As your article shows, the paperwork for approval was prioritized = accelerated, but the usual years of testing we see with other "mandated" vaccines was bypassed. That is why many of us see these covid vaccines as "experimental". That staus underscored by the makers of the vaccines being absolved of any liability for "side effects" or other adverse reactions.
As I pointed out in prior post, vaccines for other conditions have a longer track record of testing and corrections before having become "mandated".
Further more, the covid vaccines are a non-typical path to vaccine design, being mRNA which as this very long article will show, is a process and concept which while have a few decades history in R&D, has only recently reached status that some think it could be used. There are not years of application data to back up how safe or effective they really are.
The tangled history of mRNA vaccines
Hundreds of scientists had worked on mRNA vaccines for decades before the coronavirus pandemic brought a breakthrough.
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The mRNA vaccine idea had a more favourable reception in oncology circles, albeit as a therapeutic agent, rather than to prevent disease. Beginning with the work of gene therapist David Curiel, several academic scientists and start-up companies explored whether mRNA could be used to combat cancer. If mRNA encoded proteins expressed by cancer cells, the thinking went, then injecting it into the body might train the immune system to attack those cells.
Curiel, now at the Washington University School of Medicine in St Louis, Missouri, had some success in mice
10. But when he approached Ambion about commercialization opportunities, he says, the firm told him: “We don’t see any economic potential in this technology.”
Another cancer immunologist had more success, which led to the founding of the first mRNA therapeutics company, in 1997. Eli Gilboa proposed taking immune cells from the blood, and coaxing them to take up synthetic mRNA that encoded tumour proteins. The cells would then be injected back into the body where they could marshal the immune system to attack lurking tumours.
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In light of those results, some mRNA experts now consider pseudouridine an essential component of the technology — and so, they say, Karikó’s and Weissman’s discovery was one of the key enabling contributions that merits recognition and prizes. “The real winner here is modified RNA,” says Jake Becraft, co-founder and chief executive of Strand Therapeutics, a Cambridge-based synthetic-biology company working on mRNA-based therapeutics.
Not everyone is so certain. “There are multiple factors that may affect the safety and efficacy of an mRNA vaccine, chemical modification of mRNA is only one of them,” says Bo Ying, chief executive of Suzhou Abogen Biosciences, a Chinese company with an mRNA vaccine for COVID-19 now in late-stage clinical testing. (Known as ARCoV, the product uses unmodified mRNA.)
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That initially disappointed many investors and onlookers, because a vaccine platform seemed to be less transformative and lucrative. By the beginning of 2020, Moderna had advanced nine mRNA vaccine candidates for infectious diseases into people for testing. None was a slam-dunk success. Just one had progressed to a larger-phase trial.
But when COVID-19 struck, Moderna was quick off the mark, creating a prototype vaccine
within days of the virus’s genome sequence becoming available online. The company then collaborated with the US National Institute of Allergy and Infectious Diseases (NIAID) to conduct mouse studies and launch human trials, all within less than ten weeks.
BioNTech, too, took an all-hands-on-deck approach. In March 2020, it partnered with New York-based drug company Pfizer, and clinical trials then moved at a record pace, going from first-in-human testing to emergency approval in less than eight months.
Both authorized vaccines use modified mRNA formulated in LNPs. Both also contain sequences that encode a form of the SARS-CoV-2 spike protein that adopts a shape more amenable to inducing protective immunity. Many experts say that the protein tweak, devised by NIAID vaccinologist Barney Graham and structural biologists Jason McLellan at the University of Texas at Austin and Andrew Ward at Scripps, is also a prize-worthy contribution, albeit one that is specific to coronavirus vaccines, not mRNA vaccination as a general platform.
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Hundreds of scientists had worked on mRNA vaccines for decades before the coronavirus pandemic brought a breakthrough.
www.nature.com