J & J Viral Vector Vaccine- how does it work? Why is is different? How is it the same?

Hello Everyone,

I felt it was important to take a small break in writing to you because I wanted people to process the information I have provided to date; information that you do not see or read about in the media regarding the global vaccination programs in place. The topic of virus mutations, eloquently called variants, and the complete inability to provide any long-term safety data to the world regarding the current vaccination programs in place, are unfortunately still very much in a nebulous arena of the unknown future. To remind the reader, long term safety in all vaccinations is not a matter of days or weeks, as we are all being led to believe. It takes years. To provide an accurate vaccination development timeline for comparison, please note:

• Pre-clinical studies normally are done over the first 1-2 years, where the vaccine is tested in animal studies for efficacy and safety, including challenge studies.
• Phase I clinical trials follow in the second year and are ongoing for at least 1 year are defined as small groups of healthy adult volunteers receive the vaccine to test for safety.
• Phase II clinical trials begin in year 3 and this is when the vaccine is given to people who have characteristics (such as age and physical health) like those for whom the new vaccine is intended
• Phase III clinical trials normally begin in Year 4 and is when the vaccine is given to thousands of people and tested for efficacy and safety.

When the world was struck by COVID-19 in 2019, pharmaceutical companies proceeded from Pre-clinical studies through the Phase III clinical trials in an overlapping fashion over the course of 1 year. Normal vaccine development performs each step-in sequence over 5 years or more.  To accelerate COVID-19 vaccine development, steps are done in parallel as seen in this table.

In the January 17, 2021 blog, Covid-19-vaccine-safety, https://yourholisticdoc.com/blogs/yhd-blog/covid-19-vaccine-safety, I attempted to explain why there has never been a corona virus vaccine as well as the potential for complications that are unknown in vaccine recipients. I believe that the Informed consent disclosure to vaccine trial subjects of risk of COVID-19 vaccines worsening clinical disease, published in The International Journal of Clinical Practice in Oct 2020, accurately depicts my concerns quite succinctly:

“Vaccines for SARS, MERS and RSV have never been approved, and the data generated in the development and testing of these vaccines suggest a serious mechanistic concern: that vaccines designed empirically using the traditional approach (consisting of the unmodified or minimally modified coronavirus viral spike to elicit neutralizing antibodies), be they composed of protein, viral vector, DNA or RNA and irrespective of delivery method, may worsen COVID-19 disease via antibody-dependent enhancement (ADE). This risk is sufficiently obscured in clinical trial protocols and consent forms for ongoing COVID-19 vaccine trials that adequate patient comprehension of this risk is unlikely to occur, obviating truly informed consent by subjects in these trials.”

After the published literature was reviewed to identify preclinical and clinical evidence that COVID-19 vaccines could worsen disease upon exposure to challenge or circulating virus, the conclusions drawn were as stated “The specific and significant COVID-19 risk of ADE should have been and should be prominently and independently disclosed to research subjects currently in vaccine trials, as well as those being recruited for the trials and future patients after vaccine approval, in order to meet the medical ethics standard of patient comprehension for informed consent. (citation: Int J Clin Pract. 2020 Oct 28;e13795. doi: 10.1111/ijcp.13795).

How do the Pfizer, Moderna and J&J COVID vaccines differ? I have described the mRNA vaccination in a former blog. Let me explain how the J&J differs from them, since it has now been granted Emergency Use Authorization (EUA) and is poorly understood by most people. Vaccines of this type have been used to respond to recent Ebola outbreaks. This means they have been used in humans, unlike the mRNA technology. Unlike the mRNA vaccines by Pfizer and Moderna that are connected to nanoparticles that bring the mRNA into the body, the J&J Viral Vector vaccine uses a modified but live virus to enter our body. In the development of viral vector vaccines, several different viruses have been used as vectors, including influenza, vesicular stomatitis virus (VSV), measles virus, and adenovirus, which causes the common cold. These vectors act as platforms to allow the COVID-19 protein to enter our body so we can fight COVID in the future, by making antibodies. 

The way it works:

In the J&J Viral vector vaccine, the adenovirus is the viral vector that has been modified to deliver a gene to instructs our cells to make a SARS-CoV-2 antigen-- THE SPIKE PROTEIN. Once inside us, this COVID-19 spike protein gene triggers production of antibodies and a resulting immune response. The virus used in a viral vector vaccine is NOT SUPPOSED TO pose a threat of causing illness in humans because it has been modified or, in some cases, because the type of virus used as the vector cannot cause disease in humans. This of course is up for debate without long term studies in my mind.

IN SUMMARY:

In the J&J viral vector vaccine, the gene that codes for the COVID-19 spike protein that is only found on the surface of SARS-CoV-2, is added to the adenovirus viral vector DNA. The viral vector is used to shuttle this COVID-19 gene into our body. Once inside, the adenovirus viral vector uses this gene and our cell’s machinery to produce the spike protein and display it on our cells’ surfaces.

Once displayed on the cell’s surface, the Spike protein (or antigen) causes the immune system to begin producing antibodies and activating T-cells to fight off what it thinks is an infection. These antibodies are specific to the SARS-CoV-2 virus, which means the immune system is primed to protect against future infection.

Called, Ad26.COV2.S, Johnson & Johnson reported phase 3 trial results for their single-dose Ad26.COV2.S viral vector vaccine in late January 2021. The trial was conducted in different geographical regions and during a time when several variants emerged. This is important.  Of the 43,783 participants randomized 1:1 to receive placebo or vaccine, 468 symptomatic cases of COVID-19 were reported 28 days after vaccinations were given. Hence, the following statistics outlined below are from 468 cases of COVID- 28 days after receiving the vaccine or the placebo - not 43,783 participants.

Unlike the outcome results reported from Pfizer and Moderna, who reported the percentage of volunteers infected with COVID in the placebo vs. the vaccinated population was 95% from the unvaccinated group (hence the 95% efficacy of the vaccine reported 8 days after vaccine dose #2 in less than 200 of the 40,000 people enrolled in each study), J&J does not tell us what percentage of these two groups actually became infected 28 days after vaccination. What they do report at 28 days is the intensity of disease manifested in those infected:

“The vaccine was 72% effective in the US, 61% in Latin America, and 64% in South Africa (where the B.1.351 variant was circulating) at preventing moderate-to-severe COVID-19 infection.”

From my exhausted review of the literature, what J&J tells us and the reason they have received EUA, is because:
Of the 43,783 participants randomized 1:1 to receive placebo or vaccine, the 468 symptomatic cases of COVID-19 reported at Day 28 may well have come from both placebo and vaccinated groups, BUT moderate-to-severe COVID-19 infection symptoms were prevented in the vaccinated group by:

• 72% in the US,
• 61% in Latin America,
• 64% in South Africa

I think these statistics are revealing and important in an emerging virus that is constantly mutating.

Also important, the vaccine was 85% effective in preventing severe disease in all geographic regions and this efficacy against severe disease increased over time with no cases in vaccinated participants reported after day 49. Additionally, the vaccine provided 100% protection against COVID-19 related hospitalization and death at Day 28. I believe this vaccine may well keep us out of the hospital, may more adequately protect us from death, and may likely prevent long hauler and post-covid symptoms DUE to the data I highlighted in RED.

Additionally, J&J vaccine showed consistent protection across all variants and regions studied, including South Africa where nearly all cases of COVID-19 (95%) were due to infection with a SARS-CoV-2 variant from the B.1.351 lineage. I believe this is also very important information and proves to me that over time the science will provide better protection from COVID deaths and long-term sequelae. But, read between the lines here…at 28 days, vaccinated patients are getting COVID - it is just less severe and may have less severe long-term sequelae.

I promised myself I would make this a short easy to read blog.

Take home messages:

J&J is a type of vaccine -viral vector- used in humans in the past with Ebola- it is not 100% experimental in humans.

J&J is a 1 shot vaccine that was developing and tested when there were mutations (FYI: B.1.1.7 variant (ie, UK variant) and the B.1.351 variant (ie, South African variant) circulating at the time of testing, hence J&J may work on these variants better in the long term.

Like the mRNA vaccines, Moderna and Pfizer, there are NO LONG-TERM studies for safety. THIS IS IMPOSSIBLE to do over months- it requires analysis of controls (placebo vaccine) compared to vaccinated over years.

Once Emergency Use Authorization is in place, we are not able do any long-term studies for the vaccines, because it is ethically and morally improper to not vaccinate a population that was deemed Emergency Use Authorized- We lose our control over time- I touched on this a lot in prior blogs

Without long term studies, Antibody Determined Enhancement (ADE) in patients vaccinated could lead to significant inflammatory changes in the body that will never be connected to the vaccinations we give, because we have no control over time to compare those vaccinated and those not vaccinated. We have no data.

All people all over the world are told it is their social and global responsibility to receive (i.e. test) the vaccine and be a permanent part of the PHASE III study – (the living test tube all over the world) - we just have not told anyone they are in the study and they have never seen the consent I shared above, telling them of the possible long-term dangers of the vaccine. We have no good research in place to study long- term impact of the vaccine because it is now considered an Emergency Use Authorized Vaccine and we are all supposed to do our part and get vaccinated. Lose controls- lose data-no connection with long term sequelae from the vaccine.

 I am so impressed by how well the patient population I work with has either defied COVID with our natural prevention program, or recovered very quickly from their infection. I would like to remind everyone, to receive a COVID-19 vaccine has not yet proven to be more effective than natural immunity if infected with COVID-19. However you proceed with the COVID-19 vaccination decision, it is my job to keep you informed. I hope I have done that. Please remember, my entire COVID-19 prevention and treatment program is on my website and can be found here Corona Virus and Viral Prevention Program. 

I so value your thoughts and questions as well as your opinions. Share them on the blog. I would also like to have a show of hands in the blog comments from those who want to learn more about Ivermectin. 

Finally remember the 15% Discount code STAYWELL when you check out. 

As some know, I am officially addicted to surfing. It has provided amazing COVID stress relief! Cheers, and let me know how I can be helpful!