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Pfizer submits Covid vaccine to FDA for approval, to distribute in December (pfizer.com)
225 points by KoftaBob 15 days ago | hide | past | favorite | 398 comments



Pfizer selected New Mexico, Rhode Island, Tennessee and Texas for their pilot delivery program "due to the states' immunization infrastructures, urban and rural variations, size and population diversity". First batches of vaccine will probably go to frontline medical workers first, followed by frail old people. a paper in Medrxiv favored "older first" model based on evolutionary game theory and mobility data, for largest decrease in mortality rates.


Can I get a link to the Medarxiv paper? Would be an interesting read.




Pretty interesting paper, although I'm not sure it's the one OP was referring to. It's a pretty short paper with a whole pile of graphs at the end, so I encourage people to read it themselves. Quick notes from skimming:

- 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.


Yes, there could be many different scenarios; when vaccine supply is limited, vaccinate those at risk of death. BioNTech claims their vaccine efficacy is consistent across age groups, but we won't know for sure until large clinical trials are completed. Also, older people are less willing to be vaccinated earlier. More variables to include in the model...


From reading the abstract, that study comes to the interesting finding that with a highly effective vaccine, it is better to vaccinate the YOUNG first, to reduce the spread.


What about... workers in the cafeteria who handle our food, cashiers at supermarkets and waiters who bring food over to you. I'm shocked most of the papers I'm reading don't mention these folks who are at the very intersection of our daily lives!


The paper assumes those people are vaccinated first, before the analysis for other age groups comes into play.

"Here, we consider that front-line health care workers and other essential personnel (e.g. firefighters, police) who should obviously be prioritized, have already been vaccinated."


Probably too late for anybody's interest, but the risk of getting this from food is suspected to be incredibly low. Droplets being inhaled, entering through the eyes, or nasal mucous membranes are the likely real threats.


I guess that makes sense. The young seem to be the primary spreaders of the disease. Stop them, and then it slows the whole chain of infections. I can also see why they'd want to vaccinate the most vulnerable, if the young aren't really affected by the disease, it makes sense to skip them first. Conundrum I suppose.


>> The company has developed specially designed, temperature-controlled shippers for the BNT162b2 vaccine candidate, which can maintain recommended storage conditions (-70°C ±10°C) up to 15 days. Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment. Once thawed, the vaccine vial can be stored for up to 5 days at refrigerated (2 - 8oC) conditions.

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.


Here are some larger on-market -80 class medical shippers: https://www.thermosafe.com/files/Product_Sheets/DurablesforH...

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.


You don't have to guess, this is published information. They have trays of 1000 doses, and up to 5 trays fit in a shipping box with the dry ice.


In the US, they already have pre-purchased millions of dosages that are ready to go within 24 hours of FDA approval.

https://www.cbsnews.com/news/operation-warp-speed-covid-19-v...

It's quite remarkable in terms of logistics.


I'm curious if anyone knows why Pfizer's mRNA vaccine still needs this while Moderna's mRNA vaccine does not?

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?


The second option. Stability testing is done quite early with any drug candidate and is a requirement for FDA approval. There is zero chance that Pfizer didn't test their vaccine at higher temperatures.

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.


Lipid nanoparticle used to envelope and deliver the mRNA. They’re using different makeups which affect the mRNA delivery and stabilization in the vaccine.


Did they publish the mRNA code?


Isn’t it pretty easy to sequence anyways? Assuming you can get a hold of a vaccine sample.


Probably, but why bother. If you have the ability to do that, you also have the Covid DNA sequence, and probably the ability to make your own mRNA vaccine. The only thing your vaccine would be lacking is the safety trials which you probably also have the ability to run, and you have already started them (if you haven't why not, and why would you care to start now).

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)


If it’s patented the sequence would need to be public.


One question I have about mRNA vaccines that I haven't been able to find the answer to through my own searching: how is the mRNA delivered to the cell?

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?


John Campbell talks about that here in a digestible way: https://youtu.be/smm_ZvJqJk4?t=438


Very very simplified: Basically, you have a blob of fat that the mRNA sits in. The fat sticks to the cell, merges with the cell membrane and the mRNA pokes into the cell. It's not a modified virus, it's a much simpler structure but it has a similar mechanism. It's much simpler in that it can't replicate itself or do much else. It's literally just the code for a protein that's found on the surface of the covid virus, in a blob of fat.

That's for the BioNTech/Pfizer vaccine. Other vaccines, such as the Oxford/AstraZeneca one do use a modified virus.


So no spike protein needed?

Safe to assume that in time these will evolve into new forms of fat-embeded rna virus which no living being has immunity to?


No, they won't. They can't survive for long enough inside the body, and are even less durable outside.


The mRNA contains the spike protein or at least a sufficient part of it for the immune system to recognize, as well as other genes.


In both the Moderna and Pfizer-BioNTech vaccines the RNA is encapsulated in “lipid nanoparticles”. These microscopic droplets of oily liquid — about 0.1 micron in diameter — enclose and protect the fragile genetic instructions as they are manufactured, transported and finally injected into people. https://archive.is/6dxTg


So it's naked mRNA wrapped in oil, basically?


“The lipid nanoparticles have some adjuvant activity, providing a little inflammation with the vaccination that helps the immune system to make antibodies and T-cells that target the Sars-Cov-2 virus,”


Itchy oil, then.


https://www.acsh.org/news/2020/10/21/how-pfizers-rna-vaccine...

Essentially the mRNA is packaged into a lipid, which the body's cells can uptake thru its phospholipid bilayer


It appears there are a few different approaches, described here:

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.


Anyone know why China is not on the list of countries in which Pfizer is seeking regulatory approval?


Perhaps because the Chinese company "Fosun Pharmaceutical", as the other sponsor[1] of this vaccine, is the one which has the right to distribute it in China?

[1]: https://en.wikipedia.org/wiki/BNT162b2#Funding


Pfizer will start another smaller trial in China to generate local safety data, which will be combined with its global data as it seeks regulatory approval in china. [1]

[1]: https://www.scmp.com/news/china/science/article/3110042/coro...


China has its' own regulatory requirements which typically (I don't know in this case if China is asking for it) requires a specific trial in an Asian population in order to get approval.

I'm assuming that China is probably not waiving that requirement since they have their own vaccines.


China is making their own vaccines.


Because China already has a "national" vaccine, and they see no chance getting through Chinese bureaucracy for such a politicised deal?


"yes you can sell here, we only need to know the ingredients and know-how of this vaccine to approve its safety"


The requirement of forming joint ventures has been dropped since 2014. The 'forced tech transfer' rhetoric has been out of date since the first day of the trade war.


This page says any manufacturing except electric automobiles and airplanes is subject to 50% requirement as of 2018:

https://www.mondaq.com/china/export-controls-trade-investmen...


Isn’t it like that in the rest of the world?


Not really, China is notorious for IP infringements.


Imagine the world helping to develop a vaccine to help all of society being open source and made up capitalist fantasy free.


Don't worry they already have it in hand and analyzing it I would be willing to bet.


Now we (average folks) only have to wait 6 months (minimum). So don't hold your breath. This is kinda good news though.


There’s plenty of fear montering going around so many people don’t actually want to be vaccinated. Your turn may come sooner than expected.


Well just like I don't immediately update to the latest OS I think I'll wait for the beta testing to happen :)


To continue this analogy, this is more along the lines of a patch to fix a remote code execution bug that is being actively exploited in the wild at an increasing rate. Your alternative is to only connect to the network very infrequently, using a draconian firewall which doesn't completely protect you and hope for the best.

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?


The difference is that it is not yet fully understood how humans work.

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.


Its likely, that, like the flu jab, those most at risk will get it first. The vast majority of diligent users here will not be beta testers.

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.


Medical workers will get it first, as without them we can’t vaccinate the rest of us.


I wonder if it's really that smart to give our healthcare workers a minimally tested vaccine first.


My understanding of at least the Pfizer vaccine was that it primarily lowered the risk of developing COVID from a COV-19 infection. Also if I read it properly that means you could/would wond up in the asymptomatic spreader category.

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.


This is another specific scientific communication, of the type that are widely misunderstood. Remember "no evidence that masks reduce transmission" and "no evidence that immunity from COVID will last"? Both were true statements at the time, and widely misunderstood. "No evidence" of X does not mean that X is at all likely to happen, based on our current understanding of disease.

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.


Someone please correct me if I'm wrong, but the latest I had heard was that _pre-symptomatic_ spread was the issue rather than asysmptomatic. As in, if you got covid but never developed symptoms, you likely never had enough viral load to transmit the virus. If you later showed symptoms then you likely had a high viral load between contraction and showing symptoms and were likely to transmit the virus. So if this stops the symptoms, it may also stop the viral load from reaching transmitable levels.


Yeah, that's my understanding as well. There's a period of time between when you initially get it and when you start showing symptoms (4-5 days is the number I've heard) where you are contagious but most likely don't know it. That's why Covid is particularly nasty, because it spreads before it shows symptoms.


I am one of those most at risk people and like hell am I going to get it first. It looks like it will be safe but I can weather a few more months self isolation while it is adopted on a more massive scale.


Me too, give my issues with asthma/age and not having a family to support me if I get ill, I am ready right now. If other people choose to wait 10 years that is their option.


People apparently didnt like my hesitation to be first in line for the vaccine. The weird thing is that I am not against this vaccine by any means, I hope it works very well. But you and me are in a position where we would be in a very bad situation if something went wrong.

I dont mind a few more months of staying safe, its not a big deal to me and Ill get it later on


As someone who has some experience with clinical trials and drug approvals, I'd be quite comfortable taking the vaccine. A clinical trial size of 40,000 (20,000 receiving the vaccine) is way larger than a lot of other drugs that people are comfortable taking.

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.


During the 2009 Swine Flu epidemic, I designed ancillary equipment for a bioreactor used for making an experimental vaccine. If any supplier or subcontractor was dragging their feet, all we had to say was "this is for a machine which makes the swine flue vaccine" and we suddenly would somehow jump to the front of their queue. I imagine the situation is even more that way for anyone involved with Covid vaccines, so I am 0% surprised by how efficiently this was developed. Magical things happen with price and priority are no longer concerns. (edit:sp)


can you give an example of popular drugs that have been approved with smaller trials?


I have never personally seen a randomized study with anywhere near 40k+ participants for any cardiology or cancer-related treatment. Recruitment for this vaccine trial is much easier than studies with specific conditions like heart attack, stroke, or cancers, simply due to their incidence rates. In cardiology, a 20k subject study is massive in scale.

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.


I haven't dug into the older approvals of Lipitor into a ton of detail, but you can find them on the FDA website.

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.


Pretty much every psychiatric drug has been approved with much smaller trials.

Vaccine trials tend to be larger because you have to account for the fact that only a small number of people will get infected.


It also depends on the known safety profile. With AstraZeneca some people already have to take pain medications after taking the vaccine...I wouldn't be comfortable putting using that vaccine without much wider testing. Fortunately I don't need to though, because soon we'll probably have 2 great vaccines to choose from.


Taking OTC pain relief medicines after a vaccine is not that unusual, either for pain or fever. Ask any parent who has gone through a vaccine series with their kid.

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.


I was talking about AstraZeneca that would be the first vaccine using a modified adenovirus. It looks to have somewhat more side effects than the Pfitzer vaccine.


I got a tetanus shot about two months ago. I used pain medication (just normal-ass ibuprofen) because the injection site gets very sore after a few days. There's a lot of valid reasons to be concerned about being in the early run of a brand new vaccination, but injection site having a bit of pain is hardly one of them.


Is that not a common side effect of all vaccines? I can't think of a time when I haven't had to take Advil for a couple days after getting the flu shot due to body aches.


I don't think pain serious enough to warrant medication is common at all. I used to administer flu vaccines in a former life, and I've never heard of anyone having such a strong reaction. Most people have some very mild soreness in their arm at most.


> Fortunately I don't need to though, because soon we'll probably have 2 great vaccines to choose from.

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.


>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?


Bacillus Calmette-Guerin (BCG): https://medlineplus.gov/druginfo/meds/a682809.html


Isn't it using a bacterium?


I think Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo) for ebola vaccination is the most recent example. Also from Janssen (J&J).


What are your main concerns with the mRNA product? Are you afraid of long term side effects? We already know that it has less short term side effects than the adenoviral vaccine. Actually I'd like to see deeper thinking about it from professionals.


I'm not a medical doctor, but I do work in pharma and I have tried to inform myself. Still, I could be quite wrong.

Yes, I do have some concerns regarding long term effects of mRNA based vaccines. As you said, I would also like to see some deeper thinking about this. I feel that other delivery vectors may be better known and have an existing track record.

I also understand that mRNA treatments have had some excellent outcomes in cancer patients. However, these treatments have been highly personalised, based on the patient's own DNA. Therefore, I also wonder about the general medium and longer term effectiveness of mRNA for coronavirus vaccination.

I'm in no way an anti-vaxer. I'm completely vaccinated for all the common things (MMR etc). As is my child. No problems with something that's been around for a long time and is well known.

I would just like to make my own choice regarding which brand new, accelerated testing regime, vaccine I decide to inject.


> I also understand that mRNA treatments have had some excellent outcomes in cancer patients

One interesting thing is that I was quite worried that in April/May all these experimental treatments have been stopped, because all the most interesting companies were forced to redirect their focus to COVID (the only reason you could use a lab). I'm relieved, that at least we got something in return: derisking mRNA as a delivery method, and showing that it's far superior to older ones. You're right that we don't have medium / long term data yet, but this article is quite relevant:

https://www.jpost.com/health-science/could-an-mrna-vaccine-b...

Linial explained that “mRNA is a very fragile molecule, meaning it can be destroyed very easily... If you put mRNA on the table, for example, in a minute there will not be any mRNA leftover. This is as opposed to DNA, which is as stable as you get.” She said that this fragility is true of the mRNA of any living thing, whether it belongs to a plant, bacteria, virus or human. As such, she said the worry should not be that the mRNA won’t get into the cells and instead will stay outside, floating in the body and causing some kind of reaction. Rather the concern should be that if it doesn’t enter the cells, it will disintegrate and therefore be ineffective.


Maybe this is a good place to tag on a question that someone reading this might be able to answer - while I know it hasn't bee tried yet so we don't 'know' yet, are there any theories on what would happen if you take multiple vaccines? Would that provide extra protection, could they react to each other negatively, or would it have (theoretically) no effect?


I think it's better not to experiment with it. It would take too much effort, especially as the Moderna vaccine has much better stability profile (it looks like the clear winner for hot climates / places where refrigerating is hard)


These are all short-term studies. Given that this is a completely new type of vaccine, a certain amount of scepticism about its long-term effects is warranted in my opinion. Personally I fail to see what benefits non-vulnerable people have from immediately being vaccinated.


"Non-vulnerable people" means "people who probably won't die if they catch the disease". There are a lot of nasty things that COVID-19 can do to you besides kill you. Many people have lost legs because of the clotting associated with it, which can also cause strokes resulting in permanent brain damage (which is actually more common in young healthy patients), some have permanently lost their sense of taste. Even those who do come out without major disabilities have to spend two weeks with their throats constricted to the size of a coffee straw.

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.


There's a good portion of people with long-term effects that weren't "vulnerable" but end up with chronic fatigue, lung damage, or mental health problems.

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.


I doubt that's a high percentage of infected people. Do you have statistics that back up that claim?


Heart complications (inflammation): up to 60% (after removing pre-existing)

https://jamanetwork.com/journals/jamacardiology/fullarticle/...

Mental illness: 20% within 5 weeks

https://www.thelancet.com/journals/lanpsy/article/PIIS2215-0...

Chronic Fatigue: 50% at 10 weeks

https://www.medrxiv.org/content/10.1101/2020.07.29.20164293v...


How does that compare with other viral illnesses?

Not downplaying, I've had bad episodes of flu that left me low on energy for weeks, want to see how that compares and if it's been looked into (I expect not given recency).

My recovery from Covid in March was about on par with a bad flu, was late April until I felt good again and was back to normal on a physical level.


Thanks for the links. So how do I know these value are abnormally high compared to say a severe flu? I've read in the thread on hn that posted about the mental illness results that the values for a severe flu are 13%. And what implications do, say, a "lower left ventricular ejection fraction, higher left ventricle volumes, and raised native T1 and T2" have? Why is that worse than the risk of potentially (without knowing any probabilities obviously) developing autoimmune conditions as a result of taking the vaccine?


> Why is that worse than the risk of potentially (without knowing any probabilities obviously) developing autoimmune conditions as a result of taking the vaccine?

Well, in the 20,000 dosages in the pfizer vaccines, I believe there was no autoimmune conditions found. I think Moderna was the same. If that's your concern, maybe steer clear of the AstraZeneca/ChAdOx1 vaccine.

There are two main components to the vaccine, the RNA itself, and the proteins it causes the cell to make. Both naturally break down and are removed from the body very quickly--in hours to days from my understanding, so one could use that to conjecture that longer term effects are perhaps less likely in this case and something like that would show up sooner.

We're not really comparing flu stats vs. covid stats. I'd argue these things are not good whether they come from a severe flu or covid, so that seems like a red herring? Here our choice is "what is more likely to mess me up badly, a vaccine designed, tested and peer reviewed with a do-no-harm mindset, or the virus behind a pandemic that has killed more than a million people worldwide."


> We're not really comparing flu stats vs. covid stats. I'd argue these things are not good whether they come from a severe flu or covid, so that seems like a red herring?

Do you get a flu vaccine each year?


Yes. No problems, ever.


The long term covid effects are exactly what worries me about this vaccine. If a vaccine is an inactive or reduced version of the real thing, why wouldn't they have similar effects?


None of the initial vaccines use anything remotely resembling an inactive virus, much less a attenuated virus.


> Personally I fail to see what benefits non-vulnerable people have from immediately being vaccinated.

covid can do/does plenty of nasty things to "non vulnerable" people besides kill them


> A clinical trial size of 40,000 (20,000 receiving the vaccine) is way larger than a lot of other drugs that people are comfortable taking.

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.

1) https://gh.bmj.com/content/5/9/e003094


Too late for that - the beta testers have already found it good. A phase 3 trial is beta test.


Phase 4 is like the RC, and by that point it seems to be pretty stable.


I think they add more age groups and diversity as a followup.


Phase 4 trials are typically post-approval and used to validate marketing claims ("Pfizer's Covid vaccine is also proven to promote weight loss," for example). The result of a phase 3 trial is a release candidate, and the FDA (or equivalent organization) stamps the RC as gold master.


The phase 3 trials is not over yet for another 2 years... which no one wants to wait for... hence the emergency use authorization.


[flagged]


I’ll let you know the long term effects of the vaccine, and you can let me know the long term effects of Covid-19.


I'll take my chances.

My sister-in-law is dead. A brother-in-law is still unsure if we can talk across a room without fainting (6 months ago he was running several miles a day). This is just in my tiny circle of close family.

Thousands in a much larger sample of had the vaccine with no side effects anywhere near that bad.


I'm deeply sorry for your loss. It's discouraging to me to see people respond so dismissively to something so tragic when it has yet to affect them personally.


If it cheers you up: I'll get myself vaccinated as soon as possible. Not just for myself but also because "The needs of the many outweigh the needs of the few" as Mr. Spock would say.


[flagged]


> I don't care about one persons experiences.

You're not wrong about anecdata. But there's a less callous way to respond to someone who just explained that two of their relatives are dead or seriously ill...


What about 35% of respondents in n=292 (https://www.cdc.gov/mmwr/volumes/69/wr/mm6930e1.htm?s_cid=mm...)?

"Interviews were conducted 14–21 days after the test date. [...] Among 292 respondents, 94% (274) reported experiencing one or more symptoms at the time of testing; 35% of these symptomatic respondents reported not having returned to their usual state of health by the date of the interview (median = 16 days from testing date), including 26% among those aged 18–34 years, 32% among those aged 35–49 years, and 47% among those aged ≥50 years. Among respondents reporting cough, fatigue, or shortness of breath at the time of testing, 43%, 35%, and 29%, respectively, continued to experience these symptoms at the time of the interview. These findings indicate that COVID-19 can result in prolonged illness even among persons with milder outpatient illness, including young adults."


To be fair, GGP said six months (~180 days). That 35% is by 21 days, so not comparable at all. It is concerning, though, and I hope some of these observational studies are continuing to follow the people still experiencing symptoms for longer periods of time.


Is this a surprising statistic? Even with milder illnesses such as the flu, it's common to experience cough, fatigue, or shortness of breath for weeks.


It’s not common for 35% of flu patients to experience those symptoms after 14-21 days have passed, as it is with Covid.


Is it not? I'd be interested to see statistics on this, because I was coughing for weeks after 2 of the 3 times I can remember catching the flu.


Flu characteristics are well understood and you should encounter no obstacles in doing that research yourself.


Okay:

> Uncomplicated influenza signs and symptoms typically resolve after 3-7 days for the majority of people, although cough and malaise can persist for >2 weeks, especially in elderly people and those with chronic lung disease.

https://www.cdc.gov/flu/professionals/acip/clinical.htm

Seems like over 14 days of flu symptoms is common.


“can persist” is not specified with a percentage of flu patients, and thus cannot be inferred to be “common” as you state from the evidence provided alone.

Precisely what overall percentage of flu patients across the general population experience continuing symptoms after 14-21 days?

(Any common influenza in any typical year in the past decade is fine.)


I'm not sure why you're assuming bad faith here. I attempted to and found no source indicating a proportion of flu cases with lingering symptoms, with most sources only giving vague statements that symptoms can persist. If you've done the research and found it easy, would you be interested to share the results?


You indicated that a given data point would be interesting and relevant to the conversation, and then didn’t indicate that you had invested any time in researching that data point to contribute it to the conversation. It’s poor form to shrug off that effort into others when your participation in this specific discussion on HN suggests you are both familiar enough and capable enough to attempt to look it up yourself. That you attempted to do so and couldn’t find the answer would have been relevant to mention in your comment, and knowing that now, I’m happy to retract my reply.

(However, regardless, I do not consider researching your line of reasoning to be a valuable use of the time I have available for this discussion, so I will not be doing so. It’s not personal at all, though I imagine that’s of no comfort. Perhaps someone else will do so; I see someone trying in another branch.)


> I don't care about one persons experiences

While your math is sound, your empathy is horrendous.

How about, "I'm so sorry about your loss. But it doesn't change the fact that..."


N is not 1. N is 14: all of my or my wife's siblings and their spouses. If you run the statistics based on what we know about COVID my anecdotes are well within the expected range (though higher than average, not high enough to be outside of the normal standard deviation). A large portion of the world has a similar set of personal statistics.


You should balance that against your chance of contracting COVID-19, and the unknown long term effects of COVID-19.

For me, the long-term consequences of the vaccine seem to be better understood (theoretically, not empirically) than the long-term consequences of a COVID-19 infection.


I think "we" -- as a society -- should balance those two sides. Vaccinations do not always make sense at an individual level, but make a lot of sense at a societal level. If everyone was making a personal trade-off we would not reach the global maxima.


how can the long term consequences of the vaccine be better understood than the virus? The vaccine is younger than the virus, and orders of magnitude of more people have had the virus.


mRNA vaccines were understood and studied prior to Covid. Covid infections (still) are not understood.


This isn't entirely true; the technology is still very new.


A five second search finds papers on mRNA vaccines from 2018. I see no papers on Covid prior to 2019. In relative terms, as the parent comment was using, we have been studying them longer.

I am not arguing that they are well understood, but I imagine most people are filling in that word when they read the comment.


We've researched coronaviruses since the 1960s, had MERS and SARS most recently (less recent the 2018). I don't understand why we worry about long term effects of Covid, but not long term effects of mRNA vaccines? Both seem to have things to worry about, with both having different scales.

https://www.cdc.gov/coronavirus/types.html


Are there any prior mRNA vaccines that have been approved for human use? Wikipedia (currently...) says this and the Moderna ones would be the first.


There have been a few phase-1 trials in humans. But mostly it is research.


why do we get to generalize mRNA vaccines, but not SARS-Cov-2? We've known about coronaviruses since the 1960s, we've had MERS, SARS, and other more recent ones.

https://www.cdc.gov/coronavirus/types.html

I don't think we have long term information on either SARS-Cov-2 or the vaccine...


100% incorrect.

These are the very first mRNA vaccines. Here is Wikiepdia to confirm. [1]

You. Are. An. Alpha. Tester. And so is the rest of the world. We all are.

https://en.wikipedia.org/wiki/RNA_vaccine

"Up until November 2020, no mRNA vaccine, drug, or technology platform, had ever been approved for use in humans, and before 2020, mRNA was only considered a theoretical possibility for effective use in human"


From what I've read ~20% of COVID cases end up with some long term affect, some of which are quite bad and could be permanent. While the vaccine also probably has risks, I personally would rather take my chances with the vaccine instead of infection.

At the very least, the vaccine seems less likely to kill me in the very short term.


Where have you read that?



I think differently than you. I figure that 20,000 people have had this and haven't had serious complications. So probably a better than 1/20k change that if I get this I'll be okay. And I'll have a much better idea of this by the time I get it since I'm unlikely to get the first round of vaccines anyway since I'm not in an elevated risk group.

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


This comment and another got me looking into mRNA more. It seems like an mRNA vaccine is more akin to food you consume that produces a desired effect, rather than something permanently sticking around in your body. It doesn't permanently modify your genetics.

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.

[0] https://en.wikipedia.org/wiki/Messenger_RNA#Degradation


> It seems like an mRNA vaccine is more akin to food you consume that produces a desired effect, rather than something permanently sticking around in your body. It doesn't permanently modify your genetics.

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.


Is there a way to package the vaccine that would "prove" proper handling all through the chain of custody? Sort of the biological equivalent of the shock tags moving companies put on boxes containing fragile items.

Given how sensitive to temperature this vaccine is, I would like some reassurance that no one mishandled it along the way.


It's not proof to you, but Pfizer is shipping the vaccine in boxes that monitor temperature and location and transmit it to them so they can watch it. I trust that they wouldn't allow risky doses to be used. The risk to them of something bad happening and the public losing trust in the vaccine is too great.


I'm less concerned about Pfizer mishandling it than medical facilities and doctor's offices which may not be used to dealing with doses that are temperature sensitive to such an extreme.

You know, the nurse who queues up a few doses at a time and then gets delayed in actually administering them.


Do you think private companies will require vaccination to return to work?

*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-...


I fully expect that once it is widely available (major caveat), many workplaces and schools will require it absent medical exceptions. Certainly, most schools require vaccinations today and I don't expect there will be a lot of sympathy for those that want to hold off.


I don’t think voluntary exceptions will be granted for Covid, and I’m hard-pressed to come up with a case where an involuntary medical exception would be necessary for someone that is mobile. (No doubt a one in a billion case exists, of course.)


Immunocompomised people can be mobile and still lack the defenses necessary to tolerate a vaccine. I know one personally; he jogs by my house every evening, but by his own estimation, a flu vaccine would almost certainly land him in the hospital.


Pregnancy is one. It wasn't tested on them.


Allergies to one of the components? Raw egg allergies can preclude some vaccinations.


Neither vaccine under consideration today uses eggs or triggers the egg allergies that the most common influenza vaccines can. The general population degree of allergic reactions to vaccines is 1-2 people per million, with hives as the most common outcome; or between 1500 and 3000 people across the United States in a 100% vaccination scenario, of which many would get hives and no worse.

Egg allergies trigger careful treatment protocols surrounding many influenza vaccines, but do not in any way preclude vaccination or exempt one from it. Specifically, if your allergic reaction to eggs is severe enough to impair breathing, delivery of the vaccine must be delivered in a monitored medical setting that can treat you if an allergic reaction that impairs your breathing. You are only precluded from receiving an egg-based vaccination once you have experienced a severe reaction from an egg-based vaccine. Egg allergy alone is not sufficient.


I expect that state school systems will mostly apply their existing laws for required vaccines. (which is that 4 or 5 of them actually require them, and the rest give religious and/or philosophical exemptions)

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.


>will be "required" by policies but not enforced in practice

That would seem to be extremely unethical and possibly at least borderline an OSHA violation. If a workplace is claiming that certain procedures are being followed and they are in fact not being followed, I think plenty of lawyers would be happy to take that lawsuit.


I didn't necessarily mean that they would be breaking procedure -- I think it's more likely that the procedures won't be very rigorous. I doubt that procedures for vaccination will be any more rigorous than the procedures for ensuring compliance with mask wearing.

As far as this being unethical -- maybe it is -- but since when has that stopped anyone? There are people still being forced to go to work sick because they have no way to take sick leave without losing their jobs.


Dunno. Larger companies I'm familiar with have pretty rigorous back to the office procedures which I could see extending to proof-of-vaccination at some point. Without it, they could just not enable badge access. But, as you say, uncharted territory.


I think, at best, we'll see a situation similar to the requirements that state schools have for enrollment. All 50 states "require" kids to be vaccinated.... but 48 states have religious exemptions.

At the end of the day, it's a lot less risk to HR to not piss off a couple of politically fringe employees over something that the vast majority of employees will do voluntarily anyway, without any coercing. Two unvaccinated employees out of hundreds probably won't cause a problematic COVID outbreak, but they could file a lawsuit.


Most schools require vaccines which have been in circulation for a long long time and presumably whose long term risks are well understood. I think it would be pretty stupid to force mass vaccinate such a rushed vaccine, don't you think?


A lot less stupid than continuing with "distance learning".


You and I have very different definitions of stupid. Requiring an entire country to go whole hog on something with zero real understanding of long term effects is my definition of stupid. When is that ever the wise thing to do?


When the other choice is a demonstrably inferior learning environment, economic ruin, and a major public health hazard that has already killed just shy of 250k people in just over 9 months.


So vaccinate those at serious risk who we were closing things down for in anticipation of the vaccine. When the serious at risk people are no longer seriously at risk then there is no need for all the shutdowns. No need to vaccinate everyone is there?


I don't think that's how vaccines generally work. The virus won't actually disappear, it'll continue to be spread among the unvaccinated, and eventually people not at risk become at risk due to changes in life circumstances.

I'm also not sure there's quite the bright line you seem to be suggesting between "at risk" and "not at risk." Young health people still die of COVID-19, just not at as high a rate as already-unhealthy or older people.


I actually don't think the federal government has the power to require it. However, private companies and schools can impose whatever safety requirements they feel prudent for their employees, customers, and students. Which may of course make life difficult for those who don't want to go along.


State governments probably have the power to require it.


You may be right although I have a hard time seeing that happening politically. IANAL, but the relevant case law seems to be Jacobson v Massachusetts (1905) upholding mandatory smallpox vaccinations which AFAIK has never been superseded. [1] That said, the US Supreme Court also upheld a Virginia law that authorized the involuntary sterilization of “feeble minded” persons in state institutions in 1927. It's hard to imagine similar laws passing muster today, probably for 14th Amendment reasons.

[1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1449224/


The US federal government can require it by passing laws if they see fit to do so. Presumably the states with the highest Covid infection rates would fight it in court on some constitutional basis to avoid vaccination, and some armed citizens would kill medical personnel enforcing the federal directive, but none of that prohibits the laws from being passed.


Isn’t that kind of what we have done with distance learning?


It was the wise thing to do for the polio vaccine.


The risk profile for all the age groups is wildly different. I don't think its a bad idea for people > age X to get this vaccine, one because they have a much higher risk of serious harm from corona _AND_ perhaps less risk of long term affects. But for someone who has very low risk of serious harm from corona, perhaps it makes sense to wait a little bit?


Depends on what you mean by "a little bit." My understanding is that general availability isn't expected until probably April of 2021, by which point health care workers and other high risk groups of people will have had the vaccine for five months, and the trial participants for six months.


I think it will depend on the political climate of the particular workspace.


I hope so. I would be upset if I got the vaccine and people who didn't have it were allowed to work near me, but I would just keep WFH. I would be outraged if I were forced to work with them


Why would you be upset for? It's their life, not yours. Once you get vaccinated, ideally, you get immune to the virus. You neither can develop the disease nor spread it. It's the same as saying you don't want to work with people who didn't got vaccinated by any other number of vaccines (let you search wiki for full list as exercise) and I'm pretty sure it already happened.


> It's their life, not yours

This attitude is why the pandemic rages on with such intensity in so many places


Because I don't want to be around people with a disease that's serious enough to shut down our society, if I am only 95% resistant to it


The 95% effective figure refers to the percentage of people who develop full immunity, not how resistant an individual is. A more accurate way of phrasing that would be "[...] if I only have a 95% chance of immunity".

I don't mean to split hairs; the distinction is important.


Because it is only 95% effective. If everyone around me is also vaccinated it is likely that even if my vaccine doesn't work I'm still protected. This is what herd immunity is about.

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.


The 95% effective is not a cliff function. The 5% that ‘get it’ have mild symptoms. We won’t know how effective it at preventing serious disease until millions have been inoculated, but it will likely be 99%+ effective with that outcome.


We know that in one of the trials one of the serious cases was in the intervention group. We will of course need a lot more data to figure out what the real reduction in rate of serious events is.


>It's their life, not yours

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.


Dude, read my point again. I was asking why would he get upset if is his colleagues decide not to vaccinate. Not anything else.


isn't in insane how over the last few months people just assume their fellow man is a murderer for BREATHING?

this virus is causing more insanity than health effects.


* the vaccine is not 100% effective

* 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.


If we don’t even know a basic facts about the vaccine (whether people vaccinated can still transmit, how long it lasts), isn’t it natural for people too feel concerned about what else we don’t know ?

Seems to be a few unknowns still ?


It’s natural for people to want perfect certainty before making health care decisions. That’s why public health policy exists: because there is never perfect certainty in vaccination, and yet we’ll be required to all the same.


You really missed my point. Read again my above comment.


Well, unless you're over 75, you probably won't be offered it for quite a long time. For that age group, the chances of dying of covid are far higher than the risks from the vaccine, to the degree of precision we know from the phase 3 trial. By the time they've been vaccinated, we'll have a lot more data, and those error bounds will be quantified so you can make a better informed decision.


There is a known zero day in the current version that is being actively exploited in the wild. If your system is sufficiently air gabbed waiting is probably fine, but otherwise would you risk it?


Same. I'm not an anti-vaxxer or anything like that. But I think "don't use version 1.0" advice applies here just like it does for software. Especially given the possibility that things have been "hurried" in the name of expediency in terms of getting the vaccine(s) developed, tested, and approved.

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".


If the enemy is charging my base and someone offers me armor I'm not going to wait for all my fellow soldiers to try it out and see what happens.


Sounds like a reasonable position, until you extend the analogy: there is a slight, but nonetheless real chance that said armor has seriously adverse health effects on you. Maybe it spontaneously grows spikes and punctures your insides.

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.


>"Sounds like a reasonable position, until you extend the analogy: there is a slight, but nonetheless real chance that said armor has seriously adverse health effects on you. Maybe it spontaneously grows spikes and punctures your insides."

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.


Still, parents analogy seemed flawed so I tried to extend it.

All analogies are flawed. That's why they are merely suggestive and not meant to be interpreted overly literally.


The issue here isn’t is the armor effective but would it explode and kill you without even being hit.

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.


I wonder if any software product managers ever conceived that in shipping software with known bugs to meet a deadline, they'd somehow be slightly eroding people's faith in vaccination science.

It's kind of wild when you think about it.


From all the data data we have it looks like the vaccine is orders of magnitude safer than the virus.

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.


[flagged]


We now know that Covid is not nearly as deadly as was first perceived, and that a relatively narrow band of the population is vulnerable to its worst effects.

It's foolish to act as though this is worse than it is.


The original estimates put COVID-19 at approximately 3-4%. At the time I'm writing this post, the United States has had 253,309 deaths from 11,789,304 cases, or 2.14%.

Without the lockdowns, without the mask mandates, without social distancing, without closing establishments where people congregate, COVID-19 easily overwhelms healthcare systems. We saw this play out in Wuhan, New York City, Italy, and elsewhere. When the healthcare capacity is overwhelmed, the results are catastrophic.

It's all well and good to say, "well, 2% isn't as bad as we thought." But that's not how it is. The problem is that with 10-20% of all patients requiring hospitalization, the hospitals can't keep up. Healthcare is a finite resource. It's not just the COVID patients who suffer, it's everybody who needs hospitalization for anything.

It is foolish to act as though this isn't as bad as it is.


  We now know that Covid is not nearly as deadly as was first perceived
That seems to depend on where you live. The 250k deaths from 11M infections number in the US is putting it within the original estimates. If you assume the actual case count is 2x or 3x the tested positive number, then its still roughly 1%, which will result in a lot of early deaths. If your over 50 then you should be taking it very seriously.

If the vaccine numbers are right, it could literally save over a million peoples lives just in the US.


1917 people died from COVID-19 yesterday in the US, alone. That's a 9/11 of deaths every 36 hours. It might not be as deadly as was first feared, but it is deadly.


You would be foolish not to get vaccinated given what we know about COVID.

Nobody said anything about not getting vaccinated. The point of discussion here is about not rushing to do it the first day the vaccine is available.


So if not Day 1, when? 6 months out, 1 year out, 2 years out, 10 years out? What arbitrary standard should those who are concerned about long-term effects apply?


That's up to the individual to decide. I'm not trying to be prescriptive here: I"m talking about what I would do. If you want the vaccine on Day 0, by all means, do it. Risk tolerance is obviously a very personal and subjective thing, so "you do you".


> But I think "don't use version 1.0" advice applies here just like it does for software.

No it doesn’t, because vaccine development is more like bridge building than software development.


https://en.wikipedia.org/wiki/Tacoma_Narrows_Bridge_(1940)

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.


As a somewhat nit, the Tacoma Narrows Bridge was known to have issues before construction was even finished although, obviously, it wasn't expected to fall down.

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. "


You’re suggesting that people prioritize decisions based on individual uncertainty over decisions based on public good. That the logistics of distribution will result in the same outcome as your suggestion does not mitigate the perceived selfishness of your suggestion.


> You’re suggesting that people prioritize decisions based on individual uncertainty over decisions based on public good.

this is a simplistic and somewhat naive take. the decision to approve and distribute a covid vaccine is not going to be based solely on "public good". a vaccine has immense economic and political significance. it's not unreasonable to wonder how that might affect the approval process.


That the logistics of distribution will result in the same outcome as your suggestion does not mitigate the perceived selfishness of your suggestion.

I could not care less about anyone's opinion of my "perceived selfishness".


Can you pull out the threads on that argument a little? Taken at face value, it's not meaningful. Bridges launch with huge, sometimes catastrophic problems.


And that's exactly the point. Once it launches it either crashed down or stays up. As for this vaccine it got 30k tests. It's the equivalent of before launching said bridge the entire heavy machinery of the construction company stood on it and didn't collapsed.


The Italian bridge that collapsed after decades because of faulty assumptions about the concrete involved is a more accurate comparison. Assuming we know more than we do, and thinking it has no serious side effects because non have appeared in the first few months is not logically consistent.


That’s fine, as long as you don’t expect other people to limit their lives in lockdowns because of your choices.


Few key facts:

• 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....).


> These studies were larger than usual to make up for the decreased time

Larger studies don't make up for decreased time in either identifying long term effectiveness or identifying delayed effects.


If you want to wait a lifetime to see if there are any issues you have that choice. But vaccines, even mRNA ones, are unlikely to have any long term effects worse than the disease itself.


This sums it up quite nicely. What is worse? The vaccine or covid?


>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....).

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.


What does "EUA" stand for?


Emergency Use Authorization (EUA)


I'm not an anti-vaxxer in any shape or form but I have found a major flaw in our medical system through my own struggles. I was given a flouroquinolone antibiotic about 8 years ago and it really had a huge negative impact on my health. It resulted in chronic pain and some neurological issues. Neurological issues where instant, but pain took a few months to start. Even though the current research and drug information align with most of my symptoms doctors refuse to even entertain the idea. I have been to Mayo, Rush, Northshore, etc. Out of 40+ doctors one confirmed it and 2nd agrees it is possible.

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.


Don't worry to much, you will not be able to get your hands on a vaccine for quite a while even if you wanted it. By the time this will be available for regular people like you and me, millions of frontline healthcare workers and emergency personnel will have gotten it.


On a risk basis, it’s clearly better to get the shot than COVID. But you aren’t wrong in you belief the vaccine may have unknown side effects. The trails were not powered to find the 1 in 10000 side effects that pop up. We won’t know those for months.

Not that you’ll be able to get the vaccine for months anyway, unless you work in healthcare.


The real ques is: What % of the population are willing to be the "early adopters"? I wonder how things will develop in countries where that % is less than 5.


I have a friend who is very anxious about how quickly these vaccines were developed. What can I tell them to reassure them that it is safe?


Something that resonated with me... Which do you think is more likely to have a significant negative effect on your health? These vaccines or COVID?

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.


This NYT article clicked with me: https://outline.com/bVnccw

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.


This is a game of probability of which risk is greater: covid or vaccine? So, a doctor that has a great chance to get covid it's worth to use the vaccine even if it has risks. For me that I have low probability to get covid (I try to be very careful) it's not worth to have the vaccine risks.


But that's just it, we anecdotally know they're safe. There are tests we've run and the results are promising, but the true large scale inoculations haven't happened.

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.


can you add emergency use to the title!


Do we know how long does the vaccine holds?

Is that like polio and lasts for years, or like the flu and you need a new dose each year?


There isn't really a way to know for certain (as not much time has passed), but there are hints that it might last for years[0].

[0]: https://www.nytimes.com/2020/11/17/health/coronavirus-immuni... (with links to the studies inside)


Unless I missed it, there hasn't been any data released. I'm only seeing PR accouncements.


AIUI, the thing that makes a vaccine's effectiveness very short term, like flu vaccines, is the natural evolution of the virus, not its effect on the immune system. It's not that people who got a 2015 flu aren't still immune to the 2015 flu, it's that wild flu virii look different in specific ways that cause them to slip by. As such, I think these drug companies don't really have much to release for each vaccine.

(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.)


> As such, I think these drug companies don't really have much to release for each vaccine.

They should still release the data. PR releases don't always match reality.


> Unless I missed it, there hasn't been any data released. I'm only seeing PR accouncements.

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.


There's still data, and it hasn't been released. I would like to know the details of 95% effective.


I was listening to an interview with Paul Offit[1] a vaccinologist and member of the FDA Vaccines and Related Biological Products Advisory Committee (which advises on COVID-19 vaccines).

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.

[1] https://open.spotify.com/episode/6Z7m56ACJ1VZ0ZKuw4iiGb


I'm in a rush, so hopefully someone can dig up some actual links to scientific papers, but current immunity from naturally infected people has stayed strong and shows no sign of weakening. The immune response from the vaccination has at least as strong, so in all likelihood we're looking at very long response.


Doesn't immunity only last several months though?


No, that's just been a popular conspiracy theory.


No, it stays strong and shows no sign of weakening.


According to several studies, that's not true.

"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...


You (or rather the writer of that news piece) apparently confused antibodies and immunity. Not only are antibodies not the only mechanism of the adaptive immune system, T cells are harder to test for but equally important. Also it's normal that the body doesn't keep them around indefinitely after an exception. It creates memory cells and quickly recreates antibodies and T cells when needed.

There is evidence that reinfection does occasionally happen, but none that it happens frequently enough to worry about. The paper you've linked mentions four cases.


You're right, but are there any peer reviewed papers that back up your argument?

> The paper you've linked mentions four cases.

Those are confirmed cases. That doesn't mean there's only 4 total.


I don't know if there are any papers for Covid in particular but it's how the immune system works in general. AFAIK there is no reason to assume it Covid differs in that respect.

> Those are confirmed cases. That doesn't mean there's only 4 total.

I'm sure there are more, but how many? There have been hundreds of millions of infections (according to the WHO). If there are a few dozen or even a thousand reinfections among them, it's not a phenomenon we need to worry about.

We could assume that reinfections are common even without any evidence for or against, but then we are playing something akin to Pascal's wager. Also, I think if reinfections were common, by now we would very likely have evidence for that by now.


Your first link only focuses on (the easier to test) antibodies, and doesn't mention T cell memory, which is the much more important factor in long-term immunity.

And of course there are going to be individual cases of reinfections with 55+ million cases.


Your logic checks out, but are there peer reviewed papers that back up your argument? This isn't my field, so I'm not aware of any.


There is one right in the list on the CDC page you linked[0]. There is also a recent Nature paper[1] that shows that T cells levels are stable for at least the first 100 days they observed. I don't know of a specific link to send you for that, but that usually indicates T cell immunity on the timescale of multiple years (otherwise some drop in levels would have already been visible in the observed time period).

[0]: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7427556

[1]: https://www.nature.com/articles/s41591-020-01143-2


> The immune response from the vaccination has at least as strong

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?


I wonder how long it'll be before third world countries get the vaccine


WHO has a fund specifically for vaccines for developing countries, I can't find the latest total, but it's in the hundreds of millions.


A good portion of the WHO is funded by the Bill & Melinda Gates foundation. Imagine contributing billions towards world health and then somehow you are painted as the villain by insane people like Q, Russian propaganda and anti-Vaxx organizations.


Slightly off topic, but it's crazy how polarized this topic is - even on HN. Try scrolling through this thread with dead comments on.

Many of them are probably trolls, still, it's weird to me.


TBH, it's concerning. Not that HN is immune from strongly-held polarizing opinions. But, it's pretty obvious that for a lot of people, you're either in camp "Get it as soon as available, no questions asked" or you're an anti-vaxxer. (Personally, I'll get it as soon as I can.)

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 waiting on getting the vaccine are fine with having the same lockdown type precautions. (Wearing masks, not seeing people as frequently, less travel, working remotely, etc.)

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...)


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