Does this feel rushed to anyone? Why don’t they stagger the release? Why jump from initial trials involving thousands to widespread distribution involving millions?
Historically, vaccines were huge biological black boxes with all kinds of biomachinery inside that weren't understood at all, that weren't even known. Vaccines were routinely developed, purely by clever trial and error search strategies long before any of their actual mechanisms were understood. In particular this meant that most of the molecular machinery included weren't even needed for the effect. You want a lipstick so you steal cars until you find one that contains a lipstick. Who knows what else you acquired.
This generation of vaccines is the opposite, they know exactly what molecules they want, where, for what reason. And it's basically one molecule. One molecule you'd be exposed to, in much larger dosage, anyways one day if the vaccines are unsuccessful (the virus is well past flash-in-the-pan now, it will become endemic unless perhaps vaccination also prevents spread and not only illness, which isn't clear at all). The only uncertainty was the question of whether the immune system will react to the sound protein if it comes without a virus attached and wether an immune system that was already acquainted with that molecule will actually work better against the actual virus, not worse (some viruses are even worse if the immune system thinks it already has a defense and focuses on that but the defense is only partial). Both are easily checked in trials if you don't skip them (we didn't). The black box full of surprises of historic vaccines, the trunk of the car that you stole to find lipstick, it's just not there.
[0] https://blogs.sciencemag.org/pipeline/archives/2020/04/15/co...
I have been around people risking their lives in B.A.S.E jumps, scuba diving or aircraft acrobatics.
If people can risk their own lives for the adrenaline rush, I don't know why they can't risk their lives for the improvement of all humanity.
The issue is finding professionals and professional institutions willing to risk the lives of others to administer those trials.
Those are more risks of a quick end doing something you love, which is much more attractive than a risk of ruining a long life ever after, which being on the wrong end of a failed medical experiment very much is. If we somehow had cultural conventions and processes about controlled opt-out from life then this might be different, but we don't. I don't know how those cultural mechanisms would look and I don't know if they would even be possible without doing more harm than good, but I do know that we clearly don't have them.
But the real issue with challenge trials is that they just don't tell you that much as the trial group would undoubtedly be extremely biased. Basic validation can be done in a dish, in programmerese that's the suite of unit tests, and it can be done well enough to skip from safety tests (that don't involve the virus) right to observed staged deployment. The main thing challenge tests would add is that they would be a big lure for reckless people who try to be faster by skimping on the initial dish tests that are the majority of development (the equivalent of skipping unit tests).
Furthermore, these are considered normal trial sizes it's been tested on tens of thousand of individuals. Every test subject remains tracked. Up to now, there are no permanent adverse effects found in the population that was tested.
In settings like nursing homes, with a 16% case-fatality rate, a vaccine with no reported safety concerns at the 0.003% level or better sounds real good.
Also, 170 cases is a _lot_ in terms of phase III studies.
Other than that, the vaccine is following basically the normal course. It won't get final approval until there is more time to monitor, but the EUA will be based upon saving lives now.
For more, see: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4944327/
I mean, what did you expect?
Literally the whole world is holding its breath for a vaccine to arrive.
If this works out, we will be far less prepared for the next one because, why bother ?
95% with a p of < .0001 is unheard of in Vaccines. This is an amazing feat for science.
That can't possibly be true.
Not to diminish the accomplishment though.
Most are 85-90% but the jump from high 80s --> 95% is massive,
I would think extremely low p values are not just normative, but required for a vaccine to reach public acceptance. This vaccine is noteworthy for the speed at which it was developed, but its not the first really good vaccine.
edit: and because I'm getting a lot of downvotes for some reason, Anthrax, Measles, Rubella, and Polio also seem to have 90%+ effectiveness ratings.
edit edit: and as a corollary, with equivalent n sizes for the trials and higher effect sizes, the p value is by necessity smaller, not that it matters below very small thresholds
edit^3: high 80s to 95 isn't that noteworthy, and is likely within the margin of error of the clinical trials.
This leads to frightening considerations. The reason FDA testing is so stringent is that trying to explain statistics along with a myriad of other fields, that are at this point likely too complex and exhaustive for any one human to fully comprehend even if they spent their entire lifetime learning, to the "public" for them to truly make an informed decision is a futile effort.
A vaccine is no doubt a great thing and much needed. Two things bother me very greatly about it:
1) A lot of testing was skipped. This will be injected into tens, possibly hundreds, of millions of people long before we even know the long term side effects. If by some very low chance this introduces an inheritable change, and if by an even lower chance that inheritable change leads to genetic collapse in 10-20 generations - just to be very clear, this is extremely unlikely - we have opened the window to humanity's end.
2) A far more realistic ethical concern is what happens to states (god forbid if the fed does it) who legally require this (unconstitutionally, of course, since most modern laws already are and nobody seems to have an issue with this) like New York who've already had a number of terrifying assembly bills for something similar, if this backfires and causes permanent harm to people?
The human body is incredibly complex. A doctor's oath includes "above all, do no harm", and most of the people that will be vaccinated have a 90%+ survival chance. Granted, the above is a very myopic view that completely ignores large scale economics - so please bare with me and use your medicine/ethics hat for it. Is this the right thing to do in the long run?
As a country, the US has proven track record of making stupid decisions in tough times (911 -> PATRIOT, etc).
That's such a vague, unqualified (in the "lacking specificity" sense) concern, that you could apply that to practically any new technology or medical treatment.
10-20 generations is 250-500 years, if somehow this particular vaccine did cause inheritable damage, I'm sure that medical technology would be advanced enough at that point to find a solution.
And on that timescale there's also much more tangible and evidential existential crises, like climate change and nuclear war.
Indeed, extremely unlikely. Have you considered that writing this comment could also trigger the "end of humanity" by some as-of-yet unknown and unforeseen butterfly effect? Extremely unlikely, but still. Better consider it.
As for the rest of this nonsense, no, there is no chance that this induces a genetic collapse. mRNA vaccines do not alter your DNA.
The IPV polio vaccine is actually over 99% effective after three doses (the standard schedule in the US is four doses).
In this context it means that the probability of getting the result they got, in the assumption that vaccine does not work, is less than 1 in 10000.
I've heard about a guy who volunteered to try the Russian vaccine - he got extremely sick and almost died from inflammatory cardiomyopathy as the result. So I want to see thousands of people who to get vaccinated and keep fine for some long time after that.
It always is. This can never change. Experience has cemented "always wait for a service pack" as my #1 rule of life.
Sputnik 5 is a live virus vaccine, Moderna and Fizer are RNA vaccines with, hopefully, no live viral material as such.
Importantly, the vaccine does not use SARS-CoV-2, even in a weakened form. It just presents a SARS-CoV-2 spike protein.
Maybe take notice the of 20k in each trial who have received the vaccine?
Or maybe just go get Covid and trust those results?
I believe I already had it. I have experienced unusual body temperature fluctuations and really unusual heart quirks on a weekend some months ago. My boss got tested (out of curiosity) positive for the antibodies. The numbers are huge and I meet a huge lot of people every day (nobody I've met in person reported any symptoms though). It seems logical to me all of us (people I know) have already had light/asymptomatic covid. I never meet old or fat people, I miss some but prefer not to risk.