The Johnson & Johnson vaccine just got FDA EUA approval. Here is a summary of what we know so far.
Hi Dr. Jeffrey Mark here. This week, I would like to answer some questions people have asked me about the immune system, the two approved messenger RNA vaccines put out by Pfizer BioNTech and Moderna and immune resiliency. If you need a refresher on how the details on these vaccines and how they work I refer you to the previous two blogs on the website regarding these vaccines.
Let me first start with the question about how long immune memory might last. The three primary aspects of immune memory are antibodies, killer T cells, and helper T cells. The following graphics and images are from the article in Cell Volume 181 issue 7, pages 1489-1501.E15, June 25, 2020: Targets of T Cell Responses to SARS-CoV-2 Coronavirus in Humans with COVID-19 Disease and Unexposed Individuals.
Circulating SARS-CoV-2-specific CD8+ and CD4+ T cells were seen in ∼70percentage and 100% of COVID-19 recovered patients, respectively. CD4+ T cell responses to spike, the main target of the current vaccines that are approved and were robust and correlated with the anti-SARS-CoV-2 IgG and IgA titers. The M, spike, and N proteins each accounted for 11%–27% of the total CD4+ response, with additional responses commonly targeting nsp3, nsp4, ORF3a, and ORF8, among other sites. For CD8+ T cells, spike and M proteins were recognized, with at least eight SARS-CoV-2 ORFs targeted. Of note, it was also found that SARS-CoV-2-reactive CD4+ T cells in ∼40%–60percentage of unexposed individuals, suggesting cross-reactive T cell recognition between circulating “common cold” coronaviruses and SARS-CoV-2.
There is a recently released paper November 1, 2020 entitled “Immunological memory to SARS-CoV-2 assessed for greater than six months after infection.” The authors included lead author Jennifer M. Dan and they analyzed multiple compartments of circulating immune memory to SARS-CoV-2 in 185 COVID-19 cases, including 41 cases at > 6 months post infection. They found that IgG antibody to the Spike protein was relatively stable over 6 months. Spike-specific memory B cells were more abundant at 6 months than at 1 month. The SARS-CoV-2-specific CD4+ T cells and CD8+ T cells declined with a half-life of 3-5 months. In their examination of antibody, memory B cell, CD4+ T cell, and CD8+ T cell memory to SARS-CoV-2 in an integrated manner, they observed that each component of the SARS-CoV-2 immune system memory exhibited continued activity at least to 6 months.
There have been questions about mutations in the SARS COV-2 spike protein in the UK. News outlets implied that new strains were developing but most virologists believe these are variants to SARS COV2 at this time and it is hard to prove that they are more virulent or accounting for higher rates of infection in the UK. Reports of mutations were also brought up recently with the extermination of the most of the mink population in Denmark. People infected minks, which apparently have similar susceptibility of the SARS COV2 virus, and then a mutation occurred where at least 12 humans apparently were infected back by the minks. There was concern that the spike or other proteins were changed enough that the current vaccines in development potentially would not be as effective or be effective. Most virologists believe that the spike protein remains stable enough for now so that there will be continued immune protection from the current two vaccines. Of course, coronaviruses like the flu can have significant season variations and are always mutating so we will have to see over time if this SARS COV2 will behave more like other coronaviruses. As you may know, we get new yearly flu vaccines based on the most prevalent new variation of the flu virus and our immunity starts to wane after a few months. We were initially worried that antibody counts initially dropped to undetectable after 3-4 months with the SARS COV2 but with the study above other components of the immune system like the memory T cells and helper T cells, and B cells may still be involved in immune memory for at least 6 months.
How long does the RNA last? Typically, the RNA is made from a DNA template and can last several hours to 1 day. After vaccination with the messenger RNA based vaccine, the lipid bilayer surrounding the messenger RNA gets incorporated into muscle cells or lymphoid tissue at the injection site and the cell will make read the RNA several times making SARS-CO2 spike protein for several hours up to 2 days as the messenger RNA was specifically engineered to last 1-2 days but then gets broken down like any normal messenger RNA. There have been questions about whether an enzyme call reverse transcriptase can convert the viral messenger RNA into DNA and then be incorporated our human DNA. In theory, this might be possible but it has not been demonstrated in any study with the current engineered RNA that I know of and this messenger RNA is in the cytosol and not in the nucleus of the cell, which houses our genetic library or DNA.
Is there any additives to the current messenger RNA vaccines? From what I’ve heard from the companies there are no preservatives or other additives other than saline and perhaps buffering agents to adjust for pH and other characteristics to keep the lipids in adequate suspension.
Should people who have already had COVID-19 be vaccinated? The current CDC and FDA recommendation is that even people with who have had COVID-19 be vaccinated and the rationale may be that immune responses may vary as people that have less severe symptoms may not have as vigorous an immune memory and lasting protection as people with more severe symptoms. The paper we mentioned seems to indicate immune memory is present for least 6 months but we don’t know if the body were challenged with another infection with the same virus or a variation if the body would mount an adequate protective immune response. We unfortunately do not know how long the vaccine protection would last as well so the strategy seems to follow the one we currently have the flu vaccine. In terms of immunity from natural infection, versus immunity from the vaccine, there have not been enough studies to draw definitive conclusions. The vaccine immunity is based on a single component of the virus namely the spike protein and the premise that this protein would be conserved as the virus goes through its cycles of mutation. As I’ve shown you in the previous diagrams, people that had the actual COVID-19 infection after exposure to the SARS-COV-2 virus also develop immune memory to other 25 or so proteins found in the in the virus including the M and N proteins and other sites like nsp3, nsp4, ORF3a, and ORF8. In theory, this would be more a “complete” immune memory response to multiple potential targets for antibodies and killer T cells to target and may increase the chance of an effective immune response to re-exposure to the virus. Of course, even young people can have long lasting negative health effects from an actual COVID -19 infection so the added immune memory may come at a significant cost. At the present time, those known to have had COVID-19 within the past 4-6 months will likely be asked to wait until non-infected people have been vaccinated.
There are always questions about safety. So far, during the phase three trials of these vaccines over 40,000 people have been studied. In the Pfizer vaccine study, less than 0.5 percent had serious adverse events reported in both the vaccine and the placebo group. Four cases of Bell’s palsy were reported in participants who received the vaccine, while none has been reported in those who got the placebo. Study authors noted that those four cases are consistent with the rate of Bell’s palsy in the general population. They concluded that there was no clear evidence that the Bell’s palsy was caused by the vaccine. The most common reaction to the vaccine was pain at the injection site. 63 percent reported fatigue while 55 and 38 percent of participants reported headache and muscle pain respectively. Less people reported chills, joint pain and fever after the vaccination with the more people having reactions after the second dose. There were reports of a severe anaphylactoid reaction requiring the use of an EpiPen in two healthcare workers in the UK on the first day of their vaccination roll out. These two healthcare workers were known to have multiple allergies and fortunately always carried an epipen around anyway. Because of these cases, vaccines were no longer given to people with allergies until more studies are done. At least two people vaccinated in Alaska with severe reactions with one having a septic shock response requiring significant medications to support blood pressure and a 1 day stay at the hospital for stabilization. These patients were not known to have previous allergies and there is not a definitive reason why these reactions occurred. Likewise, four workers in a suburb in Chicago had severe vaccination reactions serious enough to that halted their vaccination program for about a day while the facility reviewed their vaccination protocols. Again, definitive reasons have not been known or disclosed.
So at this point, I’ve answered a lot of the more common questions but as you can see there are a lot more unanswered questions at this time. I didn’t mention this much before but we have no meaningful studies on our pediatric population. There is even controversy on the Pfizer BioNTech vaccine for people aged 16-18 as the phase 3 trial date released to the public were consenting adults over the age of 18 yet the FDA granted 16 and 17 year olds emergency use authorization as well for the Pfizer and Biotech vaccine. It is possible that they have more data than the rest of us. In addition, we are just at the beginning of this vaccine roll out and even though over 1 million people are expected to have had the vaccines before the end of the year many will not have access. There are also surveys that show up to half the U.S population is hesitant on getting a vaccine and at least 20 percent who would refuse a vaccine if offered. This leaves the majority of us with the only option of following CDC guidelines, optimizing our immune health and building up immune resiliency. Vitamin D, D3&K2 drops, may play a key role and I’ve discussed this extensively in my articles and blogs. I’ve also mentioned Zinc Support, Allergy and Immune support, Immuno Max, Immune Defense, Virax, Liposomal Glutathione, and Liposomal Vitamin C. All these natural supplements support the immune system and are pharmaceutical grade, properly dosed, and well absorbed. You can click on the links provided, go to the blogs on immune optimization or immune boosting supplements, or contact us by emailing firstname.lastname@example.org or call (925) 736-9828.
Have an intimate, meaningful, healthy holiday with your loved ones at your home. Take care, stay healthy.
Jeffrey Mark, M.D.
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