According to reports, the original BioNTech vaccine was developed in a matter of hours: https://www.businessinsider.com/pfizer-biontech-vaccine-desi... Moderna's was done in two days.
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.
By tech you mean mRNA vaccines? How did those studies go about it? Why was it not a thing before COVID-19?
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.
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.
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.
It seems that major news sources have decided to suppress any information that disputes the reductive and simplistic storyline that the vaccine and masks are the perfectly effective and only solution.
It is quite interesting.
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.
The smallpox vaccine causes roughly comparable rates of myocarditis, but that didn’t stop us from undertaking a worldwide vaccination campaign to eradicate the disease.
* * *
If there were like 100x more common serious side effects, we should maybe have a conversation about whether certain populations with low Covid risk or heightened vaccine risk should pick which vaccine to take based on potential side effects. But we are so far away from that kind of risk that it is hard to see the commentary from the anti-vax side as any kind of good faith conversation, compared to grasping at whatever straws they can find to spread FUD.
The basic summary is: these vaccines are extremely safe and extremely effective for people of every age. Please everyone get vaccinated. If you have had 2 doses >4 months ago, get boosted. Anyone who tells you that the vaccine is unsafe compared to catching Covid is either grossly misinformed or lying.
Life is deadly, but both sex and covid vaccine rank low on the death list, and high on the life list.
They face ~3 orders of magnitude less risk than elderly people (of whom ~1e7 have died so far), but it is still nontrivial and much higher than the risks from vaccination.
Small kids also spread Covid effectively. There have been a bunch of places with high vaccination rates where there were outbreaks in daycares.
> It has been said [the vaccine] reduces spread, but this is not what you observe
This is what you observe. There have been a large number of studies published examining the effects of vaccination rate on community spread showing that the reproductive number of the virus (at least the original and alpha/delta strains) is significantly depressed by vaccination.
With omicron, vaccine effectiveness vs. initial infection / mild disease is much worse than with previous Covid variants (though it seems that protection vs. severe disease / death is still robust), so we can expect to see significant spread in highly vaccinated areas, but still less and slower than among an unvaccinated population.
> The vaccine does not prevent spread of Covid. Period. The smallest amount of research proves this to be the case.
So what is the truth?
The vaccines significantly reduce the chance of infection given identical exposure. For those who still get infected, the vaccines reduce the viral load throughout the infection, eliminate or ameliorate symptoms, and shorten the time during which an infected person is contagious.
They do not completely prevent any spread of the virus (nor does any other vaccine ever created for any disease), but they make a significant beneficial impact on the rate of spread. They both cut the rate of secondary infections within each household, and reduce the amount of inter-household spread in the community.
https://www.thelancet.com/journals/laninf/article/PIIS1473-3...
A few months after the second dose, 2 doses of the mRNA vaccines is insufficient to reduce peak viral load for breakthrough infections by the delta variant of the virus, making the vaccine less effective over time at preventing basic transmission and mild illness (the 2-dose vaccine was more effective with previous variants). However, a booster dose seems to make a significant improvement:
> By analyzing viral loads of over 16,000 infections during the current, Delta-variant-dominated pandemic wave in Israel, we found that BTIs in recently fully vaccinated individuals have lower viral loads than infections in unvaccinated individuals. However, this effect starts to decline 2 months after vaccination and ultimately vanishes 6 months or longer after vaccination. Notably, we found that the effect of BNT162b2 on reducing BTI viral loads is restored after a booster dose. These results suggest that BNT162b2 might decrease the infectiousness of BTIs even with the Delta variant, and that, although this protective effect declines with time, it can be restored, at least temporarily, with a third, booster, vaccine dose.
https://www.nature.com/articles/s41591-021-01575-4
* * *
For the omicron variant, there is still further reduced effectiveness of these vaccines on basic transmission and mild illness (only 70% effectiveness after a 3 shots; I don’t think there’s much data yet about viral loads), though protection against severe illness should still be robust (but reliable data about this will not be available for another few weeks or months).
In any case... from what I heard, the omicron variant is somewhat close to common cold, and that it causes mild symptoms. If that is the case, then this is good news, especially if this applies to everyone, or most.
If this omicron variant is indeed much less severe, then would it not be a good thing for as many people as possible to go through it and develop immunity?
Some recent findings and whatnot:
> How SARS-CoV-2 evolves over the next several months and years will determine what the end of this global crisis looks like — whether the virus morphs into another common cold or into something more threatening such as influenza or worse.[1]
> Yet researchers expect such gains to become ever smaller. Scientists measure a virus’s inherent ability to spread in an immunologically naive population (that is, unvaccinated and not exposed to the virus previously) by a number called R0, which is the average number of people an infected person infects. Since the start of the pandemic this figure has jumped as much as threefold. “At some point, I would expect that increased transmissibility will stop happening,” says Bloom. “It’s not going to become infinitely transmissible.” Delta’s R0 is higher than seasonal coronaviruses and influenza, but still lower than that of polio or measles.[1]
Might be of interest:
> That evolutionary path, towards immune evasion and away from gains in infectivity, is common among established respiratory viruses such as influenza says Adam Kucharski, a mathematical epidemiologist at the London School of Hygiene and Tropical Medicine. “The easiest way for the virus to cause new epidemics is to evade immunity over time. That’s similar to what we see with the seasonal coronaviruses.”[1]
and
> A more likely, but still relatively hopeful, parallel for SARS-CoV-2 is a pathogen called respiratory syncytial virus (RSV). Most people get infected in their first two years of life. RSV is a leading cause of hospitalization of infants, but most childhood cases are mild. Waning immunity and viral evolution together allow new strains of RSV to sweep across the planet each year, infecting adults in large numbers, but with mild symptoms thanks to childhood exposure. If SARS-CoV-2 follows this path — aided by vaccines that provide strong protection against severe disease — “it becomes essentially a virus of kids,” says Rambaut.[1]
and
> Influenza offers another scenario — in fact two. The influenza A virus, which drives global seasonal influenza epidemics each year, is characterized by the rapid evolution and spread of new variants able to escape the immunity elicited by past strains. The result is seasonal epidemics, propelled largely by spread in adults, who can still develop severe symptoms. Flu jabs reduce disease severity and slow transmission, but influenza A’s fast evolution means the vaccines aren’t always well matched to circulating strains.[1]
> But if SARS-CoV-2 evolves to evade immunity more sluggishly, it might come to resemble influenza B. That virus’s slower rate of change, compared with influenza A, means that its transmission is driven largely by infections in children, who have less immunity than adults.[1]
That said:
> “There may be multiple directions that the virus can go in,” Rambaut says, “and the virus hasn’t committed.”[1]
So I suppose we will see. I am hoping for something like common cold. Mild symptoms. I am also hoping to get rid of some of these mandates and this COVID-19 pass stuff in the future, but once it is in place, do you think it is likely that they will revert it? I do not know, but I hope they will.
I cannot get the vaccines for health reasons, but I am unlikely to get a medical exemption as my country is full of idiots. Other countries do give exemption to immunocompromised people, whereas my country prioritizes them. I wonder if I could get a religious exemption. But yeah, the vaccines might give me a flare-up of whatever I have, and I would rather not risk it. My immune system is in a tough spot with all the inflammations going on, on top of some autoimmune disease. I hope to treat some I can.
[1] https://www.nature.com/articles/d41586-021-03619-8 (Beyond Omicron: what’s next for COVID’s viral evolution, 07 December 2021)
No, we don’t have anywhere near enough data yet to draw that conclusion.
What we know for sure is that it generally doesn’t cause hospitalization/death among people that have previously been infected by Covid or vaccinated. Which is generally true for every variant. And we also know that it has a significant degree of immune escape, causing a much higher rate of reinfections / breakthrough infections than previous variants.
It may be that it turns out to cause less severe disease even for the immunologically naïve, and many observers are hopeful that that turns out to be the case.
> cannot get the vaccines for health reasons
I would recommend you consult a physician who is an expert in your condition before making this decision.
For more explanation, https://cdn1.sph.harvard.edu/wp-content/uploads/sites/2623/2...
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,...).
In a normal trial, you give half of participants a vaccine, and half of participants a placebo. Then, you wait around and see how many people in each group catch COVID naturally and get sick. Your vaccine works if fewer people who received a vaccine get sick compared to the placebo.
In a challenge trial, you give half of participants a vaccine and half of participants a placebo, and then purposefully expose them all to COVID so you don’t have to wait around for them to catch the virus naturally. As before, your vaccine works if fewer people who received a vaccine get sick.
A challenge trial gives you data which is more, not less, robust, because you’re controlling for more variables between groups. And we’ve used challenge trials to test vaccines in the past—just, never with a disease that’s nearly as deadly as COVID.
Any firestorm would result from a trial participant dying from the COVID they were purposefully given (which could absolutely happen), not from the vaccine. This has nothing to do with vaccine mandates.
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.
https://www.gov.si/en/news/2021-11-30-expert-commission-conf...
> 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.
Soon after, astrazeneca was slowly pulled out due to a few deaths elsewhere (not in slovenia), then a wife of our diplomat died in belgium (jannsenn), and the media talked a lot about the hospital procedures, and how she could be saved... then this 20yo girl (from the report) died from jannsen, and we stopped using jannsen too, then scandinavian countries stoped using moderna due to heart issues in younger people, and we're down from 4 to 1 vaccine, with huge mandates that indirectly force you to get vaccinated. ...and the antivaxxers are just waiting for something bad to happen with pfeizer, to show they were right about safety issues.
https://en.wikipedia.org/wiki/Human_challenge_study#Vaccines...
Yes, we do[1][2].
[1] https://www.cdc.gov/flu/vaccines-work/effectivenessqa.htm
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)
[1] https://www.cidrap.umn.edu/news-perspective/2020/07/hopeful-...
This is the answer for why not all annual flu vaccines need clinical trials.
Which one?
Here is a pretty good summary of the history of vaccine development.
https://www.medscape.com/viewarticle/812621_1
While nearly all influenza vaccines generate similar antibodies, Covid and influenza vaccines generate significantly different antibodies
Influenza vaccines generate antibodies against influenza Hemagglutinin proteins targeting sialic acid receptors
Covid vaccines generate antibodies for (S) glycoproteins targeting ACE-2 receptors.
In short, we have 80+ years of experience generating antibodies for hemagglutinin, and much less for (S) glycoproteins.
Going forward, the FDA has already said that a reformulation of the mRNA Covid vaccine would face a similarly shortened approval process.
>FDA says Covid vaccines that target new variants won’t need large clinical trials to win approval
https://www.cnbc.com/2021/02/22/covid-vaccine-fda-says-shots...
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.
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.