Aerosolized viral vectors, mRNA vaccines, these technologies seem so revolutionary and yet so simple that in less than three years, the vast majority of the human species has already been exposed to one or the other.

With laboratory precision down to a single base pair, synthetic genetic segments can be manufactured and deliver customized outcomes to their targets, with supposedly little fear of the risks of side effects from live-attenuated viruses, or even analogue strains like the original variola vaccine using cowpox.

Still, in the rush to approve such vaccines and mass vaccinate populations so that bars could reopen, hotels could resume full capacity, and borders could swing open for the globetrotting Western metropolitan elite, was a necessary minimization of the risks of injecting the majority of the human population with experimental technologies.

This took place with little concern or testing for their long term consequences.

This is not to say that using mRNA or other synthetic genetic material, or for that matter synthetic proteins, and the related technology are any more inherently dangerous than any other biotechnology. Still, the scale of the uptake, and the unpredictability of the consequences should have frightened anyone who saw how quickly such concerns were dismissed by the FDA, in their partially rightful concern about the global spread of a novel virus. Nonetheless, as time has passed, instead of regulatory agencies calling for the re-normalization of long term safety testing for these technologies, these products have instead been grandfathered in to a special new regulatory framework.

This allows existing producers to undergo only the most basic safety testing, and they no longer need to provide convincing evidence that such vaccines are even effective at preventing disease or death.

Forget the large scale, years long, clinical tests for vaccine safety of years past. Because the production process of the bivalent mRNA vaccines mirror those of the monovalent vaccines, neither of the updated vaccines were tested on a sample of more than 800 people, with those trials running for an indeterminate length of time post-booster not published by the FDA, before their approval. They were also exempt from the normal process showing efficacy against symptomatic infection or serious disease as part of the approval process, with the approval statement simply citing immunogenicity, despite providing absolutely no correlation between that immunogenicity and the proteins present in wild COVID strains other than unspecified non-clinical data.

What this meant was that data from animal testing was included in the approval process, but the FDA’s opaque release did not make that clear. The FDA also declined to consult its advisory body before approving the vaccines, but again did not make that clear, instead citing the advisory body in suggesting that they include omicron genetic material, a factor totally independent of the FDA’s review of the data. This misleading verbage and clear lack of transparency appear more like a producer press release than a regulatory statement, calling into question the objectivity of the FDA.

The FDA states that the Advisory Committee, which was excluded from the approval process, instead “voted overwhelmingly to include an omicron component in COVID-19 booster vaccines,” and that “the FDA based its decision on the totality of available evidence, including… nonclinical data obtained using a bivalent COVID-19 vaccine that contained mRNA of the original strain and mRNA in common between the BA.4 and BA.5 lineages of the omicron variant.”

Normalizing such laissez faire approval of technologies without the proper precautions has in fact created a staggeringly large moral hazard in which pharmaceutical companies, in competition with one another, are incentivized to aggressively release updated products, without the need for regard towards their long term safety, or even efficacy.

The oft-touted advantages of utilizing mRNA over traditional live attenuated, inactivated, or virus vector vaccines were in the development cost, and in the claim that mRNA vaccines were lower risk because the encoded-for proteins would not cause significant illness, and that mRNA could not be incorporated into the human genome.

Excluding anecdotal cases of pathogenic safety concerns including myocarditis, thrombosis, and Guillain-Barré syndrome as a result of the spike proteins themselves, there is in vitro data of autoimmune reactions to the reverse transcription of the mRNA contained in certain vaccines.

This raises questions of whether using mRNA as a vector, as opposed to the slightly more costly protein subunits, represents less of a long term social risk.

Further to the point, if the proteins themselves are perhaps sufficient to cause significant pathologies, perhaps we should also reconsider the emergency authorization of any vaccines, and instead reassess such safety concerns with a significantly longer time horizon.

With the proliferation of prion diseases with varying degrees of infectivity and fatality, and the knowledge that the time span on symptom appearance can be in the decades rather than days, the potential that a misfolding disease-producing protein could exist in one of the potentially dozens of COVID-19 subvariant boosters that will be released in the coming decades should be at the very least considered, and addressed. This caution is even more valid as developers work to create aerosolized vaccine vectors that could potentially be used not only to deliver vaccines against patient consent to at-risk, allergic, or immunocompromised patients.

Rushed approval and proliferation of such technology could even lay the scientific groundwork for bioterrorism in the form of commercially-available, aerosolized, pathogenic genetic material.

When millions or potentially billions of lives are at stake, even an astronomically low risk should not be ignored by any responsible government or its regulatory bodies. Citizens should demand

  1. a separation between the regulatory organizations and pharmaceutical developers,
  2. elimination of all regulatory conflicts of interests,
  3. an end to government subsidies and producer favoritism that may bias the approval process,
  4. an assessment of the long terms risks of new technologies to create an appropriate time horizon for testing,
  5. randomized, controlled, long-term efficacy tests based on preventing serious disease and symptomatic infection and not artificial immunogenicity markers,
  6. randomized, controlled, long-term safety tests,
  7. transparent and publicly available testing data,
  8. and accountability for all those who when acting in their own interests instead of the public’s cause harm to others.