emergency?  I cannot tell you because, frankly, I get lost in the language.  HHS claims its authority for EUAs in the absence of an emergency declaration dates back a decade, to the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013.  Regardless, the intention is clear: EUAs will continue after the emergency is lifted.

And what will become of those PREP Act liability protections?  According to HHS, these will also continue, but only for a select group of manufacturers:

Currently, the amended PREP Act declaration provides liability immunity to manufacturers, distributors, public and private organizations conducting countermeasure programs, and providers for COVID-19 countermeasure activities related to a USG [United States Government] agreement (e.g., manufacturing, distribution, or administration of the countermeasures subject to a federal contract, provider agreement, or memorandum of understanding). That coverage will not be affected by the end of the PHE. However, PREP Act liability protections for countermeasure activities that are not related to any USG agreement (e.g., products entirely in the commercial sector or solely a state or local activity) will end unless another federal, state, or local emergency declaration is in place for area where countermeasures are administered. HHS is currently reviewing whether to continue to provide this coverage going forward.

Fact Sheet: COVID-19 Public Health Emergency Transition Roadmap, February 9, 2023

Manufacturers of EUA products that have an agreement with the US Government will continue to have liability protection.  Other manufacturers will not.  Collusion between the federal government and big businesses like this asymmetric post-emergency liability protection is the very definition of fascism.  

If Emergency-Use-Authorizations without an emergency seem illogical to you, you are not alone.  Even members of congress have assumed that EUAs will end with the emergency declaration.  

This is not just an assault on language and logic.  It is an assault on liberty.  

The emergency declaration will end soon, but the emergency power-grab will continue indefinitely.

Categories
2022 COVID-19 Science Vaccine

Vaccination Does Not Prevent Long COVID

Infections by SARS-CoV-2 can cause acute COVID-19 which may last up to four weeks.  Post COVID Conditions, also known as Long COVID, are health consequences that persist or develop more than four weeks (or twelve weeks, according to WHO) after infection.  Individuals who have had acute COVID-19 are at risk for Long COVID.

According to government health agencies, Long COVID prevention is another reason to get vaccinated.  Without offering any evidence, or even a plausible mechanism for why it might be so, the CDC says that “people who did not get a COVID-19 vaccine” are more likely to develop Long COVID.  Health+ Long COVID, a report sponsored by HHS and released last month, contains the recommendation to “promote vaccination as a preventative measure for Long COVID.”  NIH even encourages unvaccinated people to get vaccinated after recovering from COVID-19 because it “may prevent Long COVID.”  But there are good reasons to doubt that any of this is true.

Long COVID can follow mild or asymptomatic infections by SARS-CoV-2.  Although there may be more than one pathway to Long COVID, autoimmunity is responsible for some, if not most, cases of Long COVID.  The intensity of the initial disease does not matter.  Mild or asymptomatic infections can stimulate the autoantibodies that cause Long COVID.  Even if you believe that vaccination reduces severity of COVID-19—I am not saying you should—there is still no reason to believe that vaccination can prevent Long COVID.

Recent studies back this up.  According to an article published in Nature last month, vaccination status does not modify the risk of Long COVID.  Instead, Long COVID correlates to the number of SARS-CoV-2 infections a person has, regardless of vaccination status.  Even though vaccination cannot prevent Long COVID, it may make it worse.  

Think about how autoimmunity causes Long COVID.  Once the immune system is stimulated to recognize the spike protein of SARS-CoV-2, the immune system may attack the body’s own cells.  Whether by an accident of nature or by design, antibodies to spike protein cause autoimmune disease in some people.  It does not matter whether the antibodies are formed in response to vaccine or natural infection, the effect is the same.  Vaccination injuries can look like Long COVID.

Dr. Marivic Villa, a Florida pulmonologist who has treated thousands of COVID patients in The Villages, agrees.  According to a recent publication, Dr. Villa says, “The signs and symptoms profile and clinical presentation of long-haulers from moderate to severe natural COVID infection, and individuals vaccinated three to four times, are almost indistinguishable from one another.”  The formation of autoantibodies by either natural infection or vaccination connects Long COVID to vaccine injuries, consistent with Dr. Villa’s observation.  She concludes, “Halting this vaccination is the highest emergency!”

Long COVID has White House attention.  This focus seems timed to perpetuate the emergency, just like the government distribution of free tests earlier this year.  These substandard tests, purchased by the government and mailed to anyone with a U.S. address, were bad laboratory medicine, saved no lives, and have not been missed since funding ran out.  But the program stirred up COVID activity, keeping the crisis going.  And it enriched test suppliers.

Similarly, attention to Long COVID is a pretext to extend the emergency powers of the executive branch by combining a tragic reality with bad medicine, unsupported by honest science.  And it enriches vaccine manufacturers.  

Every case of COVID-19, every SADS death, every victim of Long COVID, and every individual injured by vaccine is a life lost or damaged by the tragedy of the pandemic.  Long COVID cannot become just another excuse to promote vaccine.

Categories
2022 Vaccine

Immunizations for Vaccinations

Last week, CDC published an interim COVID-19 vaccination schedule that recommends unapproved COVID-19 vaccines for routine administration to children less than twelve years of age. This is the first time CDC has placed an unapproved vaccine on the childhood vaccination schedule, permanently transferring liability for these vaccines from the manufacturer to American taxpayers, even after the emergency ends.  Only Congress can change this now.

We knew this was coming.  The PREP Act Declaration issued by the Secretary of HSS more than two years ago granted immunity “from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration or use of a covered countermeasure” while the nation is under the COVID-19 emergency declaration.  “Countermeasures” include vaccines.

PREP Act immunity is not permanent.  When the emergency declaration is finally lifted, continued use of COVID-19 vaccines will expose the vaccine manufacturers to liability unless it becomes a “covered vaccine” under the National Vaccine Injury Compensation Program. 

What is a covered vaccine?

For a vaccine to be covered, the Centers for Disease Control and Prevention (CDC) must recommend the category of vaccine for routine administration to children or pregnant women.  

Those where not my words; they come directly from the HRSA website.  Once covered, the vaccine is protected for all recipients, not just children and pregnant women.  By recommending COVID-19 vaccines for children, the CDC transferred all associated product liability to the American taxpayer.

This action is an assault on many levels, but I want to focus on only one.  The recommendation applies to an unlicensed product.  No matter your opinion of FDA’s approval and licensing process, the process should be completed before a product is recommended for routine use.  An emergency use authorization does not apply to non-emergent administration.

COVID-19 vaccines are not approved for anyone younger than 12 years of age.  Furthermore, approved COVID-19 vaccines remain unavailable to Americans of any age—although that will probably change now that permanent immunity has been secured.  A vaccine that is not approved for children should not be recommended for children, and it has never happened before.  This is the first time that the recommendation for routine administration has preceded FDA approval.

FDA approval is a slow and laborious process with many critics.  Despite decades of attempts at acceleration, at the pandemic’s outset the FDA’s process was seen as a liability that put Americans at greater risk than citizens of other nations.  The fear that the FDA would slow down an effective pandemic response led to the emergency declaration by HHS and the use of Emergency Use Authorizations to bring new countermeasures to market.  Although careful, meticulous approvals can be painstaking, rapid approvals compromise safety.  I did not take an oath to eliminate frustration; I took an oath to do no harm. 

But what harm is there in vaccine?  Surely vaccines are the most benevolent of therapies, protecting against dread diseases while rarely causing harm.

This thinking is an example of association fallacy.  A risk-benefit analysis that favors some vaccines is not a favorable risk-benefit calculation for all vaccines.  Each vaccine must be carefully evaluated on its own merits.  The slow, methodical FDA approval process meets that standard.  Or at least I thought so.

FDA’s approval process has let us down, plenty of times.  Think of television commercials promising large litigation settlements to victims of injury by various drugs.  There will be no such advertisements for COVID-19 vaccine injuries since these vaccines have immunity under the law.  Unless the law changes.

Congress has the power to change law, and Congress has the duty to change bad laws.  

Although Congress did not directly grant liability protection to COVID-19 vaccine manufacturers, by passing the National Childhood Vaccine Injury Act of 1986, the 99th Congress created a loophole that gave the CDC power to shelter COVID-19 vaccine manufacturers from liability, setting the stage for what happened last week.

CDC’s actions are unprecedented.  Recommending an unapproved vaccine for children is reckless. Transferring product liability risk from manufacturers to taxpayers is corrupt.  Congress owns this.  Congress can change this.

The election for the 118th Congress is only days away, and early voting has already begun.  Please keep this in mind as you consider your vote.

Categories
2022 Vaccine

The Vaccine Is a Virus

mRNA Vaccine Lipid Nanoparticle

A virus is a sequence of genetic code wrapped in an envelope.  Viruses are classified by their envelope and genetic code configurations.  Since they do not possess independent means of reproduction, viruses are not technically alive, yet they yield to the primal force of life—the urge to propagate their genes.  To do this, each virus seeks a host, hijacking its means of reproduction to pump out as many copies of the virus as possible.  Each copy seeks its own host to infect, and the cycle repeats.  In this way, the virus and its genes live without being alive.

An mRNA vaccine is a sequence of genetic code wrapped in an envelope.  The genetic code is messenger RNA and the envelope is a lipid nanoparticle, but that does not change the similarity to a virus.  Like a virus, each mRNA vaccine particle infects a host cell, hijacks the cell’s means of production, and pumps out copies of the encoded spike protein.  

Both virus and vaccine introduce spike protein into the body.  When virus enters through the nose and upper airways, the spike protein on the virus causes an immune response and spike antibodies are formed.  A successful immune response clears the virus, but the immune memory lingers, spike antibodies and all.  Inoculation by mRNA vaccine is also an infection, except this infection occurs in the arm.  

We were told—and I wrote in this blog—that vaccine mRNA stays in the cells of the arm muscle and is broken down quickly, but that is not true.  Studies published this year have demonstrated vaccine mRNA in breast milk, blood, lymph nodes, liver, and skin.  Unlike spike protein from a mild infection, vaccine induced spike protein can be detected in blood up to four months after vaccination; from there, it can distribute widely throughout the body.  Clearly, the mRNA does not stay in the arm and is not broken down quickly.  Compared to natural infection, genetic COVID-19 vaccines are more likely to spread spike protein throughout the body. 

This wide distribution of vaccine is significant.  Every cell that ingests a lipid nanoparticle will express spike protein, marking the cell as an immune target.  As a result, the cell will die.  This process is a direct mechanism for adverse effects like vaccine-induced myocarditis.  When a heart muscle cell absorbs vaccine, the spike proteins generated incite inflammation that kills the cell.  If this happens to enough heart cells, the person will die—suddenly and unexpectedly.

Yet this mechanism may not explain all the adverse effects of vaccines.  Serious conditions such as acute myocardial infarction, Bell’s palsy, cerebral venous sinus thrombosis, Guillain–Barré syndrome, myocarditis, pericarditis, pulmonary embolism, stroke, thrombosis with thrombocytopenia syndrome, appendicitis, herpes zoster reactivation, neurological complications, autoimmune hepatitis, and autoimmune peripheral neuropathies have been reported.

Since these conditions have also been observed after SARS-CoV-2 infection, a common autoimmune pathway is proposed.  Whether introduced by virus or vaccine, spike protein shares features with molecules naturally found in the body.  There are enough similarities that antibodies to spike protein may cause disease.  The antibodies that remain after infection or inoculation are unable to distinguish between the harmless molecules of the body and viral spike protein.  The result is an attack on one or more parts of the body by the body’s own immune system. 

SARS-CoV-2 virus and mRNA COVID-19 vaccines share structural features and pathogenic effects.  Both consist of genetic material within a lipid envelope.  Both introduce spike protein to the body, and both stimulate antibodies against spike proteins and their lookalikes, which may damage one or more organs.  The adverse effects of vaccine can look like long COVID.

The vaccine is a virus, with one important difference.  The virus, you catch.  The vaccine, you take.

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Science Vaccine

Irrelevant Vaccines and Untested Boosters

Until now, all COVID-19 vaccines and boosters available in America were engineered for the original strain of SARS-CoV-2.  Over time, mutations have made this target irrelevant.  Now for the first time, boosters and vaccines will have different formulas.  But beware.  Bivalent vaccines are the latest product of a corrupt system that threatens your health.

On August 31, the FDA authorized new bivalent boosters by Pfizer and Moderna for individuals 12 years and older.  At the same time, FDA withdrew the EUA for monovalent mRNA boosters for the same age group.  The next day, the CDC signed-off on the distribution of these new booster formulas.  There has been no change in Janssen’s monovalent booster authorization, and Novavax does not yet have a booster authorization.  The new bivalent boosters are unlicensed, unapproved, and—this part is new—untested in human trials.  More about that later.

The new boosters are called “bivalent” because they stimulate immunity against two different targets—the original SARS-CoV-2 strain isolated in January 2020, and the Omicron BA.4/BA.5 strains.  “Monovalent” vaccines have not changed; they only stimulate immunity against the original SARS-CoV-2 strain, now largely irrelevant.  Monovalent mRNA boosters are no longer available; all mRNA boosters are bivalent.  The newly authorized boosters are already listed on vaccines.gov, but unvaccinated individuals cannot get one.  You must receive a monovalent primary series vaccine before you can receive a bivalent booster.  

The bivalent boosters were brought to market so quickly because they bypassed FDA’s standard process.  Manufacturers were not required to present clinical trial data.  

We knew this was coming.  At its June 28 meeting, the FDA’s Vaccines and Related Biological Products Advisory Committee recommended that new booster formulations be authorized without examination of data by the FDA.

COVID-19 vaccine trials have been flawed.  The clinical trials for each of the four authorized vaccines lack long term follow-up.  All four vaccinated the control group so that we will never know of vaccine complications that occur more than a few months later.  FDA authorized and approved mRNA vaccines without knowing whether the vaccines cause birth defects or whether they are safe to give during pregnancy.  The mechanism of major adverse effects such as VITT or myocarditis is still unknown.  None of the trials showed that vaccination resulted in a reduction in all-cause mortality.   Despite these flaws, FDA has insisted on clinical trials before granting emergency use authorization.

Instead of addressing the flaws and tightening up the process, FDA has decided to do away with clinical trials altogether.

Dr. Paul Offit said he felt the fix was in.  “I’ve seen nothing like this,” he said.  “Both Moderna and Pfizer presented data during the June 28 meeting, and it was not compelling.”  Dr. Offit noted the lack of a control group in the scant data presented.  “That’s the obvious thing to do because that’s why you have control groups for your experiment, and I just found it odd that neither presented,” he added. “That bothered me.”

If this bothers Dr. Offit, it should bother you too.  Dr. Offit and I have had very different perspectives during the pandemic.  In an PBS interview last year, Dr. Offit said that vaccine opponents are the cause of pandemic deaths.  Dr. Offit has gone on record in favor of vaccine and mask mandates for school children.  As a member of the FDA’s VRBPAC, Dr. Offit has supported most vaccine and booster authorizations, until now.  Dr. Offit cast one of the two dissenting votes at the June meeting, and he was so bothered that he co-authored an Op-Ed shortly afterward.

Could these new genetic injections cause unforeseen harm?  Of course they can.  This blog has warned of the unintended consequences of new technology.  There are many examples in medicine of well-intentioned novel therapies having disastrous results, harming many more than they helped.  Again, Dr. Offit makes this point, “No one would have predicted myocarditis associated with mRNA vaccines. I don’t think anybody would have predicted this clotting problem so-called thrombosis with thrombocytopenia syndrome.  So, humble yourself.”  

It will be hard to prove that vaccines cause injury without methodical study.  And methodical study is what FDA is eliminating.  We may never know the harm caused by these boosters.

There is one thing for sure.  With 105 million doses of the new bivalent booster already on order, Pfizer is going to receive a large check from American taxpayers this fall—at least $3.2 billion.  Money and corruption are often found together.

Irrelevant vaccines and untested boosters are products of a corrupt system that intends to trap you in an unending cycle of injections, robbing your money before robbing your health.

I saw this in my crystal ball last year.

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Testing Vaccine

Institutionalized Misconceptions

The CDC quietly changed its COVID guidance last week.  In an August 11 update to Isolation and Precautions for People with COVID-19, the CDC removed the vaccination advantage for ending COVID-19 isolation.  Now the CDC expects everyone to follow the same isolation guidance, regardless of vaccination status.  Yet even its newest guidance perpetuates myths that extend the COVID emergency unnecessarily.

Here is the new guidance.  If you suspect you have COVID-19, you should test.  Isolate until you receive your test result.  If your test is negative, end isolation.  Asymptomatic individuals with a positive test should isolate for five days and wear a mask for ten.  If your test is positive and you have symptoms, isolate for five days from the first day of your symptoms or for 24 hours after you are fever-free, whichever is longer.  Mask for ten days.  Better yet, mask until you have had two negative antigen tests 48 hours apart.

Previously, CDC recommended different isolation protocols depending on vaccination and booster status.  Now there is no difference, another tacit admission that the vaccinated and unvaccinated spread infection similarly.  This is a softening of its once bellicose “Pandemic of the Unvaccinated” position, and not the first time either.  In the last paragraph of a June MMWR report, the CDC admitted, “Despite the introduction of highly effective vaccines and medications to treat COVID-19, by the end of the study period, COVID-19 continued to cause substantial morbidity and mortality.”  Hopefully, this new direction will reduce fuel for those actively practicing health discrimination against the unvaccinated, or against the vaccinated but not up-to-date.

I am not holding my breath.  There continues to be a lot of momentum in that direction.

Despite this small positive, the new guidance continues to perpetuate misconceptions that have been institutionalized within the CDC.  Here are three examples.

There is a test for COVID-19.  The CDC confuses a SARS-CoV-2 test with COVID-19, something this blog has warned against since the early days of the pandemic, but which has become an institutionalized misconception at the CDC.  There is not a test for COVID-19.  Symptoms are necessary for diagnosis.  

Asymptomatic individuals should be tested.  Different guidance for those with and without symptoms implies a recommendation for testing asymptomatic individuals.  “Asymptomatic spread” is an unsubstantiated idea at best and deliberate fearmongering at worst.  Guidelines that promote asymptomatic testing perpetuate the myth that “asymptomatic spread” is a real concern, effectively prolonging the emergency.  Testing should be limited and focused.

Tests can determine when to end isolation. The updated guidance uses test results instead of symptoms to end of the isolation period.  This misconception relies on the assumption that an individual who has tested negative is unlikely to spread infection.  The fallacy of this assumption is embedded in the guidance, which requires two consecutive negative antigen tests to end masking.  Why two tests?  Antigen tests have low sensitivity, meaning lots of false negative results.  If the first test is not reliable, should the second test be any better?  “Past performance is no guarantee of future results.”—that works for investing and for testing.  The guidance might as well say, “Flip a coin every 48 hours; leave your mask on until you get two heads in a row.”  SARS-CoV-2 tests do not test for cure of COVID-19.  

Many people just ignore the CDC, but there are those who live in trauma and fear unnecessarily.  Misconceptions institutionalized by the CDC trap those individuals in a cycle of stress and panic.  It is time for sensible, uncomplicated, time-tested guidance.

If you feel sick, stay home.  When you feel better, get on with your life.

Stop scaring people already.

Categories
Vaccine

Am I Up to Date?

Government health policy says Americans should be “up to date” with COVID-19 vaccines, but what does that mean?  To answer this question, I had a conversation with CDC’s website.  CDC responses are copied verbatim, correcting only misspellings and grammar for ease of reading.  Use the links if you want to check the responses for context.

KH: Why should I get a COVID-19 vaccine?

CDC: COVID-19 vaccines available in the United States are effective at protecting people from getting seriously ill, being hospitalized, and even dying.

KH: Then all I need is a vaccination, right?

CDC: COVID-19 vaccines available in the United States are effective at protecting people—especially those that are boosted—from getting seriously ill, being hospitalized, and even dying.

KH: You’re saying that vaccination isn’t enough—I need a booster too?

CDC: You are protected best from COVID-19 when you stay up to date with the recommended vaccines.  You are up to date with your COVID-19 vaccines when you have received all doses in the primary series and all boosters recommended for you when you are eligible.

KH: How do I know what boosters are recommended for me?

CDC: Vaccine recommendations are different depending on your age, the vaccine you first received, and time since last dose.

KH: Let’s say I got Pfizer.  When am I fully vaccinated?

CDC: Two weeks after final dose in primary series.

KH: How long do I have to wait after my first dose before I can get my second one?

CDC: Three weeks (or 21 days) after the first dose.

KH: First dose, wait three weeks, then second dose, then wait two weeks, then I’ll be fully vaccinated, right?

CDC: People ages 6 months through 64 years, and especially males ages 12 through 39 years, may consider getting the second primary dose of an mRNA COVID-19 vaccine (Pfizer-BioNTech or Moderna) eight weeks after the first dose. 

KH: Why is that?

CDC: A longer time between the first and second primary doses may increase how much protection the vaccines offer, and further minimize the rare risk of heart problems, including myocarditis and pericarditis.

KH: Myocarditis!  That sounds serious.

CDC: There is a rare risk of myocarditis and pericarditis associated with mRNA COVID-19 vaccination, mostly among males ages 12 through 39 years.  Those who have been diagnosed with myocarditis should consult with their cardiologist (heart doctor) about return to exercise or sports.

KH: I don’t want to stop playing sports, so maybe I should wait eight weeks before my second shot.  Do I need a booster?

CDC: One booster, preferably of either Pfizer-BioNTech or Moderna COVID-19 vaccine, at least five months after the final dose in the primary series.

KH: I’m 59–just one booster?

CDC: Second booster of either Pfizer-BioNTech or Moderna COVID-19 vaccine for adults ages 50 years and older, at least four months after the first booster.

KH: Primary series—two shots—then two boosters.  I need four shots to be up to date?  What if I’m immunocompromised?

CDC: First dose-primary series; second dose-primary series three weeks after first dose; third dose-primary series at least four weeks after second dose; forth dose-booster at least three months after third dose; fifth dose-booster at least four months after forth dose.

KH: Five doses!  Is that safe?

CDC: The safety, effectiveness, and benefit of the third primary dose in people who are moderately or severely immunocompromised continues to be evaluated.

KH: Let me review.  You’re saying that to be up to date and fully vaccinated in the safest possible way, I should get my first shot, wait eight weeks (or did you say three weeks?), get my second shot, wait four more weeks (or is it eight weeks?), get my third shot (I’m immunocompromised, remember?), then wait three months (or is that five months?), get my fourth shot, wait four more months, then get my fifth shot.  How can I afford so many shots?

CDC: COVID-19 vaccines are available for everyone ages 6 months and older at no cost.

KH: Great!  Vaccine makers are sacrificing profits to give away vaccines to Americans.  How patriotic!

CDC: Vaccines were paid for with taxpayer dollars.

KH: Oh, I see.  COVID-19 vaccines are not free.  Taxpayers are paying vaccine makers for the shots given to fellow citizens…

CDC: …to all people living in the United States, regardless of health insurance or immigration status.

KH: You mean my tax dollars are paying for vaccines for all those people crossing the southern border illegally?

CDC: Jurisdictions (state, tribal, local, and territorial) cannot add U.S. citizenship requirements or require U.S. citizenship verification as a requirement for vaccination.

KH: Let me get this straight.  The government takes money from me and gives it to vaccine makers so that anyone living in the United States can access vaccines.  What do you call that?

CDC: If anyone asks you to pay for access to a COVID-19 vaccine, it’s a scam. 

KH: You said it.

Categories
Ethics Science Vaccine

Against the Rules

FDA made significant changes to COVID-19 vaccines available in the United States last week.  In its recent actions, the FDA displays pattern of blatant rule breaking that indicates negligence and corruption.  Here are three examples.

Pfizer.  FDA gave license to vaccinate middle-schoolers twelve years and older with COMIRNATY by its supplement approval letter of July 8, 2022.  This approval was issued in response to Pfizer’s submission of pediatric Study C4591001 regarding safety and effectiveness of COMIRNATY in children 12 through 15 years of age.  However, Pfizer reports that this study relied on data from a trial using 16 to 25 year-olds conducted prior to Delta and Omicron surges, raising questions regarding its relevance.

FDA rules require manufacturers to inform FDA within 6 months of “a permanent discontinuance in manufacturing”, or “an interruption that could lead to a meaningful disruption in the supply of the product in the United States” (page 7, lines 208-210), even if the manufacturer decides to cease production for business reasons (lines 221-222).  COMIRNATY has never been available in the United States in the eleven months since initial approval.  I am not an attorney, but this seems like a meaningful supply disruption of the licensed product to me, which should trigger a reconsideration of the vaccine’s license.  An expansion of COMIRNATY’s license while the product is still unavailable violates the spirit, if not the letter, of FDA’s own rules.  Instead, the approval appears to be merely a merit badge providing a marketing advantage to Pfizer without changing that fact that no approved vaccines are yet available to Americans.

Novavax.  The predicted authorization of the all-protein Novavax vaccine happened with fanfare last week.  FDA’s press release welcomed the arrival of “another option” for Americans, and assured that “the American public can trust that this vaccine, like all vaccines that are used in the United States, has undergone the FDA’s rigorous and comprehensive scientific and regulatory review.”  I have issues with both statements.

The use of emergency use authorization to provide “another option” violates the rules governing emergency use authorizations.  The purpose of the EUA is to make products available when “there are no adequate, approved, and available alternatives.”  There are approved alternatives—COMIRNATY and SPIKEVAX—which are, by manufacturers’ choice, unavailable.  But adequate alternatives are available.  Search vaccine.gov to see whether you can find vaccines in your area.  If you cannot, please let me know. If you can, another unapproved option is unneeded.

The assurance of “rigorous and comprehensive scientific and regulatory review” is misleading, since that describes the approval process, not the authorization process.  EUA is for emergencies, like bailing water out of a sinking ship.  “Rigorous and comprehensive” describes a process to assure seaworthiness before putting the ship into water and results in a license to sail.  Novavax has no license. It has not been through a truly rigorous and comprehensive scientific and regulatory review.

Moderna.  Authorization letters require manufacturers to comply with section 502(a) and (f) of the FD&C Act, which prohibits false or misleading labelling.  Yet children ages 6 through 11 are to be vaccinated with Moderna Purple, which is labelled “BOOSTER DOSES ONLY” because Moderna Teal is still unavailable.  Unreliable labelling is a setup for medical error, which is why the rules prohibiting misleading labels are so clear.  Instead of insisting that Moderna relabel product before distribution, FDA issued a “Dear Healthcare Provider” letter, instructing caregivers to ignore the printed label.

Vaccine chart, updated July 16, 2022.

This is the current state of vaccines in America.  We did not get here honestly.  Instead, we got here by bending, twisting, and breaking the rules established to keep us safe.

FDA is a law enforcement agency that should respect rules.  If you come under FDA’s jurisdiction, you rigorously follow its rules and regulations because FDA has the power to shut you down.  Just ask Abbott Nutrition, the operator of the Michigan baby food plant forced to cease production earlier this year.  The resulting baby formula shortage is a serious emergency, yet there have been no emergency use authorizations for manufacturers racing to have new product approved.  Meanwhile, we still have an emergency declaration that short-circuits the process for vaccines.

The FDA has compromised its rules related to vaccines.  It is a clear signal of negligence and corruption.  There is something pathologic at the FDA.

Categories
Science Vaccine

Medical Publications Bow to a Political Narrative Causing Loss of Public Trust

Publications in top-tier medical journals must comply with a narrative.  As a prerequisite for publication, authors must affirm that universal vaccination is the best response to pandemic, and that the benefits of vaccination outweigh any harm it causes.  Even articles that describe vaccine injuries must minimize their risks in deference to the goal of universal vaccination.  This misuse of the medical literature suborns the mission of journals to a political agenda, squandering the trust they once enjoyed.

I noticed this trend during research for these blogs.  Here are a few examples to give a flavor of the narrative.

  • In a recent review of clotting complications caused by vaccine published in Journal of Stroke and Cerebrovascular Diseases, Kakovan et al. end their article by saying, “Finally, since the advantages of COVID-19 vaccination outweigh the risk of stroke or any other neurological complication, the public should be reassured that the vaccination program is still the best way to combat COVID-19.”  The article gives no support for this conclusion.  It is as if the authors knew that homage to this dogma was the price of publication.
  • In a Reviews in Medical Virology article presenting data showing that vaccination causes a 13.6 times increase in myocarditis among 16-19 year-old males, Faziollahi et al. conclude that these complications are “rare,” missing this obvious data signal.  
  • “The very low prevalence of this complication of vaccination, however severe, relative to the benefits of preventing Covid-19 (a condition with 1 to 2% mortality and potential long-term sequelae) must be emphasized.” Clines and Bussel in New England Journal of Medicine.
  • “Independent safety reviews by regulatory authorities of available clinical and real-world evidence have concluded that the benefits of AZD1222 outweigh the potential risks.”  Falsey et al. in New England Journal of Medicine.
  • “The thromboembolic complications do not represent a contraindication to complete the vaccination cycle…” and “The vaccination for SARS-Cov-2 is essential to overcome the pandemic…” Serrao et al. in Journal of Thrombosis and Thrombolysis.

The narrative is fully stated in this quote from an article published in Journal of Clinical Medicine to help practitioners provide “evidence-based counseling to their often-alarmed patients” who have new blood clots after vaccination.  Abrignani et al. conclude,

“All scientific societies emphasize the value of continuing vaccination programs to protect patients from severe forms of COVID-19 and to slow the circulation of the virus and its variants. Vaccine hesitancy risks regressing progress in infectious disease control. Abstention is not an option, as it results in a failure to assist a large population that remains in danger. Action, with increased vigilance, is the best solution in our public health mission.”

Medical journals should be places of conflict, where ideas clash, paradigms are upended, and the status quo is challenged.  The New England Journal of Medicine claims, “Our mission is to publish the best research and information at the intersection of biomedical science and clinical practice and to present this information in understandable, clinically useful formats that inform health care practice and improve patient outcomes.”  But the crossroads of biomedical science and clinical practice is not a static location, unchanging over time.  Without medical journals exposing dangers of established practice, physicians might never have learned that diethylstilbestrol treatment causes cancer or that thalidomide therapy causes birth defects.  

Today’s medical journals have devolved into a repository of orthodoxy where platitudes are exchanged among the sanctified.  They bow to a narrative that coincides with a political agenda, mocking the missions of these publications.  The trust accumulated from two centuries of diligence and integrity has been lost in a few months.

The erosion of trust does not stop with the journals.  It extends to my entire profession of physicians. Yet too few of my colleagues have acknowledged this trend.  Instead, most parrot the narrative to their patients.  Why?  Are they afraid they will never be published again?  Are they afraid they will be ostracized from the society of physicians and scientists?  Or are they just too lazy to observe and think for themselves?

Physicians have a sacred duty to the patient in front of them.  This duty requires honest observation, independent thought, and attention to the patient’s best interest.  Without these, we deserve the loss of public trust.

Categories
Vaccine

Regulatory Capture

Up to now, all the vaccines have been the same.  The only differences in the vials are the concentrations of genetic material for various age groups and boosters.  As the virus continues to mutate at a rapid pace, current vaccines are becoming irrelevant.  That may be about to change, but not for better.  The roadmap to release of future vaccine versions will be the subject of the FDA’s Vaccines and Related Biological Products Advisory Committee meeting on Tuesday.  This plan could open the door to genetic engineering without safety oversight. 

Simplicity and standardization reduce error, yet vaccine rules are becoming more complex.  Instead of mandating standardization, the FDA has allowed manufacturers to establish packaging, dosing, and interval parameters.  This is the result of regulatory capture—regulators overtaken by those they are charged with regulating.  Regulatory capture has caused FDA to authorize so many versions that it is easy to forget there are still just three vaccines available in the United States.  

Pfizer, Moderna, and Janssen vaccines have not changed since their introductions.  All three are designed to produce immunity against a virus which is no longer a threat.  Although the many different vials in the Pfizer and Moderna vaccine families make it appear these companies have been hard at work making new vaccines, they only adjusted the product concentrations and doses for different age groups and boosters without the slightest change in the immunity target.  We’re skating to where to puck has been, not to where it is going.  

The FDA and vaccine manufacturers are aware of the problem.  Like the needlessly complicated vaccine landscape, their solution will be another example of regulatory capture.  If approved, future Covid-19 vaccines versions will skip clinical trials.  The manufacturer can change the genetic material in these vaccines without understanding the consequences of the change.  If you want plan details, read this Substack article by Dr. Toby Rogers of Brownstone Institute.

Why is this dangerous?  Afterall, if we are going to keep up with this virus, shouldn’t we give scientists the freedom to engineer the vaccines on the fly?

The first problem with this idea is that scientists do not know what they are doing.  Because the understanding of genetics and immunology is incomplete, we cannot expect scientists to flawlessly produce genetic code that is safe for human injection.  If I download and install a hack I find online, the worst outcome is a bricked phone (it’s happened; ask my wife).  If genetic engineers make a mistake, the consequences are frightful—think Zombie movies, Frankenstein, and Jurassic Park.  Afterall, they are tinkering with the operating system of life.  Genetic engineering should require more oversight, not less.

The motives of vaccine manufacturers represent a worse problem.  These companies have a duty to their boards and shareholders that supersedes the health and wellbeing of their customers.  We regulate the healthcare industry for this reason.  If we give pharmaceutical companies license to sell untested versions of genetic code, they will use it to bulk up balance sheets.  Honest clinical trials are the only way to check these corrupt intentions.

We must get integrity back into the oversight and approval process, and we do this by getting the money and corruption out.  Safety cannot be ensured when studies performed at universities and published in journals by scientists are presented to advisory committees.  At least not when the company pays for the study, endows the university, advertises in the journal, pays royalties to the scientists, and funds committee member projects.  These cozy arrangements must end.  Anti-kickback laws must apply to all parties in the biomedical-industrial-regulatory complex.