Lipid nanoparticle toxicity has long been an industry concern.
In a profile of Moderna back in 2016, Katalin Karikó (instrumental in the development of mRNA vaccines) mentioned this issue:
“I would say that mRNA is better suited for diseases where treatment for short duration is sufficiently curative, so the toxicities caused by delivery materials are less likely to occur” [1]
Numerous studies have found vax-derived spike persisting for months and even years after vaccination, giving rise to concerns expression of spike can continue long after the claimed 24-48 hours.
A recent study found spike protein persisting for 17 months in the cerebral arteries of stroke victims. [1]
It's very hard not to see the whole marketing of the legislation as an exercise in misdirection.
The media campaign was led by Rupert Murdoch's News Ltd (who see a commercial opportunity in cutting a demographic from their competitors audience for advertisers), and the government's marketing of it entirely focused on children being restricted, avoiding until the last weeks an admission it actually meant all adults would have to undertake verification processes to use social media.
The gulf between the practical effect of the legislation (all adults are impacted) and the claimed intent (only children under 16 are the focus), is so large the claims shouldn't really be accepted at face value.
Combine that with the abuse of democratic process: what would usually be weeks of public feedback was shortened to 24 hours, and after passing the lower house the government attempted to force the legislation through in the senate with no debate, finally conceding to a brief 1 hour debate before passing it in the final hours of the last sitting day of the year.
When opposition arose earlier in the week to the idea this is about a backdoor mechanism to force the government's recently rebranded myId (from myGovId), the government hastily made changes to the bill and loudly said social media companies would not be allowed to ask for government id, in physical or digital form.
But that itself was misdirection. A clause was added saying this does not apply if an alternative option is also provided.
But age assurance based on biometrics from webcams has poor accuracy, as one senator argued in the final debate. Fresh-faced youths will have no option but to go for the myID solution on their 16th birthday - which as that same senator pointed out is the age at which you can apply for a myID account.
On the topic of digital id and myID: it was also apparent that the Government seemingly feigned ignorance that this system, designed specifically for this purpose, would be the ideal and primary solution.
Yet we know just how much focus and energy has been going into designing these systems and working out how to get the public to accept them: witness this piece from 2018 [1].
It's of course fine to argue pros and cons of digital id, both philosophically, and in terms of specific implementation details, but that's not what happened here.
Everything clearly indicates the legislation was designed to sidestep any substantial debates on this topic.
What was also sidestepped was any reasonable discussion of specific implementation options. Instead we have vague details of an age assurance trial being run for many more months, with no specifics that help us understand how this legislation may work, or fail to work.
Beyond fundamental moves in any partner dance style, the complexity increases significantly.
It's not just your coordination and flexibility in placing legs, feet, arms, hands, torso in various positions at the right time, it's also leading your follower, adapting to their own abilities, tension, movement, mobility, and mood, connecting with them energetically, with the music, with the floor, and practicing dance floor awareness to avoid collisions with other dancers, adapt your moves to a rapidly shifting available dance space, and being creative and spontaneous.
mRNA vaccines are a gene therapy, and a gene therapy does not mean "must irreversibly change the genome".
Take for instance Moderna's own SEC filing discussing mRNA [1], which summarised the regulatory situation:
"Currently, mRNA is considered a gene therapy product by the FDA. Unlike certain gene therapies that irreversibly alter cell DNA and could act as a source of side effects, mRNA-based medicines are designed to not irreversibly change cell DNA; however, side effects observed in gene therapy could negatively impact the perception of mRNA medicines despite the differences in mechanism.
In addition, because no product in which mRNA is the primary active ingredient has been approved, the regulatory pathway for approval is uncertain. The number and design of the clinical trials and preclinical studies required for the approval of these types of medicines have not been established, may be different from those required for gene therapy products, or may require safety testing like gene therapy products. Moreover, the length of time necessary to complete clinical trials and to submit an application for marketing approval for a final decision by a regulatory authority varies significantly from one pharmaceutical product to the next, and may be difficult to predict."
The industry itself was quite open about mRNA being a gene therapy [2].
At some point there were clearly industry and marketing concerns, and we saw a sharp u-turn into asserting they were vaccines, and additionally that any claim they were gene therapies was the mark of an ignorant rube.
On the marketing front: probably a concern that uninformed memes formed around the "changes your DNA" fears, which at the time were unfounded.
On the regulatory front: I seem to recall some potentially more rigorous regulatory approval if they were considered gene therapies instead of vaccines.
It seems rather clear: they are a gene therapy, and because that adds uncertainty in terms of the regulatory pathways, and consumer acceptance, commercial interests worked hard to recategorise them as a more palatable 'vaccine'.
That the term 'gene therapy' is being redefined to exclude mRNA seems an exercise in commerce rather than science, given the history available to anyone who cares to look.
While it's just an anecdote, it's more than just a funny tidbit as an increased risk of non-influenza respiratory virus is a possible side effect of flu vaccines.
"We identified a statistically significant increased risk of noninfluenza respiratory virus infection among TIV recipients (Table 3), including significant increases in the risk of rhinovirus and coxsackie/echovirus infection" [1]
That's one of the complications in assessing efficacy: if the benefit in flu vaccine is potentially quite modest (as determined by some long-running studies [2]), and it causes an increased risk of other noninfluenza respiratory viruses, then we need higher-quality, more detailed studies to understand what's happening.
But based on the discussion of the Cochrane review it seems unlikely. [3]
In a profile of Moderna back in 2016, Katalin Karikó (instrumental in the development of mRNA vaccines) mentioned this issue:
“I would say that mRNA is better suited for diseases where treatment for short duration is sufficiently curative, so the toxicities caused by delivery materials are less likely to occur” [1]
[1] https://www.statnews.com/2016/09/13/moderna-therapeutics-bio...