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Are you ready to hop onto the COVID-19 vaccine bandwagon? If so, you’ll need to read this article to learn a little more about it. It turns out that a quarter of Americans are hesitant either because they believe the vaccine will be worse than the disease itself, or they are concerned about the speed with which the vaccine is being developed says a Reuters/Ipsos poll. The authors and vaccine advocates say that the hesitancy is due to misinformation, but I’ve been collecting studies and news articles on this vaccine and what I’ve learned will allow you to make an informed decision.
Scientists have been working on vaccines for SARS and other respiratory viruses for decades without success. An early respiratory syncytial virus (RSV) vaccine was given to children in the Washington D.C. area in the 1960s. Eighty percent of those receiving the vaccine became ill with respiratory disease and two died. This new effect was called enhanced respiratory disease. You can read about it here. As the SARS viruses overtook RSV as a virus of concern many attempts were made to develop vaccines for them without success. There are many summaries of why they have failed so far, but this article from 2012, entitled Immunization with SARS Coronavirus Vaccines Leads to Pulmonary Immunopathology on Challenge with the SARS Virus, is a good representation. Here’s what happened:
- Scientists developed a SARS vaccine and injected animals with it
- The animals developed antibodies. The scientists were pleased because they believed that the antibodies would counter the virus
- SARS was introduced to the animals and they developed the same enhanced respiratory disease as the children having received the RSV vaccine.
- A conclusion of this summary is “Caution in proceeding to application of a SARS-CoV vaccine in humans is indicated.”
Similar results happened in the Phillipines in 2016 and 2017 with dengue fever. Eight hundred thousand children were injected with Sanofi’s Dengvaxia and for those who had never encountered dengue fever “the vaccine actually increases their chances of getting sick if infected with the virus.” About 600 children died. As the article concludes “between 80,000 and 120,000 of them are now more at risk of death if they contract dengue than they were before they had been vaccinated, and health authorities have no way of knowing who they might be.” These children are subject to the same enhanced effect as produced by the RSV and SARS vaccines. Nowadays other names for this event are immune enhancement or pathogenic priming.
I have heard that there are over 100 coronavirus vaccines under development and a small number of these will be chosen. Why so many? Consider the world population of 7.8 billion. If each vaccine dose costs $50, the chosen pharmaceutical companies together could earn $380 billion dollars, and twice that with a booster. If they can persuade governments to require this every year, the profits would be astronomical. I believe that this is one of the reasons we are seeing so much resistance to medications that alleviate the course of coronavirus. Pharmaceutical advertising produces the largest income for the media. If you don’t believe this, consider why we’ve heard so little about 600 dead children in the Philippines or even 55,000 dead Americans who took Merck’s Vioxx.
Several SARS CoV-2 Vaccine Variants (Note: this part is pretty technical and I hope I got all the details right. If this is boring to you, you can page down to the next section!)
By and large scientists are using very new technology to develop Coronavirus vaccines. Moderna, Inc., of Cambridge, MA, partnered with Merck appear to be one of the frontrunners favored by Dr. Antony Fauci and funded by Bill Gates, but other strong contenders are Oxford University together with AstraZeneca, GSK/Sanofi and Pfizer/BioNTech. These companies are using different approaches in developing a coronavirus vaccine.
Moderna, Inc. is using messenger RNA (mRNA) to develop its vaccine called mRNA-1273. There are no human vaccines made with this new approach. This technology uses mRNA to insert instructions into your cells that cause the ribosomes to create a stabilized form of the Spike protein which will then create antibodies. Clinical trials have started on 45 people and they will be monitored for a year after their second dose. On May 18, Moderna announced positive results from this trial. The release states that all participants had increases in their immune system and various levels of binding antibodies depending upon the group. Only eight volunteers developed the desired neutralizing antibodies. Later the results were criticized because data was not provided. This article said based on the information made available “there’s really no way to know how impressive – or not – the vaccine may be.” Another issue with the press release is that 3 of 15 exceptionally healthy people in the high-dose group experienced grade 3 adverse events which were “transient and self-resolving.” The Food and Drug Administration (FDA) identifies a grade 3 reaction as “Severe or medically significant but not immediately life- threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care.” One of these 3 people came forward to tell his story. He developed a fever of 103 degrees, went to an urgent care facility, returned home, fainted, and then recovered.
Oxford University is also using an mRNA platform with a weakened form of the common cold virus to which genetic material has been added that will cause the creation of the Spike protein. They are hoping that the immune system recognizes the protein and antibodies are created. This vaccine is called BNT162 and clinical trials were begun in late April with 200 volunteers. There are 4 candidates being tested and they are using the meningococcal vaccine as the control group. On April 27 the New York Times published a glowing report on a trial of the Oxford “vaccine” at the National Institutes of Health’s (NIH) Rocky Mountain Laboratory in Montana. Vincent Munster, the researcher conducting the test, “inoculated six rhesus macaque monkeys with single doses of the Oxford vaccine. The animals were then exposed to heavy quantities of the virus that is causing the pandemic — exposure that had consistently sickened other monkeys in the lab. But more than 28 days later all six were healthy.” Was this a success? On May 16, two articles were released by Forbes and Daily Mail. Both reported that the vaccinated monkeys all became infected with coronavirus. In addition, Forbes expressed concern at the lack of neutralizing antibodies. Daily Mail was concerned that the vaccinated monkeys could spread the virus.
Messenger RNA vaccines have not been tried on humans. This very informative article in the journal Nature explains mRNA technology and several possible pitfalls that need to be investigated: “A possible concern could be that some mRNA-based vaccine platforms induce potent type I interferon responses, which have been associated not only with inflammation but also potentially with autoimmunity” Oedema is also noted as a possible side-effect. Another source refers to “nasty side effects” when trying to deliver the mRNA into the cells. However, there are distinct advantages to this technology in that viruses are not grown in animal tissue which carries the considerable risk of introducing animal viruses and retroviruses into the human body. Another good article describes 5 things to know about mRNA vaccines in an easy to understand format.
GSK and Sanofi are using recombinant DNA technology to develop a Spike protein antigen. They will use a baculovirus which is a tool for delivery of gene therapy into the cells. It will be using a proprietary adjuvant (additive) called AS03 to the vaccine so that the antigen can be produced in a weakened form. The adjuvant’s job is to ramp up the immune response. AS03 is an oil-based additive containing squalene. This adjuvant is not in any of the vaccines that are recommended for children today. However, AS03 was added to Pandemrix, the 2009-2010 flu vaccine licensed in Europe, and some children developed narcolepsy. A 2018 study conducted by GSK itself confirmed an association between the Pandemrix vaccine and narcolepsy but attempted to minimize it. You can find this study here. You will need to access the link and then download the actual PDF to read the details. Section 4.2 discusses narcolepsy. Relative risk is used in this study to compare the likelihood, or chance, of an event occurring between two groups, the Pandemrix group and the control group. A value of 1 indicates a neutral result while a value of less than 1 indicates that the risk of narcolepsy is lessened and a value of greater than 1 shows that the risk of narcolepsy is increased. The study found that relative risks ranged from 1.5 to 25 in children and 1.1 to 18.8 in adults. Nevertheless, the study states that AS03 has an extensive safety record and should be used provided that a mimicry sequence be removed. It well may be that GSK has removed the sequence from AS03 but reading over Table 3 showing possible results like Guillain Barre Syndrome (paralysis), multiple sclerosis, and epilepsy being written off as unimportant because these things occurred in an inconsistent manner across countries is concerning. An example is the occurrence in Canada where the relative risk of Guillain Barre Syndrome is 3.02 four weeks post vaccination and 4.7 for multiple sclerosis written off as a result of increased influenza.
These experimental DNA vaccines, like the mRNA vaccines, can be quickly developed but unlike the mRNA vaccines run several risks: suboptimal potency and the possibility of potential risk of integration of exogenous DNA into the host genome.
Summary of Concerns
For a virus that will last about two years, there’s a lot of money and resources being poured into vaccine development. Short-cuts, lack of full-fledged animal trials and new technologies present a lot of risk and concerns for safety are warranted. Listed below are some of the mostly safety concerns that I’ve read about.
Immune Enhancement: In the Background section of this article we learned about how a severe immune reaction (or enhanced respiratory disease or pathogenic priming) occurred to vaccinated people who were challenged with the virus they were vaccinated against. We are a long way from the time when the vaccinated volunteers are naturally challenged with coronavirus which will depend on the level of the virus in the community. At this point we are not certain whether the vaccinated volunteers will acquire coronavirus, not acquire coronavirus, or develop a severe immune reaction. It may take a long time to understand this. By this time, coronavirus may have departed.
Animal Testing: In order to get a vaccine to the public, shortcuts are being taken. Oxford vaccine monkey trials indicated that their vaccine was not generating enough neutralizing antibodies. Other companies have skipped animal trials completely, thus running the risk of safety problems.
New Technology: Messenger RNA vaccines have not been approved by the FDA for humans yet and they are very experimental. DNA technology is being used in cancer research but there is the risk of putting a foreign genome into the vaccinated person. No one today understands the long-term effects of these vaccines.
Volunteer Health: In initial trials all the volunteers are extremely healthy. Later trials will involve children and those who may have some health problems. In the Moderna trials, 20% of the high-dose experienced significant adverse reactions. We can probably expect more reactions from later, less healthy groups.
Mandates: There have been calls by Bill Gates and others for the chosen vaccines to be made mandatory especially for health care workers. There must be personal choice available for vaccines that are poorly tested and where the long-term effects are not known.
Liability: The federal government has indemnified vaccine producers as described in this article. This means that there’s all gain for these companies and very little pain should their product cause widespread injury.
Mutations: According to one source the coronavirus has mutated into at least 30 variants making it more difficult to develop the right vaccine.
There are still many questions relating to the new DNA and mRNA vaccine platforms. While they may show promise for the future, are we ready for them now? After reading about possible issues with coronavirus vaccines are you prepared to be one of the first in line? Or will you wait a bit and see if vaccines are even necessary for coronavirus?