Someone Else

For the forth time, I did not state there were no long term effects. Why do you keep lying? Which hepatitis vaccine are you referring to? There are several. Still waiting for these answers: I am asking you to articulate your claim with some biologically plausible examples of long term effects, especially when agents such as these would not be expected to have such effects. You must be able to identify what the potential effects are to quantify them like you have (5-10%). You claim that all vaccines have long term adverse effects, waiting for you to support that statement as well.

" so you make silly claims that there is no "long term" effects" For the third time, I did not make that claim. I am asking you to articulate your claim with some biologically plausible examples of long term effects, especially when agents such as these would not be expected to have such effects. You must be able to identify what the potential effects are to quantify them like you have (5-10%). You claim that all vaccines have long term adverse effects, waiting for you to support that statement as well.

Please explain how you manage to calculate that 5-10% of the vaccinated will experience long term effects, even though you are unable to articulate what those effects might be.

" you or anyone else can make the silly claim that there is NO long term effect of the COVID vaccination" I never made this claim. "and there is some "significant probability" that there will be long term effects, like any every vaccine" Every vaccine has long term adverse effects? Please provide data to support this claim. "You simply choose to be scared and "refuse" science pillar foundation" I'm scared? Please explain, sounds like a personal attack to me. "how can you claim there is no risk?" Again I never made such a claim, don't put words in my mouth. You are the one making the claims, so I am asking you for at least theoretical support. I asked you for the mechanism of some potential long term effects concerning covid vaccines you envision, when historically there would be no such concern with an agent that gets metabolized quickly and is not chronically administered. Do you think FDA would not have considered this when bestowing full approval? What did they get wrong?

Oh I'm quite interested in and familiar with scientific research. That's why I'm asking you to provide some specifics for your claims about potential for long term risks, for example identifying a potential long term adverse event given your understanding of how the vaccines work, and explaining how, mechanistically, they would develop. Or you could explain what did FDA miss, for example, in their full approval of Comirnaty? Why specifically should this vaccine not have been approved? "maybe revisit this thread in 5 years or 10 years and see how right I was" About what? You haven't identified any concrete risks yet, so not sure how you could be right about something you haven't stated.

What specific long term risks are you proposing, and what would be the mechanism behind such risks? The question was: "why don't you edify us with some specifics (eg, data) to support your various vague and questionable claims?" You did not provide any specifics or data to demonstrate your claims are "definite".

So given your superior scientific knowledge, and since we don't have a clue, why don't you edify us with some specifics (eg, data) to support your various vague and questionable claims?

You keep calling the vaccines experimental (over and over again) despite full FDA approval, and saying something was wrong in the development, but refuse to identify any specific deficiencies in the data packages. Obviously you lose credibility when saying things that are demonstrably false and unable to articulate the specific inadequacies with the data/studies. Full approval: https://www.fda.gov/media/151707/download

You keep saying this without any specifics, and despite statements like this being debunked constantly. But I'll give you benefit of the doubt, please let us know the specific deficiencies you have identified in the data packages for these vaccines.

That would indeed be very interesting but I'm not aware of such analyses being readily available, perhaps not as I imagine they would need to integrate proprietary trail data when analyzing a potential signal. Someone with a US pharmacovigilance background might have a better idea. Also lots of info here... https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vaers/index.html

More like...trolling.

Seems like the antivax crusaders don't actually respect the "freedom" and "personal choice" they are supposedly advocating.

VAERS is certainly "worth it" for monitoring of potential rare safety signals in post-approval settings that might not otherwise be detected in phase 3/4 studies due to statistical power limitations. It is used extensively by CDC and FDA and serves a legitimate purpose. The trouble has come from antivax fanatics proffering specious safety analyses from a dataset where adverse event causality hasn't been evaluated.

Before I was exposed to forums like this, I was actually somewhat sympathetic to the "personal choice" perspective. I wasn't pleased to hear about the coercive ploys used in my home country (lotteries, weed giveaways, door to door campaigning) to get people to vaccinate, and I didn't like some aspects of the mandates. However, after being exposed to how aggressively these antisocial elements actively spread misinformation and have declared war on science, mathematics, education, their communities and the just the plain old truth; my sympathy has completely evaporated because of the endless bad-faith (and in some places illegal) tactics. So you shouldn't be surprised the altogether hostile and antisocial approach your cult has employed has generated a response by those who are sane and well educated.

Of course you can quantify relative risk, that's what people do every day in the real world! You are just afraid to acknowledge a proper analysis because it doesn't bode well for your antivax theme. " You can recover from covid easily". Some do some don't, many severe life-altering cases filling the ICUs, many more so than folks afflicted with the rare side effects from vaccines. To say each can't be quantified and analyzed is childish denialism.

"Do you not see how tiny the risk is? And for that you'd risk blood clot, stroke, paralysis, heart inflammation etc, of the "adverse effects" that we know, to say nothing of what may come in the future?" But you haven't compared the relative risks of unvaccinated hospitalizations vs. vaccine side effects in an objective manner, which is the whole point. Case in point, you fail to quantitate the side effects and only chose to speak of the most rare and dramatic. Your and the other misinformation peddlers rely heavily on such blatant cherry picking. " And in view of the leading experts like Gilbert now being on record as saying that the virus will be no worse than common cold." You keep repeating this over and over again, but what she said is it will eventually become like the common cold. "“It’s just a question of how long it’s going to take to get there and what measures we’re going to have to take to manage it in the meantime." That statement has nothing to do with current conditions and in no way means "everyone that got vaccinated made a mistake and those that did not get vaccinated got it right" as you conclude. This is not at all what she is saying. https://www.standard.co.uk/news/uk/covid-coronavirus-vaccine-common-cold-astrazeneca-oxford-sarah-gilbert-b956846.html Not sure why this sub forum caters so generously to the rabid antivax misinformation cult, I'm sure Aetna is pleased to have sponsored a refuge for these antisocial dregs.

"4 hours nine minutes and fifty seconds: an EXTREMELY telling graph and explanations." First off, why not just say 4:09:50 like a normal human being? This portion of the ADCOM is from the Open Public Hearing portion of the proceedings where any unvetted person from the general public can give a brief presentation. I found very little info online about "Dr." Jessica Rose, no affiliation stated mentioned in her intro slide (which is quite unusual), she states she's a viral immunologist but I wasn't able to verify her credentials. The first "telling graph" is an irresponsible and one-sided presentation of raw VAERS data of the like that has been debunked numerous times. She goes on to a cursory and one-sided discussion of Israel data during which she insinuates covid vaccines aren't working and "driving the emergence of new variants" without any acknowledgement of the confounding demographic and timing factors which have been analyzed and discussed here and elsewhere ad nauseam. So all I see here are the same tired conspiracies peddled by someone with no peer-reviewed literature or credentials that I can find. Thus, claiming "it doesn't get any more legit than this" seems a specious appeal to authority.

...and unvaccinated persons pose yet a greater risk to the unvaccinated than do the vaccinated. Or in less circuitous words, the unvaccinated are at greater risk overall.

Thalidomide was never approved in the US and certainly not pre-tested in any reprotox assays which would have averted the tragedy altogether. It's very normal to have ongoing phase 3 studies at the time of full approval, that's not unique to this situation or reason for alarm.

*Deleted post edited out* You can follow the links to the preprint: https://www.medrxiv.org/content/10.1101/2021.08.27.21262356v1.full#T3

The fact and law is that Comirnaty is included by the liability protections in the US conferred by the PREP Act, your suspect sources are peddling falsehoods. https://www.latimes.com/business/story/2021-09-01/hiltzik-fda-approves-pfizer-anti-vax-conspiracy-theory https://www.factcheck.org/2021/08/scicheck-researcher-distorts-facts-on-covid-19-vaccine-approval-liability/ https://www.washingtonpost.com/politics/2021/08/30/false-claim-that-fully-approved-pfizer-vaccine-lacks-liability-protection/

The "certain differences" imparted by FDA (not Pfizer) are regulatory differences. Per the previous para, the EUA covers "...certain uses that are not included in the approved BLA". It's further clarified in FDA's Q&A document https://www.fda.gov/vaccines-blood-biologics/qa-comirnaty-covid-19-vaccine-mrna: "The EUA will continue to cover adolescents 12 through 15 years of age and the administration of a third dose to certain immunocompromised individuals 12 years of age and older. Additionally, for logistical reasons, the EUA will continue to cover the use of the Pfizer-BioNTech COVID 19 Vaccine in individuals 16 years of age and older; this use is also now approved." I'm guessing the "logistical reasons" are that PFE doesn't have to label/repackage the already-distributed EUA-approved material with BLA-approval branding/PIL (which would be a logistical nightmare). Same rationale goes for the expiry extension memo discussed earlier.

Keep in mind there is a safety factor built into whatever expiry date is printed on the vial, sort of like max weight in an elevator certification. Expiry dates are based on stability data, so in the case of newer products that data would be time-constrained and subject to extensions based on newly emerging data over time (post above would be such an example). Indeed these dates are typically quite conservative as another poster mentioned, it's extremely unlikely the vaccine would suddenly "go bad" on Sep 21. Bigger risk IMO would be product not being kept at specified storage conditions.