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Comment by nanis | Hacker News Reader

Placebo-Controlled Trials of Covid-19 Vaccines — Why We Still Need Them[1].

Long-Term Studies Of COVID-19 Vaccines Hurt By Placebo Recipients Getting Immunized[2]:

> 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.

Pfizer and BioNTech speed up timeline for offering Covid-19 vaccine to placebo volunteers[3]:

> 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.

[1]: https://www.nejm.org/doi/full/10.1056/NEJMp2033538

[2]: https://www.npr.org/sections/health-shots/2021/02/19/9691430...

[3]: https://www.statnews.com/2021/01/01/pfizer-and-biontech-spee...

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None of these articles support the claim that "death rates are the same in fully vaccinated vs un/partially vaccinated populations". Probably because no such literature exists.

> None of these articles support the claim that "death rates are the same in fully vaccinated vs un/partially vaccinated populations". Probably because no such literature exists.

The documents show that the placebo arms were terminated prematurely and the fact that there is agreement that they are still needed.

Here is Moderna[1]. If you look at Table 19,

           Vaccine        Placebo
    Death* 4/15184 (<0.1) 4/15165 (<0.1)

Here is Pfizer[2]. If you look at Table 14,

           Vaccine       Placebo
    Deaths 2/21621 (0.0) 4/21631 (0.0)

Locating relevant information for other vaccines is left as an exercise for the readers.

[1]: https://www.fda.gov/media/144434/download

[2]: https://www.fda.gov/media/144245/download

> Probably because no such literature exists.

It's literally in the FDA reports (https://t.co/tIJN9pkE1B?amp=1).

The relevant line highlighted: https://twitter.com/breckyunits/status/1348080756921303041/p...

Again, I'd be surprised if it turns out they don't save lives, but I think it's a very reasonable position to be skeptical of that claim.

> I think it's a very reasonable position to be skeptical of that claim

And you believe this based entirely on wildly outdated data that tracks deaths per cohort without tracking infections per cohort, despite this same literature showing a 0.01% breakthrough infection rate and the disease itself causing a higher death rate for 2020 than any recent year in spite of massive lockdown & social isolation efforts that almost eliminated flu?

I don't really understand this position even if I do concede that there exist a couple line items from 2020 that show two similarly sized groups with similar death rates despite being on opposite ends of the vaccinated or not spectrum.

"wildly outdated data" ... you mean only data comparing outcomes in placebo versus vaccine groups?

To summarize: Placebo and treatment arms showed no difference in deaths. However, placebo arms were nixed prematurely and therefore we have no controlled and randomized studies comparing individuals who received the vaccine with individuals who did not receive the vaccine. That was the original claim. When you questioned that claim and you were shown evidence that the original claim was correct, you chose not to say "Thank you."

Instead, the downvote bandwagon is out because apparently facts are too much to bear. sigh

> you mean only data comparing outcomes in placebo versus vaccine groups?

I concede it may be the only data comparing death rates in two randomly selected groups, but I completely contest that I "[was] shown evidence that the original claim was correct". I came into this thread to argue whether "these vaccines had saved lives", and a point we used to as a litmus test for that was if "death rates [due to COVID] differed in proportion between a fully-vaccinated population vs. a partially or unvaccinated population".

Therefore, if you were to show evidence that the original claim was correct, you would prove that litmus test. Instead, two data points were provided: a Moderna study where 4/~15k people died in both a vaccinated and placebo population, and a Pfizer study where 2 vaccinated died and 4 placebo died in a population of 20k. In the Pfizer case, it is especially unclear to me these deaths are related to COVID at all in either population [1];

I certainly have conceded this is a piece of evidence towards your argument, but I continue to believe the onus of "proof" in this case continues to fall to you, as multiple large pieces of evidence point to drastically better outcomes when infected as a fully vaccinated person vs. an unvaccinated, alongside other pieces of evidence showing reduced transmission to and from infected individuals. Therefore given the high infection and relatively significant mortality of the disease we already have these attributes to tell us that as time goes forwards it is virtually guaranteed that "deaths in unvaccinated populations will rise to a level proportionate to IFR and population size", while that outcome seems not true for vaccinated populations. Therefore it seems clear the null hypothesis is that the vaccine saves lives, because it would defy our intuition and known population effects were that to be false. Therefore two data points on small populations in the relatively distant past without associated mechanisms are not enough to prove the original claim correct without significant amounts of further evidence.

I also concede that perhaps in some sense these studies should have continued, and that it may be easy to take this discontinuation as a signal of dubious value of the vaccines; I personally hold that given the other data points at hand they became completely unnecessary and don't show anything statistically significant at all talking about total death counts on the order of 10.

[1]: https://www.fda.gov/media/144246/download#page=50

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