The FDA initially granted Emergency Use Authorization (EUA) in December …

Comment on Dr. Walter Veith and the anti-vaccine arguments of Dr. Geert Vanden Bossche by Sean Pitman.

The FDA initially granted Emergency Use Authorization (EUA) in December of 2020. The FDA usually requires at least six months of data for the clinical trial participants before full FDA approval is granted. Pfizer, in particular, has previously said that it planned to apply for full FDA approval this month (April 2021). With full FDA approval, Pfizer would be allowed to sell its vaccine directly to hospitals and other health care providers. (Link)

The process required to get the initial EUA from the FDA is fairly extensive and detailed upfront. The mRNA vaccines (put out by Pfizer and Moderna) underwent double-blinded placebo-controlled trials in 70,000 humans, along with double-blinded placebo-controlled trials with animals as well – at the same time. These Phase III trials continued for 10 weeks and showed >95% efficacy against COVID-19 infections – far better than expected. Perhaps even more impressively, none of those vaccinated had severe COVID-19 symptoms, required hospitalization, or died – while more than two dozen such cases were noted in the placebo arms (along with 6 deaths). This data, together with other data dealing with vaccine production protocols and other such safety data, was taken into account as the basis for the FDA’s EUA.

Of course, since the general rollout of the mRNA vaccines worldwide, the data has only gotten better. Take the results of the rollout in Israel for example (since Israel is far ahead of the rest of the world in the percentage of its population that it has been able to vaccinate). So far, the mRNA vaccines in Israel have shown a 98.9% efficacy rate in “preventing hospitalizations” from COVID-19 (Link). That’s amazing! The data in the US is similar with less than 1 in 1 million deaths for those vaccinated so far (Link). Now, let’s say that the overall death rate for COVID-19 is 1% (or 1 in 100 people on average, but exponentially higher with age beyond the age of 50). The mRNA vaccines would be able to reduce that death rate to between 1 in 100,000 and 1 in a million! That’s miraculous! It truly is!

“The 2 mRNA vaccines have similar efficacy of approximately 95% for the prevention of symptomatic COVID-19 and nearly 100% efficacy in preventing death from COVID-19 after 2 doses.” (Rio and Malani, JAMA, March 4, 2021)

If that’s not enough, around 1/3 of people who come down with a COVID-19 infection who don’t die, will end up with some long-term illness or injury (Link). Commonly, these long-term injuries involve the lungs, heart, and brain – and affect even 1/3 of those who had no symptoms or just mild symptoms during their initial infection. The mRNA vaccines can dramatically lessen “Long-Hauler’s Syndrome” as well… and are even showing some benefit for those who already have long-term illnesses as many seem to recover once they get vaccinated.

Given that the technology for the mRNA vaccines isn’t new either (mRNA vaccines have been studied for over 30 years now), it isn’t like scientists don’t have a very good understanding as to how they work and what to look out for already. Known potential risks have been solved, such as ADE. Also, the mRNA vaccines require no adjuvants, like mercury or aluminum. They are the cleanest vaccines ever produced since they also require no culture on any kind of cellular tissue or organic medium.

In short, the mRNA vaccines will have full FDA approval very soon, and for very good reason. They have been studied and tested far more than most vaccines or other drugs or medications have been tested before receiving full FDA approval. They have demonstrated amazing efficacy, far far better than expected, and are far far safer than getting sick with the live SARS-CoV-2 virus. I don’t know about you, but I’ve lost more than a dozen family friends to this pandemic so far. So, not only have I been vaccinated with the Pfizer vaccine, but my wife as been vaccinated (Moderna), both of my parents have been vaccinated (Moderna), both of my wife’s parents have been vaccinated (Pfizer), my brother and his wife have been vaccinated (Moderna), all three of my wife’s siblings and their spouses have been vaccinated (Pfizer and Moderna)… and many more. I highly recommend that you do the same as soon as the vaccine becomes available to you!

For more information, you might find some benefit from a short talk I just gave on this topic: Link

Sean Pitman Also Commented

Dr. Walter Veith and the anti-vaccine arguments of Dr. Geert Vanden Bossche
If you understood how these vaccines actually work, you would understand that they are part of helping to preserve life and health – part of ending all the death and suffering that the SARS-CoV-2 virus is causing on this planet.

Not all science is bad. Most of the discoveries of science are actually good – especially when it can be tested and observed in real-time. True scientific knowledge and medical advancements are a gift of God to ease the pain of humanity in this fallen world…

Dr. Walter Veith and the anti-vaccine arguments of Dr. Geert Vanden Bossche
I don’t know when Novavax will be approved? Here’s the latest on their clinical trials: Link

Dr. Walter Veith and the anti-vaccine arguments of Dr. Geert Vanden Bossche
I don’t know what is happening in Orange County, but I do know that the vaccines have not been approved for anyone under 16-years-of-age. And certainly, any medical procedure done on a child or a minor should first be approved by the parents…

That being said, I would certainly have my own two boys (9 and 11) vaccinated as soon as the mRNA vaccine is available for children.

Again, the evidence is very very clear that the risks associated with the mRNA vaccines are far far outweighed by the risks associated with getting the actual live COVID-19 infection where up to 1/3 of children sustain long-term/permanent injuries – not to mention the risk of passing it on to others who may also be die or be permanently injured.

Recent Comments by Sean Pitman

The Arguments of Adventists Opposed to Vaccines
Here’s a pre-print of a paper demonstrating that the antibodies produced in response to the mRNA vaccines are actually more effective, and probably last long-term, as compared to a natural infection (Link). This is yet additional information in favor of the idea of going ahead and getting vaccinated against COVID-19 even if one has already been previously infected.

The Arguments of Adventists Opposed to Vaccines
The LORD does not suffer fools who deliberately put themselves in paths of known dangers. If you deliberately jump off a cliff, putting the LORD to the test, this is not virtuous faith, but presumption – a sin against God.

The Arguments of Adventists Opposed to Vaccines
After extensive review of the available data, the FDA issued “emergency use authorization” for the Pfizer and Moderna mRNA vaccines. Pfizer, in particular, is planning on applying for full FDA approval as early as the middle of this month (April 2021).

As far as the length of immunity, it is currently known that robust immunity following mRNA vaccination lasts “at least” six months, and probably years (Link). However, if additional variants arise that aren’t effectively covered by the current vaccines, additional booster shoots would be needed.

Are mRNA Vaccines for COVID-19 helpful or harmful?

1. I assume some defective mRNA strands and lipid layers can be generated during the myriad of involved complex chemical processes. Do we understand percentage of defective nanoparticles / mRNA strands? Does process include QA that somehow reduces or eliminates potentially harmful defects. What is risk of defective mRNA strands that could encode for harmful proteins? Any other associated risks here that I am not addressing?

Given that the mRNA sequences in the Pfizer and Moderna vaccines are synthetically produced, I would say that there are very few defective mRNA sequences. And, when it comes to producing proteins based on these few defective sequences, the additional risk from such defective sequences for the human body would be, effectively, zero. In fact, a few slight variations in the protein sequence for the spike protein would only result in slight variations in the immune system response. And, producing such slight variations are already part of how our human immune system is programmed to work – automatically producing slight variations in the antibodies produced against a particular type of foreign antigen, for example.

2. How much independent review occurred with these vaccines? Is the Global Advisory Committee on Vaccine Safety the only body that reviewed. Do scientiests get hands-on and eyes-on access to the actual chemical processes to verify what is happening (in vitro and in vivo), or are they just provided with white papers and reports for review?

A great many scientists were involved in the production and review of the mRNA vaccines. These vaccines, how they work, and their effects on human biochemistry are very well known by a great many scientists who work in this field of immunochemistry. There are no fundamental secrets here.

3. Some papers and FAQs claim the generated viral “spike protein” is presented on the cell surface. Some of your dialogue here seems to indicate that this is not the case. Which is it? How is it presented? Is it presented in a variety of ways?

Here are a few diagrams that illustrate what’s happening within different cells of the body where the mRNA sequences are decoded and presented:

Mechanism of action of mRNA vaccines. 1. The mRNA is in vitro transcribed (IVT) from a DNA template in a cell-free system. 2. IVT mRNA is subsequently transfected into dendritic cells (DCs) via (3) endocytosis. 4. Entrapped mRNA undergoes endosomal escape and is released into the cytosol. 5. Using the translational machinery of host cells (ribosomes), the mRNA is translated into antigenic proteins. The translated antigenic protein undergoes post-translational modification and can act in the cell where it is generated. 6. Alternatively, the protein is secreted from the host cell. 7. Antigen protein is degraded by the proteasome in the cytoplasm. The generated antigenic peptide epitopes are transported into the endoplasmic reticulum and loaded onto major histocompatibility complex (MHC) class I molecules (MHC I). 8. The loaded MHC I-peptide epitope complexes are presented on the surface of cells, eventually leading to the induction of antigen-specific CD8 + T cell responses after T-cell receptor recognition and appropriate co-stimulation. 9. Exogenous proteins are taken up DCs. 10. They are degraded in endosomes and presented via the MHC II pathway. Moreover, to obtain cognate T-cell help in antigen-presenting cells, the protein should be routed through the MHC II pathway. 11. The generated antigenic peptide epitopes are subsequently loaded onto MHC II molecules. 12. The loaded MHC II-peptide epitope complexes are presented on the surface of cells, leading to the induction of the antigen-specific CD4 + T cell responses. Exogenous antigens can also be processed and loaded onto MHC class I molecules via a mechanism known as cross-presentation. (Link)

Now, The mRNA-1273-encoded prefusion stabilizes the S protein (Moderna Vaccine) consists of the SARS-CoV-2 glycoprotein with a transmembrane anchor and an intact S1–S2 cleavage site. The presence of the transmembrane anchor would seem to enable some of the spike proteins to remain attached to the surface of the cell that produced them, such as a muscle cell, but would still be recognized as “foreign” by the immune system. (Link)

See also: Link

Are mRNA Vaccines for COVID-19 helpful or harmful?
The following commentary by organic chemist Derek Lowe is also helpful in understanding this question (December 4, 2020):

Bob Wachter of UCSF had a very good thread on Twitter about vaccine rollouts the other day, and one of the good points he made was this one. We’re talking about treating very, very large populations, which means that you’re going to see the usual run of mortality and morbidity that you see across large samples. Specifically, if you take 10 million people and just wave your hand back and forth over their upper arms, in the next two months you would expect to see about 4,000 heart attacks. About 4,000 strokes. Over 9,000 new diagnoses of cancer. And about 14,000 of that ten million will die, out of usual all-causes mortality. No one would notice. That’s how many people die and get sick anyway.

But if you took those ten million people and gave them a new vaccine instead, there’s a real danger that those heart attacks, cancer diagnoses, and deaths will be attributed to the vaccine. I mean, if you reach a large enough population, you are literally going to have cases where someone gets the vaccine and drops dead the next day (just as they would have if they *didn’t* get the vaccine). It could prove difficult to convince that person’s friends and relatives of that lack of connection, though. Post hoc ergo propter hoc is one of the most powerful fallacies of human logic, and we’re not going to get rid of it any time soon. Especially when it comes to vaccines. The best we can do, I think, is to try to get the word out in advance. Let people know that such things are going to happen, because people get sick and die constantly in this world. The key will be whether they are getting sick or dying at a noticeably higher rate once they have been vaccinated.

No such safety signals have appeared for the first vaccines to roll out (Moderna and Pfizer/BioNTech). In fact, we should be seeing the exact opposite effects on mortality and morbidity as more and more people get vaccinated. The excess-death figures so far in the coronavirus pandemic have been appalling (well over 300,000 in the US), and I certainly think mass vaccination is the most powerful method we have to knock that back down to normal.

That’s going to be harder to do, though, if we get screaming headlines about people falling over due to heart attacks after getting their vaccine shots. Be braced.