Permanent Emergency? VRBPAC Committee Votes for Annual COVID-19 Injections

When a supposed independent committee with ties to pharma makes decisions on vaccines without having all the data or considering safety signals it's really just regulatory theater.

On January 26 the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) held a meeting to discuss updates to the now infamous COVID-19 genetic vaccine program. Twenty-one voting committee members, the largest panel to date, met to discuss future strain composition for COVID-19 genetic vaccines, simplification of the different formulations and dose schedules, and plans for future strain recommendations.

VRBPAC members finally concede that the monovalent injections are useless

Once adopted by the FDA and CDC, the change could effectively end the use of the original monovalent shots that were aimed at the original Wuhan strain of the virus. The meeting comes more than two years after the genetic vaccines were rolled out followed by vaccine mandates, despite failing to stop infection or transmission – as top public health officials promised they would – and the original strain has been extinct for well over a year and a half.

Under a proposal floated by the FDA to the committee, most Americans would get one dose a year. Some Americans – including unvaccinated young children and older at-risk adults – would be eligible for two or more doses a year going forward, similar to what is recommended for influenza vaccines. The committee suggested meeting annually by early June, ahead of a fall rollout, to decide on changes to the strains targeted by COVID-19 genetic vaccines.

As has happened in previous meetings, the members of the VRBPAC panel voted unanimously in favor of "harmonizing" the initial shots given to unvaccinated Americans with the updated booster shots rolled out last year, in a bid to simplify COVID-19 genetic vaccines. Thursday's vote means unvaccinated people could soon skip straight to the bivalent shots that had been given as booster doses over the winter. (I see another change to the definition of “fully vaccinated” ahead.)

More Regulatory Theater by the VRBPAC

I tried to watch some of the meeting yesterday and it made me so angry I had to disconnect. Most members had “nothing to add” to the discussion and didn’t ask any questions with regard to this suggested approach. This all seemed like regulatory theater. Committee members had their minds made up even before seeing any data on the updated “booster” injections. And why not? This is what they did when they approved the so-called bivalent “booster” injections when they first rolled out last fall without even having been tested in humans.

The biggest concern of the voting members seemed to be that the focus was solely on mRNA shots and was taking into consideration the other genetic vaccine platforms in use. One committee member mentioned that his vax card was full and they would need to explore other ways to catalogue “vaccine” status going forward (smacks of upcoming digital vaccine passport systems).

“The most concerning data point that I saw this whole day was that extremely low vaccination coverage in 6 months to 2 years of age and also 2 years to 4 years of age,” said Dr. Amanda Cohn, director of the US CDC Division of Birth Defects and Infant Disorders.

Meanwhile, data to date has clearly supported these age groups are the least likely to experience severe disease or hospitalization from SARS-CoV-2.

Here are just a few reasons why continued injections make no sense (this list is in no way exhaustive):

1. The genetic vaccines are NOT fully FDA licensed. This one speaks for itself. Why are we still recommending a product that has not been given full FDA-approval? If these genetic vaccines are so great why are they not getting fully licensed?

   

2. Annual shots are not an emergency! To repeat what I said in point number one in another way, the genetic vaccines are only emergency use authorized (EUA). This means that they can only be deployed under an emergency situation. Are we really still in an “emergency” situation?! Even the POTUS acknowledged last fall that the pandemic is over. Given that SARS-CoV-2 has now become endemic, it is safe to say that we are no longer in an emergency situation. However, ending the emergency declaration would mean that use of all EUA products would cease until they obtain full FDA approval. In other words, there is no emergency for annual COVID-19 vaccines.

3. Immunity from the mRNA injections quickly wanes. The committee suggests moving the genetic vaccines to an annual shot similar to flu shots. (There is so much I can say on this point that may be a blog post on its own.)

   Ahead of a fall “booster” rollout by September, the committee would convene annually by early May or June to decide on changes to the strains targeted by the genetic vaccines. This would give manufacturers about three months to update their shots and get the new doses to pharmacies. One big issue with this is that the virus has been present year round with surges in the summer months as well as in the winter. It is too early in the endemic phase to understand the seasonality of SARS-CoV-2.

   The biggest issue is that within the time frame it takes to make the genetic vaccine and distribute them, new variants may have already emerged. It has been well documented that the benefit from these genetic vaccines is only a few months at most. In fact, one committee member admitted that the genetic vaccines only prevents infection for 3 months.

   These vaccines don’t provide protection from infection and more importantly, immunity wanes more quickly with each successive injection. Some would say we need “better vaccines” but what we really need is freely available effective early treatments.

4. There is NO data on the effect of multiple sequential doses of mRNA injections. A new study recently came out showing that with each successive injection the immune response is being skewed towards immune tolerance!

   "Here, we report that several months after the second vaccination, SARS-CoV-2-specific antibodies were increasingly composed of non-inflammatory IgG4, which were further boosted by a third mRNA vaccination and/or SARS-CoV-2 variant breakthrough infections."

   The implications of this are quite disturbing. The role of IgG4 as a ‘tolerizing antibody’ is inherently linked to T regulatory cells (Tregs). Tregs are essential to the maintenance of immunological unresponsiveness to self-antigens thus protecting the host from unwanted immunological responses to self. What this means in laymen’s terms is increased potential for autoimmune diseases and cancers.

5. While CDC is finally recognizing a safety signal, regulators are still not acknowledging the adverse effects from these injections. There has been a strong single for myocarditis following the mRNA injections. A recent study highlighted yet again that the risk-benefit scenario does NOT favor vaccination, particularly in young, healthy age groups. A higher incidence of heart inflammation directly correlated with an increased dose of Spike mRNA used for the Moderna vaccine. Spike is toxic to heart muscle and causes formation of amyloid fibrils that likely play a role in microclotting.

   "...we observed a 2- to 3-fold higher odds [of myocarditis/pericarditis] among individuals who received mRNA-1273 vs BNT162b2. The rate of myocarditis following mRNA-1273 receipt is highest among younger men (age 18-39 years)."

   Not only that, following the availability and use of the updated (bivalent) COVID-19 genetic 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 genetic bivalent vaccine. 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 genetic bivalent vaccine were more likely to have an ischemic stroke in the 21 days following vaccination compared with days 22-44 following vaccination.

   These are just a few of the exhaustive list of adverse events that have been reported after taking the genetic vaccines. Again, this could be a few blog posts on their own so I won’t go too much into all of them here, except to say that people are being damaged, disabled, and dying from these genetic vaccines. These poor people are being shame, gaslit, and ignored. What they need is their voices to be heard. They need support, compassion and most of all treatment for the ill effects they have suffered after taking these injections.

At the end of the day, the one thing I can agree with the VRBPAC committee on is that it is long past time for the monovalent genetic vaccines to be retired. The use of all the genetic vaccines needs to be halted pending further investigation into their TRUE safety and efficacy. At this point a vast majority of people in the world now have some level of immunity to SARS-CoV-2 so further vaccinations are unnecessary.