I’m not sure I understand the question? As far …

Comment on Are mRNA Vaccines for COVID-19 helpful or harmful? by Sean Pitman.

I’m not sure I understand the question? As far as the mRNA vaccine trials for Pfizer and Modern vaccines, they did show a 95% reduction in symptomatic viral infection. And, as far as severe cases were concerned, there were 10 severe cases of Covid-19 observed in the Pfizer trial, with nine of the cases occurring in the placebo group and one in the BNT162b2 vaccinated group. With the Moderna mRNA vaccine, by the end of the Phase 3 Trial:

“Primary efficacy analysis of the Phase 3 COVE study of mRNA-1273 involving 30,000 participants included 196 cases of COVID-19, of which 30 cases were severe. Vaccine efficacy against COVID-19 was 94.1%; vaccine efficacy against severe COVID-19 was 100%… There was one COVID-19-related death in the study to date, which occurred in the placebo group. (Link)”

So, I’d say that the odds of the mRNA vaccines reducing hospitalizations and deaths are very good based on the evidence so far in hand.

Note: Adapted from Polack et al. Efficacy of COVID-19 mRNA vaccine compared to placebo by cumulative incidence of COVID-19 from the time of the first dose. Second dose given at day 21. Each symbol represents a COVID-19 case; filled symbols represent severe COVID-19 cases. The inset shows the first 21-day data on an enlarged y-axis. From NEJM, Polack et al., Safety and efficacy of the BNT162b2 mRNA COVID-19 vaccine. (Link)

Sean Pitman Also Commented

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.


Are mRNA Vaccines for COVID-19 helpful or harmful?
I know that various European countries, including the Netherlands, Denmark, and Spain, have reported outbreaks of COVID-19 in mink pelt farms – leading to the culling of more than a million animals. From laboratory experiments, it’s also clear that ferrets (a relative of the mink) are also readily infected with the “novel coronavirus”. Aside from this, however, I’m not aware of any “issues” with animal experiments regarding COVID-19 in particular. However, in 2008 there was an interesting experiment involving ferrets that were given the flu vaccine against the H1N1 virus – who then became sicker once exposed to the live virus as compared to those ferrets that weren’t vaccinated. The reason for the effect was unclear, and Skowronski, the lead author, urged other research groups to take up the question.

“Skowronski likened the mechanism to what happens with dengue viruses. People who have been infected with one subtype of dengue don’t develop immunity to the other three. In fact, they are more at risk of developing a life-threatening form of dengue if they are infected with one of the other strains.”

Skowronski called the second theory the infection block hypothesis. Having a bout of the flu gives the infected person antibodies that may be able, for a time, to fend off other strains; flu shots only protect against the strains they contain. So under this theory, people who didn’t have flu in 2008 because they got a flu shot may have been less well armed against the pandemic virus.”

While interesting, such an effect has not been identified in the animal or human trials for the mRNA vaccines against COVID-19. Also, subsequently updated flu vaccines to the H1N1 strain haven’t had this problem either (Link).


Recent Comments by Sean Pitman

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.


Dr. Walter Veith and the anti-vaccine arguments of Dr. Geert Vanden Bossche
If that makes you more comfortable, that’s fine. However, when it comes to the mRNA vaccines, in particular, there really are no more remaining questions of any real seriousness to be answered. The technology has been around and studied for over 30 years now and the vaccine trials were a great success, demonstrating amazing efficacy as well as safety. The same has been true of the general rollout around the world. Those countries with the highest percentage of vaccinations are doing the best regarding a reduction in death rates and injuries from the COVID-19 virus. The longer you wait, the greater your personal risk and the risk to others around you.


Dr. Walter Veith and the anti-vaccine arguments of Dr. Geert Vanden Bossche

Can you talk about the blood clot side affect — the rash side affect — and the other side affects listed in the VAERS document? Are these deaths and suffering are just “ho-hum” dispensable humans to the cause of good for all?

I talk about VAERS here (Link). The Herpes Zoster rash happens in a low percentage of immunocompromised people who have previously been infected with the Herpes virus (Link). While certainly uncomfortable, it’s not life-threatening and it isn’t a risk for most people. The blood clot risk is a very rare risk (about 1 in a million for young women) for the DNA vaccines, possibly related to the adenoviral vector used for the vaccines. I talk about this here (Link). There is also a very rare risk for severe immune thrombocytopenia (Link). Note that for all of these risks for the vaccines, the very same risks are much much much higher when it comes to being infected by the live COVID-19 virus. So, if you want to reduce your risk as much as possible, the best way to do that is to get vaccinated.

What is happening to cause so many side affects? How is one to know if there is a chance of dangerous side affects of the vaccine for a person?

The thing about risk is that it is impossible to know, ahead of time, exactly how a particular person will react. That’s just the nature of the concept of “risk”…

Are vaccinated women who get the vaccine during pregnancy, or get pregnant and give birth having any side affects among their babies?

No. I talk about this rumor here (Link).

Also, have your children been vaccinated? What is your opinion of elementary or high schools requiring the vaccine for school children? Which childhood conditions need to be studied before administering the vaccine to children with these conditions?

The mRNA vaccines are not approved for children under the age of 16. They are currently in the trial phase of testing for younger children. My own boys are 9 and 11 years of age, so no, they haven’t been vaccinated yet. However, once approved, I would be getting them vaccinated since even children are at risk for long-term injury and sickness from COVID-19 (30% of children get Long-Hauler’s following even asymptomatic infections with COVID-19). As far as childhood “conditions”, I know of no common childhood conditions which would preclude vaccination…

What “empirical evidence” is there that mRNA vaccines do not cause any side affects “a year or two or three down the line”? Is there a study I can read – link?

As I’ve already mentioned, the evidence for this is the very long history that we’ve had with vaccines and understanding how they work with the human immune system. When complications arise, they do so within the first few months for large populations (Link). It is extremely unlikely that something brand new and unexpected will come to light years down the line (Link). Also, by that time, millions will have been killed and permanently injured by the very real and very well-known risks of the COVID-19 virus itself.

Yes, your glowing recommendation is convincing with several issues not addressed in the glow.

I have addressed most of your questions already in other posts on this topic…

Do you recommend a yearly booster vaccine like now is being developed? I think big Pharma announced a flu/covid combo vaccine coming out for next fall. What is your opinion please?

For now, it seems likely to me that the mRNA vaccines will produce immunity lasting more than a year, likely several years. However, as with most viruses, the COVID-19 virus mutates. If a new mutant strain comes along that “breaks through” the immunity provided by the original vaccine(s), then yes, a booster would be necessary. However, if enough people would get vaccinated quickly, it would make the odds of such breakthrough mutations less likely.

Thanks for your help in understanding the full spectrum of topics about these mRNA vaccines.

Thank you for your thoughtful questions.