FDA Issuing Emergency Use Authorization for First Covid-19 Vaccine
fda.gov
fda.gov
This likely didn't matter much to FDA because 16 and 17 year olds aren't likely to receive any doses before the full throated approval because they by and large aren't in the people first in line for the vax (1st line workers, vulnerable groups, old people).
[1]: https://www.smfm.org/covidclinical
[2]: https://s3.amazonaws.com/cdn.smfm.org/media/2632/FDA_final.p...
[3]: https://www.gov.uk/government/publications/covid-19-vaccinat...
[1]: https://www.statnews.com/2020/12/11/podcast-pfizer-covid-19-...
I think children should get the vaccines ASAP provided the vaccine is proven safe as missing a year of school is going to have profound impact on their life and society. Many students from marginalized society, especially from poor countries might never go to school again as they have been employed by their parents for meager sum.
But I think definition of who's 'vulnerable' is what going to be contentious, apart from obvious front-line workers and elderly whom would you decide are vulnerable? Immunity compromised individuals? I'm myself house ridden for over 2 years now due to spine surgery and so likely immunity compromised but there's no way that could be informed to the Govt. I just hope my elderly parents get their vaccine.
And the schools are not closed right now because of the fear that younger children are going to get the virus. Schools are closed because teachers are (rightly) concerned about getting the virus, and families are (rightly) concerned that their children might pick up the virus at school and bring it home with them and infect more at-risk individuals. If the teachers and family members are vaccinated, then I think it is pretty clear the risk/benefit analysis would highly suggest sending children back to school, even if they aren't vaccinated yet.
Schools in the US have already opened in many places before there is a vaccine, so I don't doubt schools are going to be opening ASAP, and that is almost certainly before most children are vaccinated.
https://www.nationalgeographic.com/science/2020/12/we-now-kn...
It'll probably be at least a year before enough vaccine is produced that low-risk groups like children become eligible, so modified education in one form or another will have to continue till that point. This doesn't mean they can't go to school, but things like pods, wearing of PPE, social distancing, and other such things will need to continue till herd immunity can be achieved through vaccination.
Someone at the CDC disagreed with the strategy of vaccinating people in long-term care facilities first because their weaker immune systems might not have an effective response to the vaccine. I'm not even sure if vaccinating front-line heathcare workers first makes sense because they've probably been exposed already (or not; this is easily checked with antibody tests).
You want to vaccinate people most likely to spread it. Who that is, I'm not sure.
https://www.npr.org/2020/12/07/943945361/think-health-care-w...
> 42% of RNs in hospitals said they had ever been tested for the virus.
and anyways that's different from a one-time pre-vacccination test.
Not when your vaccine isn't proven to stop spread.
So you'd want to give it first to people who are very likely to become severely ill themselves, and whose infection would cause others to become severely ill, directly or indirectly (eg through disease spread or through lost resources, as if an ER doc in an understaffed area became severely ill).
Schools in the UK have been open since September. Typically if there's a positive case then they isolate and typically their closest contacts isolate, if there's more than one then the entire class isolates.
There's no evidence that teachers are any more likely to die from covid than many other essential workers who aren't working from home.
There's no evidence that these vaccines stop spread, so there's little point in prioritising vaccination of children who - even if they did catch covid - are practically immune. Same with the majority of teachers. Makes far more sense to vaccinate older people who are at serious risk (with IFR in the 5, 10, 15% range) - then they don't need to worry about the kids bringing the virus home.
What's the death rate for teachers been since September compared to other occupations like nurses? Is there "no evidence" because the evidence shows they're less likely to die, or is there no evidence because no one is bothering to keep track?
>There's no evidence that these vaccines stop spread
Nothing is 100%, but my understanding is that the AstraZeneca has results showing that it significantly reduces the chance that someone who has the vaccine will spread the disease
It is like the titanic is burning and these guys are playing violin...
There was no decision that shouldn’t have been made ahead of time. Either it met the predefined criteria or it didn’t.
Everything else should have been a continuous process of pre-verification up to the point the 128 positive confirmed COVID cases were unblinded.
Assume the unblinded results will be good enough, and verify everything else you would normally verify ahead of time. The only thing that remains is to verify the unblinded cases the day they are announced.
And not just that but your approval thresholds should already be preset and preregistered, the doses already distributed to point-of-care, and nurses start administering shots the very next day.
Yes it’s a big waste of money if it turns out not to work. That’s the whole point.
Turns out the vaccine is highly effective 10 days after the first dose. We could have been doing at least a million doses a day since November 19th. Realistically even long before then.
Remember when the FDA wouldn’t let public or private labs run their own COVID tests and everything was being shipped to CDC headquarters to PCR?
The CDC and the FDA essentially guaranteed through extraordinary ineptitude that the US would not fend off COVID back in January/February. They deserve zero benefit of the doubt.
The FDA’s 70 years of process likely worked against them here. What I can say for certain is that there was a t-minus one, the day before the results were unblinded, and there was a t-zero, the day results were unblinded. On that day t-zero they uncovered which of the patient IDs got the vaccine versus which got placebo.
No expense should have been spared in preloading the analysis, verification, whatever could have been done, it should have been done up until t-minus-1. On day t-zero you get 15,000 patient IDs in column A and 15,000 in column B, that’s the only new thing you learn that day. There should be nothing new to talk about or discuss, the approval criteria should already be set in stone. Check the IDs and launch.
They shut down testing back when we needed it most, allowing us to pretend there was no spread in the US for far too long: https://www.statnews.com/2020/05/27/coronavirus-testing-seat...
They spent far too long before approving any kind of at-home testing and to this day have not approved most rapid testing.
Three weeks ago the EUA was submitted, so three weeks ago there was an entire team of people at pfizer who had reviewed all the data and were confident FDA would approve the application, but somehow nobody at FDA was part of that set of people. In any reasonable process that application would have contained no new information, if it contained any new information they were not communicating closely enough.
I understand spending a few days doing some final checks on the data before approving. Three weeks, however, is suspiciously long. It's possible they were in fact doing important work which could not possibly have been done before the application was submitted, but nobody seems able to articulate what that important work actually was.
I love HN who is normally vehemently anti-business (with good reason) suddenly flips and says “well Pfizer said the vaccine was ok, isn’t that good enough?”
No. It’s not good enough. The reason we spend billions per year on the FDA is because we want an independent, critical and evidence based body making decisions on drugs given to hundreds of millions of Americans.
I mean, hell, Trump was bullying the FDA (which was stupid) and HN seems to be arguing for that exact thing.
Nowhere in my comment did I say the FDA should just take Pfizer's word for anything.
I'm also not sure why you're trying to use Trump's actions as evidence here. "Trump did a thing and therefore doing that thing was the correct action" is an argument which requires some justification.
Highly doubtful. Pushing out an unsafe vaccine would be disastrous to Pfizer. They have every incentive in the world to be as absolutely certain as possible that the data is solid.
And so is the argument that Pfizer would have any incentive to fudge the data.
How is it you think the UK was able to approve it already???
https://marginalrevolution.com/marginalrevolution/2020/12/ho...
EDIT: Multiple downvotes already. Anyone care to refute what's presented in my post? Did you read any of the sources cited in the linked blogpost?
Are Gov jobs granted overtime work by ruling party, and how was this important work prioritized and coordinated by top leader?
I understand that it is extensive data (for about 44,000 patients), but taking 3 weeks to compile/analyze seems excessive. They should have put in an army of analyzers into it...
There are about 3,000 people dying every day.... it is like 9/11 every day, or 9 jumbo jets falling....
The FDA should be treating this as a war effort, and not drag their feet into pointless bureaucratic 'safety' theater.
https://marginalrevolution.com/marginalrevolution/2020/12/th...
The rigor is to give the public confidence that we're better off getting the vaccine than not.
The first two phases are the safety tests, the third one is efficacy (so we knew the vaccine was "safe" after phase 2, we just didn't know the efficacy - that's what the poster above is alluding to).
If you managed to give 5 million doses a week earlier, you save about 200 lives (about 40 deaths per million per week).
> If you managed to give 5 million doses a week earlier, you save about 200 lives (about 40 deaths per million per week).
No, that’s wrong.
https://marginalrevolution.com/marginalrevolution/2020/12/th...
No we didn't. :P The US has 6.4 million doses of the Pfizer vaccine now. Projections of up to 50M delivered worldwide by the end of the year. We're on a crazy ramp.
If you want to complain about a misallocation, a key complaint would be that they're holding slightly more than half the doses back to ensure everyone dosed can get a second dose... but with rolling production such a large holdback isn't necessary.
> What could matter is if delay increases the speed at which you can ramp up.
All the jurisdictions I know will blow through the entire supply of existing doses allocated to them very quickly. It doesn't go on a slow distribution ramp gated by approval like your ridiculous source suggests. What governs the ramp is production rates, which have been running flat-out irrespective of this decision.
You misunderstand. "Blowing through entire supply" and being left with nothing is exactly the "slow distribution" Alex Tabarrok, a professor at GMU, talks about in the link I gave. He contrasts it with vaccinating entire population on day 1. Read it carefully.
> What governs the ramp is production rates, which have been running flat-out irrespective of this decision.
I consider the vaccine production regulation people to be just as incapable at cost-benefit analysis as vaccine approval people, so I assume that most production constraints are just as artificial as the approval constraints.
>You misunderstand. "Blowing through entire supply" and being left with nothing is exactly the "slow distribution" Alex Tabarrok, a professor at GMU, talks about in the link I gave. He contrasts it with vaccinating entire population on day 1. Read it carefully.
Vs.
"Now assume that the vaccine can’t roll out to everyone immediately. For the sake of this simple model let’s assume that on day one you can only vaccinate half the population. By doing so you save 1000 lives on day 1 and 2000 lives every day thereafter for the length of the pandemic. That’s the fourth panel. Now suppose we delay the vaccine rollout by one day. 2000 people die on Day 1 but you save 1000 on Day 2 and 2000 on Day 3 and every day thereafter for the length of the pandemic. How many people were killed by the delay? Compare the 4th and 5th panels. 2000 exactly as before! "
This compares vaccinating 50% on day 1, and the remaining 50% on day 2, to vaccinating 50% on day 2 and the remaining 50% on day 3.
But in blowing through the supply, we're comparing vaccinating 1% on day 1 and another 1% on day 7 and another 1% on day 15 to vaccinating 1% on day 7 and 1% on day 8 and 1% on day 15. Not at all the same scenario.
You can't make a baby in 1 month with 9 women.
This is wrong. Median expected remaining healthy lifespan of a 9/11 deceased was ~35 years, whereas for a COVID decease it's ~3.5 years. So 9/11 is still 10x worse.
Don't get me wrong, COVID is still terrible, but it is not a "9/11 every day".
Ok, math is off, but covid is going to last for at least 2 more months with death rates like this and that accrues.
Also, do you know what they call it when I kill your grandmother 2 days before she was supposed to die of old age?
Murder.
Just because someone doesn't have much life left makes it no less of a tragedy when they die early.
At the risk of being cold hearted, isn’t this exactly what it does?
https://www.pnas.org/content/117/36/22035
> We calculate, using these same cohort life tables, that the average person dying of COVID-19 had 11.7 y of remaining life expectancy
The calculation you reference was done using all people in the US. Just two sentences later they wrote, "... would on average lose about 0.2 y of remaining life ..." You need to compare to the groups of affected people, which is generally not 100% of people in the US.
average remaining lifespan across the entire population:
> we calculate that the 2020 American population of 330 million people has on average 45.8 y of remaining life expectancy, totaling 14.9 billion person years.
reduction in remaining lifespan in the 70-89 age group:
> Older individuals ages 70 to 89 y, taking those who die and those who survive together, would on average lose about 0.2 y of remaining life, and younger individuals would lose far less.
I did not include these calculations because they are not comparable to the number to which I was responding.
From the paper:
> Both of the above calculations may overstate the loss of remaining life in that they assign the remaining life expectancy based only on age, without taking into account that COVID-19 deaths are disproportionately occurring among those with compromised health status.
So their 11.7 average years remaining ignores the critical bit of information that we know this person died of COVID. It is extremely unlikely that if you took 2 80 year olds, one who died of COVID and one who did not, that if neither got COVID they would live to be the same age. I wouldn't be surprised if it was a 10x difference. While they do mention this and add some caveats (a good thing), I think because it completely changes the conclusions of the paper, they should have gone with a range and not a 11.7 number, which seems very improbable.
> Avoiding 1.75 million deaths or 20.5 trillion person years of life lost would be valued at $10.2 to $17.5 trillion
Then they take the 11.7 figure from above and multiply it by the estimated average value of a year of life. Again, there is at least an order of magnitude difference between a year of life at age 90 and a year of life at age 30, for most people.
Finally, although my ~3.5 number is much closer to the truth than 11.7, there is a difference between life expectancy and "healthy lifespan", aka "healthspan" (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6136295/). Healthspan is a newer concept but I expect will be the primary term in a decade or two.
Thank you for providing the link, a good read.
The next sentence:
> Hanlon et al. (10) estimate that those dying from COVID-19 have only about 1 y less of remaining life on average than those at the same age in the general population, which would mean that the overstatement is not very large, around 8%.
Your own link states that healthspan is not quantifiable, so your claim that it is 3.5y doesn't make a whole lot of sense.
> "used to construct a plausible scenario for the prevalence of combinations of LTCs among people who died from COVID-19 for the modelling presented here."
Second, the dataset used at the time to generate their synthetic data was weak. You can see it immediately in their bar charts, where they have mostly healthy 50-69 y.o. dying in their synthetic data, skewing their YLL to the right.
> Your own link states that healthspan is not quantifiable, so your claim that it is 3.5y doesn't make a whole lot of sense.
I provided a link to a "conservative" description of healthspan, but in the field people are more optimistic about it.
Very good questions you brought up though, thanks!
And are you suggesting that it’s easier because the data isn’t as extensive as what the rest of us deal with? That only makes it harder.
Sure if it’s some random A/B test with data from your own systems from an experiment you designed, but this is a vaccine the whole fucking world has been waiting for for most of the year. God forbid people treat it a little more carefully.
I would absolutely need to start a performance improvement process. They are definitionally 1/3 as productive as they should be. Also in terms of stakes, please show me even a modicum of work that suggests the downside risk of approval is greater than the delayed vaccinations. What reason have I to believe there is great risk in approval? Again, the UK approved this over a week ago.
> And are you suggesting that it’s easier because the data isn’t as extensive as what the rest of us deal with? That only makes it harder.
No, I'm mocking the idea of it being extensive data. It's not.
> but this is a vaccine the whole fucking world has been waiting for for most of the year.
And that's reason to go slower!? There's no need for this delay!!! https://thedispatch.com/p/fda-career-staff-are-delaying-the
As I understand it, medical ethics isn’t about utilitarianism, or else we’d skip the rats and monkeys and just go straight to testing on the poor for money. They don’t seem to prioritize minimizing the opportunity cost of avoiding bad outcomes. Their guiding principle seems to be avoiding giving harmful treatment.
Meanwhile some healthcare workers at my partner’s facility are skeptical about whether the vaccine was rushed (I think they’re crazy, for the record). But there’s real risk if enough of the public doesn’t trust the vaccine. I’d bet that kind of angle is part of why they focus on “do no harm” instead of “minimize cumulative regret.”
Answering the question of whether the experiment harmed anything important is always much harder, as I’m sure you know. You see some metric is way down, but after a multiple comparisons correction it might just as well be noise, so then you have to start digging, doing a bespoke analysis for the fact that these non iid metrics point in these particular directions. You can’t pre-automate it because with N metrics that are practically significantly up/flat/down, that’s at least 3^N possible investigations to convince yourself whether it’s enough to stop rollout.
That’s the part that takes time, in any analysis I’ve ever done. Maybe literally zero time to check efficacy because that part is automated, then sometimes days to check whether there’s anything else worrisome in the probably-just-noise on other metrics, spending time proportional to the cost of getting the harm part wrong. Some of the hard questions aren’t statistical. You see some KPIs definitely up and some KPIs definitely down and deciding whether to roll out becomes a bitter fight between competing interests. Maybe you don’t roll it out yet for client segment X (like this trial and kids and pregnant women, as I understand it).
Re US vs UK, no idea. I’m not saying 3 weeks is necessarily the right amount of time here. I’m just so taken aback at the idea that 3 weeks is necessarily too long to the point you “would probably have to start firing people” and would “absolutely” have to start putting them on PIPs.
I'm glad we have actual specialists checking the data and not people thinking it's only putting stuff on excel and writing a function
Why is the UK able to approve it over a week ago but the FDA needs longer?
Where you think processing the data just means loading up an excel table (or running a CSV through R) and that's the only data relating to the studies. Patient data is not the only thing being analyzed and it includes things like manufacturing, transport, etc
> Where is this MD, MPH from Johns Hopkins wrong?
He's not wrong but his worries as a clinical trial expert are a subset of the worries of an agency like the FDA. And I'm sure his workflow as clinical study expert is more fine tuned for that.
Or as in a developer analogy: making a code change is a 5 minute job. Actually making the change, testing, deploying, etc may take a whole day.
> Why is the UK able to approve it over a week ago but the FDA needs longer?
Pfizer sent the last info to the FDA on 22th of November. The MHRA had started a rolling review and received the last batch of info they needed on the 23rd of November.
I am certainly frustrated with the speed as well, but I don't think it's too much of a difference. Yes, maybe it could be faster.
Is it possible you could construct an even more ridiculous straw man?
> I am certainly frustrated with the speed as well... Yes, maybe it could be faster.
Oh, so you agree with what I'm saying and your problem is the straw man argument you created.
Sure, you can come up with some standard numbers in an hour. But it wouldn't be the most thoughtful analysis, and the decision isn't really about a single efficacy estimate anyway.
I guess I figure if you're going to go down this route of pissing matches over how fast you can do an analysis on how big of a dataset, why the hell even have an FDA anyway? Just require the company post all their information and get rid of the regulation entirely. I actually think this isn't an unreasonable argument, even if I don't necessarily agree or disagree with it. It certainly seems more reasonable to me than "we should have a regulator that just rubber stamps things."
I'm fine with the FDA taking their time. The problem with risk in decisions is people forget in high stakes high risk decision making, it's about the process. This whole discussion about the FDA taking too long will look a lot different if a year from now the vaccine turns out to have some horrible long term effects (which it could, even though I think it's unlikely, just, you know, 'cause).
No one is saying don't be thorough. What I'm saying and Makary is saying and the UK is saying is that the required thoroughness shouldn't take this long and when it does, real human lives are lost and sustained invasive measures in the freedoms of individuals are required.
> I guess I figure if you're going to go down this route of pissing matches over how fast you can do an analysis on how big of a dataset, why the hell even have an FDA anyway?
What a ridiculous leap. That's so many logical steps away from "the FDA moves way too slow" it's an absurdity. Who is arguing against the FDA's existence other than I guess you now sort of???
https://www.worldvision.com.au/global-water-crisis-facts#:~:....
No one gives a shit.
The vaccines are gonna be supply constrained for a while. The same number of people will be vaccinated on Jan 31 (or the day before the next batch of vaccines become available) whether we start today or a few weeks from now.
At this point the more important consideration should be not doing anything that might even slightly reduce public faith in the vaccine.
It's not like they've executed well on your last point in the meantime.
That could still mean a big difference in the number of deaths. Some of those people may die/become seriously ill before Jan 31 before the vaccine gets to them
Furthermore, how many lives would be lost if society didn't have confidence in the approval process and declined vaccination? Russia is suffering this exact problem at the moment.
https://www.washingtonpost.com/world/europe/rusisia-vaccine-...
Contrary to what some people would like to believe government agencies are not rubber-stamping factories.
Is it because they're genuinely more careful? Or is it just bureaucracy?
Personally I'm hoping I get the mRNA vaccine not so much because they're currently the most effective, but because it will make me some small part of one of the most impactful scientific works of our lifetimes.
We should be seeing another announcement in a week for the Moderna mRNA vaccine as well as their committee review is scheduled for 12/17.
[0]https://nymag.com/intelligencer/2020/12/moderna-covid-19-vac...
- developing the lipid nanoparticles that the mRNA is delivered in, so your cells could actually take it up intact - figuring out how to get the mRNA to evade the immune system
https://www.statnews.com/2020/11/10/the-story-of-mrna-how-a-...
Within an in-group, the definite article is often dropped just out of efficiency. We did the exact same thing at NASA when I worked there.
When was the last time you heard someone say “The NASA”?
“Taxol gains quick FDA approval”
“Taxol gains quick the FDA approval”
“Three FDA officials say the drug's approval was warranted”
“Three the FDA officials say the drug's approval was warranted”
Taxol gains quick approval of FDA.
Taxol gains quick approval of the FDA.
Or others: FDA has approved... vs. The FDA has approved...
To most lay persons, omitting "the" will look a bit weird.
Now the interesting part is that NASA has become a proper noun (probably because it is an acronym that can be pronounced). No one will say "I work at the NASA". With FDA you will see people use both forms, even though the final A in both NASA and FDA stands for Administration. I'm not sure about other government organizations. I don't think anyone says "I work at CIA" or FBI for that matter.
DHS, CPB, USCIS
The NBA, NFL, and NHL
MLB, MLS
People say that they were "investigated by (the) IRS" or "got a letter from (the) DMV" all the time. One reads in the press about companies being "fined by (the) EPA" or people being "detained by (the) FBI". Dropping the "the" doesn't look that weird.
Looking at https://www.cia.gov they use both forms "work at the CIA" and "work at CIA" (google returns twice as many results for the former than for the latter).
> The FDA has determined that ...
> In making this determination, the FDA can assure the public ...
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different...
In technical terms, it seems to me they're almost like unit testing for the body: You take out everything except the bit you care about most, and subject it to intense scrutiny until you develop a correct response.
I think the untold story of production and distribution could be interesting, but most of that is yet to be written.
Now that vaccines can be designed so quickly, I wonder what if anything can be done to speed up the testing of their safety and efficacy.
It only took 9 months to bring the U2 up to operational speed. Things can move fast if you remove the politics.
This is really at the limit of what is physically possible (at best some sort of highly flexible distributed manufacturing network maybe down to weeks for general population?): Flu vaccines are very precedented, and though this protocol had many "new bits" efficacy, infra, and scaleup are kind of more "well known".
[0] it was considered to be a dry run in case of a real pandemic; he was told that he would get a phone call during the week, and was emailed the flu virus sequence one morning, built the vaccine over the course of a day, and fed-exed the vaccine seequence to the scaleup and testing facility and by 36 hours they had validation that the vaccine caused a positive antigen response. That year's flu did not become a pandemic, well by luck so far we really haven't had a major flu pandemic since that year.
Speaking of flu vaccines reminds me of this Pfizer press release from November 2018 [1] that described “a collaboration with German biotech BioNTech to develop new RNA vaccine technology to create a better flu shot”. The press release concluded with optimism but cautioned that “the technology is several years away from being tested in the US”.
[1]: https://www.pfizer.com/news/featured_stories/featured_storie...
From a public safety perspective, I wonder if perhaps those most likely to spread the disease should be the first to be innoculated rather than those most likely to have a bad outcome.
There's concern that elderly people's weaker immune systems won't react as strongly to the vaccine, so it won't be as effective.
https://www.statnews.com/2020/12/03/cdc-advisory-panels-lone...
The argument is that the vaccine has not been proven to prevent infection and spread. Only to prevent severe disease in those who do get infected. So administering it to those with comorbidities, for now, is the most effective means of reducing overall mortality based on known evidence.
The initial rollout will target healthcare workers and extremely vulnerable populations, mostly seniors in care facilities.
Within the US, each state will be allocated vaccines in proportion to their population. Each state is then responsible for deciding how to allocate them. You can look for your state here [0]
Logisticly speaking, the plan [1] is for Pfizer to ship vaccines directly to the point of use, using custom containers featuring dryice, thermal sensors, and GPS. These containers can passively maintain temperature for up to 10 days.
Once at the point of use, the vaccine can be stored for up to 6 months if a suitable freezer is available.
Without a ultra low temperature freezer, the vaccine can be stored in the Pfizer container used for shipping for up to 30 days, provided the dry ice is replaced regularly.
Standard refrigerators can store the vaccine for up to 5 days.
The vaccine must be thawed before it can be used.
[0] https://www.usatoday.com/story/news/health/2020/12/07/state-...
[1] https://www.pfizer.com/news/hot-topics/covid_19_vaccine_u_s_...
> Accounts differ over the timing of the discussions between Pfizer and federal officials about locking in extra doses. Several people said that during late summer or early fall, Pfizer officials repeatedly warned the Trump administration that demand could vastly outstrip supply and urged it to pre-order more doses, but were turned down.
[1] https://www.nytimes.com/2020/12/07/us/politics/trump-pfizer-...
It does not make sense to get the vaccine if you already have the antibodies from a previous infection, right?
Thinking about this perhaps those who have already experienced organ damage may not be helped much. But perhaps if everyone who was hospitalized was immediately vaccinated the death rate would drop drastically. My guess (and it's just a guess) is that the phase III trials did not try to answer this question directly, and in fact may have excluded anyone who already had a COVID-19 diagnosis (the drug companies want to show maximum effectiveness which would mean vaccinating before being exposed to the disease). That does not mean it would not help prevent deaths in hospitalized cases though. If none of the early doses are given to those hospitalized then it could be a long time before we know the answer to this question. Probably as the vaccines become more widely distributed someone will try it. But trying it early could potentially save the most lives (again, if it works).
However, maybe there are good reasons you don't vaccinate someone who already has a disease. Maybe it's a large burden on the body to ramp up the immune system in a different way when the body is already fighting off the infection? I don't know, but I'd like to see more public discussion of this. Here's one article I was able to find that suggests adverse reactions at least are unlikely (seems it's actually been tried a few times):
"COVID-19 patients, those with antibodies too may be vaccinated, says Health Ministry"
https://www.thehealthsite.com/news/covid-19-patients-those-w...
Another thing I don't see being discussed much is that while the phase III trials involved tens of thousands of people, only a few hundred people who received the placebo exhibited COVID-19 as far as we know. It would seem that means the vaccines have really only been tried against the disease itself just a few hundred times (and found not to work for about ten of those few hundred). Even if you assume that 10x more people caught COVID-19 but had no symptoms or mild symptoms, that still means very few actual challenges of the vaccine against the disease. It does show that the vaccines are fairly safe since there were few adverse events in the tens of thousands vaccinated, but it does not really seem to show that the vaccines are actually widely effective. The NY Times has a good article about this:
"2 Companies Say Their Vaccines Are 95% Effective. What Does That Mean?"
https://www.nytimes.com/2020/11/20/health/covid-vaccine-95-e...
So it seems possible the vaccines may be much less effective , we won't really know until many, many people are vaccinated. That's no reason not to get vaccinated since the safety seems good from the trials. But it could affect the future dramatically. I guess since we can't know until lots of people have been vaccinated, we just have to wait to find out, nothing more can be done. Presumably data will be being collected so someone (maybe not the public) will have an ongoing readout of effectiveness.
A thing that keeps worrying me is the amount of people I've seen/chatted with (empirical evidence) that don't trust these vaccines. The most common comments they make are: "I don't want to be guinea pig", "How do I know the government won't control me", and more conspiracy theories. All of these fears seem to come from misinformation on the internet, friends and family get a ton of memes/fake news through WhatsApp highlighting the unproven negative effects of the vaccine. Is there any effective way to control the propagation of misinformation on these platforms? How would one even get started to tackle that problem?
I also think we need to build back the public's trust in institutions. Once they deserve that trust. When anyone with any motive can spread content online that reaches thousands or millions without much of an editorial process, well... it's proven to be disrupting.
These are very challenging problems.. I'm counting on Tristan Harris to bring us something.
But they're not wrong in making that risk analysis in the first place.
I do not belong to a risk group for covid-19. I don't live with anyone in a risk group, I don't hang out with people in a risk group or even meet with them. So I don't mind being at the back of the line for this vaccine, the risk of the disease is negligible to me, while the risk of the vaccine is unknown. I don't mind waiting and seeing what happens after millions of people have gotten the vaccine before I get it myself. That minimizes the risk to me.
But my dad belongs to a risk group, so for him the same risk analysis gets a different result, because his risk of dying is a hundred times greater than my risk of dying. So he will try to get vaccinated as soon as he can, as he should.
What's the data look like for long-term effects of an mRNA vaccine?
And I ask because even the rarest documented effects occur within 3-4 months of administration, which is hardly long-term.
There may be a case for a specific Lyme disease vaccine, but thanks to the anti-vaxxers, the whole thing was withdrawn (against FDA recommendation) before the actual reason could be found.
These are some of the fastest-to-market vaccines ever produced. Some were also developed with technology never used before at this scale.
There's some nuance to the fear though - for example, once frontline, health workers and people like Dr Fauci are vaccinated, and it becomes clear that these are at least as safe as flu vaccines, I'll also likely take one, if only for the sole reason that I sorely miss travel.
It's won't though, not for at least 1~5 years. All the long term studies are being skipped. So long as this vaccine is a choice, I'm okay with it. But if it becomes required for certain jobs, or to be able to enter a store or venue ... I dunno. The speed that this has been rushed through just does not feel right.
I would rather wait 5 years. I prefer that risk for myself over the risk of a rushed to market vaccine. The trouble is, everyone will yell that you not getting the shot can hurt everyone else.
This gets into the dangerous game of personal agency, liberty and autonomy vs what the State is telling you is mandatory for the safety of all. There won't be enough doses for this to matter for a while, but when it does, we'll see some big ethical concerns and court cases.
There are no long term studies. The reason vaccines take so much in "regular" circumstances are:
- Actually finding money to run the trials
- Run Phase 1, 2, 3 trials one after another
- (longest) Waiting for the events (infections) to accrue: if it's not in a pandemic, and with relatively low incidence, this takes years to happen
- Regulatory approval (if not in emergency, that's two years)
- Production scale-up (at least one year)
The fact that vaccines takes years to develop for safety is a myth. It is mostly a matter of time, and the fact that we were used to them taking years. Let's not forget smallpox and rabies vaccinations took far less to be invented, and people devising them didn't even know what viruses were. And also because most of the easy targets are now done. What's left are the harder ones (HIV). SARS-CoV-2 might have been hard, or one of the easy pickings. Luckily, it fell into the "easy" camp.
In this specific case, production was started during the trials, events, due to the fact that the virus is spreading like wildfire in the USA, took a matter of weeks to accrue (from 35 in October to 94 two weeks later, according to the Pfizer data), and the fact that an obscene amount of money was spent meant that most trials were started as soon as possible.
But, even looking at the protocols, you might notice that it ticks all the good boxes for proper clinical research.
The people who you hear say "I don't want to be guinea pig" ... they're not wrong. This vaccine could be perfectly safe .. or we could see a lot of edge cases when you start injection a million people at a time with it. On top of all of that, you can be sure hospital will be sure to force front line workers to take it first.
Please, let's be honest about this. Why are we suddenly trusting drug companies after disasters like viox. I'm not against vaccines in general. I've had all my MMRs, took my Typhoid, Meningitis, Hep B for certain overseas trips. But those took time to go through trials and were vetted for safety in a way this simply hasn't had the time to.
People are going to be weary and that's not wrong. That's not "anti-science." This is legitimately going to be an experiment which, if they get wrong, can potentially harm a lot of people. You only need to look back to the 70s and the Swine Flu vaccine disaster.
The Department of English Pedantry advises:
Thou art not weary of aforementioned indignances, but thou mightest be wary of them.
Whether or not you agree with their opinions or the sources they derived them from, what you're advocating is dangerous. Who should have that authority to determine what is and is not misinformation?
Some people think emotionally, not logically. Figuring that out took me way longer in life than it should have.
Logical thinkers will be able to do the risk/benefit analysis with “good enough” fidelity so long as data is available, so you don’t really have to worry about convincing them.
For the emotional thinkers, whom I am assuming have a large intersection with the people that believe misinformation (that assumption may need to be checked, but I ... just don’t have that data), perhaps we would have had better luck by pushing a message like “we are all soldiers in a war now, and soldiers take risks to protect each other.” Complete with an advertising campaign featuring a frontline combat veteran recounting how she walked out under enemy fire to rescue her comrades, and subtly or not-so-subtly shaming people who are unwilling to take tiny risks to protect their fellow soldier-citizens.
https://www.forbes.com/sites/joewalsh/2020/12/11/white-house...
I don't know which sources add new information (if any of these):
https://www.cnbc.com/2020/12/11/white-house-threatens-to-fir...
https://www.independent.co.uk/news/world/americas/us-politic...
https://www.cnn.com/2020/12/11/politics/white-house-fda-chie...
It's the same mechanism I use to impress people with my ability to order cats to "come to me or don't, or... go scratch that couch".
In the US, given by Feb, there will have been about 100M infected, It really only takes about 100M vaccines to hit herd immunity. Between Pfizer, Moderna, J&J and Astrazeneca it's reasonable to expect/demand 100M out by Feb.
The FDA's approach of "moving slow to give confidence" cost lives and does not actually build confidence. Allowing this vaccine to be taken by the willing was among the easiest decisions ever made, and their pretending otherwise was absurd. It would have built more confidence if they said within 24 hours of the EUA filing "hey public, this was an easy call. We already looked at all this data over months, cut no corners. This isn't a borderline approval, this looks amazing."
> The actual number of coronavirus infections in the U.S. reached nearly 53 million at the end of September and could be approaching 100 million now, according to a model developed by government researchers.
> The model, created by scientists at the Centers for Disease Control and Prevention, calculated that the true number of infections is about eight times the reported number, which includes only the cases confirmed by a laboratory test.
Though I see no reason to complain about the FDA dragging its feet, given that the bottleneck to vaccinating the populace is manufacturing, not authorization.
Citation please? Dr. Fauchi says we need 70% innoculations to achieve herd immunity. https://news.yahoo.com/fauci-america-reach-herd-immunity-004...
From the numbers I've been able to gather, you need 200M vaccinated people to achieve herd immunity, which is 400M doses.
Sources:
Wikipedia gives the US population as 308,401,808. Seventy percent of that is 215,881,266.
Latest COVID-19 infection totals come to about 16 million. https://www.nytimes.com/interactive/2020/us/coronavirus-us-c...
Unclear why I'm being downvoted.
But: 1-1/R0 assumes universal, uniform susceptibility and uniform contact graph, which aren't true-- so it's pessimistic. And some people have caught the virus already and are no longer susceptible through that means.
Many computational models put it at about `25% of people infected will result in herd immunity with normal behavior, and the US is presently at about 16%. Unfortunately, getting the "right" additional 9% of people will require vaccinating much more than 9% of the population (we're not as good at selecting the most susceptible and most involved in spreading as the virus itself), but substantially less than 70%.
Further, R0 is based on baseline behavior. I suspect a decent chunk of us will be much more careful for some time, which effectively changes the required decrease in susceptibility to cause a case count decay.
> Latest COVID-19 infection totals come to about 16 million. https://www.nytimes.com/interactive/2020/us/coronavirus-us-c...
Current COVID-19 infection total estimate per CDC is about 53 million infections so far. https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/burd...
Oh, ideally you wouldn't vaccinate people who are already immune, but saying it hinders herd immunity is a bit silly.
I find it's always helpful to do thought experiments at the limit.
Do you think reaching herd immunity requires more doses A) in a population that is 99% of the way to herd immunity, but that 25% of doses will be wasted because they'll be given to people who are already immune, or B) in a population that is 1% of the way to herd immunity, but only 4% of doses will be wasted in this way?
If you only have 100M doses and you waste half on undetected positives, that definitely hinders achieving herd immunity. Unless you are saying uncontrolled spread helps develop herd immunity. It does, but it isn't a desirable method.
Nobody said it was a desirable method. But I did assert that past infections does reduce the doses you need to give to reach herd immunity, which is a point you seemed to argue with.
We'll likely be at >70M natural infections before vaccination efforts hit full steam in mid-January. This is pretty close to the lower end of where models predict herd immunity effects (not ~60% because of non-uniform contact graphs and susceptibility). You don't need a whole lot of vaccination tacked on top of this to start to tamp things down, even though A) some of the vaccinations will be wasted, and B) the vaccinations will not be as "on-target" to break important links in the graph as infection itself is.
Sorry for the misunderstanding. I wasn't arguing that past infections change the needed doses, I was arguing that undiagnosed positives waste limited doses. Hope that's clarified.
As I understand it, both pauses ended over a month ago, and there hasn't been any "ban".
Both studies were paused, as is customary, due to medical complications from someone in the study. Upon investigation it was deemed in both cases to likely have not come from the vaccine, and the trials were resumed.
The other interpretation is that all pharmaceutical drugs are banned by default and that approving a drug is actually removing that ban. I suspect the original commenter was using "ban" in this context.
For vast amount of people living in the United States the virus isn’t going to be dangerous. But for certain groups it’s extremely dangerous.
We shouldn't see to fast track any drug, vaccine or treatment outside of the normal process. I wish the inhaled steroid controlled studies had completed because I was curious of that would have been a useful treatment (a lot of doctors are using them off label) and we wouldn't need something this untested.
Fast tracking medications is how mistakes are made. Let's be critical of how these emergency powers are used.