26 ms·

No one who got Moderna's vaccine in trial developed severe Covid-19

450 points by jakozaur 6y ago

inglor_cz 6y ago
RNA vaccines have a huge potential in treating cancer as well. Basically, you can whip up a personalized vaccine which wakes the immune system up to the fact that it has a growing tumor on its hands. So far, the success rate is very far from 100 per cent, but the therapy sometimes works even in patients with severe late stage metastatized cancer and, in all likelihood, we will learn how to use it better in coming years. This progress could save way more lives down the line than just those at risk with Covid. https://www.nature.com/articles/d41586-019-03072-8 https://www.nature.com/articles/d41586-019-03072-8
- hprotagonist 6y ago
  if mRNA works in anything close to a general case, i’m beginning to think that it might be as fundamentally transformative as the move from sulfa drugs to antibiotics was.
  - SomeoneFromCA 6y ago
    I do not know if you aware or not, but there is a similar to mRNA vaccines, yet different (actually, almost mirror reflection of what mRNA vaccine is) invention called antisense drugs. Those are actually already used as antivirals.
    - wxnx 6y ago
      Antisense drugs are the same biological material, but have a very different mechanism of effect. Specifically, mRNA vaccines require an immune response to be effective. The mRNA (vaccine) encodes a viral protein, and the host (human) immune system still has to learn to respond to that protein. Antisense drugs are much simpler, with no immune response required. The mRNA (the drug) itself simply binds to the target mRNA.
      - SomeoneFromCA 6y ago
        I know all that. Besides, one pedantic point - antisense are not the same to typical mRNA, they have thiophosphate group instead of normal phosphate in their backbone, or some other tweak to make them bind mRNA permanently.
        papa_bear 6y ago
        Some of us don't know, so the extra detail is appreciated :) Interesting re: the thiophosphate group. It sounds like it just floods your body with some mRNAs complementary to the viral mRNA that blocks it from getting turned into proteins by your cells' ribosomes?
        SomeoneFromCA 6y ago
        Yes, pretty much; almost like NOPing out code in binary patches. However double check about the thiophosphates. I might be wrong. It is either Morpholinos are blockers and thios are promoting destruction of the mRNA or the opposite.
      - philsnow 6y ago
        > Antisense drugs are much simpler, with no immune response required. The mRNA (the drug) itself simply binds to the target mRNA. Does that make them a class of "cures" rather than "immunizations"? If I get infected with the same thing a year later, will I need another dose of the antisense drug?
        SomeoneFromCA 6y ago
        Yes, they are "cures". Yes, you will.
        abiogenesis 6y ago
        Is it correct to say that an mRNA based vaccine wouldn't work for that virus anyway if you can get infected with the same thing a year later?
- Antimateri4 6y ago
  Yes i read some interesting article aswell regarding mRNA vaccines, but from my understanting mRNA vaccine aren't yet tested in humans right? Only animals or am i mistaken? EDIT: what my question is: is there another mRNA type vaccine out there fully developed (i'm not suggesting that they are bad!)? EDIT2: Guys, i will never ask question again in here. Begin downvoted for a genuine question.
  - inglor_cz 6y ago
    They have already been tested on cancer patients, with some very promising results. https://acir.org/weekly-digests/2020/august/rna-vaccine-for-melanoma-shows-promise-in-early-clinical-trial https://acir.org/weekly-digests/2020/august/rna-vaccine-for-... https://www.sciencedaily.com/releases/2020/11/201110102550.htm https://www.sciencedaily.com/releases/2020/11/201110102550.h... Some of the patients would probably already be dead if it wasn't for RNA vaccines.
    - Antimateri4 6y ago
      Yes, mRNA is pretty good and very promising (Moderna and BioNTech are mRNA based and they seems the most developed as for now)! My question was not asking if they are safe or not good (they have multiple points that make them probably the next big thing in vaccines and cancer treatments), i was asking if there are already mRNA vaccine type 100% developed and used as today.
  - corin_ 6y ago
    These Covid ones aren't the first that have been tested and shown safe in humans, but I believe they will be the first to be approved for release.
    - Antimateri4 6y ago
      BioNTech one is also a 95% succesfull and mRNA based.
  - NicoJuicy 6y ago
    You're probably being downvoted because this information is easily looked up. https://en.m.wikipedia.org/wiki/RNA_vaccine https://en.m.wikipedia.org/wiki/RNA_vaccine
- delfinom 6y ago
  Sadly from the manufacturing process description alone, we are going to be decades away from when it's actually ...not a few million dollars per individual to treat.
  - faitswulff 6y ago
    An individually tailored cancer treatment is already available in the form of the CAR-T therapies, which might give an indication of how expensive it’ll be - you were pretty much right on the dot, since each treatment in a course of treatments is estimated at $375,000.
    - iguy 6y ago
      What is this money spent on? Is it a real cost per dose, or just a made-up number for something made in a research lab? Maybe another way to ask is: On the scale from 400k of white-shoe lawyer-hours, to 400k of custom 7nm silicon-etching, where should I mentally place this? The former isn't going to budge, the latter will cost pennies in a generation's time.
      - seibelj 6y ago
        What they charge might be made up, but the costs of developing these drugs are astronomical. My wife is a cancer research scientist in immunotherapies and she can burn through tens of thousands of dollars in materials running a single experiment. And if she makes a mistake - the money is wasted!
        iguy 6y ago
        For sure, I don't mean to suggest it's cheap research. But whether you charge a lot or nothing for the first few doses out of the lab, it seems like this won't really make a dent in the research cost. (I don't know if this $375,000 number is in that category, or not.)
        xorfish 6y ago
        If the cost for every individual treatment is low, then the cost per treatment gets lower with more patients that can benefit from it.
- fullstackchris 6y ago
  Honest question here, is the mechanism in those mRNA treatments totally different? I can't imagine there is a 'spike protein' you can focus on with cancer - but perhaps I am totally wrong.
deleted 6y ago
[deleted]
philshem 6y ago
>>> Anti-vaxxers immediately jump on any report of possible adverse events in a vaccine trial (which are thoroughly investigated, of course). >>> Let’s spare a thought today for the person who signed up for the Moderna vaccine trial, received two placebo shots and died of covid19. https://twitter.com/kakape/status/1333401133260419072 https://twitter.com/kakape/status/1333401133260419072 --- edit: Please explain the downvotes. The vaccine volunteer would be alive if he was randomly assigned the actual vaccine, and not two doses of placebo. The tweet is from a respected journalist at Science Magazine.
- function_seven 6y ago
  I think the downvotes are from people assuming you're denouncing the placebo portion of a randomized clinical trial? Maybe indicate otherwise? (Or explicitly state it if I'm wrong). All of those that died during clinical trials deserve respect for signing up and helping us advance the medicine. Their death is a statistic, but not in the Stalin quote sense! It's a statistic that helped us find the treatment that will save millions.
  - philshem 6y ago
    not sure what you mean "denouncing the placebo portion of a randomized clinical trial" but I'm going to move on with my life and accept my -4 reputation :)
    - function_seven 6y ago
      I meant that your original comment could have been read to imply that this placebo-recipient died a needless death. (e.g. "They should have just given him the vaccine!") I didn't read it that way, but I could see how others would.
      - philshem 6y ago
        ah ok, I get it now. thanks.
- 6y ago
ck2 6y ago
Yeah but imagine being dumb enough to get infected and very sick over the next month before you can get both shots next year. Because there are going to be thousands, maybe millions who do that in the USA alone for no good reason.
- SomeoneFromCA 6y ago
  They are failing the Marshmallow test.
  - smt88 6y ago
    You are accidentally correct. You seem to think the Marshmallow Test is a test of willpower. That interpretation is debunked. It is actually a test of poverty. https://www.smithsonianmag.com/smart-news/new-research-marshmallow-test-suggests-delayed-gratification-doesnt-equal-success-180969234/ https://www.smithsonianmag.com/smart-news/new-research-marsh...
    - jokethrowaway 6y ago
      That's a very interesting take! I'm not sure how much to read into it, there are so many variables to consider I doubt this study qualifies as science (like most of social science). Incidentally, I failed the marshmallow test and I tend to behave and think with a scarcity mindset (I can't tolerate wasting food, it's hard for me to spend money). My parents are quite well off and went to uni. Their parents started middle class and made some money. I bet my parents wouldn't have failed the test - and they definitely always stocked the house with food and could provide resources and a stable environment. My grandparents had a harder life (thanks to the wars, most likely) and share the same mindset I had (even though I never spent much time with them, we lived far away). I wonder how much of that it's actually genetic, more than environmental. You could still find correlations compatible with the study, if it were. Passing down the "poor" genes would create genealogical lines of poor families.
    - SomeoneFromCA 6y ago
      No I meant actually what I meant. Did you actually read the paper itself, which was supposed to be debunking the experiment? You probably should: https://journals.sagepub.com/doi/abs/10.1177/0956797618761661 https://journals.sagepub.com/doi/abs/10.1177/095679761876166... It does not debunk anything, the effect does not vanish, it just diminshes to 1/3 of what was originally calimed. Which means, that within a single socieconomical group, the effect will still be quite noticeable.
CodeWriter23 6y ago
Wonder what the trial exclusion criteria was...it’s not referenced in this article.
- renewiltord 6y ago
  Why wonder? Just use the primary source. Here's the Phase 1 https://clinicaltrials.gov/ct2/show/NCT04283461?term=NCT04283461&draw=2&rank=1 https://clinicaltrials.gov/ct2/show/NCT04283461?term=NCT0428... Phase 2a and Phase 3 similarly listed.
- mrjaeger 6y ago
  Can read all of them in their published protocol at https://www.modernatx.com/sites/default/files/mRNA-1273-P301-Protocol.pdf https://www.modernatx.com/sites/default/files/mRNA-1273-P301... under section 5.2.
  - tpmx 6y ago
    Relevant criteria for the question "does it it exclude old, fragile people with various common pre-existing conditions?" (not exhaustive, but indicative): Included: Pre-existing conditions are okay as long as they are in a stable condition (defined as no significant change in therapy etc for the 3 months before enrollment). Excluded: Immunosuppressive or immunodeficient state, asplenia, recurrent severe infections (HIV-positive participants with CD4 count ≥350 cells/mm 3 and an undetectable HIV viral load within the past year [low level variations from 50-500 viral copies which do not lead to changes in antiretroviral therapy [ART] are permitted]). Looks fair enough to an amateur like myself. Edit: Not sure how common a immunosuppressive or immunodeficient state is in a typical population. Perhaps it's common enough to be relevant?
    - disgruntledphd2 6y ago
      I think (from my parents and in-laws) that immunosuppression is normally associated with current cancer treatment. So, for example, it looks like this protocol would exclude people getting chemotherapy. Happy to be proven wrong on this by someone with more information.
mchusma 6y ago
FDA says Dec 17 meeting to discuss. This contradicts some earlier opinions that the reason the FDA was taking so long to review Pfizer (Dec 10 scheduled date) was that they were planning to review 2-3 candidates together. For context, scheduling the meeting to review the candidates is running at 5-10% of the development time for these vaccines. 20M vaccines represent about 1/3 the elderly population in the US, there are about 1,300 deaths a day right now, and most deaths are in the high risk category. So you can estimate the cost of the delay to be quite high (depending on your assumptions, but hard not to estimate the cost to be >1000 lives). I'm unsure of any vaccine side effect or release that could be considered worse. Pendemrix caused 1 in 18,000 narcolepsy, which for the 20M at risk who could get the vaccine seems like a good trade-off (if this was as bad as that). Moderna entered phase 1 trials in March. Vaccines entering phase 1 trials have a 33% success rate overall, 85% successful for efficacy. So this is not a case of hindsight bias, this was always reasonably likely to work. And these numbers include issues like enrollment issues, or the diesease dying out (ebola). So lets make some assumptions to see what it would look like to "just approve things for the high risk in a pandemic": For example, let's say that a vaccine maker instead of pushing something 85% likely to be efective pushed through pushed through something 40% likely to work. And for safety, let's just assume it's going to be 2x worse than the worst vaccine ever, so maybe 1 in 10,000 get narcolepsy. But they still push it through. This implies taking the untested vaccine has a 40% chance of protecting you and 0.1% chance of serious side effect. For the elderly, who at the beginning of the pandemic has a conservative IFR of >10% and let's assume a 10% chance of getting it. Not taking the vaccine has something like a 1% chance of death. For the elderly, taking the untested vaccine would in this example would reduce your chance of death by 0.6% but increase the chance of serious disease by 0.1%. For most people, this should be an obvious decision to vaccinate, even using the most pessimistic adaptions possible. It almost sounds like a conspiracy theory, but in the real world Moderna had a working vaccine in March, and it was always statistically likely to work with low relative downside (for some population), and it has been banned the entire time until now. The next pandemic could be completely prevented if we focus our efforts on how to approve vaccine candidates in days not months. Note: I think the bar for requiring a vaccination can/should definitely be higher than the bar to lift a total ban on a vaccine.
- ghaff 6y ago
IronRanger 6y ago
What was the age profile of the trial? If you fill it with healthy people under 50 during Summer you would expect the same results with a placebo, given the profile of the virus.
- mumblemumble 6y ago
  That would be a likely outcome even under the null hypothesis in a phase II trial, but, for a 30,000 person efficacy trial, I wouldn't be so quick to offhandedly dismiss the assertion that that's a significant result.
- ulfw 6y ago
  They would never be that dumb to do that. In fact "The Phase 3 COVE study was designed in collaboration with the FDA and NIH to evaluate Americans at the highest risk of severe COVID-19 disease. As of today, the COVE study includes more than 7,000 Americans over the age of 65" https://investors.modernatx.com/news-releases/news-release-details/moderna-completes-enrollment-phase-3-cove-study-mrna-vaccine https://investors.modernatx.com/news-releases/news-release-d...
- renewiltord 6y ago
  Here's a starting point for your search https://investors.modernatx.com/static-files/34f97bb2-d89a-45e4-a770-cae0591fa807 https://investors.modernatx.com/static-files/34f97bb2-d89a-4... I've found the answer starting from there. Good luck.
- lultimouomo 6y ago
  Second paragraph in the article, it says there were 30 severe COVID cases in the placebo group; unless there trial was ridiculously botched the age profiles of the intervention and trial branch are going to be identical. With the reasonable caveat that definitive answer can only be given once we have read the full trial report.
- zetazzed 6y ago
  Is anyone else on HN depressed by the number of people who seem to think - "AHA, based on not reading anything, I believe there is a meaningful chance that the whole medical and regulatory community just missed this extremely obvious possible flaw that just popped in my head?" Do people really think that the most-publicized clinical trials of our times were conducted by over-reaching noobs?
amurale 6y ago
> No one developed severe Covid-19 > No one developed severe adverse effects (yet) There is a reason vaccine trials normally take several years. I'll wait until we're a few years into phase IV trials, thankyouverymuch.
- lultimouomo 6y ago
  Honest question: would you wait if there was a pact to the effect that either everyone takes the vaccine, or no one does? Because obviously not getting vaccinated when everybody else does is almost always the best choice game-theoretically speaking; it doesn't really say anything on the vaccine (it may say more on the civic sense of the individual).
  - amurale 6y ago
    Let's see... it's a calculus of death vs potential long term adverse effect: P(death) < 0.05% for the vast majority of the population (Age < 65) vs P(unknown) long term harm in life quality, my wild estimate: P(0.1%). It's within the same order of magnitude. I'd take the vaccine in a heartbeat, long term effects and all, if P(death) was 10% or higher.
    - toast0 6y ago
      If you get covid, there's a P(unknown) of long term harm as well. It's an unknown vs an unknown. Novel virus, novel immunization (first mRNA or maybe first widespread modified adenovirus)
      - amurale 6y ago
        You're correct about long term harm, I lumped them together. A better formula would be: P(covid death or long term harm) < 0.05% vs. P(vaccine long term harm) = ? since my estimate is they're about the same order of magnitude, I prefer to take the devil-I-know vs. the small-scale-tested vaccine. I model the potential harm based on a similarly rushed vaccine of 1976 which caused a large increase in cases of Guillain-Barré Syndrome [0]. Longer trials and phase IV monitoring was instituted in response to this rushed vaccine. [0] https://en.wikipedia.org/wiki/1976_swine_flu_outbreak https://en.wikipedia.org/wiki/1976_swine_flu_outbreak
afrojack123 6y ago
They used the vaccine on 5 people and gave 40 people the placebo.
blhack 6y ago
Does anybody have a good link for a layman's overview of how mRNA vaccines work? Lot's of nervousness from people around this, and would love to be able to help quell some of that.
- ed25519FUUU 6y ago
  Edit: I do plan to get the vaccine, but as a software engineer I know beta versions usually have the most “bugs” — and I have the health privilege to be in the back of the line so I will!
  - mchristen 6y ago
    Citation?
  - nobleach 6y ago
    A sunburn can change/damage your DNA.
    - throwaway894345 6y ago
      And people take precautions to avoid it because skin cancer can result. Not sure that's the best counter example.
      - nobleach 6y ago
        I'm not trying to argue that it's a "good" thing, simply that tons of things hack our DNA (there are even some studies that emotional trauma can have repercussions imprinted on our DNA) My major point is that DNA hacking/damage isn't always a life-ender. Even skin cancer is often removed without issue.
  - itodd 6y ago
    It can't fundamentally change your own DNA. The mRNA codes for a stabilized version of the sars-cov2 spike protein. Your cells then use the mRNA to build that protein. Your immune system will then build up a response. It is a terrible idea to wait for a version 2 of this vaccine. Get vaccinated or this will not go away.
newdude116 6y ago
Thats good but I would not be overly optimistic. Two question since I dont know much about mRNA vaccines 1. The mRNA has to express the target Protein for the Anitbodies. If injected, how does this happen? It has to go somehow into the cell to be translated? Or is the delivery vehicle the magic sauce? 2. What makes mRNA vaccines so special? What is the difference of injecting the expressed protein sequence directly?
- IgorPartola 6y ago
  I have no knowledge of this but if injecting spike proteins worked wouldn’t we just always do that? Seems like way easier than the rest of the delivery mechanism.
  - newdude116 6y ago
    Yes, but it is still a legit question.
  - roywiggins 6y ago
    The AstraZeneca vaccine puts the spike protein onto a chimp cold virus. My understanding is that the hard part is to make the body understand that it needs to produce an immune response. Just injecting spike protein doesn't work, because it isn't recognized as a threat. The AstraZeneca one uses an attenuated virus that the body is going to respond to anyway. I believe the mRNA vaccines work by getting cells to express the spike protein themselves. You can't smuggle the protein into cells just by injecting it, but mRNA will get in there and do its thing.
  - inglor_cz 6y ago
    Whenever you inject foreign biological material, you have to avoid two scenarios: a) the scenario when the foreign material is immediately degraded by enzymes or other mechanism, before actually accomplishing anything, b) the scenario when the foreign material causes massive immune reaction in form of inflammation, potentially killing the host. AFAIK navigating between those two extremes took decades during development of RNA vaccines. But now it seems that we can avoid both.
- 6y ago
whb07 6y ago
Hurray for a vaccine that is > 90% effective on a disease that for those who get it have a > 99% survival rate. Bring on the new overlords.
- nkjoep 6y ago
  I guess survival rate means a different thing from side effects. I would be still cautious with that statement and not underestimate it.
  - macintux 6y ago
    Not to mention the side effect of the collapse of our healthcare system.
    - whb07 6y ago
      I agree, by having a shutdown and mandatory at-home confinements and fear mongering, you have people not attending hospitals and the like for routine and checkups for more serious diseases.
  - whb07 6y ago
    Side effects of shutdowns include: * depression * suicide * poverty -> famine and disease * missed education * dependency on gov * freedoms given up and transferred to gov I also agree that there are other side effects, just like every disease.
    - marvin 6y ago
      Soooooo... If you were somewhat pragmatic, you'd acknowledge that a lot of people, maybe even a majority, actually support various social distancing measures and shutdowns. These measures certainly have a negative economic impact, irrespective of whether a negative economic impact would happen just due to the voluntary measures of these people. And regardless, wouldn't it be a net gain to deploy a vaccine? It would certainly be more effective at placating this group of people than implying they're all idiots. It would be a huge benefit towards resuming a relatively normal society, regardless of whether they're right or whether they're somehow all just a bunch of nervous morons. So why would you criticise it?
officialjunk 6y ago
note there is not a claim this vaccine prevents infection, only lessens symptoms, meaning you are still contagious. "We all expect an effective vaccine to prevent serious illness if infected. Three of the vaccine protocols—Moderna, Pfizer, and AstraZeneca—do not require that their vaccine prevent serious disease only that they prevent moderate symptoms which may be as mild as cough, or headache." "Prevention of infection is not a criterion for success for any of these vaccines. In fact, their endpoints all require confirmed infections and all those they will include in the analysis for success, the only difference being the severity of symptoms between the vaccinated and unvaccinated." https://www.forbes.com/sites/williamhaseltine/2020/09/23/covid-19-vaccine-protocols-reveal-that-trials-are-designed-to-succeed/ https://www.forbes.com/sites/williamhaseltine/2020/09/23/cov...
- refurb 6y ago
  Right, but are there any vaccines out there that protect against disease but don’t prevent transmission? I thought that’s what herd immunity was all about.
  - harambae 6y ago
    You're asking if there are vaccines that do not lead to sterilizing immunity? Yes. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7296151/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7296151/
    - refurb 6y ago
      As per the article, the flu vaccine looked at didn’t provide sterilizing immunity, but did significantly lower viral titre in the lungs. So I guess the question is - even if not sterilizing immunity, would these vaccines significantly reduce (but not eliminate) transmission?
  - deleted 6y ago
    [deleted]
- jaywalk 6y ago
  With this being the case, how does it even make sense for companies like Ticketmaster and Quantas to announce that they'll require their customers to be vaccinated? Yeah, 90-95% of your customers won't have symptoms if they get infected. But they'll still have the ability to pass on that infection to someone who wasn't vaccinated, or falls into the 5-10% of people who the vaccine isn't effective for. Obviously the vaccines have benefits, especially for high risk populations. But I see very little benefit to these corporations requiring their customers to have it, since their customers can still be infected and spread the virus.
CyberRabbi 6y ago
Why is AstraZeneca asking for exemption from liability claims stemming from their COVID-19 vaccine? https://uk.reuters.com/article/us-astrazeneca-results-vaccine-liability/astrazeneca-to-be-exempt-from-coronavirus-vaccine-liability-claims-in-most-countries-idUKKCN24V2EN https://uk.reuters.com/article/us-astrazeneca-results-vaccin...
- jimbob45 6y ago
  > “This is a unique situation where we as a company simply cannot take the risk if in ... four years the vaccine is showing side effects,” Ruud Dobber, a member of Astra’s senior executive team, told Reuters. Seems pretty straightforward to me. It’s an unproven method of vaccine creation and hasn’t been tested by anyone. I really can’t imagine this holding up in courts though.
  - deleted 6y ago
    [deleted]
  - lisper 6y ago
    > I really can’t imagine this holding up in courts though. Why not? Liability waivers are common in other industries.
    - jimbob45 6y ago
      The law is upheld by the people. If you damage the health of nearly an entire national via vaccine, no one will care to stay true to the letter of the law when it comes time for your retribution. Same thing with the Nazis. Nuremberg was a kangaroo court but people stop caring about due process when you ruin the lives of everyone in their country.
      - mam2 6y ago
        In that case the negociation is with europe so they are untouchable basically
  - 6y ago
hedora 6y ago
The null hypothesis (people with symptomatic covid are as likely to get severe symptoms, regardless of whether they received the vaccine) predicts this many cases with severe symptoms: 30 / 185 * 11 = 1.7 1.7 ~= 0, so the sample size is too small to support the headline.
- laurentoget 6y ago
  Headline is "no one in the trial developed severe symptom" - i am not sure how your computation proves this wrong.
  - jwilk 6y ago
    OK, but what about the "absolutely remarkable" part?
- Majromax 6y ago
  If you take a Beta(1,1) distribution as your prior, then the control group's risk-of-severe-covid-given-symptoms posterior is Beta(31,156), and the experimental group's conditional risk posterior is Beta(1,12). Drawing 100,000 samples from these distributions (`betarnd` function in matlab) gives an 87.8% sampled likelihood that the intervention reduces the conditional risk (intervention(i) < control(i)), and a 64% sampled likelihood that it reduces the risk by at least half (intervention(i) < control(i) / 2). This is suggestive (but not yet "clearly convincing") evidence that the vaccine reduces the risk of severe covid conditional on being infected in the first place, and that comes on top of the obviously compelling evidence that the vaccine reduces the baseline risk of infection. This conclusion makes intuitive sense since the vaccine is intended to produce an immune response. A patient who has a moderate response to the vaccine itself may not neutralize the infection before developing symptoms but would still have a primed immune system to control the disease before it becomes severe. (That is: the response to the vaccine intuitively falls on a range, rather than being "all or nothing").
  - hedora 6y ago
    “Absolutely remarkable” was removed from the HN headline since I posted this. Thanks for running through the math; I’m guessing we came to the same conclusion about the strength of the evidence.
thisistheend123 6y ago
There a lot of comments that are being downvoted just for questioning different aspects of such a vaccine and other related issues. That's not what I have come to expect from a crowd of curious people carrying a scientific temper. C'mon HN. Let's answer the questions without downvoting someone to oblivion.
- tantalor 6y ago
  "people are allowed to be wrong and/or ignorant because that’s what most of us are on most topics" https://www.newyorker.com/news/letter-from-silicon-valley/the-lonely-work-of-moderating-hacker-news https://www.newyorker.com/news/letter-from-silicon-valley/th...
- ARandomerDude 6y ago
  You're only allowed to have certain ideas about certain topics. Step outside those bounds and the thought police will attack you.
spullara 6y ago
The vaccine was developed in 48 hours (Feb 24th) following China sharing the DNA sequence. How many could we have saved?
- shawnz 6y ago
  How many could have been killed if we rushed and it turned out to have serious side effects?
  - _underfl0w_ 6y ago
    That's still a possibility, though "rushing" can be somewhat subjective. By strictly adhering to the scientific method/process, we can hope to eliminate uncertainty in this regard. Unfortunately... as the parent points out, that requires cooperation between geographically dispersed parties (some of whom may have priorities emphasizing social norms such as "saving face")
- tantalor 6y ago
  There is plenty of reason to question the safety of mRNA vaccines because none have ever been approved for use in humans. https://en.wikipedia.org/wiki/RNA_vaccine https://en.wikipedia.org/wiki/RNA_vaccine
- fasteddie31003 6y ago
  The FDA needs to make a fast-track vaccine approval process for mRNA vaccines where the pathway to deliver the mRNA has been pre-approved and the only change is in the mRNA payload. However, I don't have much faith in the FDA.
- Antrikshy 6y ago
  It seems obvious in hindsight, but such trials do have an important role in this process. Not to mention mRNA vaccines are new and it could possibly just have made things worse.
- noja 6y ago
  How many could have been saved from injecting an untested vaccine on billions of people? What a weird question.
briefcomment 6y ago
But basically no one gets severe Covid-19. I don't know anyone who has even tested positive.
- _underfl0w_ 6y ago
  Equivalent to: "I've personally never seen it, therefore it does not exist, despite documented proof to the contrary."
- the_af 6y ago
  I personally know people who were hospitalized due to severe COVID19. I personally know more than a couple of people who tested positive, with mild symptoms (a fever). My parents personally know people who died of it.
tim333 6y ago
Same with the Oxford / AstraZeneca vaccine "No hospitalizations or severe cases of COVID-19 were reported in those receiving the vaccine." https://apnews.com/article/astrazeneca-vaccine-third-cheaper-oxford-c99d26eb2946f6fde45a1edc002ff028 https://apnews.com/article/astrazeneca-vaccine-third-cheaper... They all seem quite promising.
- theferalrobot 6y ago
  Like all things with the oxford vaccine - that is only if you look at one slice of the data (in which there were no elderly)... why they didn’t include elderly is beyond me but of course there aren’t going to be severe cases in vaccinated patients 18-55 https://blogs.sciencemag.org/pipeline/archives/2020/11/23/oxford-az-vaccine-efficacy-data https://blogs.sciencemag.org/pipeline/archives/2020/11/23/ox...
  - tim333 6y ago
    I think the no serious cases includes the over 55s. The BMJ are clearer in their wording >The analysis included 131 covid-19 cases and showed the vaccine was 62% effective when given as two standard doses (8895 participants) one month apart, but 90% effective when a half dose followed by a standard dose regime (2741) was used. No hospitalised or severe cases were found in anyone who received the vaccine. https://www.bmj.com/content/371/bmj.m4564 https://www.bmj.com/content/371/bmj.m4564 I think the 62% effectiveness which on the surface doesn't look that good, included basically asymptomatic people who PCR tested positive. I'm not sure the other testing included asymptomatics so the difference between the vaccines may not be as large as it looks.
  - sobani 6y ago
    Why is it so obvious that there wouldn't be any severe cases in vaccinated patients 18-55, when there have been severe cases in infected people 18-55 (outside this trial, I don't know enough about this trial to make a comment about that)?
  - jrochkind1 6y ago
    Were there no severe cases in the control group either? From my limited understanding of how these things are done, I assumed there must have been severe cases in the control group (which would have the same exclusions), and enough of them for some statistical test to show meaningful difference between the groups, for them to be trumpeting no severe cases in experimental group. No? If not, that would indeed to my non-statistician eye seem kind of sketchy. But if yes, thats how it works right?
kevincox 6y ago
It is presumably good that we will have a variety of vaccines. This way if one of them has unnoticed harmful long-term effects it will only affect a subset of the population. Is there some sort of system like this for flu shots? Or are we injecting a large portion of the population with the exact same stuff?
aaron695 6y ago
As an example of un-intended side effects the vaccine trial I'm on sets off HIV tests. This obviously means HIV will increase. Plus other things to consider. Like conspiracies. And the fact the cheap HIV test I ordered from China can tell me if I'm on the placebo or not. With deaths from lockdown blowing up, HIV will explode anyway after shutting do the world economy for so long. But don't think it'll be smooth sailing politically and with today's media it's a nightmare.
ping_pong 6y ago
How do they know that participants were exposed to Covid-19? Just simply through statistics?
- alisonkisk 6y ago
  They don't fullly know. They rely on statistics. I hope they at least ask subjects about exposure.
  - nradov 6y ago
    Subject reports of exposure are notoriously unreliable. People forget. And even when anonymity is guaranteed they lie about shameful behavior.
  - justinc8687 6y ago
    I'm in the AZD1222 (AstraZeneca) trial, and for the next two years, I need to fill out an online symptom questionnaire every single week. They also draw blood at the 6-month and 1-year mark, so presumably could test for antibodies.
- stephenroller 6y ago
  They don't. But half the people got a placebo and half got the vaccine. 185 in the placebo group got covid, with 30 having severe covid, but 11 with covid and 0 severe in the vaccine group got it. So do you really think that totally by chance, one random group of 15,000 people got a ton of exposure, and another group of 15,000 had little-to-no exposure? The probability of that is quite low.
  - mlindner 6y ago
    Just to clarify, 185 got symptomatic covid. The 185 doesn't include the unknown number of asymptomatic people.
    - shakhahxhcj 6y ago
      I am curious why they didn’t test everyone. Is it just a cost/test capacity thing? Wouldn’t testing to catch asymptomatic cases increase statistical power to allow the study to yield results sooner with smaller error bars? Also, isn’t preventing asymptomatic cases an important function of the vaccine (to get to herd immunity)?
JasonFruit 6y ago
I was reading about Moderna today, and I found a number of articles from 2017-18 expressing concern about their secretiveness and impatience with both safety precautions and the failures that are inevitable in drug trials, based on the experiences of former employees and science journals. I can't deny that makes me nervous. I didn't see anything about it after that time, however.
- 93po 6y ago
  Combined with their legal immunity from any liability, that can be concerning.
  - casefields 6y ago
    That's true, but also true in general which is why we have a National Vaccine Injury Fund aka vaccine court: https://en.wikipedia.org/wiki/National_Vaccine_Injury_Compensation_Program https://en.wikipedia.org/wiki/National_Vaccine_Injury_Compen...
  - benevol 6y ago
    Plus the fact that they want us to let them hack our DNA. It's a bit like giving them root to the OS of my being.
    - fsh 6y ago
      No, mRNA is not DNA.
      - abiogenesis 6y ago
        Not that I agree with the parent but isn't technically mRNA used to "hack" DNA to make it synthesize a specific protein?
        detaro 6y ago
        no. DNA doesn't synthesize proteins. Roughly: Protein descriptions are "read" from DNA into mRNA, which is then used by ribosomes to synthesize proteins. An mRNA vaccine adds additional mRNA with instructions to synthesize the vaccine-specific protein to the cells. So it uses some of the same mechanisms that are also used to generate proteins from DNA, but does not involve DNA itself.
zyxzevn 6y ago
How does it compare with Vitamin-D?
dopylitty 6y ago
I don’t see it in the article but the majority of the work for this and other mRNA vaccines was done by a lab at the US government NIH which has been working on stabilizing coronavirus spike proteins for years now in collaboration with university labs. Moderna and other companies have supplied the platforms for distributing the mRNA coding the protein. There’s a great lecture [1] from an NIH researcher that covers this history. 1. https://youtu.be/xpqfdr9FPWM https://youtu.be/xpqfdr9FPWM
- m-ee 6y ago
  She was also on TWiV recently https://www.microbe.tv/twiv/twiv-670/ https://www.microbe.tv/twiv/twiv-670/
  - TaupeRanger 6y ago
    Glad to see TWiV mentioned here. I just started listening a couple of weeks ago and find it fascinating and very informative. The episodes can be quite long. I usually listen while working out and it takes me 3-5 days to get through a single episode, but it's as good as anything else out there. Also highly recommend the Plenary Session podcast with oncologist Vinay Prasad, who has had several COVID-focused episodes.
- ab3rC1te 6y ago
  Well I'm ex military and just tired of this shit. I've experience shit half if not 99% have seen in their lifetime. I think this shit is funny and I'll add to my negative account. Get flagged for telling the truth and being honest. Oh and the system tells me to slow down cause I'm posting too fast for the fucking system to render my post. Big FUCK YOU moderator computer system. I'll be you "Baba Yaga"
ab3rC1te 6y ago
Is COVID real? Yes! Is is really that bad as everyone makes it out to be? No! If it was that deadly of a virus, 9 out of 10 people would be dead by now. Do you need a vaccine? Nope, unless you want to take one and die. I have only been sick one time, and that was during Dec to Feb of 2019 when every human being was exposed to COVID. Have I wore a mask this entire time? No! Have I went and got tested? No! Will I go get tested? No! If man would quit playing GOD, there would be no diseases to fabricate vaccines for people to take. Ultimately it merely becomes a money racket to align the rich pharmaceutical companies with power and control. And as for cancer, that's man made and there's a cure for that as well.
- mplewis 6y ago
  It’s rare to see a comment as full of misinformation as this one.
  - ab3rC1te 6y ago
    Yeap, so much misinformation that I get negative ratings. That's so awesome. Hey did you ever ask me if I got COVID-21 yet. Cause sure shit its a coming by next year. Cause everything in this world is all about misinformation. Hell even this site would be labeled as misinformation.
    - happyhomer 6y ago
      You are not alone. We just have to use throwaway accounts and hide in catacombs like early Christians.
      - mhluongo 6y ago
        Please don't compare this nonsense to that.
        Aeolun 6y ago
        To be fair, I’m sure the ones prosecuting the early christians thought it was exactly the same kind of nonsense. It’s only in hindsight that we realize that the early christians were quite sane compared to what we have now.
tesmar2 6y ago
Is it true that the flesh of murdered babies (embryonic stem cells) was used during the research for this vaccine?
- deleted 6y ago
  [deleted]
happyhomer 6y ago
https://m.youtube.com/watch?v=K5iy8ujw3mc https://m.youtube.com/watch?v=K5iy8ujw3mc /s
tesmar2 6y ago
Is it true that the flesh of murdered babies (embryonic stem cells) was used during the research for this vaccine?
- staticautomatic 6y ago
  I don’t think this should be downvoted just because it’s crass. In a way its crassness illustrates an important point. We have a vocabulary for abortion which very deliberately avoids confronting the simple fact that it involves killing an unborn child. That is the choice in pro-choice. Anyway, yeah, we make valuable things out of dead unborn babies. It’s a hell of a silver lining.
  - tesmar2 6y ago
    > dead murdered, usually. I'd love to know if they were used in the making of this particular vaccine.
  - kennywinker 6y ago
    You’re making a choice to see fetal tissue as a baby or an unborn child - something that is not in any way inherently true. Since there are opposing strongly held viewpoints on abortion and neither can be proven to be more correct than the other - neutral language seems like the best way forward. You can claim the language is biased, but as a medical procedure it’s coded in all the same language as any other medical procedure - which seems to me to be the neutral thing to do. How you feel about the emotional or moral content of a medical procedure is separate from what is done. To take a less emotional example - I think genetically modified organisms are basically a bad thing, but that doesn’t make the term wrong - calling them monsterplants would make me happy but it’s not more accurate and it linguistically enforces a viewpoint that is not “correct” just because i happen to hold it (for many nuanced reasons i won’t go into here)
    - tesmar2 6y ago
      > something that is not in any way inherently true Wrong. The egg has been fertilized and there is unique human DNA. This is a new, unique human we're dealing with.

450 points by jakozaur 6y ago

RNA vaccines have a huge potential in treating cancer as well. Basically, you can whip up a personalized vaccine which wakes the immune system up to the fact that it has a growing tumor on its hands. So far, the success rate is very far from 100 per cent, but the therapy sometimes works even in patients with severe late stage metastatized cancer and, in all likelihood, we will learn how to use it better in coming years. This progress could save way more lives down the line than just those at risk with Covid. https://www.nature.com/articles/d41586-019-03072-8 https://www.nature.com/articles/d41586-019-03072-8

hprotagonist 6y ago
if mRNA works in anything close to a general case, i’m beginning to think that it might be as fundamentally transformative as the move from sulfa drugs to antibiotics was.
- SomeoneFromCA 6y ago
  I do not know if you aware or not, but there is a similar to mRNA vaccines, yet different (actually, almost mirror reflection of what mRNA vaccine is) invention called antisense drugs. Those are actually already used as antivirals.
  - wxnx 6y ago
    Antisense drugs are the same biological material, but have a very different mechanism of effect. Specifically, mRNA vaccines require an immune response to be effective. The mRNA (vaccine) encodes a viral protein, and the host (human) immune system still has to learn to respond to that protein. Antisense drugs are much simpler, with no immune response required. The mRNA (the drug) itself simply binds to the target mRNA.
    - SomeoneFromCA 6y ago
      I know all that. Besides, one pedantic point - antisense are not the same to typical mRNA, they have thiophosphate group instead of normal phosphate in their backbone, or some other tweak to make them bind mRNA permanently.
      - papa_bear 6y ago
        Some of us don't know, so the extra detail is appreciated :) Interesting re: the thiophosphate group. It sounds like it just floods your body with some mRNAs complementary to the viral mRNA that blocks it from getting turned into proteins by your cells' ribosomes?
        SomeoneFromCA 6y ago
        Yes, pretty much; almost like NOPing out code in binary patches. However double check about the thiophosphates. I might be wrong. It is either Morpholinos are blockers and thios are promoting destruction of the mRNA or the opposite.
    - philsnow 6y ago
      > Antisense drugs are much simpler, with no immune response required. The mRNA (the drug) itself simply binds to the target mRNA. Does that make them a class of "cures" rather than "immunizations"? If I get infected with the same thing a year later, will I need another dose of the antisense drug?
      - SomeoneFromCA 6y ago
        Yes, they are "cures". Yes, you will.
        abiogenesis 6y ago
        Is it correct to say that an mRNA based vaccine wouldn't work for that virus anyway if you can get infected with the same thing a year later?
Antimateri4 6y ago
Yes i read some interesting article aswell regarding mRNA vaccines, but from my understanting mRNA vaccine aren't yet tested in humans right? Only animals or am i mistaken? EDIT: what my question is: is there another mRNA type vaccine out there fully developed (i'm not suggesting that they are bad!)? EDIT2: Guys, i will never ask question again in here. Begin downvoted for a genuine question.
- inglor_cz 6y ago
  They have already been tested on cancer patients, with some very promising results. https://acir.org/weekly-digests/2020/august/rna-vaccine-for-melanoma-shows-promise-in-early-clinical-trial https://acir.org/weekly-digests/2020/august/rna-vaccine-for-... https://www.sciencedaily.com/releases/2020/11/201110102550.htm https://www.sciencedaily.com/releases/2020/11/201110102550.h... Some of the patients would probably already be dead if it wasn't for RNA vaccines.
  - Antimateri4 6y ago
    Yes, mRNA is pretty good and very promising (Moderna and BioNTech are mRNA based and they seems the most developed as for now)! My question was not asking if they are safe or not good (they have multiple points that make them probably the next big thing in vaccines and cancer treatments), i was asking if there are already mRNA vaccine type 100% developed and used as today.
- corin_ 6y ago
  These Covid ones aren't the first that have been tested and shown safe in humans, but I believe they will be the first to be approved for release.
  - Antimateri4 6y ago
    BioNTech one is also a 95% succesfull and mRNA based.
- NicoJuicy 6y ago
  You're probably being downvoted because this information is easily looked up. https://en.m.wikipedia.org/wiki/RNA_vaccine https://en.m.wikipedia.org/wiki/RNA_vaccine
delfinom 6y ago
Sadly from the manufacturing process description alone, we are going to be decades away from when it's actually ...not a few million dollars per individual to treat.
- faitswulff 6y ago
  An individually tailored cancer treatment is already available in the form of the CAR-T therapies, which might give an indication of how expensive it’ll be - you were pretty much right on the dot, since each treatment in a course of treatments is estimated at $375,000.
  - iguy 6y ago
    What is this money spent on? Is it a real cost per dose, or just a made-up number for something made in a research lab? Maybe another way to ask is: On the scale from 400k of white-shoe lawyer-hours, to 400k of custom 7nm silicon-etching, where should I mentally place this? The former isn't going to budge, the latter will cost pennies in a generation's time.
    - seibelj 6y ago
      What they charge might be made up, but the costs of developing these drugs are astronomical. My wife is a cancer research scientist in immunotherapies and she can burn through tens of thousands of dollars in materials running a single experiment. And if she makes a mistake - the money is wasted!
      - iguy 6y ago
        For sure, I don't mean to suggest it's cheap research. But whether you charge a lot or nothing for the first few doses out of the lab, it seems like this won't really make a dent in the research cost. (I don't know if this $375,000 number is in that category, or not.)
      - xorfish 6y ago
        If the cost for every individual treatment is low, then the cost per treatment gets lower with more patients that can benefit from it.
fullstackchris 6y ago
Honest question here, is the mechanism in those mRNA treatments totally different? I can't imagine there is a 'spike protein' you can focus on with cancer - but perhaps I am totally wrong.

deleted 6y ago

[deleted]

philshem 6y ago

>>> Anti-vaxxers immediately jump on any report of possible adverse events in a vaccine trial (which are thoroughly investigated, of course). >>> Let’s spare a thought today for the person who signed up for the Moderna vaccine trial, received two placebo shots and died of covid19. https://twitter.com/kakape/status/1333401133260419072 https://twitter.com/kakape/status/1333401133260419072 --- edit: Please explain the downvotes. The vaccine volunteer would be alive if he was randomly assigned the actual vaccine, and not two doses of placebo. The tweet is from a respected journalist at Science Magazine.

function_seven 6y ago
I think the downvotes are from people assuming you're denouncing the placebo portion of a randomized clinical trial? Maybe indicate otherwise? (Or explicitly state it if I'm wrong). All of those that died during clinical trials deserve respect for signing up and helping us advance the medicine. Their death is a statistic, but not in the Stalin quote sense! It's a statistic that helped us find the treatment that will save millions.
- philshem 6y ago
  not sure what you mean "denouncing the placebo portion of a randomized clinical trial" but I'm going to move on with my life and accept my -4 reputation :)
  - function_seven 6y ago
    I meant that your original comment could have been read to imply that this placebo-recipient died a needless death. (e.g. "They should have just given him the vaccine!") I didn't read it that way, but I could see how others would.
    - philshem 6y ago
      ah ok, I get it now. thanks.
6y ago

ck2 6y ago

Yeah but imagine being dumb enough to get infected and very sick over the next month before you can get both shots next year. Because there are going to be thousands, maybe millions who do that in the USA alone for no good reason.

SomeoneFromCA 6y ago
They are failing the Marshmallow test.
- smt88 6y ago
  You are accidentally correct. You seem to think the Marshmallow Test is a test of willpower. That interpretation is debunked. It is actually a test of poverty. https://www.smithsonianmag.com/smart-news/new-research-marshmallow-test-suggests-delayed-gratification-doesnt-equal-success-180969234/ https://www.smithsonianmag.com/smart-news/new-research-marsh...
  - jokethrowaway 6y ago
    That's a very interesting take! I'm not sure how much to read into it, there are so many variables to consider I doubt this study qualifies as science (like most of social science). Incidentally, I failed the marshmallow test and I tend to behave and think with a scarcity mindset (I can't tolerate wasting food, it's hard for me to spend money). My parents are quite well off and went to uni. Their parents started middle class and made some money. I bet my parents wouldn't have failed the test - and they definitely always stocked the house with food and could provide resources and a stable environment. My grandparents had a harder life (thanks to the wars, most likely) and share the same mindset I had (even though I never spent much time with them, we lived far away). I wonder how much of that it's actually genetic, more than environmental. You could still find correlations compatible with the study, if it were. Passing down the "poor" genes would create genealogical lines of poor families.
  - SomeoneFromCA 6y ago
    No I meant actually what I meant. Did you actually read the paper itself, which was supposed to be debunking the experiment? You probably should: https://journals.sagepub.com/doi/abs/10.1177/0956797618761661 https://journals.sagepub.com/doi/abs/10.1177/095679761876166... It does not debunk anything, the effect does not vanish, it just diminshes to 1/3 of what was originally calimed. Which means, that within a single socieconomical group, the effect will still be quite noticeable.

CodeWriter23 6y ago

Wonder what the trial exclusion criteria was...it’s not referenced in this article.

renewiltord 6y ago
Why wonder? Just use the primary source. Here's the Phase 1 https://clinicaltrials.gov/ct2/show/NCT04283461?term=NCT04283461&draw=2&rank=1 https://clinicaltrials.gov/ct2/show/NCT04283461?term=NCT0428... Phase 2a and Phase 3 similarly listed.
mrjaeger 6y ago
Can read all of them in their published protocol at https://www.modernatx.com/sites/default/files/mRNA-1273-P301-Protocol.pdf https://www.modernatx.com/sites/default/files/mRNA-1273-P301... under section 5.2.
- tpmx 6y ago
  Relevant criteria for the question "does it it exclude old, fragile people with various common pre-existing conditions?" (not exhaustive, but indicative): Included: Pre-existing conditions are okay as long as they are in a stable condition (defined as no significant change in therapy etc for the 3 months before enrollment). Excluded: Immunosuppressive or immunodeficient state, asplenia, recurrent severe infections (HIV-positive participants with CD4 count ≥350 cells/mm 3 and an undetectable HIV viral load within the past year [low level variations from 50-500 viral copies which do not lead to changes in antiretroviral therapy [ART] are permitted]). Looks fair enough to an amateur like myself. Edit: Not sure how common a immunosuppressive or immunodeficient state is in a typical population. Perhaps it's common enough to be relevant?
  - disgruntledphd2 6y ago
    I think (from my parents and in-laws) that immunosuppression is normally associated with current cancer treatment. So, for example, it looks like this protocol would exclude people getting chemotherapy. Happy to be proven wrong on this by someone with more information.

mchusma 6y ago

FDA says Dec 17 meeting to discuss. This contradicts some earlier opinions that the reason the FDA was taking so long to review Pfizer (Dec 10 scheduled date) was that they were planning to review 2-3 candidates together. For context, scheduling the meeting to review the candidates is running at 5-10% of the development time for these vaccines. 20M vaccines represent about 1/3 the elderly population in the US, there are about 1,300 deaths a day right now, and most deaths are in the high risk category. So you can estimate the cost of the delay to be quite high (depending on your assumptions, but hard not to estimate the cost to be >1000 lives). I'm unsure of any vaccine side effect or release that could be considered worse. Pendemrix caused 1 in 18,000 narcolepsy, which for the 20M at risk who could get the vaccine seems like a good trade-off (if this was as bad as that). Moderna entered phase 1 trials in March. Vaccines entering phase 1 trials have a 33% success rate overall, 85% successful for efficacy. So this is not a case of hindsight bias, this was always reasonably likely to work. And these numbers include issues like enrollment issues, or the diesease dying out (ebola). So lets make some assumptions to see what it would look like to "just approve things for the high risk in a pandemic": For example, let's say that a vaccine maker instead of pushing something 85% likely to be efective pushed through pushed through something 40% likely to work. And for safety, let's just assume it's going to be 2x worse than the worst vaccine ever, so maybe 1 in 10,000 get narcolepsy. But they still push it through. This implies taking the untested vaccine has a 40% chance of protecting you and 0.1% chance of serious side effect. For the elderly, who at the beginning of the pandemic has a conservative IFR of >10% and let's assume a 10% chance of getting it. Not taking the vaccine has something like a 1% chance of death. For the elderly, taking the untested vaccine would in this example would reduce your chance of death by 0.6% but increase the chance of serious disease by 0.1%. For most people, this should be an obvious decision to vaccinate, even using the most pessimistic adaptions possible. It almost sounds like a conspiracy theory, but in the real world Moderna had a working vaccine in March, and it was always statistically likely to work with low relative downside (for some population), and it has been banned the entire time until now. The next pandemic could be completely prevented if we focus our efforts on how to approve vaccine candidates in days not months. Note: I think the bar for requiring a vaccination can/should definitely be higher than the bar to lift a total ban on a vaccine.

ghaff 6y ago

IronRanger 6y ago

What was the age profile of the trial? If you fill it with healthy people under 50 during Summer you would expect the same results with a placebo, given the profile of the virus.

mumblemumble 6y ago
That would be a likely outcome even under the null hypothesis in a phase II trial, but, for a 30,000 person efficacy trial, I wouldn't be so quick to offhandedly dismiss the assertion that that's a significant result.
ulfw 6y ago
They would never be that dumb to do that. In fact "The Phase 3 COVE study was designed in collaboration with the FDA and NIH to evaluate Americans at the highest risk of severe COVID-19 disease. As of today, the COVE study includes more than 7,000 Americans over the age of 65" https://investors.modernatx.com/news-releases/news-release-details/moderna-completes-enrollment-phase-3-cove-study-mrna-vaccine https://investors.modernatx.com/news-releases/news-release-d...
renewiltord 6y ago
Here's a starting point for your search https://investors.modernatx.com/static-files/34f97bb2-d89a-45e4-a770-cae0591fa807 https://investors.modernatx.com/static-files/34f97bb2-d89a-4... I've found the answer starting from there. Good luck.
lultimouomo 6y ago
Second paragraph in the article, it says there were 30 severe COVID cases in the placebo group; unless there trial was ridiculously botched the age profiles of the intervention and trial branch are going to be identical. With the reasonable caveat that definitive answer can only be given once we have read the full trial report.
zetazzed 6y ago
Is anyone else on HN depressed by the number of people who seem to think - "AHA, based on not reading anything, I believe there is a meaningful chance that the whole medical and regulatory community just missed this extremely obvious possible flaw that just popped in my head?" Do people really think that the most-publicized clinical trials of our times were conducted by over-reaching noobs?

amurale 6y ago

> No one developed severe Covid-19 > No one developed severe adverse effects (yet) There is a reason vaccine trials normally take several years. I'll wait until we're a few years into phase IV trials, thankyouverymuch.

lultimouomo 6y ago
Honest question: would you wait if there was a pact to the effect that either everyone takes the vaccine, or no one does? Because obviously not getting vaccinated when everybody else does is almost always the best choice game-theoretically speaking; it doesn't really say anything on the vaccine (it may say more on the civic sense of the individual).
- amurale 6y ago
  Let's see... it's a calculus of death vs potential long term adverse effect: P(death) < 0.05% for the vast majority of the population (Age < 65) vs P(unknown) long term harm in life quality, my wild estimate: P(0.1%). It's within the same order of magnitude. I'd take the vaccine in a heartbeat, long term effects and all, if P(death) was 10% or higher.
  - toast0 6y ago
    If you get covid, there's a P(unknown) of long term harm as well. It's an unknown vs an unknown. Novel virus, novel immunization (first mRNA or maybe first widespread modified adenovirus)
    - amurale 6y ago
      You're correct about long term harm, I lumped them together. A better formula would be: P(covid death or long term harm) < 0.05% vs. P(vaccine long term harm) = ? since my estimate is they're about the same order of magnitude, I prefer to take the devil-I-know vs. the small-scale-tested vaccine. I model the potential harm based on a similarly rushed vaccine of 1976 which caused a large increase in cases of Guillain-Barré Syndrome [0]. Longer trials and phase IV monitoring was instituted in response to this rushed vaccine. [0] https://en.wikipedia.org/wiki/1976_swine_flu_outbreak https://en.wikipedia.org/wiki/1976_swine_flu_outbreak

afrojack123 6y ago

They used the vaccine on 5 people and gave 40 people the placebo.

blhack 6y ago

Does anybody have a good link for a layman's overview of how mRNA vaccines work? Lot's of nervousness from people around this, and would love to be able to help quell some of that.

ed25519FUUU 6y ago
Edit: I do plan to get the vaccine, but as a software engineer I know beta versions usually have the most “bugs” — and I have the health privilege to be in the back of the line so I will!
- mchristen 6y ago
  Citation?
- nobleach 6y ago
  A sunburn can change/damage your DNA.
  - throwaway894345 6y ago
    And people take precautions to avoid it because skin cancer can result. Not sure that's the best counter example.
    - nobleach 6y ago
      I'm not trying to argue that it's a "good" thing, simply that tons of things hack our DNA (there are even some studies that emotional trauma can have repercussions imprinted on our DNA) My major point is that DNA hacking/damage isn't always a life-ender. Even skin cancer is often removed without issue.
- itodd 6y ago
  It can't fundamentally change your own DNA. The mRNA codes for a stabilized version of the sars-cov2 spike protein. Your cells then use the mRNA to build that protein. Your immune system will then build up a response. It is a terrible idea to wait for a version 2 of this vaccine. Get vaccinated or this will not go away.

newdude116 6y ago

Thats good but I would not be overly optimistic. Two question since I dont know much about mRNA vaccines 1. The mRNA has to express the target Protein for the Anitbodies. If injected, how does this happen? It has to go somehow into the cell to be translated? Or is the delivery vehicle the magic sauce? 2. What makes mRNA vaccines so special? What is the difference of injecting the expressed protein sequence directly?

IgorPartola 6y ago
I have no knowledge of this but if injecting spike proteins worked wouldn’t we just always do that? Seems like way easier than the rest of the delivery mechanism.
- newdude116 6y ago
  Yes, but it is still a legit question.
- roywiggins 6y ago
  The AstraZeneca vaccine puts the spike protein onto a chimp cold virus. My understanding is that the hard part is to make the body understand that it needs to produce an immune response. Just injecting spike protein doesn't work, because it isn't recognized as a threat. The AstraZeneca one uses an attenuated virus that the body is going to respond to anyway. I believe the mRNA vaccines work by getting cells to express the spike protein themselves. You can't smuggle the protein into cells just by injecting it, but mRNA will get in there and do its thing.
- inglor_cz 6y ago
  Whenever you inject foreign biological material, you have to avoid two scenarios: a) the scenario when the foreign material is immediately degraded by enzymes or other mechanism, before actually accomplishing anything, b) the scenario when the foreign material causes massive immune reaction in form of inflammation, potentially killing the host. AFAIK navigating between those two extremes took decades during development of RNA vaccines. But now it seems that we can avoid both.
6y ago

whb07 6y ago

Hurray for a vaccine that is > 90% effective on a disease that for those who get it have a > 99% survival rate. Bring on the new overlords.

nkjoep 6y ago
I guess survival rate means a different thing from side effects. I would be still cautious with that statement and not underestimate it.
- macintux 6y ago
  Not to mention the side effect of the collapse of our healthcare system.
  - whb07 6y ago
    I agree, by having a shutdown and mandatory at-home confinements and fear mongering, you have people not attending hospitals and the like for routine and checkups for more serious diseases.
- whb07 6y ago
  Side effects of shutdowns include: * depression * suicide * poverty -> famine and disease * missed education * dependency on gov * freedoms given up and transferred to gov I also agree that there are other side effects, just like every disease.
  - marvin 6y ago
    Soooooo... If you were somewhat pragmatic, you'd acknowledge that a lot of people, maybe even a majority, actually support various social distancing measures and shutdowns. These measures certainly have a negative economic impact, irrespective of whether a negative economic impact would happen just due to the voluntary measures of these people. And regardless, wouldn't it be a net gain to deploy a vaccine? It would certainly be more effective at placating this group of people than implying they're all idiots. It would be a huge benefit towards resuming a relatively normal society, regardless of whether they're right or whether they're somehow all just a bunch of nervous morons. So why would you criticise it?

officialjunk 6y ago

note there is not a claim this vaccine prevents infection, only lessens symptoms, meaning you are still contagious. "We all expect an effective vaccine to prevent serious illness if infected. Three of the vaccine protocols—Moderna, Pfizer, and AstraZeneca—do not require that their vaccine prevent serious disease only that they prevent moderate symptoms which may be as mild as cough, or headache." "Prevention of infection is not a criterion for success for any of these vaccines. In fact, their endpoints all require confirmed infections and all those they will include in the analysis for success, the only difference being the severity of symptoms between the vaccinated and unvaccinated." https://www.forbes.com/sites/williamhaseltine/2020/09/23/covid-19-vaccine-protocols-reveal-that-trials-are-designed-to-succeed/ https://www.forbes.com/sites/williamhaseltine/2020/09/23/cov...

refurb 6y ago
Right, but are there any vaccines out there that protect against disease but don’t prevent transmission? I thought that’s what herd immunity was all about.
- harambae 6y ago
  You're asking if there are vaccines that do not lead to sterilizing immunity? Yes. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7296151/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7296151/
  - refurb 6y ago
    As per the article, the flu vaccine looked at didn’t provide sterilizing immunity, but did significantly lower viral titre in the lungs. So I guess the question is - even if not sterilizing immunity, would these vaccines significantly reduce (but not eliminate) transmission?
- deleted 6y ago
  [deleted]
jaywalk 6y ago
With this being the case, how does it even make sense for companies like Ticketmaster and Quantas to announce that they'll require their customers to be vaccinated? Yeah, 90-95% of your customers won't have symptoms if they get infected. But they'll still have the ability to pass on that infection to someone who wasn't vaccinated, or falls into the 5-10% of people who the vaccine isn't effective for. Obviously the vaccines have benefits, especially for high risk populations. But I see very little benefit to these corporations requiring their customers to have it, since their customers can still be infected and spread the virus.

CyberRabbi 6y ago

Why is AstraZeneca asking for exemption from liability claims stemming from their COVID-19 vaccine? https://uk.reuters.com/article/us-astrazeneca-results-vaccine-liability/astrazeneca-to-be-exempt-from-coronavirus-vaccine-liability-claims-in-most-countries-idUKKCN24V2EN https://uk.reuters.com/article/us-astrazeneca-results-vaccin...

jimbob45 6y ago
> “This is a unique situation where we as a company simply cannot take the risk if in ... four years the vaccine is showing side effects,” Ruud Dobber, a member of Astra’s senior executive team, told Reuters. Seems pretty straightforward to me. It’s an unproven method of vaccine creation and hasn’t been tested by anyone. I really can’t imagine this holding up in courts though.
- deleted 6y ago
  [deleted]
- lisper 6y ago
  > I really can’t imagine this holding up in courts though. Why not? Liability waivers are common in other industries.
  - jimbob45 6y ago
    The law is upheld by the people. If you damage the health of nearly an entire national via vaccine, no one will care to stay true to the letter of the law when it comes time for your retribution. Same thing with the Nazis. Nuremberg was a kangaroo court but people stop caring about due process when you ruin the lives of everyone in their country.
    - mam2 6y ago
      In that case the negociation is with europe so they are untouchable basically
- 6y ago

hedora 6y ago

The null hypothesis (people with symptomatic covid are as likely to get severe symptoms, regardless of whether they received the vaccine) predicts this many cases with severe symptoms: 30 / 185 * 11 = 1.7 1.7 ~= 0, so the sample size is too small to support the headline.

laurentoget 6y ago
Headline is "no one in the trial developed severe symptom" - i am not sure how your computation proves this wrong.
- jwilk 6y ago
  OK, but what about the "absolutely remarkable" part?
Majromax 6y ago
If you take a Beta(1,1) distribution as your prior, then the control group's risk-of-severe-covid-given-symptoms posterior is Beta(31,156), and the experimental group's conditional risk posterior is Beta(1,12). Drawing 100,000 samples from these distributions (`betarnd` function in matlab) gives an 87.8% sampled likelihood that the intervention reduces the conditional risk (intervention(i) < control(i)), and a 64% sampled likelihood that it reduces the risk by at least half (intervention(i) < control(i) / 2). This is suggestive (but not yet "clearly convincing") evidence that the vaccine reduces the risk of severe covid conditional on being infected in the first place, and that comes on top of the obviously compelling evidence that the vaccine reduces the baseline risk of infection. This conclusion makes intuitive sense since the vaccine is intended to produce an immune response. A patient who has a moderate response to the vaccine itself may not neutralize the infection before developing symptoms but would still have a primed immune system to control the disease before it becomes severe. (That is: the response to the vaccine intuitively falls on a range, rather than being "all or nothing").
- hedora 6y ago
  “Absolutely remarkable” was removed from the HN headline since I posted this. Thanks for running through the math; I’m guessing we came to the same conclusion about the strength of the evidence.

thisistheend123 6y ago

There a lot of comments that are being downvoted just for questioning different aspects of such a vaccine and other related issues. That's not what I have come to expect from a crowd of curious people carrying a scientific temper. C'mon HN. Let's answer the questions without downvoting someone to oblivion.

tantalor 6y ago
"people are allowed to be wrong and/or ignorant because that’s what most of us are on most topics" https://www.newyorker.com/news/letter-from-silicon-valley/the-lonely-work-of-moderating-hacker-news https://www.newyorker.com/news/letter-from-silicon-valley/th...
ARandomerDude 6y ago
You're only allowed to have certain ideas about certain topics. Step outside those bounds and the thought police will attack you.

spullara 6y ago

The vaccine was developed in 48 hours (Feb 24th) following China sharing the DNA sequence. How many could we have saved?

shawnz 6y ago
How many could have been killed if we rushed and it turned out to have serious side effects?
- _underfl0w_ 6y ago
  That's still a possibility, though "rushing" can be somewhat subjective. By strictly adhering to the scientific method/process, we can hope to eliminate uncertainty in this regard. Unfortunately... as the parent points out, that requires cooperation between geographically dispersed parties (some of whom may have priorities emphasizing social norms such as "saving face")
tantalor 6y ago
There is plenty of reason to question the safety of mRNA vaccines because none have ever been approved for use in humans. https://en.wikipedia.org/wiki/RNA_vaccine https://en.wikipedia.org/wiki/RNA_vaccine
fasteddie31003 6y ago
The FDA needs to make a fast-track vaccine approval process for mRNA vaccines where the pathway to deliver the mRNA has been pre-approved and the only change is in the mRNA payload. However, I don't have much faith in the FDA.
Antrikshy 6y ago
It seems obvious in hindsight, but such trials do have an important role in this process. Not to mention mRNA vaccines are new and it could possibly just have made things worse.
noja 6y ago
How many could have been saved from injecting an untested vaccine on billions of people? What a weird question.

briefcomment 6y ago

But basically no one gets severe Covid-19. I don't know anyone who has even tested positive.

_underfl0w_ 6y ago
Equivalent to: "I've personally never seen it, therefore it does not exist, despite documented proof to the contrary."
the_af 6y ago
I personally know people who were hospitalized due to severe COVID19. I personally know more than a couple of people who tested positive, with mild symptoms (a fever). My parents personally know people who died of it.

tim333 6y ago

Same with the Oxford / AstraZeneca vaccine "No hospitalizations or severe cases of COVID-19 were reported in those receiving the vaccine." https://apnews.com/article/astrazeneca-vaccine-third-cheaper-oxford-c99d26eb2946f6fde45a1edc002ff028 https://apnews.com/article/astrazeneca-vaccine-third-cheaper... They all seem quite promising.

theferalrobot 6y ago
Like all things with the oxford vaccine - that is only if you look at one slice of the data (in which there were no elderly)... why they didn’t include elderly is beyond me but of course there aren’t going to be severe cases in vaccinated patients 18-55 https://blogs.sciencemag.org/pipeline/archives/2020/11/23/oxford-az-vaccine-efficacy-data https://blogs.sciencemag.org/pipeline/archives/2020/11/23/ox...
- tim333 6y ago
  I think the no serious cases includes the over 55s. The BMJ are clearer in their wording >The analysis included 131 covid-19 cases and showed the vaccine was 62% effective when given as two standard doses (8895 participants) one month apart, but 90% effective when a half dose followed by a standard dose regime (2741) was used. No hospitalised or severe cases were found in anyone who received the vaccine. https://www.bmj.com/content/371/bmj.m4564 https://www.bmj.com/content/371/bmj.m4564 I think the 62% effectiveness which on the surface doesn't look that good, included basically asymptomatic people who PCR tested positive. I'm not sure the other testing included asymptomatics so the difference between the vaccines may not be as large as it looks.
- sobani 6y ago
  Why is it so obvious that there wouldn't be any severe cases in vaccinated patients 18-55, when there have been severe cases in infected people 18-55 (outside this trial, I don't know enough about this trial to make a comment about that)?
- jrochkind1 6y ago
  Were there no severe cases in the control group either? From my limited understanding of how these things are done, I assumed there must have been severe cases in the control group (which would have the same exclusions), and enough of them for some statistical test to show meaningful difference between the groups, for them to be trumpeting no severe cases in experimental group. No? If not, that would indeed to my non-statistician eye seem kind of sketchy. But if yes, thats how it works right?

kevincox 6y ago

It is presumably good that we will have a variety of vaccines. This way if one of them has unnoticed harmful long-term effects it will only affect a subset of the population. Is there some sort of system like this for flu shots? Or are we injecting a large portion of the population with the exact same stuff?

aaron695 6y ago

As an example of un-intended side effects the vaccine trial I'm on sets off HIV tests. This obviously means HIV will increase. Plus other things to consider. Like conspiracies. And the fact the cheap HIV test I ordered from China can tell me if I'm on the placebo or not. With deaths from lockdown blowing up, HIV will explode anyway after shutting do the world economy for so long. But don't think it'll be smooth sailing politically and with today's media it's a nightmare.

ping_pong 6y ago

How do they know that participants were exposed to Covid-19? Just simply through statistics?

alisonkisk 6y ago
They don't fullly know. They rely on statistics. I hope they at least ask subjects about exposure.
- nradov 6y ago
  Subject reports of exposure are notoriously unreliable. People forget. And even when anonymity is guaranteed they lie about shameful behavior.
- justinc8687 6y ago
  I'm in the AZD1222 (AstraZeneca) trial, and for the next two years, I need to fill out an online symptom questionnaire every single week. They also draw blood at the 6-month and 1-year mark, so presumably could test for antibodies.
stephenroller 6y ago
They don't. But half the people got a placebo and half got the vaccine. 185 in the placebo group got covid, with 30 having severe covid, but 11 with covid and 0 severe in the vaccine group got it. So do you really think that totally by chance, one random group of 15,000 people got a ton of exposure, and another group of 15,000 had little-to-no exposure? The probability of that is quite low.
- mlindner 6y ago
  Just to clarify, 185 got symptomatic covid. The 185 doesn't include the unknown number of asymptomatic people.
  - shakhahxhcj 6y ago
    I am curious why they didn’t test everyone. Is it just a cost/test capacity thing? Wouldn’t testing to catch asymptomatic cases increase statistical power to allow the study to yield results sooner with smaller error bars? Also, isn’t preventing asymptomatic cases an important function of the vaccine (to get to herd immunity)?

JasonFruit 6y ago

I was reading about Moderna today, and I found a number of articles from 2017-18 expressing concern about their secretiveness and impatience with both safety precautions and the failures that are inevitable in drug trials, based on the experiences of former employees and science journals. I can't deny that makes me nervous. I didn't see anything about it after that time, however.

93po 6y ago
Combined with their legal immunity from any liability, that can be concerning.
- casefields 6y ago
  That's true, but also true in general which is why we have a National Vaccine Injury Fund aka vaccine court: https://en.wikipedia.org/wiki/National_Vaccine_Injury_Compensation_Program https://en.wikipedia.org/wiki/National_Vaccine_Injury_Compen...
- benevol 6y ago
  Plus the fact that they want us to let them hack our DNA. It's a bit like giving them root to the OS of my being.
  - fsh 6y ago
    No, mRNA is not DNA.
    - abiogenesis 6y ago
      Not that I agree with the parent but isn't technically mRNA used to "hack" DNA to make it synthesize a specific protein?
      - detaro 6y ago
        no. DNA doesn't synthesize proteins. Roughly: Protein descriptions are "read" from DNA into mRNA, which is then used by ribosomes to synthesize proteins. An mRNA vaccine adds additional mRNA with instructions to synthesize the vaccine-specific protein to the cells. So it uses some of the same mechanisms that are also used to generate proteins from DNA, but does not involve DNA itself.

zyxzevn 6y ago

How does it compare with Vitamin-D?

dopylitty 6y ago

I don’t see it in the article but the majority of the work for this and other mRNA vaccines was done by a lab at the US government NIH which has been working on stabilizing coronavirus spike proteins for years now in collaboration with university labs. Moderna and other companies have supplied the platforms for distributing the mRNA coding the protein. There’s a great lecture [1] from an NIH researcher that covers this history. 1. https://youtu.be/xpqfdr9FPWM https://youtu.be/xpqfdr9FPWM

m-ee 6y ago
She was also on TWiV recently https://www.microbe.tv/twiv/twiv-670/ https://www.microbe.tv/twiv/twiv-670/
- TaupeRanger 6y ago
  Glad to see TWiV mentioned here. I just started listening a couple of weeks ago and find it fascinating and very informative. The episodes can be quite long. I usually listen while working out and it takes me 3-5 days to get through a single episode, but it's as good as anything else out there. Also highly recommend the Plenary Session podcast with oncologist Vinay Prasad, who has had several COVID-focused episodes.
ab3rC1te 6y ago
Well I'm ex military and just tired of this shit. I've experience shit half if not 99% have seen in their lifetime. I think this shit is funny and I'll add to my negative account. Get flagged for telling the truth and being honest. Oh and the system tells me to slow down cause I'm posting too fast for the fucking system to render my post. Big FUCK YOU moderator computer system. I'll be you "Baba Yaga"

ab3rC1te 6y ago

Is COVID real? Yes! Is is really that bad as everyone makes it out to be? No! If it was that deadly of a virus, 9 out of 10 people would be dead by now. Do you need a vaccine? Nope, unless you want to take one and die. I have only been sick one time, and that was during Dec to Feb of 2019 when every human being was exposed to COVID. Have I wore a mask this entire time? No! Have I went and got tested? No! Will I go get tested? No! If man would quit playing GOD, there would be no diseases to fabricate vaccines for people to take. Ultimately it merely becomes a money racket to align the rich pharmaceutical companies with power and control. And as for cancer, that's man made and there's a cure for that as well.

mplewis 6y ago
It’s rare to see a comment as full of misinformation as this one.
- ab3rC1te 6y ago
  Yeap, so much misinformation that I get negative ratings. That's so awesome. Hey did you ever ask me if I got COVID-21 yet. Cause sure shit its a coming by next year. Cause everything in this world is all about misinformation. Hell even this site would be labeled as misinformation.
  - happyhomer 6y ago
    You are not alone. We just have to use throwaway accounts and hide in catacombs like early Christians.
    - mhluongo 6y ago
      Please don't compare this nonsense to that.
      - Aeolun 6y ago
        To be fair, I’m sure the ones prosecuting the early christians thought it was exactly the same kind of nonsense. It’s only in hindsight that we realize that the early christians were quite sane compared to what we have now.

tesmar2 6y ago

Is it true that the flesh of murdered babies (embryonic stem cells) was used during the research for this vaccine?

deleted 6y ago
[deleted]

happyhomer 6y ago

https://m.youtube.com/watch?v=K5iy8ujw3mc https://m.youtube.com/watch?v=K5iy8ujw3mc /s

tesmar2 6y ago

Is it true that the flesh of murdered babies (embryonic stem cells) was used during the research for this vaccine?

staticautomatic 6y ago
I don’t think this should be downvoted just because it’s crass. In a way its crassness illustrates an important point. We have a vocabulary for abortion which very deliberately avoids confronting the simple fact that it involves killing an unborn child. That is the choice in pro-choice. Anyway, yeah, we make valuable things out of dead unborn babies. It’s a hell of a silver lining.
- tesmar2 6y ago
  > dead murdered, usually. I'd love to know if they were used in the making of this particular vaccine.
- kennywinker 6y ago
  You’re making a choice to see fetal tissue as a baby or an unborn child - something that is not in any way inherently true. Since there are opposing strongly held viewpoints on abortion and neither can be proven to be more correct than the other - neutral language seems like the best way forward. You can claim the language is biased, but as a medical procedure it’s coded in all the same language as any other medical procedure - which seems to me to be the neutral thing to do. How you feel about the emotional or moral content of a medical procedure is separate from what is done. To take a less emotional example - I think genetically modified organisms are basically a bad thing, but that doesn’t make the term wrong - calling them monsterplants would make me happy but it’s not more accurate and it linguistically enforces a viewpoint that is not “correct” just because i happen to hold it (for many nuanced reasons i won’t go into here)
  - tesmar2 6y ago
    > something that is not in any way inherently true Wrong. The egg has been fertilized and there is unique human DNA. This is a new, unique human we're dealing with.