mRNA Vaccines and EUA

open.substack.com/pub/rwmalonemd/p/mrna-vaccines-and-eua

mRNA Vaccines and EUA by Dr. Robert Malone

Whatever you may currently think about the SARS-CoV-2 vaccines, it is a fact that more than 5.41 billion people worldwide have received a dose of some type of COVID-19 vaccine, equal to about 70.5 percent of the world population.  In the United States as of October 17, 2022, 494.74 million “initial protocol doses” of SARS-CoV-2 vaccine have been administered, together with 138.16 million “booster” doses. 265.59 million US residents have received at least one dose, and 226.59 million have completed the initial vaccination protocol (see this link), out of a total population of 335.49 million (67.5%). In terms of the logistics of development, manufacturing and deployment of a novel injectable biologic product, this is undeniably a major achievement.

Of the SARS-CoV-2 mRNA vaccine doses administered in the United States as of October 19, 2022:

375.64M doses of Pfizer/Bio-N-Tech 237.61 doses of Moderna

Total U.S. of 613.25M mRNA vaccine doses administered. 

In the European Union, the corresponding numbers are:

641.89M doses of Pfizer/Bio-N-Tech 153.16M doses of Moderna

EU total of 795.05M mRNA vaccine doses administered

Grand Total of 1 Billion

408.3 million doses of mRNA vaccines in these two regions. All this involves a novel technology, product and large scale manufacturing process which was created, passed non-clinical and clinical development and was massively manufactured, distributed and globally deployed in less than three years.

At a meeting of the Special Committee of the European Union Parliament held on 11 October 2022 to discuss the findings regarding COVID-19 pandemic and recommendations for the future, a Pfizer executive confirmed that the vaccine had never been tested for its ability to prevent the transmission of SARS-CoV-2 virus before being put on the market. Data emerging since the introduction of the vaccine indicates that it is in fact unable to do so, thereby refuting the claim that the COVID-19 Passports provide any guarantee of protection.  In other words, although governments throughout the world employed a wide range of propaganda and censorship methods to promote these products as both safe and effective at stopping the spread of SARS-CoV-2 infection, there were no studies performed prior to this distribution which even tested how well the products would prevent the spread of COVID-19 disease.  It is not an exaggeration to state that this massive deployment has been the largest clinical experiment performed on human beings in the history of the world. 

All of the mRNA vaccine doses administered in the United States (to both citizens and military personnel) have been provided under “Emergency Use Authorization” (EUA), which is to say that although the FDA has licensed the Pfizer/Bio-N-Tech and Moderna vaccines for some age cohorts, the firms have elected to not manufacture, distribute, or market these licensed products in the United States.  The reason for this is not clear, but appears to relate to both liability issues as well as conditions placed by the FDA involving additional clinical studies, safety monitoring (pharmacovigilance)  and product disclosures once the products begin to be marketed.

From the standpoint of the vaccine manufacturers, EUA is a preferred pathway for marketing their products.  A single purchaser (the US Government) provides complete liability indemnification, a guaranteed market with very little oversight, and manages both the distribution and marketing.  In the case of all unlicensed products, the manufacturers are prohibited from marketing them, but under EUA the US Government has been doing this for them, and has been acting in coordination with corporate media, social media, and large technology firms to suppress any discussion of risks or limitations of the products.  From the standpoint of the vaccine manufacturers, this is all profit and no risk; a perfect business model.  Why would they ever want to consider taking up the burden of actually producing and marketing the licensed version of these products?

EUA is a process defined by US federal law (21 U.S. Code § 360bbb–3 – Authorization for medical products for use in emergencies) which in the case of these mRNA-based products involves biological products which are not approved, licensed, or cleared for commercial distribution.  Specifically, the statute authorizes “the introduction into interstate commerce, during the effective period of a declaration under subsection (b), of a drug, device, or biological product intended for use in an actual or potential emergency.”  Continued “Emergency Use Authorization” of these vaccines requires “a determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a biological, chemical, radiological, or nuclear agent or agents”. Once the domestic emergency has passed (ergo “a determination by the Secretary, in consultation as appropriate with the Secretary of Homeland Security or the Secretary of Defense, that the circumstances described in paragraph (1) have ceased to exist”),  “A declaration under this subsection shall terminate”.  In other words, when there is no longer an emergency, the “Emergency Use Authorization” for the product will cease, and the vaccine products will return to their status as not approved, licensed, or cleared for commercial distribution.  These products remain experimental, and are only to be used for a limited amount of time during an ongoing emergency. 

“Pseudouridine likely affects multiple facets of mRNA function, including reduced immune stimulation by several mechanisms, prolonged half-life of pseudouridine-containing RNA, as well as potentially deleterious effects of Ψ on translation fidelity and efficiency.”

Based on the currently available information, it appears to me that the extensive random incorporation of pseudouridine into the synthetic mRNA-like molecules used for the Pfizer/BioNTech and Moderna SARS-CoV-2 vaccines may well account for much or all of the observed immunosuppression, DNA virus reactivation, and remarkable persistence of the synthetic “mRNA” molecules observed in lymph node biopsy tissues (Roltgen et al. 2022). Many of these adverse effects were reported by Kariko, Weissman et al in their 2008 paper  “Incorporation of pseudouridine into mRNA yields superior nonimmunogenic vector with increased translational capacity and biological stability” (Kariko et al. 2008) and could have been anticipated by regulatory and toxicology professionals if they had bothered to consider these findings prior to allowing emergency use authorization and widespread (global) deployment of what is truly an immature and previously untested technology.  Therefore, neither the FDA, NIH, CDC, nor BioNTech (which employs Dr. Kariko as a Vice President) nor Moderna can claim true ignorance.  To my eyes, what we have seen is more appropriately classified as “willful ignorance”.

Based on my review of the scientific data, it is my opinion that the random and uncontrolled insertion of pseudouridine into the manufactured “mRNA”-like molecules creates a population of polymers which may resemble natural mRNA, but which have a variety of properties which are clinically relevant. These characteristics and activities may account for many of the unusual effects, unusual stability, and striking adverse events associated with this new class of vaccines. These molecules are not natural mRNA, and they do not behave like natural mRNA. 

The question that most troubles and perplexes me at this point is why the biological consequences of these modifications and associated clinical adverse effects were not thoroughly investigated before widespread administration of random pseudouridine-incorporating “mRNA”-like molecules to a global population. 

Biology, and particularly molecular biology, is highly complex and interrelated.  Change one thing over here, and it is really hard to predict what might happen over there. That is why one must do rigorously controlled non-clinical and clinical research. Once again, it appears to me that the hubris of “elite” high status scientists, physicians and governmental “public health” bureaucrats has overcome common sense, well established regulatory norms have been disregarded, and patients have unnecessarily suffered as a consequence.  These products do not use natural mRNA, and referring to them as mRNA vaccines is misleading.  I recommend that, in the future, these products which employ a synthetic unnatural polymer which is not natural mRNA, should be designated using a different term, such as Ψ-mRNA genetic medicines.

SO WHAT’S THE BIG DEAL WITH VACCINES?

By now, you’ve likely seen many of your friends and family posting about conspiracy theories tied to vaccines, Bill Gates, and New World Order. If you’re anything like me you might be asking the question, “why are so many people off their rocker?”. Today, I’m going to share with you what I’ve learned about why some folks have concerns in these areas. My hope is to genuinely educate you on things that weren’t so obvious to me, that have since given me empathy and understanding for a whole group of people and causes that were otherwise not on my radar.

OVERVIEW

Bill Gates and Tedros, WHO

I’ve come to understand at least 3 major reasons people might have concerns about vaccines:

1. Health concerns:
   1. Volume of vaccines
   2. Volume of vaccine dosages
   3. Vaccine schedules
   4. Combination Vaccines
2. Ethical concerns:
   1. Fetal tissue
   2. Vaccine approval rigor
   3. Vaccine trade-off value
   4. Vaccine mandates
   5. Vaccine producers’ lack of financial/legal liability for vaccine injuries
   6. Vaccine as population control
3. Economic concerns:
   1. Tax dollars fund Vaccine Injury Programs
   2. Big Pharma Profiteering

ANTI-VAXXERS

When most people hear about “anti-vaxxers” they tend to think of crazy people spewing all over the camera with their grotesque pictures of aborted babies, shouting angrily about MCR-5 and vaccine injuries. Because this is what we see, we’ve been dismissive towards the rest of the anti-vaxxer movement, who is a little more…subtle.

There are highly intelligent, well-mannered, respected, professional folks who have legitimate concerns about vaccines. But finding these people is like working through a level 100 Where’s Waldo puzzle. Where are they? And why don’t we hear from them? Two reasons: (1) they don’t want to be associated with the crazy people, and (2) if someone hears that they have any reservations about vaccines whatsoever, they immediately attack them with questions like, “people used to die from polio, do you really want that back, do you?!”. As you can imagine, that’s not a great opener for engaging any reasonably-minded person in a well-respecting debate. Effectually, it’s actually quite difficult to learn about the very legitimate concerns that do exist about vaccines, because the folks who might take the time to help you understand are too apprehensive that you might judge and condemn them.

MY LOVE OF SCIENCE, MATH AND LOGIC

I grew up knowing vaccines are good. I got my vaccines on schedule. I carried around my vaccination card like a well-earned A+ report card. I kept an eye on when certain vaccines were expiring and would promptly go get a new one at the right time.

Since I was four years old, I knew two things: I wanted to build computers and be a doctor. At the age of four, I built my first computer with my dad (and have gone on to build many computers since then). But medicine in particular always had my interest above math. I was fascinated by medicine. In high school, I went through a Health Science Academy for four years, which enabled me to get Pharmacy Tech certified and CNA certified. I learned every medical prefix and suffix in the book (literally), and even spent two years learning Latin to help me better understand medical terminology. To earn my Pharmacy Technician certification, I went through two years of courses in 11th and 12th grade, and was examined by the state of Texas. I had to learn about all classes of drugs, and also vaccines. I went through many internships, at Pharmacies, at a Maxiofacial surgeon, at a retirement care community, and in all wings of the hospital, from ER, to post-op, to NICU, ICU, etc.

I proceeded to go to premed school, and was enthralled by human biology, anatomy, medicine, and the likes. I actually made the study guides in all my classes for my peers. They’d go on to make A’s on every test for which they used my guide. After a year at premed, I actually realized this wasn’t the call God had on my life (which was quite disorienting, considering I had spent the last 5 years dedicated to premed programs, and had spent the last 16 years knowing I would be a doctor).

I pulled out of med school and found my way to Psychology, where he . My teachers would give me essay assignments with requirements like “minimum 13 pages and 3 references” and I was the guy who would ask “can I have 20 pages and 12 references?”. Most students were making their periods in sentences bigger as a trick to make it look like their papers were longer: I made my periods smaller to give myself more room to write. One day, I opened literally every paper relevant to my research on the Ebsco research database in a tab on Chrome. I read every one of those research papers.

In my statistics class, our teacher gave us the ability to use an Excel Spreadsheet to solve for the really challenging problems, but I preferred paper and pen, because I knew the answer would be 100% accurate if I worked it out myself and relied on pure math to find the right answer.

I ended up also with a minor in Biblical Studies, with a focus on exegetical Biblical text. I’d spent countless hours reading the Hebrew and Greek origins of words, pouring over the historical context so that I could draw the historical bridge, and would eventually map everything together to illustrate the connectedness of it all.

And today, I lead an engineering team of 35 people distributed in at least 12 countries. I’m the top-level director, responsible for estimating projects from $300k-$2M in size, ranging 3mo to 18mo in duration, and for teams ranging in size from 5-20 people. Our margins are razor thin, so if my projections are off by the slightest, our company could be devastated. Instead, in the last four years we’ve quadrupled revenue, increasing our team size from 15 to 70 people. The growth has been massive. But we’ve stayed profitable and debt free because of our attention to detail, the thoroughness of our research, and the follow through on commitment, of which I’m chiefly responsible.

For the free time I have outside of managing my team, I spend much of my time in spreadsheets creating forecasting models, and also doing research on emerging technology. On average, I’ve learned one new computer language every 3 months the last 6 years (when I had gotten my start in engineering, I had learned 6 languages in just two weeks).

The point I’m trying to make is that I am a research, math and science guy if you’ve ever met one. I trust in facts, not hypotheses; evidence, not narratives; logic, not feelings. If it weren’t for my faith in Jesus Christ, my faith would be wholly in math, science and logic. Thankfully, God had room for me in His family. My love of God, and faith in Him, however, doesn’t change anything about my love and appreciation for math and science. That’s who God made me at the core. I believe in the rigor of research, the reliability of math, and the soundness of logic and reason. Knowing God has simply positioned my trust in Him before human reason, and above reason when in conflict. But if it weren’t for God’s grace over me, you’d probably think I was Spock’s offspring or worse, even his father.

On My knee-jerk reaction was that these people were loonies. I did some research at the time, and was able to verify their claims that some vaccines had aborted baby tissue in them. That made me sick, and certainly made me for the first time ask the question, “what’s in vaccines?”. I had never asked that before. Not once. I just knew they were good. I researched a little more, wrestled with the topic of vaccines, and ended up deciding that when I had kids I’d look more into it with an open mind — but that by and large, most vaccines are still good.

That was a decade ago. The last few months, I began researching vaccines again. This time around, I’ve applied the same level of rigor that I’ve always applied to research, math, science, logic and reason. I’ve spent at least 100 hours in the last 1-2 months, and quite honestly, I’m just now starting to scratch the surface. There’s so much that I don’t yet know, so many sources and references I haven’t stored that I need to go back and save, and so much that I have yet to validate or invalidate.

But, from what I’ve learned so far, I’m convinced that we should at minimum be asking questions about vaccines. I’ve written my bonafides above so that you know in full faith and confidence, that I’m likely the most skeptical person you will meet when it comes to changing my opinion, especially on something as central as vaccines, for which in the last 26 years I have accepted as right and true without question. I’m a hardcore “INTJ” personality type: known for being unwilling to change, for always thinking I’m right, and for being out of touch with feeling and emotion. While God has tempered me with grace to love and care for those around me, my affinity for being persuaded by anything less than logic and reason (outside of faith) is exactly zero.

Below, I’ll share a high-level overview about why we should be concerned about some vaccines, and why,we should be engaged with our government to ensure that our kids and grandkids won’t grow up in a world where the government mandates vaccine injections. I’ll keep each of these relatively short and include resources below if you want to dig in to learn more.

A. HEALTH CONCERNS

1. VOLUME OF VACCINES

When I was born (1988), the recommended vaccine schedule included four vaccines:

1. Diphtheria, tetanus, & acellular pertussis
2. Inactivated poliovirus
3. Measles, mumps, rubella (MMR)
4. Haemophilus influenzae type b

Today, the vaccine schedule has tripled to fifteen vaccines:

1. Hepatitis B
2. Rotavirus
3. Diphtheria, tetanus, & acellular pertussis
4. Haemophilus influenzae type b
5. Pneumococcal conjugate
6. Inactivated poliovirus
7. Influenza (IIV) / Influenza (LAIV)
8. Measles, mumps, rubella (MMR)
9. Varicella
10. Hepatitis A
11. Tetanus, diphtheria, & acellular pertussis
12. Human papillomavirus
13. Meningococcal
14. Meningococcal B
15. Pneumococcal polysaccharide

2. VOLUME OF VACCINE DOSAGES

When I was born, the number of vaccine dosages was 15.

The number of vaccine dosages has tripled to 44.

3. VACCINE SCHEDULES

When I was born, the schedule for when to administer vaccines was less aggressive. The CDC at the time did not have an official schedule for when to administer the doses based on age of the baby. That changed in 1995.

Today, the vaccine schedule recommends 27 doses of vaccines prior to the age of 15mo, with 17 of those prior to 6mo old.

4. COMBINATION VACCINES

Some vaccines have been combined in high concentration doses. For example, Measles, Mumps and Rubella each had their own vaccine available. In the 70s-80s, these vaccines were combined into one highly concentrated vaccine, referred to as MMR. Many are concerned about injecting this high concentration of vaccine all at once into small, developing babies. Vaccine producers have taken the individual vaccines off the market and only offer the combination vaccine.

SUMMARY

In my personal research, I’ve seen an overwhelming number of stories of people’s babies who are otherwise healthy, engaged, and developing, but experience immediate seizure and disengagement upon receiving the MMR vaccine, resulting in autism. Similarly, there are an overwhelming number of people who have been paralyzed after receiving the Human papillomavirus vaccine. These are referred to as Vaccine Injuries, and these aren’t the only two vaccines that cause them. It’s challenging for parents with infants to prove that a vaccine caused an injury, because lawyers will often make the case that there’s no way to know that the vaccine caused autism since the baby is so young and still developing. I’ve scoured the web looking at many before and after narratives, with videos and pictures to boot, and there’s ample evidence that there is in fact a sudden and massive change in other-wise happy babies.

If that’s not enough though, given the Human papillomavirus vaccine is administered around 11-12 years old (or even as young as 9), it’s much more challenging for lawyers to make the case that an otherwise healthy 15 year old who became paralyzed after taking the vaccine wasn’t the cause of the vaccine. Here’s what’s most disturbing about the vaccines for HPV: the virus is only transmitted via sex, and especially via anal sex. The CDC recommends administering this vaccine automatically to all women — I should say, “adolescent girls” — between the ages of 11-12, and even as young as 9. Further, the virus is found in most cases to go away on it’s own, it’s rare that it results in the deadly condition of Cervical Cancer. On their page for the HPV Vaccine, the CDC sites that 12,000 women are diagnosed with Cervical Cancer each year — but HPV isn’t the only cause of Cervical Cancer, it’s one of many. How many cases were a result of HPV? Even still, the number is massively low: 12,000 cases and 4,000 deaths. But, they recommend every young girl in America receive the vaccine — and there are many stories of parents whose daughters contracted Guillain-Barre Syndrome within 2 weeks of being vaccinated for HPV specifically with Gardasil. Gardasil happens to be the only vaccine available for HPV. At least three states (Rhode Island, Virginia, and District of Columbia) have passed legislation mandating children be vaccinated with Gardasil by 7th grade. Many more states have put forward legislation. Gardasil is one of the darling vaccines in the Merck Co. inventory, and in 2018 alone generated $3,000,000,000+ ($3B ) in revenue.

There’s such a high number of people who report vaccine injuries, that in 1988, the federal government and CDC stood up the National Vaccine Injury Compensation Program to deal with the mass number of cases reported. The Compensation Program offers payment only with a ‘no fault’ stipulation, as a means to silence people who have experienced vaccine injuries. Since 1988, $4,027,385,399.60 ($4B) has been disbursed to vaccine injury claims and another $216,791,324.93 ($200M) paid to legal fees for the United States Government providing lawyers to defend against these claims on behalf of vaccine producers.

In this post, I’m not going deep into the Vaccine Injury data, although it’s quite voluminous. Instead, I thought I’d simply highlight that there’s been a very recent and rapid spike in the volume of vaccines, doses and acceleration of schedules, coupled with massive amount of injury claims being paid out to individuals. That’s enough to make me go, “hmm…”. If you are interested in stories from people who have experienced Vaccine Injury, check out the movie Vaxxed and Vaxxed 2. If it’s all just rubbish, it’ll be a good laugh for you. If it’s not, perhaps you’ll something.

REFERENCES

• https://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolescent.html
• https://www.historyofvaccines.org/content/history-immunization-schedule
• http://www.marinhealthcare.org/upload/public-meetings/2018-06-19-600-pm-mhd-community-health-seminar-vaccination/BRANCO_06192018_MGH%20Vaccine%20Presentation.pdf
• https://www.hrsa.gov/sites/default/files/hrsa/vaccine-compensation/data/data-statistics-report.pdf
• https://www.cdc.gov/std/hpv/stdfact-hpv.htm
• https://www.ncsl.org/research/health/hpv-vaccine-state-legislation-and-statutes.aspx
• https://www.trefis.com/stock/mrk/articles/473378/mercks-3-billion-drug-jumped-to-4x-growth-in-previous-year/2019-09-26

B. ETHICAL CONCERNS

1. FETAL TISSUE

Aborted baby fetal tissue samples from two babies (tissues referred to as MRC-5 and WI-38) are used in the production of at least four widely distributed vaccines (name of the vaccine manufactures who use the aborted fetal tissue referenced next to the vaccine name). Many object morally to using aborted baby tissue in vaccines. Some of these vaccines are mandated, which presents special challenges for those who morally object:

• Hepatitis A vaccines [VAQTA/Merck, Havrix/GlaxoSmithKline, and part of Twinrix/GlaxoSmithKline]
• Rubella vaccine [MERUVAX II/Merck, part of MMR II/Merck, and ProQuad/Merck]
• Varicella (chickenpox) vaccine [Varivax/Merck, and part of ProQuad/Merck]
• Zoster (shingles) vaccine [Zostavax/Merck]

These are just the vaccines produced through these two widely known strains of aborted fetal tissue. There are many more tissues from other aborted babies that are also used in widely administered vaccines (you can do your own googling on these!).

2. VACCINE APPROVAL RIGOR

Vaccines don’t go through the same rigor of testing that pharmaceutical drugs approved by the FDA go through. Specifically, vaccines don’t necessarily go through placebo studies. This means that when a new vaccine comes out, or if it’s been out for 50 years, scientists refuse to test the efficacy of the vaccine against the natural immunity of individuals’ who do not have the vaccine (nor of the side effect comparisons). Because of this, it is nearly impossible to link vaccine injuries to vaccines, because researchers refuse to test against placebos. So, when a new vaccine comes out, if there’s an increase in autism because of the vaccine, you wouldn’t know that necessarily because everyone would have received the vaccine, so it looks like the entire population just had an uptick in autism (for other nefarious reasons). This makes it nearly impossible to hold accountable any vaccine producer against the side effects and injuries their vaccines produce. It also makes it harder to trust the vaccines.

These scientists cite the reason for their objection to placebo studies as it being “unethical” to not give their wonderful mana-from-heaven vaccine to the children of the world. After all, their vaccine saves lives. So, we should just trust that the vaccine saves lives and not question the integrity of their work. After all, they are scientists. Scientists never make mistakes.

Some have challenged scientists on this notion, in that there are many parents who would be willing to not give a vaccine to their children, because they specifically do not want the vaccine. The objection from scientists in this case is that the parents are pre-disposed to a bias, and they cannot trust the results of the test because the parent will add confirmation bias to the results.

3. VACCINE TRADEOFF VALUE

The diseases that many of the newer vaccines on the vaccine schedule treat are low in number of affected cases and mortality rate. For example, there’s a few vaccines that treat diseases that might affect 50,000 of the population in the United States (of 323M) with less than 200 deaths. Does it really make sense to vaccinate 323M people for something that is this rare? As we see the vaccine schedule growing so large, you have to wonder if at some point if it’s worth the risk of all those chemicals in our body to protect ourselves against infections and diseases for which we have an incredibly low chance of getting, and even lower chance of dying from.

4. VACCINE MANDATES

Vaccines have become increasingly mandated by state and local governments. In most states, a child cannot attend public and many private schools without providing evidence that they have received the minimum required vaccines. In many states, a parent not providing vaccines can be constituted as Medical Neglect meaning that a parent can lose rights to their children and even be fined and serve jail time for choosing to not vaccinate their children.

5. VACCINE PRODUCERS’ LACK OF FINANCIAL/LEGAL LIABILITY FOR VACCINE INJURIES

Earlier, I mentioned the Vaccine Injury Compensation Program established in 1988. Interestingly, this program offers 100% protection to Vaccine producers from any lawsuits from vaccine injuries (including mandated vaccines), and instead, holds the United States government liable financially but not criminally for any injury (thus, no one can be held criminally liable for vaccine injuries). I mentioned earlier that this is a “no fault” program, meaning those who file must maintain the explicit understanding and make clear that they do not hold the Vaccine producers at fault for their claim of injury (this is the only way they could be eligible to receive financial recompense — and of course, if a vaccine really did cause autism, it’s highly likely they would be dependent on the financial recompense to help offset the challenge of raising an autistic child).

The logic for absolving vaccine producers from having any culpability whatsoever is that in the 80s, there were so many people filing suits against vaccine companies, that these vaccine producers were getting buried in legal fees and payouts. They couldn’t afford to stay in business, producing more (questionable) vaccines, with all the claims of injuries. The United States decided to bail them out permanently — offering amnesty, hall pass, whatever you want to call it — so that they never have to face the consequence of any of their actions. Margaret Sanger published “My Way To Peace”a pretty dangerous recipe for mistakes. We’ve removed accountability on both book-ends of the process (pre-release-testing and post-administration-audits).

6. VACCINE AS POPULATION CONTROL

The Bill and Melinda Gates Foundation is now the #1 Contributor to the WHO (was second to the United States until Trump pulled back funding this year). In addition, The Bill and Melinda Gates Foundation has invested $11B in philanthropic efforts, with most of that going towards vaccine production, and a large chunk of that focused on vaccine production in Africa and Southeast Asia.

Massive research has been performed by the WHO on human chorionic gonadotropin (hCG) vaccines (informally known as sterilization vaccines). Researchers have discovered hCG presence in vaccines administered to people in developing countries (specifically, on tetanus vaccines). More concerning, women have been found to have been sterilized through the administration of vaccines (like the tetanus vaccine) in those developing countries.

Some researchers and philanthropologists (especially Bill Gates) have theorized that CO2 emmissions from people is one of the most damaging contributors to Climate Change, and have set out on a mission to solve the problem. Most notably, these researchers (led by Bill Gates and the WHO) have deemed Africa and Southeast Asia as the most responsible countries for contributing to overpopulation by 2050 (and thus, climate change), and have committed to reducing the population curve in these countries — specifically through contraceptive “options”.

In 2010, Bill Gates led a TED talk describing the relationship between increased health, vaccines and decreased population. Years later, he clarified his intention in this relationship, describing that he believes when people are healthier they’ll choose to have less kids.

Then, in 2015, Bill Gates hosted a convention in Berlin, Germany with worldwide leaders (funders, academia, regulatory agencies, non-governmental organizations, vaccine manufacturers, and Ministries of Health from Africa and Asia) focused on increasing vaccine administration in developing countries, specifically Southeast Asia and Africa. The convention was explicitly focused on maternal immunization (MI) against influenza, pertussis, and tetanus. In lay-mens terms, the convention was focused on how to administer influenza, pertussis and tetanus vaccines to pregnant women in Southeast Asia and Africa. The convention cited that the #1 challenge to administering the vaccine to these pregnant women was in fact resistance and objection by those pregnant women. The convention goes on to demonstrate that not enough evidence is yet available to demonstrate the efficacy or safety of the MI program, but after they administer to enough women and collect evidence (hopefully supporting their hypotheses), they will be able to use this evidence to generate greater demand from more individuals in those regions. To offset the challenge of overcoming objection from the pregnant women, the convention leaders asserted that they will need to leverage family members, tribal elders and religious leaders to critically influence community acceptance for the MI program to not just the pregnant women, but the entire community.

This isn’t the first time Bill Gates has heard of this technique of leveraging a woman’s community to propagate acceptance of immunization. Bill Gates’ father, Bill Gates Senior, served on local and national boards for Planned Parenthood leading up to Roe v. Wade. Many attribute his efforts and advocacy within Planned Parenthood as a boon for the pro-choice “victory” out of Roe v. Wade. When asked how he came to be passionate about reproductive issues as a philanthropic effort, Bill Gates references the efforts of his mom and dad, and specifically referenced the work they did in Planned Parenthood leading up to Roe v. Wade. Margaret Sanger, founder of Planned Parenthood, wrote a letter in 1939 to Clarence Gambel stating the following, “The most successful educational approach to the Negro is through a religious appeal…We don’t want the word to get out that we want to exterminate the Negro population, and the minister is the man who can straighten out that idea if it ever occurs to any of their more rebellious members.” So the Bill and Melinda Gates foundation, 76 years later, takes a pretty similar approach in Africa for the MI program, using tetanus, which has been known to be a a disguised carrier for hCG sterilization.

But this isn’t the only thing concerning about Bill Gates’ ties to Planned Parenthood. Margaret Sanger started Planned Parenthood a few different times under different names, and even retreated to Germany in the midst of WWII for safe haven from the United States government for her practicing of eugenics on African Americans. Specifically, her goal was to limit population and reproduction of African Americans. The third time she started the organization, it was thus named Planned Parenthood. And her legacy lives today. 79% of all Planned Parenthood facilities are within walking distance of African American communities. According to a study by the CDC in 2015, since 1969, Black women have the highest abortion rate of any other race, consisting of 36% of all abortions in the United States (African American population is ~12%). Let me say that another way: 12% of the population is responsible for 36% of all abortions.

In 1932, Margaret Sanger published “My Way To Peace”, postulating to Congress to “direct and control the population through Birth rates and immigration”.

Three of her main objectives were as follows:

(d) apply a stern and rigid policy of sterilization, and segregation to that grade of population whose progeny is already tainted or whose inheritance is such that objectionable traits may be transmitted to offspring.

(e) to insure the country against future burdens of maintenance for numerous offspring as may be born of feeble-minded parents, the government would pension all persons with transmissible disease who voluntarily consent to sterilization.

(f) the whole dysgenic population would have its choice of segregation or sterilization.

Margaret Sanger published “My Way To Peace”

That Bill Gates derives his philanthropic loins from his father’s service in Planned Parenthood, during which time he helped Planned Parenthood win Roe v Wade, which has effectively resulted in ~62M abortions, 19M of which from African Americans — and that Bill Gates has invested $11B towards producing vaccines in Africa and Southeast Asia for the purpose of population control, and that he would focus on using the tetanus shot as one of three primary vaccines (which has been proven in developing countries to contain hCG sterilization) in specifically African pregnant women — is highly questionable and concerning.

People ask me: “why do you share this kind of knowledge” and I’ll tell you why. If there’s the smallest chance that there exists a man who is intentionally sterilizing women in developing countries against their knowledge and will, I believe we should fight against such an oppressor in prayer and otherwise. I believe that falls in the category of James 1:27, to fight for widows and orphans — to fight for the least of these.

REFERENCES

• https://www.historyofvaccines.org/content/articles/human-cell-strains-vaccine-development
• https://www.dshs.texas.gov/immunize/school/school-requirements.aspx
• https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5308147/
• https://www.hrsa.gov/vaccine-compensation/index.html
• https://www.treasurydirect.gov/govt/reports/tfmp/vaccomp/vaccomp.htm
• https://www.youtube.com/watch?v=cuFxQUDJ70I&list=PLRzLQX23nc4iJiaN1g-yvePjMZmRMQ9_M&index=24
• https://www.ncbi.nlm.nih.gov/pubmed/12346214
• https://www.ncbi.nlm.nih.gov/pubmed/7848209
• https://www.ncbi.nlm.nih.gov/pubmed/1874951
• https://www.researchgate.net/publication/320641479_HCG_Found_in_WHO_Tetanus_Vaccine_in_Kenya_Raises_Concern_in_the_Developing_World
• https://www.ncbi.nlm.nih.gov/pubmed/1514026
• https://www.ncbi.nlm.nih.gov/pubmed/26314626
• https://www.weforum.org/agenda/2020/04/who-funds-world-health-organization-un-coronavirus-pandemic-covid-trump/
• https://www.politico.com/news/2020/04/14/trump-world-health-organization-funding-186786
• https://www.sciencedirect.com/science/article/pii/S0264410X15011743?via%3Dihub
• https://www.crunchbase.com/search/funding_rounds/field/organizations/num_investments/bill-melinda-gates-foundation
• https://www.nyu.edu/projects/sanger/webedition/app/documents/show.php?sangerDoc=129037.xml
• https://www.nyu.edu/projects/sanger/articles/bc_or_race_control.php
• https://www.nytimes.com/1923/04/08/archives/apostle-of-birth-control-sees-cause-gaining-here-hearing-in-albany.html
• https://www.protectingblacklife.org/pp_targets/index.html
• https://www.geekwire.com/2015/life-and-times-of-bill-gates-sr-a-giant-impact-on-technology-philanthropy-and-the-seattle-region/
• https://www.cdc.gov/mmwr/volumes/67/ss/ss6713a1.htm
• https://www.historyofvaccines.org/content/blog/vaccine-randomized-clinical-trials

C. ECONOMIC CONCERNS

1. TAX DOLLARS FUND VACCINE INJURY PROGRAMS

The United States has paid out $4B in vaccine injury claims and $200M in legal fees since 1988 on behalf of vaccine producers. Where does Uncle Sam get his money? Taxpayers, not vaccine producers, pay the price for vaccine injuries.

2. BIG PHARMA PROFITEERING

Meanwhile, vaccine manufactures are on schedule to earn $60,000,000,000 ($60B) in 2020 alone. Since they aren’t bogged down with dealing with pesky lawsuits, they can focus on generating more vaccines to add to the schedule.

Let’s take a quick look at how Coronavirus has affected stocks for seven of the biggest Vaccine producers.

Three of the biggest 10 vaccine producers are Novavax, Inovio, and Vir Biotechnology. Since Coronavirus, these three companies’ stock has skyrocketed:

Wow! If you look closely, you’ll see these companies experience a massive spike in growth around January-March. It’s quite natural that we would see vaccine stock markets increase due to COVID. But what’s interesting is not all vaccine company stock markets experienced this spike. In fact, these three are the outliers. What do these three share in common? They are all backed by Bill Gates for a collective $244M.

Here’s what the stocks look like for the #1, #2, #3 and #4 revenue producing vaccine producers:

The common thread we see here is a big dip. None of them expected Coronavirus, they all experienced massive disruption in their business and are now recovering. Why did they experience a dip? Logically: people stopped going to hospitals to get their regular vaccines and sales plummeted overnight.

If you look at the stock for the firms Bill Gates has heavily invested in, you see the inverse: there’s actually a spike. As if they were ready for Coronavirus to hit. Why is this?

Speaking of, Bill Gates in 2015 predicted this pandemic, nearly to the tee: A flu-based pandemic by around 2020 flu-based pandemic , of the weight and gravity of the 1918 Spanish Flu. He’s been leveraging this prediction to convince people of the need for a worldwide vaccine. He’s specifically been at work to ensure vaccine distribution is ready to go in Africa and Southeast Asia. We also see a massive acceleration in his financial investments in vaccine organizations starting in 2015. This overlaps well with the Berlin convention in 2015 where he asserted the biggest challenge with vaccinating pregnant women is their objection to being vaccinated.

Be on the lookout for any research that suggests pregnant women are especially at risk of Coronavirus, it wouldn’t surprise me if the CDC and WHO recommend a pregnancy specific vaccines for Cornavirus in the next year. It wouldn’t surprise me if Bill Gates graciously offers to donate another $10B to getting this vaccine to Africa and Southeast Asia.

He sure is great at predicting the future — and many still believe his intentions are pure. What do you think?

REFERENCES

• https://www.crunchbase.com/organization/bill-melinda-gates-foundation/investments/investments_list
• https://www.youtube.com/watch?v=6Af6b_wyiwI&feature=youtu.be

SUMMARY

Vaccines wouldn’t be a concern of mine if they weren’t mandatory in the United States and if they weren’t seemingly being used to propitiate sterilization of ethnic groups in developing countries.

I’d like to reiterate one thing in all of this: this is just scratching the surface. The amount of data I’ve combed through, the evidence, hours-and-hours of testimony from individuals — it’s overwhelming. I’ve included only references in here which are either neutral or pro-vaccine. I’ve specifically not included references to data in here that is clearly anti-vaccine. I’ve done this on purpose so that you may look at the data that is skewed in favor of pro-vaccines and make a determination for yourself if you have any concerns based on the best case scenarios.

Personally, in reviewing the data, I’m alarmed by the interconnectedness of what we are seeing. Coupled with the increased censorship from Facebook, the WHO, the CDC and Google, who all appear to be in lock-step, it’s hard to know what to do with all of this information. I’ve often debated internally: “should I just be silent about this?” and “of what value does this provide?”

But, I’m continually convicted of the following nine beliefs, and I cannot shake these nor be silent:

1. I’m concerned by the harmfulness of many vaccines
2. I’m concerned by the lack of good science behind testing vaccines
3. I’m concerned by the lack of accountability beholden to vaccine producers
4. I’m concerned by any group of people who would attempt to sterilize any person or group of peoples
5. I’m increasingly concerned by the calls for a worldwide vaccine, especially one that is mandated
6. I feel morally compelled to share these convictions with others, so they themselves can decide if they want to subject themselves and their families to vaccines
7. I feel morally compelled to pray often for our government leaders to be surrounded by God-fearing, righteous men and women, and to be removed from the sphere of influence of anyone who does not daily submit themselves before the Lord
8. I feel civilly compelled to figure out how to create awareness in our communities so that we can elect officials who are committed to tackling these concerns, and also advocate to already elected officials to do something about it; and to not just stop in our own communities, but to change our laws so that we are better able to hold accountable vaccine producers — and keep big money out of influencing what we do with vaccines, and how we do it
9. I feel morally obligated to figure out what my role is in helping prevent the oppression of widows and orphans in developing countries from rich and powerful men who have clearly stated their objective to reduce population in those developing countries

To be clear, I have no quarrel with anyone who is pro-vaccine. In fact, when produced with upmost ethical standards, it’s quite sensible to me that people would be highly interested in vaccines. However, I also seek to preserve independent medical freedom for individuals to weigh both the science and the testimonies of those who have had vaccines — and to decide what the best course of action is for them and their families. On a personal level, I feel responsible for the safety of my own family.

One indication that the government is not in tune with safe vaccine protocols is that they still maintain a “no fault” policy on vaccines, and refer only to vaccine “allergic reactions” without acknowledging the many diseases, illnesses and deaths they do clearly cause. Despite this, it’s clear to me that there are people out there who think it best for the government to decide what is safest — that we as individuals should not maintain that freedom. I am unequivocally against these people and will oppose them at every measure

CDC reports fewer COVID-19 pediatric deaths after data correction

The U.S. Centers for Disease Control and Prevention reported 966,575 deaths from COVID-19 on Friday after it corrected the data earlier this week, which reduced the death tallies in all age-groups, including children.

The health agency, in a statement to Reuters, said it made adjustments to its COVID Data Tracker’s mortality data on March 14 because its algorithm was accidentally counting deaths that were not COVID-19-related.

The adjustment resulted in removal of 72,277 deaths previously reported across 26 states, including 416 pediatric deaths, CDC said.

The reduction cut the CDC’s estimate of deaths in children by 24% to 1,341 as of March 18.
— Read on news.yahoo.com/cdc-reports-fewer-covid-19-204027980.html

Kakistocracy: noun, government by the worst persons; a form of government in which the worst persons are in power

Kakistocracy: noun, government by the worst persons; a form of government in which the worst persons are in power.

The old saying goes that even a blind squirrel finds a nut occasionally.  So you might think that during a 50-year political career, the odds would dictate that Joe Biden would, once in a blue moon, make a correct decision — just based on the odds.  But you’d be mistaken.  Biden has stumbled and bumbled from one disastrous decision to the next.  Disastrous, that is, for America.  Biden himself has prospered handsomely in spite of his glaring incompetence and corruption. 

Biden’s long Senate career was based on being the credit card companies’ man in Washington.  While crowing endlessly about the working class being “his people,” Biden sponsored bills allowing bank issuers to charge egregious interest rates and to make it harder for working men to escape the credit trap through bankruptcy.

When Biden chaired the Senate Judiciary Committee, he turned the confirmation of Clarence Thomas into a political smear campaign that descended into a degenerate three-ring circus. In his first campaign for president, he failed to garner a single percentage point before having to withdraw when confronted with his past lies and blatant plagiarism. He literally stole a speech detailing a British politician’s life story. He ran again in 2008 but again failed to reach even one percent of the vote.

When Barack Obama took him off the primary trash heap to make him vice president, Biden first made a hash out of the 2009 American Recovery and Reinvestment Act, wasting hundreds of billions on boondoggles and giveaways to Democrat cronies. Little of the recovery billions was spent on anything useful to America. Biden went on to manage our relations with China and Ukraine, pocketing untold millions for himself and his family by selling out America’s security interests.

By the time he ran for president again in 2020 he was a spent husk of his former corrupt and incompetent self, delivering asinine performances in the Iowa caucus and New Hampshire primary. When the Democrat establishment propped him up to once again stop Bernie Sanders, Biden was set up for the strangest presidential campaign in modern history. While Donald Trump barnstormed the nation with packed, enthusiastic rallies, Biden cowered in his basement, occasionally venturing out to speak with a few dozen voters sitting in circles drawn on the floor.

For his vice presidential pick, he chose — if you can believe it — an even more buffoonish candidate than himself.

Had it not been for Mark Zuckerberg buying and staffing government election offices in swing states, and the media and Big Tech’s censorship of the Biden family’s corruption, Biden would now be enjoying his dotage in Delaware, creeping on unsuspecting children with yarns of Corn Pop and South African arrests.

Instead, the man with one of the most astonishing records of abject failure in Washington was installed in the White House, and he has remained true to form.  As one of a hundred senators and then as vice president, there was a limit to how much damage he could do.  But as president, the shackles have been removed.

His first agenda item was to throttle our oil and gas sector, offshoring tens of thousands of good paying jobs to Russia and the Middle East — along with our energy independence. He threw open our southern border and encouraged virtually unlimited illegal immigration — during a global pandemic.

He sponsored trillions of dollars in wasteful spending, pushing our national debt to over $31 trillion.  Were it not for two Democrat senators who had not yet taken leave of their senses, it would have been even worse.  As it is, Biden has sparked the largest one-year increase in inflation in 40 years.

Biden’s “defund the police” rhetoric delivered us soaring violent crime in Democrat-run cities, while he sicced federal law enforcement on parents who object too strenuously to their children being indoctrinated with anti-White racism and LGBTQIA+ ideology. 

It can truly be said that as president, Biden’s record of failure remains unblemished.  

But now comes what may be the capstone on Biden’s long history of buffoonery and corruption.  In Ukraine, we have an armed conflict that threatens to plunge the world into an economic depression and raises the specter of nuclear war.  Not only did Biden set the stage for this calamity when, as vice president, he was in charge of Ukraine policy and led Kiev to believe that NATO membership was in Ukraine’s future, but on the eve of the Russian invasion, he refused to admit that it was not.  Then Biden all but admitted to Vladimir Putin — on live TV, no less — that NATO would not defend Ukraine if Russia chose to invade. 

In the aftermath of Russia’s invasion, Biden and his administration have crafted sanctions that seem almost designed to boomerang on America’s and Europe’s fragile post-pandemic economies, while forcing Russia into a deeper alliance with China. 

With the U.S. over $31 trillion in debt, Biden seems totally oblivious to the perilous position of the U.S. dollar as the world’s reserve currency and the consequences should that privileged position end. 

Economists predict that food and gasoline will cost the average U.S. household an additional $3,000 this year, and inflation threatens to push millions of lower-middle income-earners into abject poverty.

And bumbling, corrupt Joe Biden isn’t yet halfway through his first — and please God, last — term.

Image: Gage Skidmore via Flickr, CC BY-SA 2.0.

Image: Gage Skidmore via Flickr, CC BY-SA 2.0.

Jim Daws is a recovering talk radio host at jimdaws.com.

Big Tech Censored Dozens of Doctors, More Than 800 Accounts for COVID-19 ‘Misinformation,’ Study Finds

Resource : https://www.bloomberg.com/press-releases/2022-02-08/merck-and-ridgeback-announce-that-3-1-million-courses-of-molnupiravir-an-investigational-oral-antiviral-covid-19-medicine-have

Big Tech Censored Dozens of Doctors, More Than 800 Accounts for COVID-19 ‘Misinformation,’ Study Finds

Ailan Evans / @AilanHEvans / February 09, 2022

Twitter, Google, Google+, Gmail, Facebook, Instagram, and Snapchat are among the platforms arrayed on the screen of an Apple iPhone. Many of them have used their largely unregulated power to censor information they don’t approve of as “misinformation.” (Photo: Chesnot/Getty Images)

Major technology companies and social media platforms have removed, suppressed or flagged the accounts of more than 800 prominent individuals and organizations, including medical doctors, for COVID-19 “misinformation,” according to a new study from the Media Research Center.

The study focused on acts of censorship on major social media platforms and online services, including Facebook, YouTube, Instagram, Twitter, LinkedIn, Google Ads, and TikTok.

dailycallerlogo

Instances of censorship included Facebook’s decision to flag the British Medical Journal with a “fact check” and “missing context” label, reducing the visibility of a post, for a study delving into data-integrity issues with a Pfizer vaccine clinical trial.

Facebook also deleted the page of the Great Barrington Declaration, an open letter led by dozens of medical professionals, including Dr. Jay Battacharya, a Stanford epidemiologist, and Dr. Martin Kulldorff, a former employee of the Centers for Disease Control and Prevention, which advocated for less restrictive measures to address the dangers of COVID-19.

“Big Tech set up a system where you can’t disagree with ‘the science’ even though that’s the foundation of the scientific method,” Dan Gainor, MRC vice president of Free Speech America, told the Daily Caller National Foundation. “If doctors and academic journals can’t debate publicly, then it’s not science at all. It’s ‘religion.’”

Big Tech also scrubbed podcast host Joe Rogan’s interviews with scientists Dr. Peter McCullough and Dr. Robert Malone, the latter of whom was instrumental in pioneering mRNA technology. Twitter banned Malone from its platform permanently in late December over the virologist’s tweets questioning the efficacy and safety of the COVID-19 vaccine.

“We tallied 32 different doctors who were censored, including mRNA vaccine innovator Dr. Robert Malone,” Gainor said. “Censoring views of credentialed experts doesn’t ensure confidence in vaccines. It undermines faith in government COVID-19 strategies.“

In addition to medical doctors, the study examined instances in which members of Congress were censored by tech platforms.

These included an incident last August in which YouTube suspended Sen. Rand Paul, R-Ky., for posting a video arguing that “cloth masks” are not effective against the coronavirus, a view later echoed by many prominent medical commentators. Twitter also flagged a tweet from Rep. Thomas Massie, R-Ky., in which he wrote “studies show those with natural immunity from a prior infection are much less likely to contract and spread COVID than those who only have vaccine-induced immunity.”

The study also examined Big Tech censorship of prominent media personalities, such as Rogan, Tucker Carlson, and Dan Bongino.

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NIH Quietly Edits Section of Website on Gain-of-Function Research

Leah Barkoukis

The National Institutes of Health edited a section of its website explaining gain-of-function research this month as scrutiny over the research the NIH funded in Wuhan, China intensified.

The original page, seen on the Wayback Machine, displays several sections including Potential Pandemic Pathogens, Gain-of-Function Research, U.S. Government Funding Pause, HHS P3CO Framework, Research Within P3CO Scope, Research Outside P3CO Scope, and a Timeline.

The Gain-of-Function section stated:

The term gain-of-function (GOF) research describes a type of research that modifies a biological agent so that it confers new or enhanced activity to that agent. Some scientists use the term broadly to refer to any such modification. However, not all research described as GOF entails the same level of risk. For example, research that involves the modification of bacteria to allow production of human insulin, or the altering of the genetic program of immune cells in CAR-T cell therapy to treat cancer generally would be considered low risk. The subset of GOF research that is anticipated to enhance the transmissibility and/or virulence of potential pandemic pathogens, which are likely to make them more dangerous to humans, has been the subject of substantial scrutiny and deliberation. Such GOF approaches can sometimes be justified in laboratories with appropriate biosafety and biosecurity controls to help us understand the fundamental nature of human-pathogen interactions, assess the pandemic potential of emerging infectious agents, and inform public health and preparedness efforts, including surveillance and the development of vaccines and medical countermeasures. This research poses biosafety and biosecurity risks, and these risks must be carefully managed. When supported with NIH funds, this subset of GOF research may only be conducted in laboratories with stringent oversight and appropriate biosafety and biosecurity controls(link is external) to help protect researchers from infection and prevent the release of microorganisms into the environment. (NIH)

Now the page lists only Potential Pandemic Pathogens, ePPP Research, and Oversight.

The edits come as Sen. Rand Paul is calling for Dr. Anthony Fauci to resign for lying about gain-of-function research.

“He should be fired,” Paul told “Axios on HBO” in an interview that aired Sunday. 

“The thing is, is just for lack of judgment of nothing else, and I, you know, he’s probably never going to admit that he lied, he’s going to continue to dissemble and try to work around the truth and massage the truth,” he added.

While Paul has been making this case for awhile, the sentiments were renewed after Lawrence Tabak, the principal deputy director at the NIH, revealed new details in a letter about an NIH grant to EcoHealth Alliance, which conducted research at the Wuhan Institute of Virology.

NOTICE – Regulations.govVaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for CommentsPosted by the Food and Drug Administration on Oct 12, 2021

Action

Notice; establishment of a public docket; request for comments.

Summary

The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. Members will participate via teleconference. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

Dates

The meeting will be held on October 26, 2021, from 8:30 a.m. to 5 p.m. Eastern Time. Submit either electronic or written comments on this public meeting by October 25, 2021. Comments received on or before October 21, 2021, will be provided to the committee. Comments received after October 21, 2021, and by October 25, 2021, will be taken into consideration by FDA.

Addresses

Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. The online web conference meeting will be available at the following link on the day of the meeting: https://youtu.be/laaL0_xKmmA.

FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2021-N-1088. The docket will close on October 25, 2021. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of October 25, 2021. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.

In the event that the meeting is cancelled, FDA will continue to evaluate any relevant applications, submissions, or information, and consider any comments submitted to the docket, as appropriate. 

You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.

• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

• Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2021-N-1088 for “Vaccines and Related Biological Products; Notice of Meeting; Establishment of a Public Docket; Request for Comments.” Received comments, those filed in a timely manner (see ADDRESSES ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.

• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” FDA will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify the information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

For Further Information Contact

Prabhakara Atreya or Kathleen Hayes, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6307C, Silver Spring, MD 20993-0002, 301-796-7864; via email at CBERVRBPAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s website at https://www.fda.gov/AdvisoryCommittees/default.htmand scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.

Supplementary Information

Consistent with FDA’s regulations, this notice is being published with less than 15 days prior to the date of the meeting based on a determination that convening a meeting of the VRBPAC as soon as possible is warranted. This Federal Register notice could not be published 15 days prior to the date of the meeting due to a recent request to amend the Pfizer-BioNTech’s Emergency Use Authorization (EUA) for administration of their COVID-19 mRNA vaccine to children 5 through 11 years of age and the need for prompt discussion of this request given the COVID-19 pandemic.

Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. On October 26, 2021, the committee will meet in open session to discuss a request to amend Pfizer-BioNTech’s EUA for administration of their COVID-19 mRNA vaccine to children 5 through 11 years of age.

FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, background material will be made publicly available on FDA’s website at the time of the advisory committee meeting. Background material and the link to the online teleconference meeting room will be available at https://www.fda.gov/advisory-committees/advisory-committee-calendar. Scroll down to the appropriate advisory committee meeting link. The meeting will include slide presentations with audio components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting.

Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. All electronic and written submissions submitted to the Docket (see ADDRESSES) on or before October 21, 2021, will be provided to the committee. Comments received after October 21, 2021, and by October 25, 2021, will be taken into consideration by FDA. Oral presentations from the public will be scheduled between approximately 12:45 p.m. and 1:45 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before October 19, 2021. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by October 20, 2021.

For press inquiries, please contact the Office of Media Affairs at fdaoma@fda.hhs.gov or 301-796-4540.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Prabhakara Atreya or Kathleen Hayes ( CBERVRBPAC@fda.hhs.gov) at least 7 days in advance of the meeting.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at: https://www.fda.gov/advisory-committees/about-advisory-committees/public-conduct-during-fda-advisory-committee-meetings for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).Dated: October 8, 2021.Lauren K. Roth,Associate Commissioner for Policy.[FR Doc. 2021-22452 Filed 10-8-21; 4:15 pm]BILLING CODE 4164-01-P

https://www.regulations.gov/document/FDA-2021-N-1088-0001