Pfizer submits Covid vaccine to FDA for approval, to distribute in December
pfizer.com
pfizer.com
- Treats it as an optimization problem for various levels of vaccine efficacy (10-100%), availability(10-100%), spread rate (R0 in {1.5, 2, 2.5, 3}), susceptibility to infection and symptomatic infection per age group.
- Four objective functions: symptomatic infections, deaths, non-ICU hospital usage at peak, and ICU usage at peak
- 5 age buckets: 0-19, 20-49, 50-64, 65-74, 75+
- Assumes 20% of population has immunity, and immunity lasts for a year.
- At higher efficacy and availability levels, there are some odd shifts to optimal vaccine distribution strategies. It's not strictly "oldest first" or "youngest first", there are some weird discontinuities in the middle buckets as well.
I had some questions about the wide 20-49 age bucket but it appears that it comes from a CDC planning scenario. It does look like that various curves start accelerating sharply past 50 or higher, so I guess treating the 20-49 group as one reasonably low risk group could be reasonable.
I read somewhere they already have 20 million doses ready to shipped once they get the approval. Wonder what is the capacity of each of these specially designed shippers and how the logistics of the eventual vaccination are going to be handled?
But this is surely an interesting problem to solve and I look forward to how they tackle it.
Guessing by eye, you can fit at least several hundred, up to low thousands of doses in each shipper. The inner volumes on these are pretty large, but a good chunk of it will be taken up by dry-ice.
https://www.cbsnews.com/news/operation-warp-speed-covid-19-v...
It's quite remarkable in terms of logistics.
Has Pfizer just not gone through the proper temperature testing or did they go through that testing and it showed that their vaccine needs to be stored so cold?
Although Moderna's and Pfzier's vaccines are both mRNA technologies, they aren't identical in either the mRNA itself or the lipid nanoparticle used to deliver the mRNA. That's why they have different stability profiles.
There is the possibility that you have the ability to manufacture mRNA in your factory but didn't have the idea to start making your own vaccine until late enough that it wasn't worth trying to make your own. In this case you may want to talk to Pfizer about licensing their (but you have probably been in those talks for months and are just waiting for the right time to publicly announce the deal with production already started)
All the articles I read say that the mRNA is "taken up by the cell", but what is the mechanism? Do cells naturally just absorb free-floating mRNA? Or is a modified virus used to inject the mRNA?
That's for the BioNTech/Pfizer vaccine. Other vaccines, such as the Oxford/AstraZeneca one do use a modified virus.
Safe to assume that in time these will evolve into new forms of fat-embeded rna virus which no living being has immunity to?
Essentially the mRNA is packaged into a lipid, which the body's cells can uptake thru its phospholipid bilayer
https://en.wikipedia.org/wiki/RNA_vaccine#Delivery
Viral vectors were the ones I was familiar with. I am not sure which one the Pfizer vax uses, however.
[1]: https://www.scmp.com/news/china/science/article/3110042/coro...
I'm assuming that China is probably not waiving that requirement since they have their own vaccines.
https://www.mondaq.com/china/export-controls-trade-investmen...
The security patch has been tested on tens of thousands instances for several months, the source code peer reviewed by literally the best experts in the world, and you'll most likely have to wait until its been installed on several million other endpoints before you get a chance at distribution?
If you patch a machine and leave it alone, it will stay like that.
Humans age, already have or will get other kinds of diseases, have wildly varied genes, etc..
Drugs could have side effects not manifesting immediately, v2 of the same drug might have less of those side effects.
Depending on how it works that is. It might be more effective to jab those most likely to transmit the disease first. (E.g. medical workers, children before Christmas meeting the family) or it might be better to jab those most at risk first.
IF all of that is true (and if i misunderstood, please correct me!) It would make the most sense to give it to higher risk individuals first.
Because of the test design, the test itself only measured people who got COVID. But based on current scientific consensus around disease, that means there is a very high likelihood that it also prevents asymptomatic transmission, as the immune system will generally fight off infection. One test being narrowly worded (as is correct scientific practice) does not overthrow our entire understanding of disease.
I dont mind a few more months of staying safe, its not a big deal to me and Ill get it later on
Is there zero risk of serious side effects? Of course not, there never is. But the trial gives enough data to say the risk is worth the benefit.
Edit: The FDA has already hinted that their initial approval (EUA) may be restricted to certain populations where the risk-benefit is justified. In other words, they may not approve it for healthy, young adults where the risk of serious Covid complications is low. That "full" approval could come later after additional clinical experience is gained.
All this to say that for the pivotal phase 3 trials submitted to FDA for approval, I would suppose almost all existing drugs had much fewer than 40k participants.
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?ev...
It looks like the initial approval of Lipitor was in the hundreds of patients. Now, statins were brand new and not used really broadly. Pfizer did a ton of follow up studies, but looking at the most current label.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/02...
The two biggest trials, ASCOT and CARDS, which measured improvements in mortality (needed to be big trials to measure any difference), they were ~10,000 and ~2,000 patients each.
So suffice to say, Lipitor, which is used in a massive population, has probably been tested, in clinical trials, on a total number of patients comparable to the Pfizer Covid vaccine trial. Obviously the duration of the Lipitor trials were much longer and there a massive body of clinical data from actual use, but it at least gives you some perspective on numbers.
Vaccine trials tend to be larger because you have to account for the fact that only a small number of people will get infected.
And I can remember getting my tetanus booster in secondary school and when I rolled over in my sleep waking up because my shoulder was so swollen and painful.
I'm not dismissing the fact that the vaccines might cause serious side effects. In fact, it's expected that some very small percentage will. But for the vast majority of patients, the Pfizer vaccine has a similar safety profile to other approved vaccines.
Indeed! And I'll be going with the adenoviral route which has been used for more than fifty years, rather than the brand new, first time ever mRNA product.
Interesting, I feel the exact opposite. I can't wait to take a mRNA vaccine, but the adenovirus ones seem sketchy given that Sinovac, J&J, and AstraZeneca have all seen serious adverse events in their trials, while Pfizer and Moderna have seen none, along with much higher efficacy.
I wasn't aware there were any adenoviral vaccinations approved for human use? What are you referring to?
The idea that COVID-19 is somehow less dangerous than having some RNA in your blood for a few hours (remember, it disintegrates fast when above -70C) is completely insane.
If you compare the frequency of those side effects alone vs. the rarity of side effects we've seen in historical "bad" vaccines, you still end up with a pretty obvious cost-benefit in favor of taking it. From that point of view, "even smaller chance of dying" becomes just a perk.
covid can do/does plenty of nasty things to "non vulnerable" people besides kill them
Note that the clinical trials for this vaccine 100% excluded pregnant women, and required males to agree to use two forms of contraception. IIUC they also excluded people with prior exposure to COVID-19.
I'd take it if I were 60, certainly 70 - an 80 year old with pre-existing conditions has a shockingly high 20% infection fatality rate(1). But at 35 and in decent health, with little exposure to at risk people around me? Better off to wait.
For healthy children and teens, it's going to take far more data to know if the vaccines are safer than COVID-19. For them it's about a 1 in 1 million fatality rate per infection(1). And we've screwed up before: one of the H1N1 vaccines turned out to occasionally cause narcolepsy, and that wasn't even novel vaccine technology.
Meanwhile, out of a 23,359,180 males in my age group (25-34) in the US, 1,144--or 1 in 20,418--have died [0]. And obviously, the death rate is significantly higher than 1 in 20,418, because not every 25-34 year old has had COVID.
If I get the vaccine and I can go back to living my life normally, that alone is worth the low risk to me. And sure, there's the (remote) possibility that the vaccine has some long-term side effects, but I have to weigh that against the (in my mind higher) possibility of COVID having some long term side effect.
Given that I can't practically isolate myself completely for the next 8 months, I'm getting this vaccine as soon as possible.
[0] https://www.cdc.gov/nchs/nvss/vsrr/covid_weekly/index.htm
mRNA is usually produced by DNA and is temporarily used by cells to create proteins. In this case, the mRNA is used to create proteins with a similar structure to the coronavirus. These proteins produce the desired immune response but do not harm you. Like other proteins, they don't stick around permanently, just the immune response does. Additionally, the mRNA itself only lasts several minutes to days. [0]
It's a relatively simple biological process that's well understood. This gives me a lot of confidence in its safety profile. Unlike a regular vaccine, you also don't have to create the protein directly, which leads to fewer errors during production from my understanding. You're producing a simpler, more basic compound, and can be more certain about the quality of individual doses.
This is a really good analogy. It's important to note that this stuff literally has to be stored at cryogenic temperatures just so it won't completely degrade before being injected. Once inside your body, it's completely gone within hours.
Given how sensitive to temperature this vaccine is, I would like some reassurance that no one mishandled it along the way.
*Here is an article I found on the subject. Essentially stating in general employers could require vaccination. https://www.usatoday.com/story/money/2020/08/26/coronavirus-...
But for the vast majority of workplaces, there's not much of an existing precedent to do this, and I suspect the vast majority of employers will not want to rock the boat too much. I suspect it'll be something that will be "required" by policies but not enforced in practice. The people who want to get vaccines will get them, and those who do not will ignore the policy without repercussions.
This attitude is why the pandemic rages on with such intensity in so many places
Note that we don't know if vaccinated people can spread covid or not. It seems unlikely, but if it turns out being vaccinated means you become a non-symptomatic super spreader I reserve the right to change my stance based on that information.
It's a lot of people's lives, not just theirs. Like with most vaccines, there'll be a fraction of the population who cannot safely get vaccinated. We need to think of this from a public health perspective: more unvaccinated people in spreading-prone situations means more risk to others (including those beyond the immediate situation) and more burden on health systems.
* we don’t yet know whether the vaccine prevents transmission. You can probably be a carrier and spreader even if vaccinated
Those two facts alone mean we’re going to be wearing masks for quite some time, things won’t go back to normal for a while, and people are justified in being upset with others who refuse to protect everyone around them.
The good news, in a sort of perverse sense, is that some delay to see what happens with "early adopters" is kinda inevitable anyway, due to the distribution logistics. Unless you're a health care provider, first responder, or in a high risk group, you'll probably have to wait a while to get access to the vaccine even if you want to take "version 1.0".
Additionally, you also have, as an individual, the option to just stand further back in the line. You don't have to get in immediate contact with the enemy, you can just go to the back of the army and wait for some time until the experimental armor is battle tested.
What sounds like the more rational choice (from an individual standpoint) now?
EDIT: not sure why this is getting downvotes. I do agree that the risk equation does seem leaning towards taking the vaccine. Tests have been conducted with >30.000 people, and so far it seems safe. There still exists of course a probability of that not being the case, but compared to the (known, and very real) side effects of covid, taking the vaccine asap even if it's version 1.0 seems like the sensible choice.
Still, parents analogy seemed flawed so I tried to extend it.
Maybe it does. And maybe it will also turn me into a frog. But we can only deal with known knowns and known unknowns. You have to weigh that against the risk of COVID infection, multiplied by the misery of not being able to live a normal life.
I'll take the small, abstract, unknowable chance of something bad that has no known mechanism of action versus the empirically quantifiable reality of living in fear of COVID. These are unprecedented times, and we have to trust in science. It's gotten us this far.
All analogies are flawed. That's why they are merely suggestive and not meant to be interpreted overly literally.
There have been plenty of mishaps with vaccines the last swine vaccine for example had severe side effects that caused disabilities.
When you plan to vaccinate millions of people even 1% of severe long term side effects is something you can’t afford.
Having the companies also being essentially exempt from future damages also complicates things because people might suffer from life altering side effects and would not be compensated for.
It's kind of wild when you think about it.
Yes vaccines can sometimes do weird things to the immune system, but viruses are far more likely to jack up the immune system than most vaccines.
No it doesn’t, because vaccine development is more like bridge building than software development.
It was fine... until it wasn't (four months later). Anyway, this analogy is silly. Neither software nor bridges is exactly like the human body and the myriad of complex interactions that happen within.
At the end of the day, all I'm saying is that A. under normal circumstances, it takes a lot of time to get a vaccine tested and approved - for good reason. And B. these are not ordinary circumstances, there may be reason to think the process was rushed, and it may be prudent to not rush to be among the first to take the vaccine.
And just in case anybody misunderstands what I'm saying, let me reiterate as clearly as I can:
This is NOT an anti-vax screed, or an appeal to any conspiracy theories, or anything of that nature. And I am NOT suggesting anyone refuse to get vaccinated in the long-term. I am only suggesting a certain measure of patience, which is probably going to be part of the process anyway due to the logistics of distributing the vaccine.
From your reference: "The original bridge received its nickname "Galloping Gertie" because of the vertical movement of the deck observed by construction workers during windy conditions. The bridge became known for its pitching deck, and collapsed into Puget Sound the morning of November 7, 1940, under high wind conditions. "
• In the entire history of vaccines, only one has been recalled because the vaccine itself caused long term side effects (a rotavirus vaccine that had rare complications and no deaths for those under 1yr). If you can't find any papers about it, that's why. It's like finding a paper on death by lava lamp explosions. It's happened (https://www.latimes.com/archives/la-xpm-2004-dec-01-na-brief....), but not enough to study it.
• Much of the speed was gained by relaxing enrollment rules, which are for study participant safety. The majority of normal study participants join in the last year or two anyways.
• These studies were larger than usual to make up for the decreased time. 30,000 people is a lot, and plenty to check for rare side effects.
• Then compare the odds that there's a common reaction that didn't show up in 30,000 participants against the ~5-10% chance of serious health complications from COVID. It's a no-brainer.
You can read the list of recalled vaccines and why they were recalled straight from the FDA (https://www.cdc.gov/vaccinesafety/concerns/concerns-history....).
Larger studies don't make up for decreased time in either identifying long term effectiveness or identifying delayed effects.
To be fair, it's really hard to compare this to anything that has existed before. mRNA vaccines are a whole new class of drugs that have never been approved for human use. This will be a world first when Pfizer gets the EUA next month.
I have met numerous people over the year receiving diagnosis of fibro, CFS, tendonitis without any reports from doctors to the FDA. Most negative reports are made by patients who researched it. This is extremely dangerous. I have met pharmacist who suffered from the same problems but still their colleagues would label them crazy.
I will let others test the vaccine in the real world before taking it myself.
Not that you’ll be able to get the vaccine for months anyway, unless you work in healthcare.
We have plenty of reason to believe these vaccines will be effective with minimal adverse effects (including the relatively small study of 40k individuals).
Conversely, we have definitive proof that in the best case COVID can be asymptomatic and/or a nasty, but survivable, virus. At its worst, it kills you or leaves you with long-lasting health issues that we don't yet fully understand.
Personally, I'll take my chances with the vaccine. My biggest fear isn't adverse reactions, but rather lack of efficacy.
If our best and brightest doctors are opting to get the vaccines for themselves, I feel safe doing the same - it's probably the most clear and obvious signal we're going to get.
All things point to these as being safe, but until it's more widely dispersed I don't think you can assert it as having the same safety as most modern inoculations.
Cautious optimism isn't a bad thing, nor is hesitance to taking the vaccine. Its not really your place to convince them it is safe, that's for them to decide with the facts on hand. Provide them info on the tests, share whatever you have, but it's ok to not trust the speed at which these vaccines were made.
Is that like polio and lasts for years, or like the flu and you need a new dose each year?
[0]: https://www.nytimes.com/2020/11/17/health/coronavirus-immuni... (with links to the studies inside)
(That isn't to say the immune system can't forget immunity - TDAP boosters are for evolution, but for refreshing the immune system - but that super short term immunity like flu, AIUI, is about the virus not the vaccine.)
They should still release the data. PR releases don't always match reality.
Because there is no long term data on covid19 mutation speed.
You need a cohort to take the vaccine and then some time before doing a retroactive study.
His message was "You honestly don't know ahead of time", but his caveatted guess was actually that it would be long-lasting (giving the example of measles), not like the flu.
"Two new studies demonstrate how severity of disease is predictive of longer-lasting antibody production and detail how immunity wanes over time but may exist for up to 7 months."
https://www.cidrap.umn.edu/news-perspective/2020/10/studies-...
https://www.cdc.gov/coronavirus/2019-ncov/hcp/duration-isola...
There's also evidence of re-infection
https://www.thelancet.com/journals/laninf/article/PIIS1473-3...
Is that true? I always thought it was at most as strong (eg, David Katz says so here: https://youtu.be/YLLENema1Co?t=462), but I'm seeing this assertion float around also. Which is it?
Many of them are probably trolls, still, it's weird to me.
But this has all the signs of getting very ugly once a vaccine becomes available. I certainly don't expect the military to hold people down and vaccinate them by force. But I do expect a lot of severe restrictions in some places on people who don't want to get vaccinated right-off that will put them in a tough position.
The people I know who are cautious with getting the vaccine are below 50. So, they’ll have to wait a while anyway. Most of us are not like... wait years for effects to emerge. More like 6-12 months after initial rollout.
I’m one of those people. I’m fine with still being remote and wearing a mask when in stores or whatever. I’m not going to go to any dances anytime soon even if I had the shot anyway. Effectiveness isn’t 100% after all. (Is there an easy way to tell if you’re immune after without any risk? That’d be nice...)
From experience, sometimes people are very refusing when arguing in person, but over time they think it over and might change their mind.
What would the outcome be?
I posed this question to Soccer Dads and immediately was told they wouldn’t risk the long term effects of a vaccine.
Same dads that wouldn’t wear a mask and don’t fear the unknown long term effects of COVID
The vaccine could have “unknown long term effects”.
But the virus “only has an x%” death rate”. No concern about unknown long term effects.
But I totally understand after institution after institution failed us all, that people will be skeptical about a miracle vaccine developed in mere months.
I have faith in the scientists, but anyone can see the incentives are dodgy here.
Not saying here that one should avoid the vaccine, just that experience shows that a healthy skepticism is warranted. Do your own research and draw your own conclusions.
UFOs - again, dismissive, denied for decades. And now they've casually released videos from the Navy showing aerial vehicles performing maneuvers that none of our current technology is capable of.
Gotta go kill all those animal carriers and test/innoculate every person in the world (more or less) continuously for some time, then you have a chance. The specific virus will not be eradicated within our grandchildren's lifetime, afaik.
https://www.cbsnews.com/news/covid-face-mask-protection-vacc...
https://www.health.com/condition/infectious-diseases/coronav...
This is from September before the results of the vaccines were known. The two vaccines we have data on have a ~95% protection rate from getting symptomatic COVID. Additionally, of that 5% of vaccinated folks who did get symptomatic COVID, there cases appear to be much less severe than the control group.
Think about it. Out of million people only small percentage would become infected with covid and of that, only small percentage would die.
On the other hand, vaccine must be distributed to everybody. Alternatively to people who, by occupation, have to contact many other people, daily.
We don't know yet if there are complications from the vaccine. It is not possible to judge long term effects of anything based on very short exposure.
The value of vaccine is in preventing future infections, but for a given person now it is not yet know if the vaccine is actually a good deal or not. Only time will tell.
Looking at this selfishly and from PoV of game theory, the best decision is to let vaccinate everybody else but don't take vaccine yourself. Obviously, not everybody can make same decision.
The rapid growth of racism in blue states comes back to this attitude. If people can't speak freely, when they have false beliefs, they keep them to themselves, and you can't address them. The sorts of blue state beliefs about minorities are just wacko at this point.
People should be free to speak.
No, I don't agree with OP, but this whole "why talk about it?" thing is an issue. You talk about things together, critically to come to a common understanding of the truth. That has a lot of value in itself. It's not all about impact of words, and how you can politick the change you want in the world. Society works better when people speak openly, even when those words are false and harmful, and when people can be confronted on that, not with cancel culture, but critically, logically, and civilly.
We've worked ourselves into a corner where we can't do that anymore.
I actually think OC made a valid point - that is, there is an extremely small chance this vaccination causes long term effects, and therefore, if every individual were to act independetly according to their own self-interest, they would avoid the vaccine. This is true for all vaccines, and reminds me of the tragedy of the commons.
I'm actually curious, though, why the OC wants to discuss this. There is truth to his comment, but if you aren't willing to be a team player, there's no good in recruiting others to your way of thinking.
That said, the large size of these studies should be extremely comforting to people.
I know nothing about vaccines or medicine really, but I just find it hard to believe that it’s just luck that we’re all going to be taking one in under a year when there hasn’t been much push for approval before this ?
Hopefully we’re not going to be pressured to be inoculated with something, anything that works, because of desperation and because managing the situation in an adult way was too hard for most world leaders.
As others have said, if you’re not in a high risk group, maybe some skepticism is warranted?
It is not plausible that, absent a vaccine or other cure, only a small percentage will contract it. The evidence strongly suggests that a large fraction of the population will end up catching it at some point.
We already have plenty of evidence how that goes, in the chicken-pox outbreaks in the communities that have chosen not vaccinate, presenting a threat both to themselves and others. This virus is known to be much more dangerous.
You seem to weigh your hypothetical problems of a vaccine much more heavily than the actual problems of the virus.
...
> Looking at this selfishly and from PoV of game theory, the best decision is to let vaccinate everybody else but don't take vaccine yourself. Obviously, not everybody can make same decision
There are two different ways a medicine might have long term unintended and currently unknown effects.
1. It does some kind of permanent damage to you fairly immediately after taking it that takes a long time to show noticeable effects, or
2. It does some some kind of damage that is not permanent and won't lead to any long term noticeable effects as long as the original damage is allowed to heal or at least not made worse.
Category two is what you have to worry about with things you have to take regularly, because they can accumulate the damage or risk and it can take many years before it accumulates to the point that we might notice.
Because this is a not a "take every year" kind of vaccine, I don't think there is much need to worry about category two.
With "take it once" types of medicine (yes, I know some vaccines require more than one dose over a week or two, which counts as taking it once when considering long term effects), with wide deployment, I'd expect any unintended and unknown long term side effects to start being found within maybe a year of wide deployment.
If it caused cancer, or auto an autoimmune disease, its likely these wouldn't be apparent for months or years. This is unlikely, but possible, and we could not test for this thoroughly as we didn't have the time.
I also remind you that these companies are immune from lawsuits due to the indemnity clause in their contracts.
There have been some people who have been reinfected with it, but I saw another recent article about this latest research that talked a bit about those cases. It said that they are believe to be people who did not have a strong immune response the first time. The vaccines should produce a strong response.
[1] https://science.sciencemag.org/content/early/2020/10/27/scie...
[2] https://www.darkdaily.com/mount-sinai-researchers-find-that-...
It's in our best collective interest for everyone to take this vaccine even if there's a 0.01% chance it has negative side effects.
Even on an individual level, the cost-benefit of taking the vaccine is a no-brainer. Even if there's a 0.01% chance of negative side effects, the individual benefit of re-opening society far outweighs that risk.
It's true you can freeload and reap the benefits without the small risk, but if everyone thinks this way, there are no benefits to go around. Can't you just be a team player?
To put things in perspective, a 0.01% risk is like going skydiving once, or getting out of bed and doing your usual routine for a week.
It goes without saying that if the general public doesn't get vaccinated, you should definitely get vaccinated because the risk of catching COVID is worse than the risk of this vaccine.
> for Emergency Use Authorization
https://en.wikipedia.org/wiki/Emergency_use_authorization
> authorizes FDA to facilitate availability of an unapproved product, or an unapproved use of an approved product, during a declared state of emergency from one of several agencies or of a "material threat" by the Secretary of Homeland Security
Rushed, yes, but via an existing set of rules for this sort of scenario. It's an appropriate use of this sort of process, but it does come with some risks.
I think this will end up having the opposite effect than intended.
There's truth that there's a remote chance this vaccine has long-term side effects. From my reading, I would estimate that risk to be 0.0001% - 0.01%.
If your goal is to promote vaccination, it's better to actively engage in the conversation by explaining how the benefits far outweigh the risks. Silencing dissenting opinions will only serve to reinforce those beliefs.
-Seems extremely effective at limiting covid disease.
-Very curious as to how long will the vaccine immunity will last?
-Seems with the second dose for 18-55 year olds, perhaps 75% will feel fatigue, 50% have chills and 20% will have a fever.[1] This hasn't been widely shared yet and I'm a bit concerned how the public will react.
-Safety: Given the huge trial size, we can be pretty confident that there aren't any significant negative short term effects. But yet the phase three trials will follow the participants for two years. Presumably, this is to find out about longer term safety+efficacy... but yet of course we will be vaccinating most of the world prior to the end of those two years.
How are we confident that these vaccines don't cause any long term safety concerns? Other vaccines have been pulled from the market for safety reasons - what happened in those cases that we're sure won't happen in this case?
I think given the fact that "anti-vaxxers" exist makes some people take the complete opposite position to distance themselves from the conspiracy theorists- "anything a doctor injects in your arm is safe". Of course the truth is that injecting stuff in people's arms is not always safe - which is why we have trials. Were these trials long enough to know with a high level of confidence if there are any long term effects of the vaccines?
Isn't the Flu vaccine side effects the same though?
https://www.washingtonpost.com/health/flu-shot-facts/2020/09...
This isn't true at all. There has been 2 voluntary recalls due to manufacturing issues which not led to any health problems.
A list here for the US (most of the listed vaccines on the page were later found not concerning):
https://www.cdc.gov/vaccinesafety/concerns/concerns-history....
-The results of the investigations showed that RotaShield vaccine caused intussusception in some healthy infants younger than 12 months of age who normally would be at low risk for this condition... the manufacturer voluntarily withdrew RotaShield from the market in October 1999.
-...that people who received the 1976 swine influenza vaccine had an increased risk for developing GBS .
-And the very recent Dengue vaccine made by Sanofi, which was given to 700k people. "Sanofi had found evidence that the vaccine increases the risk of hospitalization and cytoplasmic leakage syndrome in children who had no prior exposure to dengue, regardless of age."[1][2]
[1]https://www.npr.org/sections/goatsandsoda/2019/05/03/7190377...
1,769 people 25-34 have died of Covid this year. There are 23m people in that age range. .0077% have died. If the vaccine had an adverse effect at a similar rate as covid has killed young people, we'd expect it should have showed in the trials in 1-3 people.
I don't think anyone is saying that we should never sell any vaccine before it has been tested for 100+ years, that's obviously impossible. But to ignore obvious concerns is just religious scientifism in the worst possible sense.
These are good concerns for any medication.
But of course there are legitimate safety concerns with injecting stuff into people - which is why they ran a huge study to show that there are no short term safety concerns.
I'm just asking (not implying anything) a real medical question I don't know the answer to - how do we know this vaccine doesn't increase the chances of some condition 20 years later when the median time people have been vaccinated is two months? And with a brand new vaccine platform that has never been used before...
Also, that governments will show little patience for anti-vax talk of its citizens. They'll have to switch talking points from avoiding panic (It's harmless for young people!) to accepting the vaccine (There are many long-term effects of infection!). A Herculean effort in balancing propaganda with allowing free speech.
If nothing else, it is going to be interesting watching the next months unfold. Saying you are refusing the vaccine may simply put you on a list, but openly detracting from the vaccination efforts, should see some actual (and scary) pushback.
Public health will be an increasingly difficult thing to manage, when individuals get the information for their decisions online (however wrong).
The first mRNA vaccine went to phase 1 trials more than 10 years, which means we have a few people walking around who got a mRNA vaccine more than 10 years ago - if they got a side effect it wouldn't be noted. The sample size is of course too small, and it was a different vaccine, but there some long term safety data.
Anything is possible. My physics teachers like to point out that all the air in the room can teleport to the moon - but the odds of that are too low to worry about, even on the time frame of the universe.
https://www.hhs.gov/coronavirus/explaining-operation-warp-sp...
I wish there were more examples of this type of thing. One area an effort like this is badly needed is for at-home rapid testing.
Army Gen. Gustave F. Perna (who is the four-star general who is COO of Operation Warp Speed): “There will not be this vision that some have that there will be Army trucks driving through the streets delivering vaccines. The commercial industry knows how to do it.”
https://www.freightwaves.com/news/dod-planning-every-logisti...
So yeah, I think my summary -- that administration is playing a "leadership" role -- is quite right here, too.
I think a better point would be to praise the work done by NIAID and others. Obviously I wasn't diminishing the role of these fantastic scientists, or the role of people like Dr. Fauci, only highlighting that this vaccine was developed in the private sector (with roles played at every level of government).
> HHS announced up to $1.95 billion in funds to Pfizer for the large-scale manufacturing and nationwide distribution of 100 million doses of their vaccine candidate.
It's a sensible use of taxpayer funds, for sure, but Pfizer isn't doing it as a charitable work.
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.
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).
The issue is finding professionals and professional institutions willing to risk the lives of others to administer those trials.
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.
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.
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.
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.
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.
Sputnik 5 is a live virus vaccine, Moderna and Fizer are RNA vaccines with, hopefully, no live viral material as such.
It always is. This can never change. Experience has cemented "always wait for a service pack" as my #1 rule of life.