Right, but the underlying tech was in development for a decade or more.
I can deploy an app to Azure, tell it to allocate a server farm, databases, Redis, queues, etc... in 5 minutes too. But that's only because someone took years to do all the necessary work.
Sure but the delta amount of time is tiny compared to the 10 years to development so OP is correct as he never asserted that they were starting from scratch
> Before 2020, no mRNA technology platform (drug or vaccine) had been authorized for use in humans, so there was a risk of unknown effects.[79] The 2020 COVID-19 pandemic required faster production capability of mRNA vaccines, made them attractive to national health organisations, and led to debate about the type of initial authorization mRNA vaccines should get (including emergency use authorization or expanded access authorization) after the eight-week period of post-final human trials.
That risk of unknown effects was still there even when it got authorized for emergency use. Has it changed yet? Like... there was a vaccine based on old tech that has been used in humans for decades without side-effects that caused narcolepsy a year or two later, and we got lucky to have been able to make the association. It is not really only about what tech it uses, apparently.
This is honestly one of my concerns (double-vaccinated with mRNA, no issues and I am not anti-vax).
The thing is, before the COVID-19, the world had barely heard of mRNA vaccines and suddenly there are billions of people vaccinated across the world in 2 years. I have no intention of denying that these vaccines have saved millions, if not billions of lives by preventing hospitalization, death and further overloading of medical systems worldwide.
But still, a skeptic part of my brain can't seem to 100% accept the fact, even though it might be a medical miracle. It's that scratch on your back you can barely not reach, and it stays itchy for days and months.
On the other hand, vaccines that use inactivated or dead viruses to incite an immune response has been known for more than two centuries, whereas this feels... different.
Unfortunately, at the time of writing this, none of the other answers to this question in this thread have been proper responses that directly answer the question, except the one about "changing priorities from do no harm to optimize for least harm" that seems to make most sense.
So, I'd love to have a direct answer, no analogies, no "imagine how worse it could have been without vaccines", no "disease X kills more people than Covid and mortality for mRNA vaccine for Covid is negligible compared to that", no shifting goalposts, no guilt-tripping for being skeptic, just a straight, direct answer to this question of the OP.
“…if not billions of lives by preventing hospitalization, death and further overloading of medical systems worldwide.”
No remote way that it saved billions of lives. Covid is nowhere close to that level of mortality. The level of exaggeration that people have allowed themselves to succumb to over Covid is frankly quite alarming.
About particularly that, Wikipedia says "In 2018, a multinational study including Centers for Disease Control and Prevention scientists published safety data on adjuvanted pH1N1 vaccines. Sweden was the only country where increased narcolepsy IRs were found in the period after vaccination campaigns. The ability of the researchers to evaluate the Pandremix brand vaccine was limited.", but you can read other ones as well here: https://en.wikipedia.org/wiki/Pandemrix#Narcolepsy
No vaccine would have been authorized on billions of people before 2020 if it had such prevalent incidence of peri- and myocarditis! But now it's authorized even of toddlers, which have even higher chance for future heart issues! And all this, because politicians didn't have the balls to keep the face mask mandates!
There have been a few (I at least found one case study in the literature, https://pubmed.ncbi.nlm.nih.gov/34664804/) people to have died from vaccine-related myocarditis, but my impression from skimming a handful of relevant review papers and news articles is that the vast majority of vaccine-related myocarditis cases were mild and temporary, and that those were still extremely rare among vaccine recipients.
By comparison, (a) these vaccines have directly saved millions of lives (including saving at least tens of thousands of lives of healthy young men), and (b) infection by Covid-19 itself causes myocarditis at much higher rates.
It is likely that these vaccines have in fact prevented more instances of severe myocarditis than they have caused, without considering the large constellation of other dangerous chronic or fatal effects of Covid-19.
The risk/benefit calculations are stark here (in favor of universal vaccination, including for 15–25 year old men), and from what I can tell there is no evidence that the vaccines put children at nontrivial risk.
Birth control kills more women annually then any covid vaccine. If you engaged in non-procreative sex in the past year you've done something which has a greater risk for human life and health.
And in comparison to COVID-19? Do they actually need a vaccine to protect against COVID-19? If not, are we giving it to them in the chance that it reduces spread, or why? It has been said it reduces spread, but this is not what you observe in countries that are >80% fully vaccinated (at least double dose), so I do not get it.
It's not because of mask mandates, it's because every politician is invested in pfizer and moderna, it's because pharma has massive lobbying power, and because pharma companies make up much of the advertising revenue of the news networks in the USA
It would have been much faster if regulators and ethicists hadn’t been so squeamish about challenge trials.
In order to save dozens of lives that might have been lost in challenge trials, we sacrificed hundreds of thousands of lives so that we could wait for more ethically-sound vaccine trials to complete.
If you (soft or hard) mandate a vaccine, and you kill someone with it, that's a lot of responsibility to take, if the vaccine didn't go through a full trial.
If the vaccines were as optional as eg. flu vaccines are, then a simple waiver would solve most of the issues.
(a 20yo girl died in slovenia due to jannsen vaccine not that long ago, and she got vaccinated, becase she was soft-forced by the government mandates (48 hour testing, far away from home, but unable to use the bus without a test, to go to the testing site, 12eur/test,...).
I see why you're saying that, but I think you missed their point. Challenge trials might well allow us to make a safe vaccine available sooner to those who want it, but if we mandate a vaccine that has only undergone challenge trials and then that vaccine kills someone, it would certainly be politically disastrous for challenge trials.
Well, not me personally but a "five-member commission, namely, three doctors (neurologist, infectologist and vascular specialist), a pharmacologist and Zoran Simonovič, a representative of the epidemiological profession" has.
> Minister of Health, Janez Poklukar, the head of the regional unit of the Maribor National Institute of Public Health, Zoran Simonovič, professor Borut Štrukelj from the Faculty of Pharmacy, Ljubljana and Maja Bratuša held a press briefing on the current situation regarding Covid-19 disease.
...
> “The commission unanimously assessed that there was a direct link between the vaccination with Janssen Johnson & Johnson and the tragic complication, i.e. the onset of the syndrome”, said Simonovič.
...
> Moreover, he said that he is to propose to the vaccine advisory group to stop vaccinating with Janssen in Slovenia, or to enable vaccination with Janssen only at the explicit request of an individual, who must confirm this with signature. “This means that the currently valid provisional vaccination protocol with Janssen will become permanent”, said Minister Poklukar.
Were 100,000 of lives lost because of a delayed vaccine? Considering the third world hasn't had access to the vaccine and death rates are lower with delta I'm not sure skipping trials would have done much good.
Vaccine challenge trials are faster not because they are any less rigorous. They are faster because you are actively infecting people, instead of just waiting for participants to be randomly infected as they go about their lives. You can have a much higher level of reliability with a trial that is orders-of-magnitude smaller, and you can have definitive results within weeks compared to months.
> We also have 80 years of experience with the flu vaccine opposed to 8 months
8 months is incorrect. Here's[1] an article from 17 months ago about results from Moderna's covid-19 trials for vaccinations dating back to mar16 2020. So it's been 21 months, not 8 (and that's ignoring trials of mRNA vaccines years earlier as they weren't for this specific virus)
Drug assessment goes through three stages of human testing, after other models, to assess safety, efficacy, and finally, dosing.
If possible, basic efficacy testing is done on non-human models, either in vitro or animal models. For species-specific viruses, this is difficult and may be impossible. I'm not sure what if any such testing was done with the SARS-COV-2 vaccine candidates.
A basic safety test with dosages thought to be low enough not to present any risks. The goal here is simply to see what if any side effects occur. Any comorbidities, no matter how unrelated, are reported. Note that these may occur in a control / nontreated population, so the key isn't "individual was treated, had condition", but "there is a statistically robust difference in rates of co-morbidities between treatment and control populations" In normal circumstances, such safety testing may take a year or more, and data reporting are ongoing through drug development and use.
Efficacy is determined, where groups treated are assessed for whether or not the drug provides any measureable effect. Note that this can range anywhere from "provides 100% immunity from infection" to "cancer patient dies a horrible painful death 2 weeks after control group". (If you're familiar with cancer research, it is rife with very marginal "positive responses" to therapy. Yes, with some spectacularly better instances.)
Finally, dosing is dialed in to find out how much and how often to deliver the drug. That's how we're ending up with single vs. double innoculation recommendations, and/or boosters, and wait times between dosing. Again, multiple groups followed over time.
All of this takes time. Since COVID-19 has a course of about 1--2 months from exposure to resolution (you get better or you die), and vaccinations have a lead time of about 2 weeks after second dose to full efficacy, that's about four momths just to get baseline measurements.
A typical drug study might have as few as 30--60 patients, though many have more. In the case of the SARS-COV-2 vaccines, trials were much larger as I understand (I don't have data or reports in front of me, so don't take my comments here as significant.)
If there's earlier research to build off of (e.g., mRNA base models of solutions and methods) then some of this process can be based on earlier research, which helps.
But you're still looking at 6--9 months before a vaccine can be recommended with strong assurances even under highly expedited conditions. Given circumstances, health authorities might be willing to operate more quickly and with less data, but those decisions would have to be considered preliminary and subject to revision. Revised understanding around COVID-19 has been highly problematic around the world, leading to trust issues and opportunists spreading disinformation.
And once you have a candidate treatment, you've still got to produce and supply that, with manufacturing and logistics considerations, all of which were evident in the rollout of existing SARS-COV-2 vaccines (e.g., production issues, patent licensing, quality control, storage and refrigeration, cold-chain management, patient contact, scheduling, and follow-up, etc.).
It's complicated.
Source: Some ancillary PHARMA related work in the past, eccelctic interests.
> And once you have a candidate treatment, you've still got to produce and supply that, with manufacturing and logistics considerations, all of which were evident in the rollout of existing SARS-COV-2 vaccines (e.g., production issues, patent licensing, quality control, storage and refrigeration, cold-chain management, patient contact, scheduling, and follow-up, etc.).
One of those manufacturing / logistics consideration was "we need to make a lot of high quality, sterile glass that can withstand the temperatures that the pharmaceutical companies are saying they're going to be using for transport."
Corning was part of Operation Warp Speed - https://youtu.be/asDKBi5Ungc - they had to build a glass plant to make 0.5B vials/year.
Although this time we have the advantage that the high volume production and distribution process for mRNA vaccines requiring a cold chain is all set up and ready to go.
I can deploy an app to Azure, tell it to allocate a server farm, databases, Redis, queues, etc... in 5 minutes too. But that's only because someone took years to do all the necessary work.