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[Note: This article represents Part I of a two-part series examining COVID-19 vaccine technologies and their implications.<\/em>]<\/p>\n For weeks, talking heads have been promoting the\u00a0liability-free<\/a>\u00a0vaccine(s) that will save the world\u2014so Bill Gates and Tony Fauci proclaim\u2014from what Gates has now dubbed \u201cPandemic I.\u201d As\u00a0Microsoft News<\/em>\u00a0peddles self-congratulatory stories about the Gates Foundation\u2019s reorientation of its priorities to devote \u201c\u2018total attention<\/a>\u2019 to the pandemic,\u201d Fauci\u2014making the rounds of talk shows\u2014pledges that a vaccine will make its debut in\u00a0January 2021<\/a>. Not to be outdone, the White House has now unveiled \u201cOperation Warp Speed\u201d\u2014a joint pharmaceutical-government-military effort aimed at \u201csubstantially\u00a0shrinking the development time<\/a>\u00a0for a vaccine\u201d\u2014and President Trump promises one by the\u00a0end of the year<\/a>.<\/p>\n Planet-wide COVID-19 vaccination\u2014the overt objective that has all of these players salivating in anticipation\u2014ignores a number of irrefutable obstacles. For one, the RNA virus being targeted, SARS-CoV-2, already \u201chas mutated into\u00a0at least 30 different genetic variants<\/a>.\u201d The variants include 19 never seen before as well as \u201crare changes that scientists had never imagined could happen.\u201d Knowledge about these mutations may prove useful to clinicians wanting to better tailor their COVID-19\u00a0treatments<\/a>, but the proliferation of mutations makes the chances of developing an effective vaccine immensely more uncertain.<\/p>\n Not to worry, say the entities funded by\u00a0Gates<\/a>\u00a0(and also the\u00a0Pentagon<\/a>). Scientists working in the burgeoning field of synthetic biology are confident that they can \u201coutdo\u201d and outsmart\u00a0nature<\/a>\u00a0using next-generation vaccine technologies such as\u00a0gene transfer<\/a>\u00a0and\u00a0self-assembling nanoparticles<\/a>\u2014along with invasive new vaccine delivery and record-keeping mechanisms such as smartphone-readable\u00a0quantum dot tattoos<\/a>. Does it matter that the researchers who have been experimenting with these approaches have never been able to overcome \u201cnasty side effects<\/a>\u201d? Apparently not. Aided and abetted by the generous Gates and military funding, high-fanfare COVID-19 vaccine planning is proceeding apace.<\/p>\n From a manufacturing standpoint, vaccine makers\u2014and particularly those making\u00a0viral\u00a0<\/em>vaccines\u2014have long chafed at the\u00a0limitations<\/a>\u00a0of traditional vaccine technologies, which rely on processes that necessarily entail \u201ca considerable\u00a0lag time<\/a>\u00a0between antigen production and vaccine delivery.\u201d Researchers reiterated this point again in 2018, writing in\u00a0Nature Reviews Drug Discovery<\/em>\u00a0that \u201cfor most emerging virus vaccines, the main obstacle is not the effectiveness of conventional approaches but the need for\u00a0more rapid development and large-scale deployment<\/a>.\u201d<\/p>\n In the 1980s, manufacturers were elated when scientists developed new\u00a0genetic engineering techniques<\/a>\u00a0(recombinant DNA technology) that\u2014through the use of \u201cexpression systems\u201d (bacteria, yeast, insect cells, mammalian cells or plants such as\u00a0tobacco<\/a>)\u2014made it possible to jumpstart vaccine production and produce so-called \u201csubunit vaccines.\u201d The hepatitis B vaccine was the first to employ this \u201centirely new<\/a>\u201d vaccine production approach, and a number of the COVID-19 vaccines currently\u00a0in the works<\/a>\u00a0are deploying these techniques. However, a complicating factor of subunit vaccines is that they must be bundled with \u201cimmunopotentiating\u201d\u00a0adjuvants<\/a>\u00a0that tend to trigger an imbalanced immune response.<\/p>\n Desirous of streamlining vaccine technology still further and enabling vaccine stockpiles\u00a0in an even shorter time frame<\/a>, researchers began tinkering in the mid-1990s with nucleic acid vaccines, which include DNA vaccines and messenger RNA (mRNA) vaccines. As a form of gene therapy, both represent a\u00a0significant departure<\/a>\u00a0from classical vaccines. Whereas the latter introduce a vaccine antigen to produce an immune response, nucleic acid vaccines instead send the body\u00a0instructions<\/a>\u00a0to produce the antigen itself. As one researcher\u00a0explains<\/a>, the nucleic acids \u201ccause the cells to make pieces of the virus,\u201d with the goal being that the immune system then \u201cmounts a response to those pieces of the virus.\u201d<\/p>\n Researchers quickly learned that both the DNA and mRNA vaccine options have serious downsides, and as a result, vaccines of this type have never been licensed. Nonetheless, almost one-fourth (20\/83) of the vaccines\u00a0listed<\/a>\u00a0by the World Health Organization as COVID-19 \u201ccandidate vaccines\u201d as of April 23\u2014including two of the leading contenders\u2014are DNA (Inovio) or mRNA (Moderna) vaccines (see table).<\/p>\n DNA vaccines are intended to penetrate all the way into a cell\u2019s nucleus. According to one biotech scientist, \u201cThis is an incredibly difficult task given that our nuclei have evolved to prevent any\u00a0foreign DNA<\/a>\u00a0from entering (Think viruses!).\u201d Not surprisingly, then, when some DNA vaccines made it into clinical trials in the late 2000s, they were plagued by \u201csuboptimal potency<\/a>.\u201d Scientists then came up with the idea of solving this problem by augmenting vaccine delivery with \u201celectroporation<\/a>\u201d\u2014electric shocks applied to the vaccine site (using a \u201csmart device<\/a>\u201d) to make cell membranes more permeable and force the DNA into the cells. The improvements in vaccine efficacy were significant enough that electroporation remains a key design feature of some COVID-19 vaccine candidates today, including the Moderna vaccine that is now speeding toward Phase 2 clinical trials.<\/p>\n A second aspect of DNA vaccines\u2014their gene-altering properties\u2014is even more troubling and remains unresolved. DNA vaccines, by definition, come with the risk of \u201cintegration of exogenous DNA into the host genome<\/a>, which may cause severe mutagenesis and induced new diseases.\u201d Framed in more understandable terms, \u201cdisruption from DNA is like\u00a0inserting a foreign ingredient<\/a>\u00a0in an existing recipe, which can change the resulting dish.\u201d The permanent incorporation of synthetic genes\u00a0into the recipient\u2019s DNA<\/a>\u00a0essentially produces a genetically modified human being, with unknown long-term effects. Speaking of DNA gene therapy, one researcher has stated, \u201cGenetic integrations using viral gene therapies . . . can have a devastating effect if the integration was\u00a0placed in the wrong spot<\/a>\u00a0in [the] genome.\u201d Discussing DNA vaccines specifically, the\u00a0Harvard College Global Health Review<\/em><\/a>\u00a0elaborates:<\/p>\n Potential side effects could include chronic inflammation, because the vaccine continuously stimulates the immune system to produce antibodies. Other concerns include the possible integration of plasmid DNA into the body\u2019s host genome, resulting in mutations, problems with DNA replication, triggering of autoimmune responses, and activation of cancer-causing genes.<\/em><\/p><\/blockquote>\n Because mRNA vaccines are \u201cparticularly suited to speedy development,\u201d it is perhaps unsurprising that they are attracting attention as the \u201ccoronavirus frontrunners<\/a>.\u201d mRNA vaccines can reportedly generate savings of \u201cmonths or years<\/a>\u00a0to standardize and ramp up . . . mass production.\u201d Making lemonade out of lemons, insiders casually state that \u201cwhile no mRNA vaccine has ever been licensed, the threat of a pandemic is a\u00a0great incentive<\/a>\u00a0to accelerate their progress.\u201d<\/p>\n Companies are enamored of the mRNA approach despite observations that the large mRNA molecules are \u201cintrinsically unstable<\/a>,\u201d \u201cprone to degradation\u201d and may overactivate the immune system. On the plus side, from vaccine scientists\u2019 standpoint, mRNA vaccines need only reach the\u00a0cell cytoplasm<\/a>\u00a0rather than the nucleus\u2014an apparently \u201csimpler technical challenge\u201d\u2014although the approach still demands \u201cdelivery technologies that can ensure stabilization of mRNA\u00a0under physiological conditions<\/a>.\u201d Formulations such as Moderna\u2019s mRNA-1273 vaccine tackle these challenges by using \u201cchemical modifications<\/a>\u00a0to stabilize the mRNA\u201d and liquid nanoparticles to \u201cpackage it into an injectable form.\u201d<\/p>\n mRNA approaches seem to attract researchers with a highly mechanistic view of human beings. One such individual praises mRNA for its \u201cinherent \u2018programmability<\/a>,\u201d stating \u201cMuch like [a] computer [operating system], mRNA therapy can\u00a0reprogram\u00a0<\/em><\/strong>[one\u2019s] body to produce its own therapies\u201d [emphasis in original<\/em>]. The CEO of Moderna describes mRNA approaches\u2014which use \u201ccustom-built\u201d strands of mRNA to \u201cturn the body\u2019s cells into ad hoc drug factories\u201d\u2014as being \u201clike\u00a0software<\/a>: You can just turn the crank and get a lot of products going into development.\u201d Likewise, the journal\u00a0Nature\u00a0<\/em>(commenting on mRNA technology from \u201ca biotech and industrial perspective\u201d) enthuses that the approach \u201callows rapid refinement with\u00a0almost limitless combinations<\/a>\u00a0of derivatives.\u201d<\/p>\n Vaccine researchers familiar with both DNA and mRNA vaccines like to play up mRNA vaccine safety, citing the fact that the vaccines do not have to penetrate the cell nucleus. However, with years of mRNA vaccine experimentation behind them, none of these researchers has yet achieved licensure. Why? One answer may be that in preclinical studies, mRNA vaccines have displayed an \u201cintrinsic\u201d\u00a0inflammatory component<\/a>\u00a0that makes it difficult to establish an \u201cacceptable risk\/benefit profile.\u201d mRNA enthusiasts admit that there is, as yet, an inadequate understanding of the\u00a0inflammation and autoimmune reactions<\/a>\u00a0that may result. This raises many questions about what will happen if regulators grant the manufacturers of COVID-19 mRNA vaccines their wish for \u201ca\u00a0fast-track process<\/a>\u00a0to get mRNA vaccines to people sooner.\u201d<\/p>\n The hijacking of nearly all economic, social, artistic and religious activity by SARS-CoV-2 is disturbing on many levels, not least because of what it reveals about the public\u2019s uncritical acceptance of official spin and its yearning for medical silver bullets. As a vaccine researcher at Sweden\u2019s Karolinska Institute has\u00a0stated<\/a>:<\/p>\n When China quarantined an entire megacity in January, People said \u201conly China can do that.\u201d Then we saw similarly drastic measures in several democratic countries. I think it says something about our trust in medical solutions. Today, we expect to be able to develop medicines and vaccines against different diseases in a way we didn\u2019t in the past.<\/em><\/p><\/blockquote>\n The rush to develop gene-tampering COVID-19 vaccines is also accelerating the conjoined-twins fusion of pharma and biotech. The lucrative\u00a0biopharma sector<\/a>\u00a0is now the fastest-growing segment of the global drug industry, currently representing 20% of the worldwide market and displaying an annual growth rate that is more than double that of conventional pharma. And COVID-19 vaccines are helping rescue some biopharma companies\u2019 shaky bottom lines. In 2017, for example, Moderna was\u00a0struggling<\/a>\u00a0to \u201ckeep afloat its brash promise to reinvent medicine\u201d after an experimental therapy that it was counting on proved too unsafe to test in humans. Fast forward to 2020, when \u201cbad news about the coronavirus is\u00a0good news<\/a>\u00a0for Moderna stock.\u201d Other biopharma companies formerly on the skids are likewise poised to make\u00a0record profits<\/a>\u00a0from COVID-19.<\/p>\n As biopharma pursues its unfettered, medical-ethics-be-damned race toward a COVID-19 pot of gold, the public needs to take a critical look at the industry\u2019s disincentives for safety and also take a firm stand against the horrifying prospect of coronavirus vaccine mandates. Otherwise, genetically engineered COVID-19 vaccines are likely to start permanently altering genes, triggering autoimmunity and serving as the catalyst for\u00a0other vaccine injuries or deaths<\/a>, and\u2014unhampered by any\u00a0legal liability<\/a>\u2014none of the commercial or government actors responsible will likely care.<\/p>\n“Researchers reiterated this point \u2026 \u00a0that for most emerging virus vaccines, the main obstacle is not the effectiveness of conventional approaches but the need for more rapid development and large-scale deployment.”<\/em><\/h3>\n
Speed, not safety<\/strong><\/h2>\n
“DNA vaccines, by definition, come with the risk of integration of exogenous DNA into the host genome, which may cause severe mutagenesis and induced new diseases.”<\/em><\/h3>\n
DNA vaccines<\/strong><\/h2>\n
mRNA vaccines<\/strong><\/h2>\n
Racing toward profits<\/strong><\/h2>\n
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