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I'm already triple vaxxed (booster), but there are plenty of aspects to this that help drive people's fear: - Phase 3 trials for Pfizer not complete until May

I'm already triple vaxxed (booster), but there are plenty of aspects to this that help drive people's fear: - Phase 3 trials for Pfizer not complete until May 2023: (https://clinicaltrials.gov/ct2/show/NCT04368728 https://clinicaltrials.gov/ct2/show/NCT04368728) - Control group(s) were given vaccines after 14 days: (https://www.npr.org/sections/health-shots/2021/02/19/969143015/long-term-studies-of-covid-19-vaccines-hurt-by-placebo-recipients-getting-immuni https://www.npr.org/sections/health-shots/2021/02/19/9691430...) - Pfizer generates 1.9bn in revenue off of 100m doses, just in the USA alone, creating a massive revenue loop for them that governments cannot get out of due to predatory contracts (https://www.fiercepharma.com/pharma/pfizer-eyes-higher-covid-19-vaccine-prices-after-pandemic-exec-analyst https://www.fiercepharma.com/pharma/pfizer-eyes-higher-covid...) - Pfizer's incredibly predatory, leaked, contract (https://www.documentcloud.org/documents/20616251-albanian-pfizer-covid-19-vaccine-contract https://www.documentcloud.org/documents/20616251-albanian-pf...)

Grim-444 5y ago
I know very little about this, but could someone give a good explanation on how is a drug officially approved for mass use when the manufacturer of the drug still hasn't finished their testing?
- CogitoCogito 5y ago
  It has emergency approval. The CDC decided the result of waiting for a full approval would likely cost more than allowing it early. Also to be fair it's not like they just rushed it out the door. There are probably very few things on the market (short of fully approved pharmaceuticals) that have been through more testing than these "rushed" vaccines. edit: https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained https://www.fda.gov/vaccines-blood-biologics/vaccines/emerge...
  - ramesh31 5y ago
    A great point. The same people decrying a vaccine that has been safely administered to nearly a billion people at this point and extensively studied will be the first ones to try all sorts of untested homeopathic and "alternative" nonsense.
    - h_anna_h 5y ago
      Citation needed. This to me seems like an attempt to group various people who disagree with you and classify them as lunatics.
      - nitrogen 5y ago
        Indeed, there are plenty of people who "believe in science" and trust authority figures, who believe in various forms of woo. We can do better than guilt by association. It's a very weak argument, and turns more people away from potential vaccination. In fact insulting the remaining audience is worse than preaching to the choir, because it even turns away people who were previously 100% on one's side.
    - bratcomplex 5y ago
      This this a Bifurcation of the issue. lumping people whom; have a cation bias, are alt medicine nuts, classic anti vaxers, etc, together shuts down discourse and divides people.
      - deleted 5y ago
        [deleted]
    - myWindoonn 5y ago
      I don't know why people are disagreeing with you. Look how many people are begging for "thoughts and prayers", a totally useless gesture with no medical benefits. Religious cures are an example of alternative nonsense. Ironically, it's not untested; we know that it doesn't work.
- ivanbakel 5y ago
  Without claiming any knowledge of this particular case, the FDA has processes for accelerating approval for medication for which mass efficacy testing can only be done in the long-term, but testing for adverse side-effects is already complete. The recent approval of Alzheimer's medication[0] is one example of that. From a quick Google, it seems that Phase III trials are about comparing a new treatment to existing alternatives, rather than monitoring side-effects. Perhaps the testing simply can't be complete before 2023, since it involves checking long-term immunity? In this case, the FDA may have approved the vaccine because they are confident that the risk of negative side-effects is sufficiently small, and that the vaccine gives some benefit - even if testing hasn't established exactly how much. [0]: https://www.theguardian.com/commentisfree/2021/jun/28/alzheimers-drug-aducanumab-approval-dementia https://www.theguardian.com/commentisfree/2021/jun/28/alzhei...
  - h_anna_h 5y ago
    You mean this one? https://news.ycombinator.com/item?id=27472107 https://news.ycombinator.com/item?id=27472107 https://news.ycombinator.com/item?id=27469092 https://news.ycombinator.com/item?id=27469092 https://news.ycombinator.com/item?id=27468756 https://news.ycombinator.com/item?id=27468756
- hannob 5y ago
  There is nothing unusual about any of this. A drug should be approved once it is very likely causing more good than harm. But obviously that doesn't mean you should stop researching that drug. What's happening here makes perfect sense. We have more than enough information to conclude that it is extremely likely that the vaccine helps a lot and causes little harm. However if there are any rare side effects then we'd still like to know that, therefore it is a good thing that the patients in the trials are still being observed for anything unusual.
  - stathibus 5y ago
    > A drug should be approved once it is very likely causing more good than harm. Err, that sounds really scary and wrong to me. Seems to me that a drug should be approved when all the side effects are known, results are well characterized among a large sample set over a sufficiently long time frame, and it is determined that the drug is "safe" in the absolute sense. It may be the case that we are better off taking a vaccine in a pandemic _even though we are not 100% sure it is safe_ due to the opportunity cost, and that's what emergency authorizations are for. Even if the FDA really did their due diligence here, it will not convince anyone who was not already convinced; it is obvious that they were going to approve it no matter what, because the political fallout of not approving it after so many people have taken it would permanently destroy what trust remains in the US public health system.
    - sixstringtheory 5y ago
      > Seems to me that a drug should be approved when all the side effects are known, results are well characterized among a large sample set over a sufficiently long time frame, and it is determined that the drug is "safe" in the absolute sense. How long is sufficient? How large of a test group is sufficient? In the "absolute" sense, there is no known drug that is safe. That is extremist thinking that only serves to muddy the waters of the actual debate, which should be: "how safe is safe enough?" > we are not 100% sure it is safe Note that "100% sure" does not mean "100%" safe. So how much safety do you need a 100% assurance for? How do you quantify the safety? > that sounds really scary How does this not just describe life in general? And how does that help policymaking? I don't think our species would have made it to the agricultural revolution if that was the overriding force for anything. > it will not convince anyone who was not already convinced This also strikes me as a poor consideration for any policymaker, as they likely know that at the onset to any such policymaking. This adds nothing new or interesting to the debate.
dr_dshiv 5y ago
>1.9bn off of 100m doses 20 bucks? Cheep! Hopefully this drives up vaccine investment.
ruffrey 5y ago
Is $19 per dose expensive? Not knowing anything about pharma costs, it seems about what it'd expect. Especially compared to the economic savings.
- alostpuppy 5y ago
  Wow, I agree. That seems like a deal given all the special extra cold handling you have to do with it.
  - OJFord 5y ago
    That's not $19 administered, that's $19 to acquire it and the privilege of having 'all the special extra cold handling' to do.
- albatross13 5y ago
  I think it is, when you read Pfizer's contract and fact0r in things like "Governments have to pay, regardless of whether or not the shipment arrives: on time, damaged, or at all". I suggest you browse their leaked contract: https://www.documentcloud.org/documents/20616251-albanian-pfizer-covid-19-vaccine-contract https://www.documentcloud.org/documents/20616251-albanian-pf... Pfizer has also been strong arming small, Latin American countries, to the tune of trying to get military assets as "collateral" (https://www.pharmaceutical-technology.com/news/company-news/pfizer-latin-american-vaccine/ https://www.pharmaceutical-technology.com/news/company-news/...)
  - nitrogen 5y ago
    regardless of whether or not the shipment arrives: on time, damaged, or at all Weren't extremely generous provisions like that offered by the US government last year in order to jumpstart vaccine development and production ASAP?
    - parineum 5y ago
      Yes, that's operation warp speed and it worked great. That's the reason the US.had vaccine enough to go around while Canada was struggling to get everyone their first dose.
SV_BubbleTime 5y ago
> Control group(s) were given vaccines after 14 days I saw some conspiracy theory that said this weeks ago and just shook my head at how ridiculous that would be. At least it seemed like a conspiracy theory because my view of control group was apparently something else. Emergency use authorization, for a vaccine that was never tested on humans, and both Pfizer and Moderna eliminated the control groups? What the hell!? There must be… other or new control groups right? You can’t really have phase3 trials and reference nothing for control can you? What will they reference?
- nanis 5y ago
  > I saw some conspiracy theory ... What conspiracy theory? StatNews[1]: > Pfizer and BioNTech speed up timeline for offering Covid-19 vaccine to placebo volunteers > Pfizer and its partner BioNTech plan to offer their Covid-19 vaccine to any clinical trial volunteer who received placebo by March 1, several months earlier than initially planned. and NPR[2]: > Long-Term Studies Of COVID-19 Vaccines Hurt By Placebo Recipients Getting Immunized > Tens of thousands of people who volunteered to be in studies of the Pfizer-BioNTech and Moderna COVID-19 vaccines are still participating in follow-up research. But some key questions won't be easily answered, because many people who had been in the placebo group have now opted to take the vaccine. [1]: https://www.statnews.com/2021/01/01/pfizer-and-biontech-speed-up-timeline-for-offering-covid-19-to-placebo-volunteers/ https://www.statnews.com/2021/01/01/pfizer-and-biontech-spee... [2]: https://www.npr.org/sections/health-shots/2021/02/19/969143015/long-term-studies-of-covid-19-vaccines-hurt-by-placebo-recipients-getting-immuni https://www.npr.org/sections/health-shots/2021/02/19/9691430...
  - singhrac 5y ago
    I don't see the link between these articles and the control groups receiving the vaccine after 14 days? It seems here that Pfizer gave permission for participants to get vaccinated on March 1st, which is 8 months after the start of phase 3 trials. Imagine you volunteered for a very experimental trial for the greater good and then were told that you were given a placebo and now cannot receive a vaccine for several years and will have to be more cautious. You can see in the article that a volunteer from the trial is strongly advocating for giving the participants access to vaccines. Obviously this complicates the statistical analysis (you can try to use a double-blind crossover study to get some statistical power out of this, but clearly the messaging gets more complicated), but I'm not seeing anything about a "14 day" timeline. It's also worth noting that any study participant can just freely choose to break the study and go in and get vaccinated (lowering the measured efficacy of the vaccine)_whenever they want. Giving them a concrete date is a good alternative to that.
DangerousPie 5y ago
The only reason there is fear is because people keep posting stories like these without putting them into context. It has been clear for a while now that the Pfizer vaccine works and is safe. Just because Pfizer has chosen to keep collecting data doesn't make that there is any doubt about that. This is also why control groups have been given the option to get vaccinated too. It would be highly questionable to prevent them from getting vaccinated when we know that some of them might die without the vaccine. And Pfizer doesn't "make" 1.9b of 100m doses. They might have 1.9b in revenue but producing the vaccines isn't free. And 1.9b is a tiny drop in the bucket compared to the savings we have already seen thanks to the vaccine.
- jboggan 5y ago
  "It has been clear for a while now that the Pfizer vaccine works and is safe." Yes, except there is an established process for quantifying "clear for a while now" and it involves sufficient time and control groups. That process isn't being followed and it is concerning for a number of reasons, including the effect of political pressure on expedited drug approvals in the future now that this precedent is being set. The elected leaders capable of bringing such political pressure to bear are invested in the very companies which stand so much to gain by relaxing the time-tested regulatory approval process. This is bad science and bad governance.
  - pgalvin 5y ago
    This really, really is not true. Many drug and vaccine approvals in the past have been done before the trial has run its full course. Many drug and vaccine trials have given the placebo group the real drug once safety and efficacy is clear - before the end of the trial. This is not new, and frankly I’m a little surprised to see such conspiracy theories on HN.
    - notheretoo 5y ago
      Can you prove your statement by providing an example please?
jdavis703 5y ago
I don’t see anything in the article that says control groups received the experimental vaccine after 14 days. They don’t even unblind the results until they’ve gotten enough confirmed cases to determine efficacy. Perhaps some people had enrolled just before they received enough data to unblind?
andrew_ 5y ago
Having to preface a comment with vaccination status is truly unfortunate.
- spiderice 5y ago
  Agreed. It's some variation of an "appeal to authority" logical fallacy (there may be a different logical fallacy that fits better), where the truthfulness of what you say is somehow thought to be influenced by whether or not you've had the vaccine. Even though those 2 things are completely unrelated.
  - bmarquez 5y ago
    Unfortunately, if he fails to say that he risks getting downvoted, flagged, or labeled as a conspiracy theorist. This is not limited to the medical field, I was once downvoted on an HN comment until I edited it to state that I wasn't supporting Trump, because people were reading it that way.
    - criticaltinker 5y ago
      Yes this dynamic is caused by people reflexively downvoting and flagging posts which suggest facts or ideas that do not match their own opinion and cause them cognitive dissonance. Prefacing comments with vaccination status is how people have started mitigating those ad hominem fueled reactions.
      - chipotle_coyote 5y ago
        Maybe in a perfect world we wouldn't have to occasionally preface comments with "I don't actually believe the Illuminati are using mind control lasers on us, but...", but if we live in a world where people who actually believe that tend to say things that sound like what we're about to say, is it really an unreasonable disclaimer?
    - spiderice 5y ago
      > until I edited it to state that I wasn't supporting Trump It's funny you mentioned this because my original comment was something along the lines of: """ 2016-2020: "I hate Trump, but..." 2021: "I got the vaccine, but..." """ But I erased that and wrote my comment above because I thought it had a lower chance of being downvoted.
lkbm 5y ago
The NPR citation you posted suggests the Moderna control group was offered the vaccine in January 2021, about 14 days after it was approved. Moderna was approved on December 18, 2020.[0] Moderna phase 3 trial started on July 27, 2020.[1] IE, the control group was offered the vaccine more than five months after the trial began. This is before completion of the trial (Oct 2022 for Moderna, IIRC), which is an issue, but this "14 day" as written seems to be suggesting that it was 14 days after the trial began, when it's actually five month. Additionally, when a treatment proves to be highly effective, it's normal and appropriate to start providing that treatment to the control group early, because leaving them to die or otherwise suffer an illness is considered unethical. This isn't something unique to the COVID vaccines. [0] https://www.fda.gov/coronavirus-disease-2019-covid-19/moderna-covid-19-vaccine https://www.fda.gov/coronavirus-disease-2019-covid-19/modern... [1] https://www.cidrap.umn.edu/news-perspective/2020/07/phase-3-trial-moderna-covid-19-vaccine-begins-amid-us-summer-surge https://www.cidrap.umn.edu/news-perspective/2020/07/phase-3-...
- jedmeyers 5y ago
  > Moderna was approved on December 18, 2020 Moderna was not "approved" on December 18. Your own source says it was "authorized for emergency use".
neither_color 5y ago
>I'm already triple vaxxed (booster), May I ask why? I've had two shots without much hesitation but this whole booster thing came out of nowhere and gives me "fool me twice" vibes. I understand getting a flu shot every year to target new strains but this would be the exact same shot as 8 months ago.
- random314 5y ago
  The research is out there. CDC does not arrive at policy based on whims or fancies. Trust the process rather than your "vibe".
  - thrwawydeadbeef 5y ago
    I don’t know. The research I can find shows natural immunity is effective, but we don’t know the half life of it. It also shows vaccination is effective, but we don’t know the half life of it. So the CDCs stance is to vaccinate even if you have a natural immunity, because the vaccine _might_ do better. But that doesn’t seem to naturally follow. It wouldn’t bother me if companies weren’t considering forcing you to vaccinate to keep your job, even if you have a natural immunity. These stances have real world consequences. You are asking people to trigger their immune system, something complex and not fully understood. Companies are taking these recommendations and using them as policy, forcing the recommendations as corporate laws. If you are going to force this on people, the way you are communicating isn’t how you do it.
    - random314 5y ago
      Just check the 3rd dose data from Israel. Of course you don't know because you haven't looked for it. If you are unwilling to do the research just follow CDC guidelines. That's what everyone else does. What makes you think I have the power to force anyone to anything?! I honestly don't care how I communicate or what you think of what corporations should do. I am personally tired of all these lazy ignorant rants while society is suffering and the medical community is doing their best.
- giarc 5y ago
RcouF1uZ4gsC 5y ago
With regards to control, it would have been highly unethical to withhold the vaccine from them once it had been shown to save lives. Second, Pfizer’s vaccines in terms of value produced are worth trillions. Even making $10 billion is completely worth it. In terms of what we as a society should value and pay for, I would rather us pay a lot of money to Pfizer to develop life saving vaccines than 100’s of billions for ads or weapons. I actually would like for Pfizer to have made even more money than they are making now.
pkaye 5y ago
I wonder if the unvaccinated who have the above concerns will still prefer to use Remdesiver which has only gone through and EUA at this point.
015a 5y ago
Here's another interesting one I heard from a friend, pharmacist at CVS (and I have no source for it, so take what you will): Apparently, they no longer stock the J&J. Less efficacious, issues in production, sure whatever, that's not the biggest reason. The biggest reason is: J&J's biggest advantage early on was how much cheaper it is. One shot, simpler manufacturing process (which they've screwed up several times anyway, granted), it would be the one to get widely distributed because the cost-per-fully-vaccinated individual is far lower. The issue is, the government is paying for all this, and they write blank checks. CVS administers a Pfizer/Moderna; insurance or the government refunds (I'm told) $50. They administer a J&J, they get (again, hearsay) $10. Vaccination clinics are actively incentivized to stock the most expensive vaccines, because the profit per vaccine is higher. So, some have stopped stocking J&J (which, coincidentally, is the one vaccine I've heard many anti-vax people say they'd actually consider, as its kinda-sorta-not-really-but-good-enough more traditional. at least one person i've talked to has said 'well, i'd get the J&J, but the closest clinic that has it is 30 minutes away, so i just haven't gotten around to it').
- purple_ferret 5y ago
  Medicare pays $40 per dose, no matter the vaccine[0]. [0]https://www.cms.gov/medicare/covid-19/medicare-covid-19-vaccine-shot-payment https://www.cms.gov/medicare/covid-19/medicare-covid-19-vacc...

Grim-444 5y ago

I know very little about this, but could someone give a good explanation on how is a drug officially approved for mass use when the manufacturer of the drug still hasn't finished their testing?

CogitoCogito 5y ago
It has emergency approval. The CDC decided the result of waiting for a full approval would likely cost more than allowing it early. Also to be fair it's not like they just rushed it out the door. There are probably very few things on the market (short of fully approved pharmaceuticals) that have been through more testing than these "rushed" vaccines. edit: https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained https://www.fda.gov/vaccines-blood-biologics/vaccines/emerge...
- ramesh31 5y ago
  A great point. The same people decrying a vaccine that has been safely administered to nearly a billion people at this point and extensively studied will be the first ones to try all sorts of untested homeopathic and "alternative" nonsense.
  - h_anna_h 5y ago
    Citation needed. This to me seems like an attempt to group various people who disagree with you and classify them as lunatics.
    - nitrogen 5y ago
      Indeed, there are plenty of people who "believe in science" and trust authority figures, who believe in various forms of woo. We can do better than guilt by association. It's a very weak argument, and turns more people away from potential vaccination. In fact insulting the remaining audience is worse than preaching to the choir, because it even turns away people who were previously 100% on one's side.
  - bratcomplex 5y ago
    This this a Bifurcation of the issue. lumping people whom; have a cation bias, are alt medicine nuts, classic anti vaxers, etc, together shuts down discourse and divides people.
    - deleted 5y ago
      [deleted]
  - myWindoonn 5y ago
    I don't know why people are disagreeing with you. Look how many people are begging for "thoughts and prayers", a totally useless gesture with no medical benefits. Religious cures are an example of alternative nonsense. Ironically, it's not untested; we know that it doesn't work.
ivanbakel 5y ago
Without claiming any knowledge of this particular case, the FDA has processes for accelerating approval for medication for which mass efficacy testing can only be done in the long-term, but testing for adverse side-effects is already complete. The recent approval of Alzheimer's medication[0] is one example of that. From a quick Google, it seems that Phase III trials are about comparing a new treatment to existing alternatives, rather than monitoring side-effects. Perhaps the testing simply can't be complete before 2023, since it involves checking long-term immunity? In this case, the FDA may have approved the vaccine because they are confident that the risk of negative side-effects is sufficiently small, and that the vaccine gives some benefit - even if testing hasn't established exactly how much. [0]: https://www.theguardian.com/commentisfree/2021/jun/28/alzheimers-drug-aducanumab-approval-dementia https://www.theguardian.com/commentisfree/2021/jun/28/alzhei...
- h_anna_h 5y ago
  You mean this one? https://news.ycombinator.com/item?id=27472107 https://news.ycombinator.com/item?id=27472107 https://news.ycombinator.com/item?id=27469092 https://news.ycombinator.com/item?id=27469092 https://news.ycombinator.com/item?id=27468756 https://news.ycombinator.com/item?id=27468756
hannob 5y ago
There is nothing unusual about any of this. A drug should be approved once it is very likely causing more good than harm. But obviously that doesn't mean you should stop researching that drug. What's happening here makes perfect sense. We have more than enough information to conclude that it is extremely likely that the vaccine helps a lot and causes little harm. However if there are any rare side effects then we'd still like to know that, therefore it is a good thing that the patients in the trials are still being observed for anything unusual.
- stathibus 5y ago
  > A drug should be approved once it is very likely causing more good than harm. Err, that sounds really scary and wrong to me. Seems to me that a drug should be approved when all the side effects are known, results are well characterized among a large sample set over a sufficiently long time frame, and it is determined that the drug is "safe" in the absolute sense. It may be the case that we are better off taking a vaccine in a pandemic _even though we are not 100% sure it is safe_ due to the opportunity cost, and that's what emergency authorizations are for. Even if the FDA really did their due diligence here, it will not convince anyone who was not already convinced; it is obvious that they were going to approve it no matter what, because the political fallout of not approving it after so many people have taken it would permanently destroy what trust remains in the US public health system.
  - sixstringtheory 5y ago
    > Seems to me that a drug should be approved when all the side effects are known, results are well characterized among a large sample set over a sufficiently long time frame, and it is determined that the drug is "safe" in the absolute sense. How long is sufficient? How large of a test group is sufficient? In the "absolute" sense, there is no known drug that is safe. That is extremist thinking that only serves to muddy the waters of the actual debate, which should be: "how safe is safe enough?" > we are not 100% sure it is safe Note that "100% sure" does not mean "100%" safe. So how much safety do you need a 100% assurance for? How do you quantify the safety? > that sounds really scary How does this not just describe life in general? And how does that help policymaking? I don't think our species would have made it to the agricultural revolution if that was the overriding force for anything. > it will not convince anyone who was not already convinced This also strikes me as a poor consideration for any policymaker, as they likely know that at the onset to any such policymaking. This adds nothing new or interesting to the debate.

dr_dshiv 5y ago

>1.9bn off of 100m doses 20 bucks? Cheep! Hopefully this drives up vaccine investment.

ruffrey 5y ago

Is $19 per dose expensive? Not knowing anything about pharma costs, it seems about what it'd expect. Especially compared to the economic savings.

alostpuppy 5y ago
Wow, I agree. That seems like a deal given all the special extra cold handling you have to do with it.
- OJFord 5y ago
  That's not $19 administered, that's $19 to acquire it and the privilege of having 'all the special extra cold handling' to do.
albatross13 5y ago
I think it is, when you read Pfizer's contract and fact0r in things like "Governments have to pay, regardless of whether or not the shipment arrives: on time, damaged, or at all". I suggest you browse their leaked contract: https://www.documentcloud.org/documents/20616251-albanian-pfizer-covid-19-vaccine-contract https://www.documentcloud.org/documents/20616251-albanian-pf... Pfizer has also been strong arming small, Latin American countries, to the tune of trying to get military assets as "collateral" (https://www.pharmaceutical-technology.com/news/company-news/pfizer-latin-american-vaccine/ https://www.pharmaceutical-technology.com/news/company-news/...)
- nitrogen 5y ago
  regardless of whether or not the shipment arrives: on time, damaged, or at all Weren't extremely generous provisions like that offered by the US government last year in order to jumpstart vaccine development and production ASAP?
  - parineum 5y ago
    Yes, that's operation warp speed and it worked great. That's the reason the US.had vaccine enough to go around while Canada was struggling to get everyone their first dose.

SV_BubbleTime 5y ago

> Control group(s) were given vaccines after 14 days I saw some conspiracy theory that said this weeks ago and just shook my head at how ridiculous that would be. At least it seemed like a conspiracy theory because my view of control group was apparently something else. Emergency use authorization, for a vaccine that was never tested on humans, and both Pfizer and Moderna eliminated the control groups? What the hell!? There must be… other or new control groups right? You can’t really have phase3 trials and reference nothing for control can you? What will they reference?

nanis 5y ago
> I saw some conspiracy theory ... What conspiracy theory? StatNews[1]: > Pfizer and BioNTech speed up timeline for offering Covid-19 vaccine to placebo volunteers > Pfizer and its partner BioNTech plan to offer their Covid-19 vaccine to any clinical trial volunteer who received placebo by March 1, several months earlier than initially planned. and NPR[2]: > Long-Term Studies Of COVID-19 Vaccines Hurt By Placebo Recipients Getting Immunized > Tens of thousands of people who volunteered to be in studies of the Pfizer-BioNTech and Moderna COVID-19 vaccines are still participating in follow-up research. But some key questions won't be easily answered, because many people who had been in the placebo group have now opted to take the vaccine. [1]: https://www.statnews.com/2021/01/01/pfizer-and-biontech-speed-up-timeline-for-offering-covid-19-to-placebo-volunteers/ https://www.statnews.com/2021/01/01/pfizer-and-biontech-spee... [2]: https://www.npr.org/sections/health-shots/2021/02/19/969143015/long-term-studies-of-covid-19-vaccines-hurt-by-placebo-recipients-getting-immuni https://www.npr.org/sections/health-shots/2021/02/19/9691430...
- singhrac 5y ago
  I don't see the link between these articles and the control groups receiving the vaccine after 14 days? It seems here that Pfizer gave permission for participants to get vaccinated on March 1st, which is 8 months after the start of phase 3 trials. Imagine you volunteered for a very experimental trial for the greater good and then were told that you were given a placebo and now cannot receive a vaccine for several years and will have to be more cautious. You can see in the article that a volunteer from the trial is strongly advocating for giving the participants access to vaccines. Obviously this complicates the statistical analysis (you can try to use a double-blind crossover study to get some statistical power out of this, but clearly the messaging gets more complicated), but I'm not seeing anything about a "14 day" timeline. It's also worth noting that any study participant can just freely choose to break the study and go in and get vaccinated (lowering the measured efficacy of the vaccine)_whenever they want. Giving them a concrete date is a good alternative to that.

DangerousPie 5y ago

The only reason there is fear is because people keep posting stories like these without putting them into context. It has been clear for a while now that the Pfizer vaccine works and is safe. Just because Pfizer has chosen to keep collecting data doesn't make that there is any doubt about that. This is also why control groups have been given the option to get vaccinated too. It would be highly questionable to prevent them from getting vaccinated when we know that some of them might die without the vaccine. And Pfizer doesn't "make" 1.9b of 100m doses. They might have 1.9b in revenue but producing the vaccines isn't free. And 1.9b is a tiny drop in the bucket compared to the savings we have already seen thanks to the vaccine.

jboggan 5y ago
"It has been clear for a while now that the Pfizer vaccine works and is safe." Yes, except there is an established process for quantifying "clear for a while now" and it involves sufficient time and control groups. That process isn't being followed and it is concerning for a number of reasons, including the effect of political pressure on expedited drug approvals in the future now that this precedent is being set. The elected leaders capable of bringing such political pressure to bear are invested in the very companies which stand so much to gain by relaxing the time-tested regulatory approval process. This is bad science and bad governance.
- pgalvin 5y ago
  This really, really is not true. Many drug and vaccine approvals in the past have been done before the trial has run its full course. Many drug and vaccine trials have given the placebo group the real drug once safety and efficacy is clear - before the end of the trial. This is not new, and frankly I’m a little surprised to see such conspiracy theories on HN.
  - notheretoo 5y ago
    Can you prove your statement by providing an example please?

jdavis703 5y ago

I don’t see anything in the article that says control groups received the experimental vaccine after 14 days. They don’t even unblind the results until they’ve gotten enough confirmed cases to determine efficacy. Perhaps some people had enrolled just before they received enough data to unblind?

andrew_ 5y ago

Having to preface a comment with vaccination status is truly unfortunate.

spiderice 5y ago
Agreed. It's some variation of an "appeal to authority" logical fallacy (there may be a different logical fallacy that fits better), where the truthfulness of what you say is somehow thought to be influenced by whether or not you've had the vaccine. Even though those 2 things are completely unrelated.
- bmarquez 5y ago
  Unfortunately, if he fails to say that he risks getting downvoted, flagged, or labeled as a conspiracy theorist. This is not limited to the medical field, I was once downvoted on an HN comment until I edited it to state that I wasn't supporting Trump, because people were reading it that way.
  - criticaltinker 5y ago
    Yes this dynamic is caused by people reflexively downvoting and flagging posts which suggest facts or ideas that do not match their own opinion and cause them cognitive dissonance. Prefacing comments with vaccination status is how people have started mitigating those ad hominem fueled reactions.
    - chipotle_coyote 5y ago
      Maybe in a perfect world we wouldn't have to occasionally preface comments with "I don't actually believe the Illuminati are using mind control lasers on us, but...", but if we live in a world where people who actually believe that tend to say things that sound like what we're about to say, is it really an unreasonable disclaimer?
  - spiderice 5y ago
    > until I edited it to state that I wasn't supporting Trump It's funny you mentioned this because my original comment was something along the lines of: """ 2016-2020: "I hate Trump, but..." 2021: "I got the vaccine, but..." """ But I erased that and wrote my comment above because I thought it had a lower chance of being downvoted.

lkbm 5y ago

The NPR citation you posted suggests the Moderna control group was offered the vaccine in January 2021, about 14 days after it was approved. Moderna was approved on December 18, 2020.[0] Moderna phase 3 trial started on July 27, 2020.[1] IE, the control group was offered the vaccine more than five months after the trial began. This is before completion of the trial (Oct 2022 for Moderna, IIRC), which is an issue, but this "14 day" as written seems to be suggesting that it was 14 days after the trial began, when it's actually five month. Additionally, when a treatment proves to be highly effective, it's normal and appropriate to start providing that treatment to the control group early, because leaving them to die or otherwise suffer an illness is considered unethical. This isn't something unique to the COVID vaccines. [0] https://www.fda.gov/coronavirus-disease-2019-covid-19/moderna-covid-19-vaccine https://www.fda.gov/coronavirus-disease-2019-covid-19/modern... [1] https://www.cidrap.umn.edu/news-perspective/2020/07/phase-3-trial-moderna-covid-19-vaccine-begins-amid-us-summer-surge https://www.cidrap.umn.edu/news-perspective/2020/07/phase-3-...

jedmeyers 5y ago
> Moderna was approved on December 18, 2020 Moderna was not "approved" on December 18. Your own source says it was "authorized for emergency use".

neither_color 5y ago

>I'm already triple vaxxed (booster), May I ask why? I've had two shots without much hesitation but this whole booster thing came out of nowhere and gives me "fool me twice" vibes. I understand getting a flu shot every year to target new strains but this would be the exact same shot as 8 months ago.

random314 5y ago
The research is out there. CDC does not arrive at policy based on whims or fancies. Trust the process rather than your "vibe".
- thrwawydeadbeef 5y ago
  I don’t know. The research I can find shows natural immunity is effective, but we don’t know the half life of it. It also shows vaccination is effective, but we don’t know the half life of it. So the CDCs stance is to vaccinate even if you have a natural immunity, because the vaccine _might_ do better. But that doesn’t seem to naturally follow. It wouldn’t bother me if companies weren’t considering forcing you to vaccinate to keep your job, even if you have a natural immunity. These stances have real world consequences. You are asking people to trigger their immune system, something complex and not fully understood. Companies are taking these recommendations and using them as policy, forcing the recommendations as corporate laws. If you are going to force this on people, the way you are communicating isn’t how you do it.
  - random314 5y ago
    Just check the 3rd dose data from Israel. Of course you don't know because you haven't looked for it. If you are unwilling to do the research just follow CDC guidelines. That's what everyone else does. What makes you think I have the power to force anyone to anything?! I honestly don't care how I communicate or what you think of what corporations should do. I am personally tired of all these lazy ignorant rants while society is suffering and the medical community is doing their best.
giarc 5y ago

RcouF1uZ4gsC 5y ago

With regards to control, it would have been highly unethical to withhold the vaccine from them once it had been shown to save lives. Second, Pfizer’s vaccines in terms of value produced are worth trillions. Even making $10 billion is completely worth it. In terms of what we as a society should value and pay for, I would rather us pay a lot of money to Pfizer to develop life saving vaccines than 100’s of billions for ads or weapons. I actually would like for Pfizer to have made even more money than they are making now.

pkaye 5y ago

I wonder if the unvaccinated who have the above concerns will still prefer to use Remdesiver which has only gone through and EUA at this point.

015a 5y ago

Here's another interesting one I heard from a friend, pharmacist at CVS (and I have no source for it, so take what you will): Apparently, they no longer stock the J&J. Less efficacious, issues in production, sure whatever, that's not the biggest reason. The biggest reason is: J&J's biggest advantage early on was how much cheaper it is. One shot, simpler manufacturing process (which they've screwed up several times anyway, granted), it would be the one to get widely distributed because the cost-per-fully-vaccinated individual is far lower. The issue is, the government is paying for all this, and they write blank checks. CVS administers a Pfizer/Moderna; insurance or the government refunds (I'm told) $50. They administer a J&J, they get (again, hearsay) $10. Vaccination clinics are actively incentivized to stock the most expensive vaccines, because the profit per vaccine is higher. So, some have stopped stocking J&J (which, coincidentally, is the one vaccine I've heard many anti-vax people say they'd actually consider, as its kinda-sorta-not-really-but-good-enough more traditional. at least one person i've talked to has said 'well, i'd get the J&J, but the closest clinic that has it is 30 minutes away, so i just haven't gotten around to it').

purple_ferret 5y ago
Medicare pays $40 per dose, no matter the vaccine[0]. [0]https://www.cms.gov/medicare/covid-19/medicare-covid-19-vaccine-shot-payment https://www.cms.gov/medicare/covid-19/medicare-covid-19-vacc...