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Pfizer Covid vaccine approved for use next week in UK

551 points by ascorbic 6y ago

qz2 6y ago
Does anyone have any non-press infested material about this vaccine? As far as I’m aware this is the first roll out of an mRNA based vaccine. While I’m no anti vaccination idiot I’d like to understand the risks to some degree.
- adrianN 6y ago
  The wiki article is a good start: https://en.wikipedia.org/wiki/BNT162b2 https://en.wikipedia.org/wiki/BNT162b2
  - qz2 6y ago
    Thank you. Reading this now.
- gabipurcaru 6y ago
  gov.uk: https://www.gov.uk/government/news/uk-authorises-pfizer-biontech-covid-19-vaccine https://www.gov.uk/government/news/uk-authorises-pfizer-bion...
- vore 6y ago
  With regards to mRNA, mRNA is a fragile molecule that is quickly broken down inside the body after injection, so there's unlikely to be much long term risk with mRNA itself.
  - im3w1l 6y ago
    Your answer is phrased in such a way that I can't help but ask: What about the other molecules in the vaccine? Are there any notable helpers or adjuvants or preservatives?
    - kolinko 6y ago
      Not sure why you’re downvoted - it’s a legit question.
      - MagnumOpus 6y ago
        No, it's the typical gish gallop of "skeptics". Swamp others with questions you could easily answer yourself if your intent were honest inquiry rather than making something/someone look bad.
        im3w1l 6y ago
        A skillful display of ad hominems. It's a shame to see your talent wasted on an arena as HN, when twitter would appreciate it so much more.
    - Kliment 6y ago
      This particular vaccine is literally just a bit of RNA in a blob of fat. The fat sticks to cell membranes, and the RNA pokes through. There's nothing more to it (this is also why it's possible to scale up production so quickly)
  - bbarnett 6y ago
    An immediate "but if it breaks down fast, how can it do anything?" thought springs to mind. I know what you mean is "not dormant and doing something for months/years", but at the same time, if it can initiate a modification of immune response, it can do "other things". I believe we must take the utmost of care at this juncture, and make sure assurances are not construed as in a poor light.
    - kolinko 6y ago
      For me the most convincing argument regarding safety is that mRNA vaccines essentially do the same thing that the virus does, just extremely limited in scope (producing just one protein instead of a bunch of them, and not reinfecting more cells). So, even if producing the proteins turns out to be somewhat harmful long term, it cannot possibly be as harmful as the whole virus. Assuming that covid infection is inevtable without a vaccine, we really have a choice between getting a little bit of mRNA injected into our cells, and a ton of mRNA injected.
      - qz2 6y ago
        That's an interesting perspective. I've actually had the virus. I'm interested to see what the differential outcome of having the virus and having the vaccination is.
      - pfranz 6y ago
        I heard recently that there's a surprising amount of our DNA that's made up of old viruses from our ancestors. https://www.sciencedaily.com/releases/2016/03/160322100714.htm https://www.sciencedaily.com/releases/2016/03/160322100714.h...
        acqq 6y ago
        There are the viruses which can exploit the DNA involved mechanisms, but a mRNA vaccine is not using these, it uses the processes "downstream."
  - refurb 6y ago
    Holy jeeze. This is why we have the FDA. The extent to which a molecule is active in your body is only slightly correlated with toxicity. There is zero reason why a fragile molecule can't cause damage before it breaks down. This is how ended up with thalidomide. They tested it in pregnant lab rats, but the window for birth defects is incredibly short in rats. So everything checked out. In drug development you can't assume anything without data to back it up.
    - vore 6y ago
      I agree, but there's not much time we can spend to observe side effects over a long duration of time to have that level of confidence. The FDA at this point certainly doesn't have the ability to analyze that either, so the best we have is a theoretical understanding.
- bawolff 6y ago
  I don't know much about this subject but i found https://www.nature.com/articles/nrd.2017.243 https://www.nature.com/articles/nrd.2017.243 to be quite interesting. Its from 2018, before all the covid stuff hit, so i think it gives a much more detached overview. However it might not be precisely about the current crop of vaccines.
- oezi 6y ago
  Isn't there usually at least a 1:100 or 1:1000 safety buffer between vaccination and control to make a vaccine safe? At least for other vaccines that's a common threshold.
  - kolinko 6y ago
    what do you mean by buffer in this context?
    - oezi 6y ago
      The relative risk between potentially getting the disease even though the population is already highly herd immunized (compare e.g. measles) and the risk of the vaccine is still 1:1000. This means despite measles already being such a rare disease it is still a clear benefit to get vaccinated. With a disease such as Covid it might be 100000x safer to get vaccinated than not. All national vaccination programs must calculate and assess such relative risk and find so much advantage in favor of vaccination.
- pmoriarty 6y ago
  My go-to resource for educated COVID-19 coverage has been This Week in Virology[1], which usually has between 4 and 6 virologists reporting and analyzing COVID-19-related news every week. I've kind of OD'ed on COVID-19 news myself, so haven't listened to them for a while and don't know if they've commented on this vaccine yet, but they probably will, and for a thorough, educated, hype-free analysis, there's no better place I can think of to go to than TWiV. [1] - https://www.microbe.tv/twiv/ https://www.microbe.tv/twiv/
  - qz2 6y ago
    Thanks - this is perfect!
- PureParadigm 6y ago
  Wikipedia [1] has an overview of mRNA vaccines, including a summary of some potential side-effects/risks. For more technical details, this review of mRNA vaccines [2] appears to be a decent place to start. [1] https://en.wikipedia.org/wiki/RNA_vaccine https://en.wikipedia.org/wiki/RNA_vaccine [2] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5906799/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5906799/
_Microft 6y ago
How did they approve it that fast? Is the approval process so different and so much more efficient than the one in the EU or USA? Was it extremely rushed to make sure to get doses before they have to compete with other countries for limited supply? I'm pretty curious now. Let's hope for the best, i.e. a good vaccine, a good process and no trust problems, the latter because at least it feels rushed.
- chrisvxd 6y ago
  My understanding is that they've been carrying out a rolling evaluation that has been going on for the duration of the trials, which has helped accelerate the normal process. Having said that, I believe the EMA (EU) also carried out a rolling evaluation, so I'm not sure what the differences are there.
  - makomk 6y ago
    The UK has put a lot of effort into speeding up the roll-out of these vaccinations in general. Enough that it basically leaked the fact some kind of Covid vaccine was coming a few weeks in advance because so many people were involved in the pre-planning and the timescale was so aggressive.
    - tinus_hn 6y ago
      You make it sound like a bad thing. It was never a secret the vaccines were coming and as each day of delay means 5000 people dying I think putting a lot of effort into speeding up the rollout is pretty well worth it.
      - joshuahughes 6y ago
        Ummm, latest daily UK deaths "with Covid" is 414, not 5000. Ref: https://coronavirus.data.gov.uk https://coronavirus.data.gov.uk
        tinus_hn 6y ago
orobinson 6y ago
Amazing that people will be getting vaccinated against coronavirus before the year is out. Is there any evidence of whether these vaccines prevent transmission of the virus yet? Or so far do we just know that they protect the person who is vaccinated?
- redisman 6y ago
  I’m also interested is the mRNA vaccine different or the same vis-a-vis stopping(or not) transmission
- concerned_user 6y ago
  It is planned that it requires 6 weeks to acquire immunity with 2 shots (4 weeks apart) of this vaccine. Realistic outcome if enough people get vaccinated should be that spring/summer wave of covid is suppressed or at least death rate and amount of severe cases will be much lower.
- pjc50 6y ago
  If you're not actually infected, i.e. you're protected, you don't spread the virus. I'm not aware of a disease for which this isn't true, that vaccinated people can be carriers.
  - mssundaram 6y ago
    It's a bacteria and not a virus, but it's true for whooping cough, as one example.
  - _Microft 6y ago
    What I remember but cannot currently find a source for, is that there are three levels of protection that vaccines can provide. First is to protect patients from developing the sickness (but not from being infected!), second is to even prevent them from spreading it and best outcome is to prevent them getting infected at all. Only the second and third level prevent spread.
  - apendleton 6y ago
    Vaccines that prevent disease symptoms but don't completely prevent infection are definitely a thing (they're said to confer "non-sterilizing immunity," vs. "sterilizing immunity" which prevents both infection and disease). The inactivated polio vaccine (the injectable one that's used in the US) is an example of such a vaccine. The oral polio vaccine, which is the main one used in the developing world, interestingly does confer sterilizing immunity, but with the tradeoff that sometimes it also causes polio. At least in the US, the explicit target endpoint for FDA approval was just prevention of disease, not prevention of infection, and the phase III trials for both the Moderna and Pfizer/BioNTech trials were only designed to assess this criterion: they only tested symptomatic people, so it's entirely possible (though not that likely given animal model observations, etc.), that infections were just as common in the treatment groups as control groups, but they just never developed symptoms and so were never tested. More research will be needed to ascertain which kind of immunity is being conferred.
jakozaur 6y ago
In terms of rollout. UK is the ideal country to be the first: 1. Heavily impacted by Covid-19. 2. Centralised health care system makes it easier to compare results and efficiency. E.g. it's UK which figured out that dexamethasone is efficient against Covid https://www.who.int/news/item/16-06-2020-who-welcomes-preliminary-results-about-dexamethasone-use-in-treating-critically-ill-covid-19-patients https://www.who.int/news/item/16-06-2020-who-welcomes-prelim... 3. Developed country with great logistics.
- WanderPanda 6y ago
  Happy beta testing to all Brits then!
  - simonbarker87 6y ago
    My 85 year old grandparents are excited, they get to hold their great grand children again. They’d be first in line if they could be.
    - vertis 6y ago
      Aside from hospital workers they're likely to be pretty high on the list, if my understanding is correct.
      - refurb 6y ago
        The FDA already recommended (it's not binding) that front-line healthcare workers and seniors in long-term care are the first wave of 20M people (40M doses). That will take until February or so to complete.
      - newguy1234 6y ago
        Heard it was something like this: 1. Long-term care residents/staff 2. Hospital workers 3. Anyone 85+ years old.
        6y ago
waihtis 6y ago
Not sure why the posts asking for vaccine risks are getting downvoted. Pandemrix, the vaccine for swine flu, caused a notable amount of narcolepsy cases in recipients here in FIN (notable here meaning the amount of yearly cases spiked by 3-4x) and as with anything that's taken quick to market there has to be some risk of overlooking some tail events somewhere. It's not an anti-vaccine attitude, just healthy skepticism considering how much pressure there is to get this out and into distribution.
- Arkhaine_kupo 6y ago
  Healthy skepticism belong in peer-reviews, in revisions of medical journals. Skepticism in the public space fosters anti-vaccine sentiments, adds to the already growing anti-vax movements and puts in risk the vulnerable in our society as they require shielding and for the rest of us to do our part.
  - ajkdhcb2 6y ago
    I find your perspective extremely disturbing, and believe it empowers anti-vaxxers more than anything else.
    - Arkhaine_kupo 6y ago
      How could it possibly empower anti vaxxers to say to trust healthcare professionals, doctors and the worlds leading security and safety experts?
      - waihtis 6y ago
        I think anti-vaxx and other fringe groups are more driven by distrust in society, and by denying discussion to be had in the first place will further build anti-societal silos. It's a difficult problem, because inevitably there will be harm initially if you allow free discussion. But over time the harm will be less in comparison to complete shutdown of any public conversation about the vaccines. If the anti-vaxxers don't want the COVID vaccine, so be it. Let them pay with their health. That'll be the best course of action for beating down the quacks who will oppose any vaccinations.
peterburkimsher 6y ago
I'm really glad that this brings hope into a dark season. People are already rewriting Christmas carols: "wipe the halls with sanitizer, falalalala lalalala 'Til we get the cure from Pfizer falalalala lalalala" https://etcanada.com/news/712874/chris-stapleton-wants-everyone-to-disinfect-the-halls-with-new-covid-christmas-album-on-kimmel/ https://etcanada.com/news/712874/chris-stapleton-wants-every...
puranjay 6y ago
Serious question: if you're a young person with no health issues, should you even get the vaccine?
- hashmush 6y ago
  Yes.
- noir_lord 6y ago
  Yes, There are two primary things to consider the Risk/Benefit to yourself and the Risk/Benefit to those around you. The answer is still yes for both cases, long term covid damage is bad at any age and so is taking out a grandparent, co-worker you like.
  - refurb 6y ago
    the Risk/Benefit to those around you But there is a limited supply. At least in the short-term, if I get a dose, that means someone else doesn't get one. If someone around me is at risk, then they should get vaccinated and I should defer if my risk is low.
    - Latty 6y ago
      Generally it isn't on the individual to try to weigh something like that up. Here in the UK, at least, the Vaccine will be offered to people in order, so if you are offered it, there would be no reason to defer—others who need it more should have been offered it before you and you accepting won't deny them anything.
    - cr1895 6y ago
      This is why countries and public health departments are discussing and agreeing on who gets a vaccination first - people in care homes, front-line health workers, or perhaps even young, healthy people because they heavily drive the spread. I don't think there's a situation anywhere where it's a free-for-all. Personally, I will take the vaccine as soon as it's made available to me. Even if my risk is perhaps low (which may or may not be true), taking the vaccine reduces the chance that I would spread COVID to someone else. It's a collective effort to reduce the spread, not an individual or selfish one.
YaarPodshipnik 6y ago
I had COVID-19 early in the year, and so did my Wife (not sure about my Daughter, harder to tell with kids). I would really like to know whether I should get the vaccine or not? All the info that's out there says that immunity to C19 is temporary, so a vaccine after having gone through it doesn't seem redundant. Does anyone know if there's been any research on effects of the vaccine on the people who got C19 and recovered? I'm especially worried about possibility of a cytokine storm possibility as a reaction to vaccine.
- rimliu 6y ago
  From what I have seen the data says immunity is at least six months, and potentially years as with the original SARS. For me it is easier, I had it only a month ago, so I am good at least till the summer.
- Reason077 6y ago
  Having had Covid-19 should confer at least as much immunity as a vaccine does. It's possible that a vaccine could act as a "booster" to extend immunity, but I don't think there's any data on that. Your fears about "cytokine storm possibility as a reaction to vaccine" are unfounded. These vaccines have been tested on tens of thousands of trial participants.
  - aemreunal 6y ago
    > Having had Covid-19 should confer at least as much immunity as a vaccine does. [If I'm understanding what you're saying correctly] Not necessarily. There are vaccines, such as those for HPV and Tetanus that provide better immunity than the natural immunity provided by having and surviving the illness [1]. I don't recall reading any research on the immunity provided between a vaccine and the illness on COVID-19, so I don't know whether this could be such a case. [1]: https://www.chop.edu/centers-programs/vaccine-education-center/vaccine-safety/immune-system-and-health https://www.chop.edu/centers-programs/vaccine-education-cent...
- vertis 6y ago
  Disclaimer: Not a doctor. I find it hard to believe they haven't covered this with their phrase 3 trials, where the intent is to ensure that there is no risk at broad scale (in addition to effectiveness), and they pause the trial if anyone dies for unknown reason (etc) -- I definitely remember the trials pausing briefly while they investigated[1], and then continuing once resolved. I also saw a study a few weeks ago where they found people with antibodies 6-8 months later[2][3]. Suggesting longer term immunity. [1]: https://www.nytimes.com/2020/10/14/health/covid-clinical-trials.html https://www.nytimes.com/2020/10/14/health/covid-clinical-tri... [2}: https://www.sciencealert.com/evidence-grows-favouring-coronavirus-immunity-lasting-6-to-8-months-after-infection https://www.sciencealert.com/evidence-grows-favouring-corona... [3]: https://www.businessinsider.com/long-term-coronavirus-immunity-months-years-2020-11 https://www.businessinsider.com/long-term-coronavirus-immuni...
modeless 6y ago
Pfizer submitted an emergency use authorization request to the US FDA on Nov. 20. Why was it not approved within a day or two? Is it merely a matter of reading the submitted paperwork and scheduling a committee meeting? There better be a damn good reason, because people are dying out here. I understand that trials take time, but we already have trial results now, so what's the hold up?
- apsec112 6y ago
  There's thousands and thousands of pages of trial data, and if there's a significant screw-up, it would destroy public trust in all vaccines for decades. https://en.wikipedia.org/wiki/Dengvaxia_controversy https://en.wikipedia.org/wiki/Dengvaxia_controversy
  - modeless 6y ago
    It's been almost two weeks. That's more than enough time to read thousands of pages if they are literally the most important thousands of pages in the world right now.
    - apsec112 6y ago
      What makes you so confident? If someone gave you the source code to a major software project, even with a large team of highly qualified engineers working as fast as they could, how long would it take to read over the entire thing and be absolutely sure that there were no serious mistakes?
      - lacker 6y ago
        If a team from the UK had already done it, I would just go ahead and accept their analysis. The US should give emergency approval now, based on the UK approval.
        apsec112 6y ago
        That's a reasonable position, but if I were making a list of American government pandemic mistakes, this honestly wouldn't even crack the top hundred.
shusson 6y ago
Out of curiosity, how do people on HN rate the risk of long term side-effects?
- headmelted 6y ago
  That's a question for someone who's heavily schooled on mRNA vaccines and/or a practitioner involved in the trials for this particular vaccine. Not that I have a problem with your asking the question, I just don't think an opinion poll on a tech board is going to yield an accurate prediction of what to expect.
  - gwd 6y ago
    > I just don't think an opinion poll on a tech board is going to yield an accurate prediction of what to expect. I'm pretty sure they were hoping to be answered by someone heavily schooled in mRNA vaccines and/or a practitioner involved in the trials for this particular vaccine. On this particular "tech board", there's a reasonable chance of getting a response from those kinds of experts.
  - shusson 6y ago
    > I just don't think an opinion poll on a tech board is going to yield an accurate prediction of what to expect. Part of your answer, which I'm paraphrasing to "I don't know, talk to the experts", is already a good answer. But I was hoping that there was an expert lurking around that might be able to explain the risks or link to some evidence.
    - tgb 6y ago
      You asked what "people on HN" think which is not exactly the top way to fish out experts.
      - buzzerbetrayed 6y ago
        If an expert read that, they would likely respond, citing why they are an expert. So I think it’s as good a way as any on hn.
gr2zr4 6y ago
This could be the fastes approval in the whole drugs' history considering that The assessment of a marketing authorisation application for a new medicine takes up to 210 ‘active’ days. This active evaluation time is the time spent by EMA experts to evaluate the evidence provided by the applicant in support of a marketing authorisation application. This time is interrupted by one or two ‘clock-stops’ during which the applicant prepares the answers to any questions raised by the CHMP. The maximum duration of a clock-stop depend on how long the applicant thinks it will take to respond, but must be agreed by the CHMP. The first clock-stop usually lasts 3 to 6 months and the second one 1 to 3 months. Overall, the assessment of a new medicine usually lasts around a year. https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/evaluation-medicines-step-step https://www.ema.europa.eu/en/human-regulatory/marketing-auth...
- jfoster 6y ago
  Do drug approvals even have much history? My impression was that the concept of drugs needing to be approved has been around for less than 100 years, but I guess it will vary from country to country.
  - disgruntledphd2 6y ago
    It's been around (for clinical trials and whatnot) since the late 50's in the US I believe. I think it's been mandatory since thalidomide.
- akiselev 6y ago
  > This could be the fastes approval in the whole drugs' history considering that Without a doubt. The closest competitors would be imatinib (3 years) and several other chemotherapy drugs (~5 years) meant to treat malignant tumors. The vast majority of the drugs approved this quickly, with the exception of the HepC treatment, treated diseases with a life expectancy of less than the time it took to approve the drugs so long term side effects was less of a concern.
  - alexchamberlain 6y ago
ijidak 6y ago
> It is a new type called an mRNA vaccine...An mRNA vaccine has never been approved for use in humans before, although people have received them in clinical trials. Wait... This doesn't scare anybody? Why has this not been approved before? Would an mRNA vaccine be approved under less pressing circumstances...?
- 1241rtfasfasf 6y ago
  Seems like the mRNA technique is pretty new and simply hasn't been used for anything else before. The approval processes are still the same, just without the years-long idle cycles that usually slow things down. The end result will be good as any other vaccine you might get.
- ac29 6y ago
  > Wait... This doesn't scare anybody? Not really. mRNA starts to degrade within minutes of injection, and lasts maybe at most a few days in your body. It cant turn back into DNA, so once its gone, it can no longer have any effect on you. > Why has this not been approved before? Its a relatively new technology that took a lot of work and money to make a stable, effective vaccine with. Its also relatively expensive to manufacture. > Would an mRNA vaccine be approved under less pressing circumstances...? Yes, though these almost certainly were approved faster than other vaccines would be because of the pressing nature of things.
  - PureParadigm 6y ago
    > once its gone, it can no longer have any effect on you. If this is true, then how does it provide protection against COVID19 for more than a few days?
    - alibarber 6y ago
      The mRNA itself isn't doing the protection - it's training your immune system to do that for you (in a safe way).
      - 6y ago
f6v 6y ago
I remember everyone in the West saying: "vaccine can't be rushed like that!".
fab1an 6y ago
This should really be called the BioNTech or even "Mainz" vaccine (similar to the "Oxford" one), but Germany is terrible at this kind of marketing
- Cu3PO42 6y ago
  In Germany it is mostly referred to as the BioNTech vaccine. I think it's more about international publications being more likely to use the name they recognize or think their audience will recognize. Most everyone is going to know Pfizer and Oxford respectively. Internationally Mainz isn't exactly a famous city, nor is AstraZeneca a well-known pharmaceutical company.
  - fab1an 6y ago
    I get your point, but maybe Mainz would be more well known if we called it the Mainz vaccine? ;) Hell, we let Trump present the Mainz vaccine as if it was his personal achievement. Germany has got to do better here.
  - allendoerfer 6y ago
    > Internationally Mainz isn't exactly a famous city It might not be famous but it played a key role in the development of the Renaissance, Reformation, Age of Enlightenment, and Scientific Revolution, as well as laying the material basis for the modern knowledge-based economy and the spread of learning to the masses. https://en.wikipedia.org/wiki/Johannes_Gutenberg https://en.wikipedia.org/wiki/Johannes_Gutenberg
  - manquer 6y ago
    AstraZeneca is as well known as Pfizer, they are big pharma after all, the subset of people who know about Pfizer and not AstraZeneca is going to be quite small.
- garmaine 6y ago
  The "Oxford" vaccine was designed by Oxford University, hence the name.
CommieDetector 6y ago
It's not an vaccine it's a mRNA treatment, completely new and untested.
rebuilder 6y ago
Do we have any more data on what the wider effectiveness of these vaccines is likely to be? Duration of immunity? I've heard a minimum of 3-4 months reported, possibly longer, but do we know more now? Am I right that we don't yet know if they reduce transmission or simply prevent the disease? If the duration of immunity turns out to only be a few months, I wonder how this is going to play out. Will we periodically vaccinate 25-60% of the population, indefinitely? (I've seen varying estimates on what kind of coverage is needed to keep the pandemic in check.) Short of eradication, if immunity is not permanent, what options do we have apart from a perpetual vaccination program or just accepting an increased rate of mortality going forward?
- ageitgey 6y ago
  > Duration of immunity? I've heard a minimum of 3-4 months reported, possibly longer, but do we know more now? The only way to know for sure is to wait and see. But patients vaccinated for SARS in ~2004 still show immune responses now and people who received the various SARS-COV-2 trial vaccines in April of this year still show immunity. There's also studies showing many people who recovered from COVID on their own have demonstrated 9 months (and counting) of immunity. The truth is that the immune system is super complex and there isn't a single simple blood test they can do to tell if a person will resist a virus or not, so a lot of the conflicting numbers you will have seen depend on what exactly was tested and the media reporting has been pretty poor at contextualizing those study results. So there's reason to hope vaccine-derived immunity could be long lasting (say 1-10+ years), but we'll just have to see. But talk of 3-4 months of immunity seems to be media hype. > Am I right that we don't yet know if they reduce transmission or simply prevent the disease? Correct, we don't know yet. Pfizer unfortunately only tested people with symptoms for COVID in their trial, so we have no idea if it reduced asymptomatic cases or reduced transmission. Oxford did test thousands of people weekly in the UK to find asymptomatic cases and they have said they have "evidence" their vaccine reduces transmission, but they haven't published their peer-reviewed Phase 3 results yet so we don't know by how much. The scientific consensus seems to be that all the vaccines will probably reduce transmission by some amount, but by how much is unknown. But it stands to reason that the quicker someone clears the virus from their body, the less time they will be shedding infectious levels of virus. > Short of eradication, if immunity is not permanent, what options do we have apart from a perpetual vaccination program or just accepting an increased rate of mortality going forward? Luckily, this probably won't be the case. In any case, viruses tend to mutate and become less virulent over time since killing your host is a bad way to transmit yourself. So the general guess is that the virus will eventually mutate to be less lethal, similar to the how the 1918 flu virus still circulates but doesn't cause that level of mortality anymore.
cblconfederate 6y ago
The question is what will be the rate of vaccinations rather than who begins first (though, the sooner the better really). Less risky groups won't be so eager to get vaccinated ASAP, so there will slower adoption after the initial wave of vaccinations. In a few months we ll be assessing what needs to be done to reach herd immunity levels.
tzs 6y ago
There are two challenges I haven't seen talked about a lot. 1. I expect that there will be a lot of people who think that once they get the shot, they can immediately stop wearing masks and practicing social distancing. The rollout to the general public will need to be combined with extensive efforts to make sure people know that it takes time for a vaccine to actually provide protection. In the case of this one, it is about a week after the second shot, which is three weeks after the first shot, so you should keep up all your pre-vaccination measures for a month after getting the first shot. 2. In a fair number of people, the first shot is accompanied by strong symptoms similar to a severe flu, which lasts for about a day. (I haven't read anything about whether or not this can also happen with the second shot). The people who get that strong reaction might be reluctant to get their second shot. The education efforts accompanying the rollout to the general public should make sure people know that there is a decent chance of such a reaction, but they will get over it in a day, and it will be worth it for the protection from COVID.
- bluedevil2k 6y ago
  3. Vaccinated people can still be carriers of the virus and infect others who aren't vaccinated yet. As you point out in #1, vaccinated people still need to practice social distancing and wear masks.
  - xiphias2 6y ago
    Is there a high chance for it? I’d really like to know. Moderna was testing for SARS-COV-2 protection efficiency, while Pfitzer was testing for COVID protection efficiency, but they have similar targets as far as I know. I’d love to know an experts’ answer because the difference between the two is huge, I would hate myself to kill my parents by catching SARS-COV-2 after getting vaccinated.
    - sjg007 6y ago
      The answer is that we don't know. But it is not unlikely. You can still get the flu even if you had a flu shot for example. Some of that may be due to the flu shot being the wrong strain but some of it is definitely due to infection post vaccination. The main reason that they recommend a flu shot is that you usually have a milder course of illness. Covid will probably be the same way. You could have mild symptoms or be asymptomatic despite being vaccinated and infect someone else.
mchusma 6y ago
This isn't "fast" we just have low expectations of our government. The FDA in the US is taking 3 weeks to reviews, about 5-10% of the entire time to develop this is just to schedule this (3rd to last) meeting. All while over a thousand people die per day (so during this waiting period something like 10x the lives of 9/11). We just spent 9 months trying to lift the ban on this vaccine. We have the technology to beat pandemics, we only lack the regulatory structure. Vaccines are typically so safe and effective that for high risk populations taking a completely untested vaccine would be expected to (a) be effective and (b) safer than covid. So approving this was maybe the easiest call in medical history, and from first principles could have taken 1 day to approve for high risk groups. We need a regulatory framework for fast approval anyway, if we ever want to have personalized medicine. With mRNA vaccines now in play, we can beat so many things if the regulatory environment lets us.
- simonh 6y ago
  There have been many hundreds, possibly thousands of candidate vaccines in development through the year. It's not as if this one vaccine has been sitting by itself on a shelf with regulators umming and aahing about whether to try it or not. Hundreds of labs have been working on a myriad of different approaches, the vast majority of which have been cast aside. As of September there were still over 300 in development and right now there are almost 30 in clinical trials. https://en.wikipedia.org/wiki/COVID-19_vaccine#Vaccine_candidates https://en.wikipedia.org/wiki/COVID-19_vaccine#Vaccine_candi...
- thebean11 6y ago
  Isn't this the first mRNA vaccine ever approved for use?
- Slartie 6y ago
  This is so much oversimplification that it hurts. 1) BioNTech/Pfizer haven't "just" tested for safety (I'm implying that's what you meant with your "trying to lift the ban" hyperbole), they have also used the clinical trials to single out one particular candidate out of at least four initial candidates for best expected efficacy. And they have used the trials to evaluate the best dosage. Medical trials are about much more than just the safety aspect. 2) It's easy to say "we could simply have broadly distributed this vaccine back in March" now in hindsight. However, in March, there were serious doubts about whether it would even work, considering the entire technology hadn't ever yielded a fully approved commercial vaccine. 3) I don't want to highlight this once more, but COVID-19 wouldn't be so deadly if the US hadn't fucked up its response in every possible way, and some that were thought to be impossible. A good part of those "over a thousand people dying per day" are self-inflicted and have nothing to do with any vaccine tests or vaccine approval timelines.
irthomasthomas 6y ago
Some elderly friends have asked why Britain is opting to use a brand new RNA/nanotechnololgy style vaccine (which has never been approved before) and is only ~94% effective, when there is a traditional inactivated vaccine that is 100% effective? I presume Pfizer simply have better lobying, but given the choice, I would rather go with old-fashioned sinovac https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(20)30843-4/fulltext https://www.thelancet.com/journals/laninf/article/PIIS1473-3...
- ciarannolan 6y ago
  > only ~94% effective Lol.
  - TedPetrou 6y ago
    No one was deliberately inoculated with the virus and only symptomatic people were tested. 99.96% of the placebo group did not have a severe case of covid. There is no way to determine effectiveness from this trial.
- cpncrunch 6y ago
  Typically flu vaccine is 67% effective, which is similar to the AstraZeneca COVID vaccine.
  - awssucs 6y ago
    astra zeneca is 90% effective as there are two doses needed, much like pfizers
- amanaplanacanal 6y ago
  It appears that phase 3 trials haven’t started yet in that vaccine. I would expect it to be several months before it is ready to submit.
ivoras 6y ago
Russia is also starting vaccination with their own vaccine next week: https://www.livemint.com/news/world/russian-president-vladimir-putin-plans-mass-vaccinations-against-covid-19-next-week-11606918192734.html https://www.livemint.com/news/world/russian-president-vladim...
EverydayBalloon 6y ago
Good luck my beta-tester friends across the pond.
lumberingjack 6y ago
Where I live all the hospitals are shut down with the lights off and all my neighbors that were nurses got laid off moved away who's going to administer these if there's no one in the hospital
geschema 6y ago
This is an insane experiment on humanity. First, Big Pharma tried to sell us Remdesivir, an expensive drug that does not work and is potentially dangerous. Now, they're trying to sell us a rushed vaccine that has only been tested for a short time on a few tens of thousands people, and they have made deals so they're not liable for side-effects. All of this for a virus that has something like 0.05% mortality rate.
- nscalf 6y ago
  The mortality rate is much higher than that, in the US it's 1.9% based off the individuals identified. And that does not capture the significant amount of people with severe, long standing side effects. Many people have had months of decreased lung capacity and cardiovascular problems post covid recovery. Beyond all that, these drugs are being rolled out to the most at risk group, those that have a mortality rate higher than any risk rate that was not captured by a smaller sample size of the test. Unless you're elderly or a medical worker, you won't have the option to take the vaccine until millions of other do. I'm getting pretty sick of you people whining about nonsense.
standardUser 6y ago
Serious side effects from vaccines are rare and are always visible within 6 months. If you wish to pretend otherwise, I'd love for you to state your case.
hit8run 6y ago
This is not Pfizer’s Vaccine. It’s Biontechs vaccine. Biontech is a German company. Pfizer “helps” to distribute it. Trump was not fair to not mention that it’s a German vaccine and tried to claim this success as an American-only success.
blackrock 6y ago
Is it just me, or is the western world rushing to this miracle vaccine, as a cure, without fully understanding its safety. All the while, claiming that this new mRNA technology, is the panacea to all our ailments and diseases. I feel humanity might be at an inflection point here, where we divide into the world of the Morlocks and the Eloi.
breatheoften 6y ago
Another risk factor that I doubt anyone is considering -- if the vaccine is rolled out and ends up not being effective (if vaccinated populations still die from covid at more or less same rate once the vaccinated population becomes sufficiently large) -- then this could lead to a real, long term, and very unfortunate surge in anti-vaxxers ability to persuade people not to take good vaccines that are proven to be effective ... At the end of the day, a Smallpox pandemic in 10-20 years might end up killing more people than a premature covid vaccine saves ... No idea how you could quantify this risk though -- but seems unfortunate that medical science has no way to realistically factor in this kind of third order effect into their risk modeling ...
- codeulike 6y ago
  I wouldn't worry about it. There's still plenty of positive evidence for vaccines from the last 100 years. A mistake with a covid vaccine wouldn't change that.
  - totony 6y ago
    You have to take the social context into account too. There seems to be a surge in anti-anti-vaxxer sentiment (any skepticism being met with strong resistance). If the vaccine were to fail after that much hype I believe it'd be a concern for worry. (Not that I think it's likely to "fail" in obvious way, just defending OP)
    - codeulike 6y ago
      I'm not convinced that anti-vaxxers are on the increase - they've always been there, but usually only that subset with young kids (and hence faced with childhood vaccinations) had anything to specifically complain about. Now they've all got something to complain about, all at the same time. I don't see the point of considering the 'risk' of increasing anti-vaxx sentiment. We're in a pandemic, we just need to crack on with it. The anti-vaxxers aren't going to change their minds either way.
      - 6y ago
TedPetrou 6y ago
I'm surprised so many people are excited about this. I have many concerns with the Pfizer vaccine * 99.96% of the placebo group did not have a serious case of covid * 99.25% of the placebo group did not get covid * No one in the trial was deliberately inoculated - participants just lived their lives as normal. * Only symptomatic participants were tested - this seems unbelievable to me - we have no idea what the actual incidence rate is because not everyone was tested * Vaccines might just mask symptoms - since not everyone is getting tested, vaccine makers just have to make sure there are no symptoms. No symptoms equals no test. * No trials done with two placebos - we need trials where both groups are in a placebo group. One gets a shot that gives a mild side effect and the other gives no side effect * No trials done with unrelated immune boosters - we need to see how well this vaccine performs against other immune boosters. This could be a drugs or even supplements (vitamin D & C and exercise). * Two shots were given in a trial lasting just 4 months - 4 months is an incredibly short amount of time to know whether it will be effective long term. It also gives Pfizer two chances to boost immune * Long term health consequences of vaccine - we only have 4 months of data, which is way too short of time to see any longer term consequences * There is a huge incentive to provide something that masks symptoms - billions of dollars are at stake. Big pharma is one of the very last companies I would trust with a novel vaccine * No coronavirus vaccine in history - many coronaviruses currently circulate, but no vaccine has even been produced for them. It seems quite coincidental that humans finally put the pieces together for our current novel strand
- imaginenore 6y ago
  You're listing only the negatives, while ignoring the insanely great positives. The difference between sick people in placebo vs vaccinated groups is very significant. Even if the vaccine effects are not long term, I'm willing to pay $100/year for the vaccinations. Infinitely better than humanity is stuck at home and elderly terrified.

551 points by ascorbic 6y ago

qz2 6y ago

Does anyone have any non-press infested material about this vaccine? As far as I’m aware this is the first roll out of an mRNA based vaccine. While I’m no anti vaccination idiot I’d like to understand the risks to some degree.

adrianN 6y ago
The wiki article is a good start: https://en.wikipedia.org/wiki/BNT162b2 https://en.wikipedia.org/wiki/BNT162b2
- qz2 6y ago
  Thank you. Reading this now.
gabipurcaru 6y ago
gov.uk: https://www.gov.uk/government/news/uk-authorises-pfizer-biontech-covid-19-vaccine https://www.gov.uk/government/news/uk-authorises-pfizer-bion...
vore 6y ago
With regards to mRNA, mRNA is a fragile molecule that is quickly broken down inside the body after injection, so there's unlikely to be much long term risk with mRNA itself.
- im3w1l 6y ago
  Your answer is phrased in such a way that I can't help but ask: What about the other molecules in the vaccine? Are there any notable helpers or adjuvants or preservatives?
  - kolinko 6y ago
    Not sure why you’re downvoted - it’s a legit question.
    - MagnumOpus 6y ago
      No, it's the typical gish gallop of "skeptics". Swamp others with questions you could easily answer yourself if your intent were honest inquiry rather than making something/someone look bad.
      - im3w1l 6y ago
        A skillful display of ad hominems. It's a shame to see your talent wasted on an arena as HN, when twitter would appreciate it so much more.
  - Kliment 6y ago
    This particular vaccine is literally just a bit of RNA in a blob of fat. The fat sticks to cell membranes, and the RNA pokes through. There's nothing more to it (this is also why it's possible to scale up production so quickly)
- bbarnett 6y ago
  An immediate "but if it breaks down fast, how can it do anything?" thought springs to mind. I know what you mean is "not dormant and doing something for months/years", but at the same time, if it can initiate a modification of immune response, it can do "other things". I believe we must take the utmost of care at this juncture, and make sure assurances are not construed as in a poor light.
  - kolinko 6y ago
    For me the most convincing argument regarding safety is that mRNA vaccines essentially do the same thing that the virus does, just extremely limited in scope (producing just one protein instead of a bunch of them, and not reinfecting more cells). So, even if producing the proteins turns out to be somewhat harmful long term, it cannot possibly be as harmful as the whole virus. Assuming that covid infection is inevtable without a vaccine, we really have a choice between getting a little bit of mRNA injected into our cells, and a ton of mRNA injected.
    - qz2 6y ago
      That's an interesting perspective. I've actually had the virus. I'm interested to see what the differential outcome of having the virus and having the vaccination is.
    - pfranz 6y ago
      I heard recently that there's a surprising amount of our DNA that's made up of old viruses from our ancestors. https://www.sciencedaily.com/releases/2016/03/160322100714.htm https://www.sciencedaily.com/releases/2016/03/160322100714.h...
      - acqq 6y ago
        There are the viruses which can exploit the DNA involved mechanisms, but a mRNA vaccine is not using these, it uses the processes "downstream."
- refurb 6y ago
  Holy jeeze. This is why we have the FDA. The extent to which a molecule is active in your body is only slightly correlated with toxicity. There is zero reason why a fragile molecule can't cause damage before it breaks down. This is how ended up with thalidomide. They tested it in pregnant lab rats, but the window for birth defects is incredibly short in rats. So everything checked out. In drug development you can't assume anything without data to back it up.
  - vore 6y ago
    I agree, but there's not much time we can spend to observe side effects over a long duration of time to have that level of confidence. The FDA at this point certainly doesn't have the ability to analyze that either, so the best we have is a theoretical understanding.
bawolff 6y ago
I don't know much about this subject but i found https://www.nature.com/articles/nrd.2017.243 https://www.nature.com/articles/nrd.2017.243 to be quite interesting. Its from 2018, before all the covid stuff hit, so i think it gives a much more detached overview. However it might not be precisely about the current crop of vaccines.
oezi 6y ago
Isn't there usually at least a 1:100 or 1:1000 safety buffer between vaccination and control to make a vaccine safe? At least for other vaccines that's a common threshold.
- kolinko 6y ago
  what do you mean by buffer in this context?
  - oezi 6y ago
    The relative risk between potentially getting the disease even though the population is already highly herd immunized (compare e.g. measles) and the risk of the vaccine is still 1:1000. This means despite measles already being such a rare disease it is still a clear benefit to get vaccinated. With a disease such as Covid it might be 100000x safer to get vaccinated than not. All national vaccination programs must calculate and assess such relative risk and find so much advantage in favor of vaccination.
pmoriarty 6y ago
My go-to resource for educated COVID-19 coverage has been This Week in Virology[1], which usually has between 4 and 6 virologists reporting and analyzing COVID-19-related news every week. I've kind of OD'ed on COVID-19 news myself, so haven't listened to them for a while and don't know if they've commented on this vaccine yet, but they probably will, and for a thorough, educated, hype-free analysis, there's no better place I can think of to go to than TWiV. [1] - https://www.microbe.tv/twiv/ https://www.microbe.tv/twiv/
- qz2 6y ago
  Thanks - this is perfect!
PureParadigm 6y ago
Wikipedia [1] has an overview of mRNA vaccines, including a summary of some potential side-effects/risks. For more technical details, this review of mRNA vaccines [2] appears to be a decent place to start. [1] https://en.wikipedia.org/wiki/RNA_vaccine https://en.wikipedia.org/wiki/RNA_vaccine [2] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5906799/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5906799/

_Microft 6y ago

How did they approve it that fast? Is the approval process so different and so much more efficient than the one in the EU or USA? Was it extremely rushed to make sure to get doses before they have to compete with other countries for limited supply? I'm pretty curious now. Let's hope for the best, i.e. a good vaccine, a good process and no trust problems, the latter because at least it feels rushed.

chrisvxd 6y ago
My understanding is that they've been carrying out a rolling evaluation that has been going on for the duration of the trials, which has helped accelerate the normal process. Having said that, I believe the EMA (EU) also carried out a rolling evaluation, so I'm not sure what the differences are there.
- makomk 6y ago
  The UK has put a lot of effort into speeding up the roll-out of these vaccinations in general. Enough that it basically leaked the fact some kind of Covid vaccine was coming a few weeks in advance because so many people were involved in the pre-planning and the timescale was so aggressive.
  - tinus_hn 6y ago
    You make it sound like a bad thing. It was never a secret the vaccines were coming and as each day of delay means 5000 people dying I think putting a lot of effort into speeding up the rollout is pretty well worth it.
    - joshuahughes 6y ago
      Ummm, latest daily UK deaths "with Covid" is 414, not 5000. Ref: https://coronavirus.data.gov.uk https://coronavirus.data.gov.uk
      - tinus_hn 6y ago

orobinson 6y ago

Amazing that people will be getting vaccinated against coronavirus before the year is out. Is there any evidence of whether these vaccines prevent transmission of the virus yet? Or so far do we just know that they protect the person who is vaccinated?

redisman 6y ago
I’m also interested is the mRNA vaccine different or the same vis-a-vis stopping(or not) transmission
concerned_user 6y ago
It is planned that it requires 6 weeks to acquire immunity with 2 shots (4 weeks apart) of this vaccine. Realistic outcome if enough people get vaccinated should be that spring/summer wave of covid is suppressed or at least death rate and amount of severe cases will be much lower.
pjc50 6y ago
If you're not actually infected, i.e. you're protected, you don't spread the virus. I'm not aware of a disease for which this isn't true, that vaccinated people can be carriers.
- mssundaram 6y ago
  It's a bacteria and not a virus, but it's true for whooping cough, as one example.
- _Microft 6y ago
  What I remember but cannot currently find a source for, is that there are three levels of protection that vaccines can provide. First is to protect patients from developing the sickness (but not from being infected!), second is to even prevent them from spreading it and best outcome is to prevent them getting infected at all. Only the second and third level prevent spread.
- apendleton 6y ago
  Vaccines that prevent disease symptoms but don't completely prevent infection are definitely a thing (they're said to confer "non-sterilizing immunity," vs. "sterilizing immunity" which prevents both infection and disease). The inactivated polio vaccine (the injectable one that's used in the US) is an example of such a vaccine. The oral polio vaccine, which is the main one used in the developing world, interestingly does confer sterilizing immunity, but with the tradeoff that sometimes it also causes polio. At least in the US, the explicit target endpoint for FDA approval was just prevention of disease, not prevention of infection, and the phase III trials for both the Moderna and Pfizer/BioNTech trials were only designed to assess this criterion: they only tested symptomatic people, so it's entirely possible (though not that likely given animal model observations, etc.), that infections were just as common in the treatment groups as control groups, but they just never developed symptoms and so were never tested. More research will be needed to ascertain which kind of immunity is being conferred.

jakozaur 6y ago

In terms of rollout. UK is the ideal country to be the first: 1. Heavily impacted by Covid-19. 2. Centralised health care system makes it easier to compare results and efficiency. E.g. it's UK which figured out that dexamethasone is efficient against Covid https://www.who.int/news/item/16-06-2020-who-welcomes-preliminary-results-about-dexamethasone-use-in-treating-critically-ill-covid-19-patients https://www.who.int/news/item/16-06-2020-who-welcomes-prelim... 3. Developed country with great logistics.

WanderPanda 6y ago
Happy beta testing to all Brits then!
- simonbarker87 6y ago
  My 85 year old grandparents are excited, they get to hold their great grand children again. They’d be first in line if they could be.
  - vertis 6y ago
    Aside from hospital workers they're likely to be pretty high on the list, if my understanding is correct.
    - refurb 6y ago
      The FDA already recommended (it's not binding) that front-line healthcare workers and seniors in long-term care are the first wave of 20M people (40M doses). That will take until February or so to complete.
    - newguy1234 6y ago
      Heard it was something like this: 1. Long-term care residents/staff 2. Hospital workers 3. Anyone 85+ years old.
      - 6y ago

waihtis 6y ago

Not sure why the posts asking for vaccine risks are getting downvoted. Pandemrix, the vaccine for swine flu, caused a notable amount of narcolepsy cases in recipients here in FIN (notable here meaning the amount of yearly cases spiked by 3-4x) and as with anything that's taken quick to market there has to be some risk of overlooking some tail events somewhere. It's not an anti-vaccine attitude, just healthy skepticism considering how much pressure there is to get this out and into distribution.

Arkhaine_kupo 6y ago
Healthy skepticism belong in peer-reviews, in revisions of medical journals. Skepticism in the public space fosters anti-vaccine sentiments, adds to the already growing anti-vax movements and puts in risk the vulnerable in our society as they require shielding and for the rest of us to do our part.
- ajkdhcb2 6y ago
  I find your perspective extremely disturbing, and believe it empowers anti-vaxxers more than anything else.
  - Arkhaine_kupo 6y ago
    How could it possibly empower anti vaxxers to say to trust healthcare professionals, doctors and the worlds leading security and safety experts?
    - waihtis 6y ago
      I think anti-vaxx and other fringe groups are more driven by distrust in society, and by denying discussion to be had in the first place will further build anti-societal silos. It's a difficult problem, because inevitably there will be harm initially if you allow free discussion. But over time the harm will be less in comparison to complete shutdown of any public conversation about the vaccines. If the anti-vaxxers don't want the COVID vaccine, so be it. Let them pay with their health. That'll be the best course of action for beating down the quacks who will oppose any vaccinations.

peterburkimsher 6y ago

I'm really glad that this brings hope into a dark season. People are already rewriting Christmas carols: "wipe the halls with sanitizer, falalalala lalalala 'Til we get the cure from Pfizer falalalala lalalala" https://etcanada.com/news/712874/chris-stapleton-wants-everyone-to-disinfect-the-halls-with-new-covid-christmas-album-on-kimmel/ https://etcanada.com/news/712874/chris-stapleton-wants-every...

puranjay 6y ago

Serious question: if you're a young person with no health issues, should you even get the vaccine?

hashmush 6y ago
Yes.
noir_lord 6y ago
Yes, There are two primary things to consider the Risk/Benefit to yourself and the Risk/Benefit to those around you. The answer is still yes for both cases, long term covid damage is bad at any age and so is taking out a grandparent, co-worker you like.
- refurb 6y ago
  the Risk/Benefit to those around you But there is a limited supply. At least in the short-term, if I get a dose, that means someone else doesn't get one. If someone around me is at risk, then they should get vaccinated and I should defer if my risk is low.
  - Latty 6y ago
    Generally it isn't on the individual to try to weigh something like that up. Here in the UK, at least, the Vaccine will be offered to people in order, so if you are offered it, there would be no reason to defer—others who need it more should have been offered it before you and you accepting won't deny them anything.
  - cr1895 6y ago
    This is why countries and public health departments are discussing and agreeing on who gets a vaccination first - people in care homes, front-line health workers, or perhaps even young, healthy people because they heavily drive the spread. I don't think there's a situation anywhere where it's a free-for-all. Personally, I will take the vaccine as soon as it's made available to me. Even if my risk is perhaps low (which may or may not be true), taking the vaccine reduces the chance that I would spread COVID to someone else. It's a collective effort to reduce the spread, not an individual or selfish one.

YaarPodshipnik 6y ago

I had COVID-19 early in the year, and so did my Wife (not sure about my Daughter, harder to tell with kids). I would really like to know whether I should get the vaccine or not? All the info that's out there says that immunity to C19 is temporary, so a vaccine after having gone through it doesn't seem redundant. Does anyone know if there's been any research on effects of the vaccine on the people who got C19 and recovered? I'm especially worried about possibility of a cytokine storm possibility as a reaction to vaccine.

rimliu 6y ago
From what I have seen the data says immunity is at least six months, and potentially years as with the original SARS. For me it is easier, I had it only a month ago, so I am good at least till the summer.
Reason077 6y ago
Having had Covid-19 should confer at least as much immunity as a vaccine does. It's possible that a vaccine could act as a "booster" to extend immunity, but I don't think there's any data on that. Your fears about "cytokine storm possibility as a reaction to vaccine" are unfounded. These vaccines have been tested on tens of thousands of trial participants.
- aemreunal 6y ago
  > Having had Covid-19 should confer at least as much immunity as a vaccine does. [If I'm understanding what you're saying correctly] Not necessarily. There are vaccines, such as those for HPV and Tetanus that provide better immunity than the natural immunity provided by having and surviving the illness [1]. I don't recall reading any research on the immunity provided between a vaccine and the illness on COVID-19, so I don't know whether this could be such a case. [1]: https://www.chop.edu/centers-programs/vaccine-education-center/vaccine-safety/immune-system-and-health https://www.chop.edu/centers-programs/vaccine-education-cent...
vertis 6y ago
Disclaimer: Not a doctor. I find it hard to believe they haven't covered this with their phrase 3 trials, where the intent is to ensure that there is no risk at broad scale (in addition to effectiveness), and they pause the trial if anyone dies for unknown reason (etc) -- I definitely remember the trials pausing briefly while they investigated[1], and then continuing once resolved. I also saw a study a few weeks ago where they found people with antibodies 6-8 months later[2][3]. Suggesting longer term immunity. [1]: https://www.nytimes.com/2020/10/14/health/covid-clinical-trials.html https://www.nytimes.com/2020/10/14/health/covid-clinical-tri... [2}: https://www.sciencealert.com/evidence-grows-favouring-coronavirus-immunity-lasting-6-to-8-months-after-infection https://www.sciencealert.com/evidence-grows-favouring-corona... [3]: https://www.businessinsider.com/long-term-coronavirus-immunity-months-years-2020-11 https://www.businessinsider.com/long-term-coronavirus-immuni...

modeless 6y ago

Pfizer submitted an emergency use authorization request to the US FDA on Nov. 20. Why was it not approved within a day or two? Is it merely a matter of reading the submitted paperwork and scheduling a committee meeting? There better be a damn good reason, because people are dying out here. I understand that trials take time, but we already have trial results now, so what's the hold up?

apsec112 6y ago
There's thousands and thousands of pages of trial data, and if there's a significant screw-up, it would destroy public trust in all vaccines for decades. https://en.wikipedia.org/wiki/Dengvaxia_controversy https://en.wikipedia.org/wiki/Dengvaxia_controversy
- modeless 6y ago
  It's been almost two weeks. That's more than enough time to read thousands of pages if they are literally the most important thousands of pages in the world right now.
  - apsec112 6y ago
    What makes you so confident? If someone gave you the source code to a major software project, even with a large team of highly qualified engineers working as fast as they could, how long would it take to read over the entire thing and be absolutely sure that there were no serious mistakes?
    - lacker 6y ago
      If a team from the UK had already done it, I would just go ahead and accept their analysis. The US should give emergency approval now, based on the UK approval.
      - apsec112 6y ago
        That's a reasonable position, but if I were making a list of American government pandemic mistakes, this honestly wouldn't even crack the top hundred.

shusson 6y ago

Out of curiosity, how do people on HN rate the risk of long term side-effects?

headmelted 6y ago
That's a question for someone who's heavily schooled on mRNA vaccines and/or a practitioner involved in the trials for this particular vaccine. Not that I have a problem with your asking the question, I just don't think an opinion poll on a tech board is going to yield an accurate prediction of what to expect.
- gwd 6y ago
  > I just don't think an opinion poll on a tech board is going to yield an accurate prediction of what to expect. I'm pretty sure they were hoping to be answered by someone heavily schooled in mRNA vaccines and/or a practitioner involved in the trials for this particular vaccine. On this particular "tech board", there's a reasonable chance of getting a response from those kinds of experts.
- shusson 6y ago
  > I just don't think an opinion poll on a tech board is going to yield an accurate prediction of what to expect. Part of your answer, which I'm paraphrasing to "I don't know, talk to the experts", is already a good answer. But I was hoping that there was an expert lurking around that might be able to explain the risks or link to some evidence.
  - tgb 6y ago
    You asked what "people on HN" think which is not exactly the top way to fish out experts.
    - buzzerbetrayed 6y ago
      If an expert read that, they would likely respond, citing why they are an expert. So I think it’s as good a way as any on hn.

gr2zr4 6y ago

This could be the fastes approval in the whole drugs' history considering that The assessment of a marketing authorisation application for a new medicine takes up to 210 ‘active’ days. This active evaluation time is the time spent by EMA experts to evaluate the evidence provided by the applicant in support of a marketing authorisation application. This time is interrupted by one or two ‘clock-stops’ during which the applicant prepares the answers to any questions raised by the CHMP. The maximum duration of a clock-stop depend on how long the applicant thinks it will take to respond, but must be agreed by the CHMP. The first clock-stop usually lasts 3 to 6 months and the second one 1 to 3 months. Overall, the assessment of a new medicine usually lasts around a year. https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/evaluation-medicines-step-step https://www.ema.europa.eu/en/human-regulatory/marketing-auth...

jfoster 6y ago
Do drug approvals even have much history? My impression was that the concept of drugs needing to be approved has been around for less than 100 years, but I guess it will vary from country to country.
- disgruntledphd2 6y ago
  It's been around (for clinical trials and whatnot) since the late 50's in the US I believe. I think it's been mandatory since thalidomide.
akiselev 6y ago
> This could be the fastes approval in the whole drugs' history considering that Without a doubt. The closest competitors would be imatinib (3 years) and several other chemotherapy drugs (~5 years) meant to treat malignant tumors. The vast majority of the drugs approved this quickly, with the exception of the HepC treatment, treated diseases with a life expectancy of less than the time it took to approve the drugs so long term side effects was less of a concern.
- alexchamberlain 6y ago

ijidak 6y ago

> It is a new type called an mRNA vaccine...An mRNA vaccine has never been approved for use in humans before, although people have received them in clinical trials. Wait... This doesn't scare anybody? Why has this not been approved before? Would an mRNA vaccine be approved under less pressing circumstances...?

1241rtfasfasf 6y ago
Seems like the mRNA technique is pretty new and simply hasn't been used for anything else before. The approval processes are still the same, just without the years-long idle cycles that usually slow things down. The end result will be good as any other vaccine you might get.
ac29 6y ago
> Wait... This doesn't scare anybody? Not really. mRNA starts to degrade within minutes of injection, and lasts maybe at most a few days in your body. It cant turn back into DNA, so once its gone, it can no longer have any effect on you. > Why has this not been approved before? Its a relatively new technology that took a lot of work and money to make a stable, effective vaccine with. Its also relatively expensive to manufacture. > Would an mRNA vaccine be approved under less pressing circumstances...? Yes, though these almost certainly were approved faster than other vaccines would be because of the pressing nature of things.
- PureParadigm 6y ago
  > once its gone, it can no longer have any effect on you. If this is true, then how does it provide protection against COVID19 for more than a few days?
  - alibarber 6y ago
    The mRNA itself isn't doing the protection - it's training your immune system to do that for you (in a safe way).
    - 6y ago

f6v 6y ago

I remember everyone in the West saying: "vaccine can't be rushed like that!".

fab1an 6y ago

This should really be called the BioNTech or even "Mainz" vaccine (similar to the "Oxford" one), but Germany is terrible at this kind of marketing

Cu3PO42 6y ago
In Germany it is mostly referred to as the BioNTech vaccine. I think it's more about international publications being more likely to use the name they recognize or think their audience will recognize. Most everyone is going to know Pfizer and Oxford respectively. Internationally Mainz isn't exactly a famous city, nor is AstraZeneca a well-known pharmaceutical company.
- fab1an 6y ago
  I get your point, but maybe Mainz would be more well known if we called it the Mainz vaccine? ;) Hell, we let Trump present the Mainz vaccine as if it was his personal achievement. Germany has got to do better here.
- allendoerfer 6y ago
  > Internationally Mainz isn't exactly a famous city It might not be famous but it played a key role in the development of the Renaissance, Reformation, Age of Enlightenment, and Scientific Revolution, as well as laying the material basis for the modern knowledge-based economy and the spread of learning to the masses. https://en.wikipedia.org/wiki/Johannes_Gutenberg https://en.wikipedia.org/wiki/Johannes_Gutenberg
- manquer 6y ago
  AstraZeneca is as well known as Pfizer, they are big pharma after all, the subset of people who know about Pfizer and not AstraZeneca is going to be quite small.
garmaine 6y ago
The "Oxford" vaccine was designed by Oxford University, hence the name.

CommieDetector 6y ago

It's not an vaccine it's a mRNA treatment, completely new and untested.

rebuilder 6y ago

Do we have any more data on what the wider effectiveness of these vaccines is likely to be? Duration of immunity? I've heard a minimum of 3-4 months reported, possibly longer, but do we know more now? Am I right that we don't yet know if they reduce transmission or simply prevent the disease? If the duration of immunity turns out to only be a few months, I wonder how this is going to play out. Will we periodically vaccinate 25-60% of the population, indefinitely? (I've seen varying estimates on what kind of coverage is needed to keep the pandemic in check.) Short of eradication, if immunity is not permanent, what options do we have apart from a perpetual vaccination program or just accepting an increased rate of mortality going forward?

ageitgey 6y ago
> Duration of immunity? I've heard a minimum of 3-4 months reported, possibly longer, but do we know more now? The only way to know for sure is to wait and see. But patients vaccinated for SARS in ~2004 still show immune responses now and people who received the various SARS-COV-2 trial vaccines in April of this year still show immunity. There's also studies showing many people who recovered from COVID on their own have demonstrated 9 months (and counting) of immunity. The truth is that the immune system is super complex and there isn't a single simple blood test they can do to tell if a person will resist a virus or not, so a lot of the conflicting numbers you will have seen depend on what exactly was tested and the media reporting has been pretty poor at contextualizing those study results. So there's reason to hope vaccine-derived immunity could be long lasting (say 1-10+ years), but we'll just have to see. But talk of 3-4 months of immunity seems to be media hype. > Am I right that we don't yet know if they reduce transmission or simply prevent the disease? Correct, we don't know yet. Pfizer unfortunately only tested people with symptoms for COVID in their trial, so we have no idea if it reduced asymptomatic cases or reduced transmission. Oxford did test thousands of people weekly in the UK to find asymptomatic cases and they have said they have "evidence" their vaccine reduces transmission, but they haven't published their peer-reviewed Phase 3 results yet so we don't know by how much. The scientific consensus seems to be that all the vaccines will probably reduce transmission by some amount, but by how much is unknown. But it stands to reason that the quicker someone clears the virus from their body, the less time they will be shedding infectious levels of virus. > Short of eradication, if immunity is not permanent, what options do we have apart from a perpetual vaccination program or just accepting an increased rate of mortality going forward? Luckily, this probably won't be the case. In any case, viruses tend to mutate and become less virulent over time since killing your host is a bad way to transmit yourself. So the general guess is that the virus will eventually mutate to be less lethal, similar to the how the 1918 flu virus still circulates but doesn't cause that level of mortality anymore.

cblconfederate 6y ago

The question is what will be the rate of vaccinations rather than who begins first (though, the sooner the better really). Less risky groups won't be so eager to get vaccinated ASAP, so there will slower adoption after the initial wave of vaccinations. In a few months we ll be assessing what needs to be done to reach herd immunity levels.

tzs 6y ago

There are two challenges I haven't seen talked about a lot. 1. I expect that there will be a lot of people who think that once they get the shot, they can immediately stop wearing masks and practicing social distancing. The rollout to the general public will need to be combined with extensive efforts to make sure people know that it takes time for a vaccine to actually provide protection. In the case of this one, it is about a week after the second shot, which is three weeks after the first shot, so you should keep up all your pre-vaccination measures for a month after getting the first shot. 2. In a fair number of people, the first shot is accompanied by strong symptoms similar to a severe flu, which lasts for about a day. (I haven't read anything about whether or not this can also happen with the second shot). The people who get that strong reaction might be reluctant to get their second shot. The education efforts accompanying the rollout to the general public should make sure people know that there is a decent chance of such a reaction, but they will get over it in a day, and it will be worth it for the protection from COVID.

bluedevil2k 6y ago
3. Vaccinated people can still be carriers of the virus and infect others who aren't vaccinated yet. As you point out in #1, vaccinated people still need to practice social distancing and wear masks.
- xiphias2 6y ago
  Is there a high chance for it? I’d really like to know. Moderna was testing for SARS-COV-2 protection efficiency, while Pfitzer was testing for COVID protection efficiency, but they have similar targets as far as I know. I’d love to know an experts’ answer because the difference between the two is huge, I would hate myself to kill my parents by catching SARS-COV-2 after getting vaccinated.
  - sjg007 6y ago
    The answer is that we don't know. But it is not unlikely. You can still get the flu even if you had a flu shot for example. Some of that may be due to the flu shot being the wrong strain but some of it is definitely due to infection post vaccination. The main reason that they recommend a flu shot is that you usually have a milder course of illness. Covid will probably be the same way. You could have mild symptoms or be asymptomatic despite being vaccinated and infect someone else.

mchusma 6y ago

This isn't "fast" we just have low expectations of our government. The FDA in the US is taking 3 weeks to reviews, about 5-10% of the entire time to develop this is just to schedule this (3rd to last) meeting. All while over a thousand people die per day (so during this waiting period something like 10x the lives of 9/11). We just spent 9 months trying to lift the ban on this vaccine. We have the technology to beat pandemics, we only lack the regulatory structure. Vaccines are typically so safe and effective that for high risk populations taking a completely untested vaccine would be expected to (a) be effective and (b) safer than covid. So approving this was maybe the easiest call in medical history, and from first principles could have taken 1 day to approve for high risk groups. We need a regulatory framework for fast approval anyway, if we ever want to have personalized medicine. With mRNA vaccines now in play, we can beat so many things if the regulatory environment lets us.

simonh 6y ago
There have been many hundreds, possibly thousands of candidate vaccines in development through the year. It's not as if this one vaccine has been sitting by itself on a shelf with regulators umming and aahing about whether to try it or not. Hundreds of labs have been working on a myriad of different approaches, the vast majority of which have been cast aside. As of September there were still over 300 in development and right now there are almost 30 in clinical trials. https://en.wikipedia.org/wiki/COVID-19_vaccine#Vaccine_candidates https://en.wikipedia.org/wiki/COVID-19_vaccine#Vaccine_candi...
thebean11 6y ago
Isn't this the first mRNA vaccine ever approved for use?
Slartie 6y ago
This is so much oversimplification that it hurts. 1) BioNTech/Pfizer haven't "just" tested for safety (I'm implying that's what you meant with your "trying to lift the ban" hyperbole), they have also used the clinical trials to single out one particular candidate out of at least four initial candidates for best expected efficacy. And they have used the trials to evaluate the best dosage. Medical trials are about much more than just the safety aspect. 2) It's easy to say "we could simply have broadly distributed this vaccine back in March" now in hindsight. However, in March, there were serious doubts about whether it would even work, considering the entire technology hadn't ever yielded a fully approved commercial vaccine. 3) I don't want to highlight this once more, but COVID-19 wouldn't be so deadly if the US hadn't fucked up its response in every possible way, and some that were thought to be impossible. A good part of those "over a thousand people dying per day" are self-inflicted and have nothing to do with any vaccine tests or vaccine approval timelines.

irthomasthomas 6y ago

Some elderly friends have asked why Britain is opting to use a brand new RNA/nanotechnololgy style vaccine (which has never been approved before) and is only ~94% effective, when there is a traditional inactivated vaccine that is 100% effective? I presume Pfizer simply have better lobying, but given the choice, I would rather go with old-fashioned sinovac https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(20)30843-4/fulltext https://www.thelancet.com/journals/laninf/article/PIIS1473-3...

ciarannolan 6y ago
> only ~94% effective Lol.
- TedPetrou 6y ago
  No one was deliberately inoculated with the virus and only symptomatic people were tested. 99.96% of the placebo group did not have a severe case of covid. There is no way to determine effectiveness from this trial.
cpncrunch 6y ago
Typically flu vaccine is 67% effective, which is similar to the AstraZeneca COVID vaccine.
- awssucs 6y ago
  astra zeneca is 90% effective as there are two doses needed, much like pfizers
amanaplanacanal 6y ago
It appears that phase 3 trials haven’t started yet in that vaccine. I would expect it to be several months before it is ready to submit.

ivoras 6y ago

Russia is also starting vaccination with their own vaccine next week: https://www.livemint.com/news/world/russian-president-vladimir-putin-plans-mass-vaccinations-against-covid-19-next-week-11606918192734.html https://www.livemint.com/news/world/russian-president-vladim...

EverydayBalloon 6y ago

Good luck my beta-tester friends across the pond.

lumberingjack 6y ago

Where I live all the hospitals are shut down with the lights off and all my neighbors that were nurses got laid off moved away who's going to administer these if there's no one in the hospital

geschema 6y ago

This is an insane experiment on humanity. First, Big Pharma tried to sell us Remdesivir, an expensive drug that does not work and is potentially dangerous. Now, they're trying to sell us a rushed vaccine that has only been tested for a short time on a few tens of thousands people, and they have made deals so they're not liable for side-effects. All of this for a virus that has something like 0.05% mortality rate.

nscalf 6y ago
The mortality rate is much higher than that, in the US it's 1.9% based off the individuals identified. And that does not capture the significant amount of people with severe, long standing side effects. Many people have had months of decreased lung capacity and cardiovascular problems post covid recovery. Beyond all that, these drugs are being rolled out to the most at risk group, those that have a mortality rate higher than any risk rate that was not captured by a smaller sample size of the test. Unless you're elderly or a medical worker, you won't have the option to take the vaccine until millions of other do. I'm getting pretty sick of you people whining about nonsense.

standardUser 6y ago

Serious side effects from vaccines are rare and are always visible within 6 months. If you wish to pretend otherwise, I'd love for you to state your case.

hit8run 6y ago

This is not Pfizer’s Vaccine. It’s Biontechs vaccine. Biontech is a German company. Pfizer “helps” to distribute it. Trump was not fair to not mention that it’s a German vaccine and tried to claim this success as an American-only success.

blackrock 6y ago

Is it just me, or is the western world rushing to this miracle vaccine, as a cure, without fully understanding its safety. All the while, claiming that this new mRNA technology, is the panacea to all our ailments and diseases. I feel humanity might be at an inflection point here, where we divide into the world of the Morlocks and the Eloi.

breatheoften 6y ago

Another risk factor that I doubt anyone is considering -- if the vaccine is rolled out and ends up not being effective (if vaccinated populations still die from covid at more or less same rate once the vaccinated population becomes sufficiently large) -- then this could lead to a real, long term, and very unfortunate surge in anti-vaxxers ability to persuade people not to take good vaccines that are proven to be effective ... At the end of the day, a Smallpox pandemic in 10-20 years might end up killing more people than a premature covid vaccine saves ... No idea how you could quantify this risk though -- but seems unfortunate that medical science has no way to realistically factor in this kind of third order effect into their risk modeling ...

codeulike 6y ago
I wouldn't worry about it. There's still plenty of positive evidence for vaccines from the last 100 years. A mistake with a covid vaccine wouldn't change that.
- totony 6y ago
  You have to take the social context into account too. There seems to be a surge in anti-anti-vaxxer sentiment (any skepticism being met with strong resistance). If the vaccine were to fail after that much hype I believe it'd be a concern for worry. (Not that I think it's likely to "fail" in obvious way, just defending OP)
  - codeulike 6y ago
    I'm not convinced that anti-vaxxers are on the increase - they've always been there, but usually only that subset with young kids (and hence faced with childhood vaccinations) had anything to specifically complain about. Now they've all got something to complain about, all at the same time. I don't see the point of considering the 'risk' of increasing anti-vaxx sentiment. We're in a pandemic, we just need to crack on with it. The anti-vaxxers aren't going to change their minds either way.
    - 6y ago

TedPetrou 6y ago

I'm surprised so many people are excited about this. I have many concerns with the Pfizer vaccine * 99.96% of the placebo group did not have a serious case of covid * 99.25% of the placebo group did not get covid * No one in the trial was deliberately inoculated - participants just lived their lives as normal. * Only symptomatic participants were tested - this seems unbelievable to me - we have no idea what the actual incidence rate is because not everyone was tested * Vaccines might just mask symptoms - since not everyone is getting tested, vaccine makers just have to make sure there are no symptoms. No symptoms equals no test. * No trials done with two placebos - we need trials where both groups are in a placebo group. One gets a shot that gives a mild side effect and the other gives no side effect * No trials done with unrelated immune boosters - we need to see how well this vaccine performs against other immune boosters. This could be a drugs or even supplements (vitamin D & C and exercise). * Two shots were given in a trial lasting just 4 months - 4 months is an incredibly short amount of time to know whether it will be effective long term. It also gives Pfizer two chances to boost immune * Long term health consequences of vaccine - we only have 4 months of data, which is way too short of time to see any longer term consequences * There is a huge incentive to provide something that masks symptoms - billions of dollars are at stake. Big pharma is one of the very last companies I would trust with a novel vaccine * No coronavirus vaccine in history - many coronaviruses currently circulate, but no vaccine has even been produced for them. It seems quite coincidental that humans finally put the pieces together for our current novel strand

imaginenore 6y ago
You're listing only the negatives, while ignoring the insanely great positives. The difference between sick people in placebo vs vaccinated groups is very significant. Even if the vaccine effects are not long term, I'm willing to pay $100/year for the vaccinations. Infinitely better than humanity is stuck at home and elderly terrified.