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.