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Re:FDA Approves First Covid-19 Vaccine by albatross13 on Monday August 23, 2021 @11:58AM (#28277863)
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) - Control group(s) were given vaccines after 14 days: (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...) - Pfizer's incredibly predatory, leaked, contract (https://www.documentcloud.org/documents/20616251-albanian-pf...)

Re:FDA Approves First Covid-19 Vaccine by DangerousPie on Monday August 23, 2021 @12:16PM (#28278151)
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.

Re:FDA Approves First Covid-19 Vaccine by jboggan on Monday August 23, 2021 @12:29PM (#28278353)
"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.

Re:FDA Approves First Covid-19 Vaccine by pgalvin on Monday August 23, 2021 @12:39PM (#28278496)
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.

Re:FDA Approves First Covid-19 Vaccine by jboggan on Monday August 23, 2021 @12:59PM (#28278797)
I would like to see an example of previous trials where the placebo group was invalidated prematurely by informing them and giving them the actual drug. If this is common practice I'm not aware of it.

Note the date on this article - this was back in February of this year: https://www.npr.org/sections/health-shots/2021/02/19/9691430...

Don't denigrate a perfectly valid criticism of deviations from historical norms of drug validation and approval by calling it a "conspiracy theory".

Re:FDA Approves First Covid-19 Vaccine by gzer0 on Monday August 23, 2021 @01:14PM (#28278993)
The use of placebos in controlled clinical trials must be justified by a positive risk-benefit analysis, and the subjects must be fully informed of the risks involved in the assignment to the placebo group.

Continued assignment of subjects to placebo is unethical, once there is good evidence to support the efficacy of the trial therapy.

Unfortunately (or fortunately) since there was such strong evidence to prove the efficacy, it became unethical for the continued assignment of placebo.

Re:FDA Approves First Covid-19 Vaccine by ninorata on Monday August 23, 2021 @06:22PM (#28282763)
The good old "is unethical to do a double blind study". This one is by far the best invention of the Big Pharma PR departments, you basically cannot make the study that will prove for sure that their product is safe (and stick it to all those anti vaxxers once and for all) Talk about having your cake and eating it too...
Re:FDA Approves First Covid-19 Vaccine by js2 on Monday August 23, 2021 @01:31PM (#28279237)
Here's one. I'm sure you can find others ("terminated for benefit"). For statistical reasons, terminating a trial for benefit is relatively uncommon (most terminations occur for other reasons):

https://www.ahajournals.org/doi/10.1161/CIRCHEARTFAILURE.111...

Here's an article on the ethics of a placebo-controlled trial in the first place. It's complicated.

https://acrpnet.org/2018/12/06/ethical-deliberations-on-usin...

Re:FDA Approves First Covid-19 Vaccine by Enginerrrd on Monday August 23, 2021 @01:14PM (#28278998)
This happened with low-dose Aspirin for prevention of heart-attacks and strokes. The protective effect was so profound that they considered it unethical to let the control group proceed without it.
Re:FDA Approves First Covid-19 Vaccine by 7952 on Monday August 23, 2021 @01:43PM (#28279405)
Surely the point of a placebo in this case was to measure effectiveness rather than detect long term side effects. There are other methods of establishing a control such as comparing to the general population.
Re:FDA Approves First Covid-19 Vaccine by yonaguska on Monday August 23, 2021 @01:55PM (#28279547)
Not if the general population is mandated to be vaccinated.
Re:FDA Approves First Covid-19 Vaccine by 7952 on Monday August 23, 2021 @03:26PM (#28280759)
But that is not what happened. Not everyone has had the jab. And those that were vaccinated did not all receive the same vaccine.

Anyway none of your comments actually address the science involved. A few factoids without any context is not useful.

Re:FDA Approves First Covid-19 Vaccine by notheretoo on Monday August 23, 2021 @12:43PM (#28278559)
Can you prove your statement by providing an example please?
Re:FDA Approves First Covid-19 Vaccine by pgalvin on Monday August 23, 2021 @01:10PM (#28278943)
Sure.

Garasdil was approved by the FDA in 2006 and, as this press release shows [0], continued running studies into it as a condition of the approval. They conceded that full results could not be available before approval; “While the study period was not long enough for cervical cancer to develop, the prevention of these cervical precancerous lesions is believed highly likely to result in the prevention of those cancers.”

From what I can gather, the Phase III study participants continued to receive follow-up checks for at least a decade.

[0]https://web.archive.org/web/20091019080918/https://www.fda.g...

Re:FDA Approves First Covid-19 Vaccine by zuminator on Monday August 23, 2021 @01:00PM (#28278804)
Remdesivir [0], for one, which received Fast Track and Priority Review designation from the FDA. It was also noted in a 2019 Wall Street Journal article [1] that the majority of new drug approvals are now done through a Fast Track process.

[0] https://www.fda.gov/news-events/press-announcements/fda-appr...

[1] https://www.wsj.com/articles/fast-track-drug-approval-design...

Re:FDA Approves First Covid-19 Vaccine by StephenAmar on Monday August 23, 2021 @01:15PM (#28279023)
Please actually look at the change history in https://clinicaltrials.gov/ct2/history/NCT04368728

The completion date was changed multiple times since April 2020 and they clearly appended booster trials to the existing trials and pushed back the dates.

It truly is that simple.

Re:FDA Approves First Covid-19 Vaccine by mattigames on Monday August 23, 2021 @01:19PM (#28279088)
The quality of discourse here is so so low, disguising antivax stands as concerns for the speed of the vaccine approval while disregarding simple verifiable facts such that 98%[0] of the people on ICU are unvaccinated

[0] https://apnews.com/article/coronavirus-pandemic-health-941fc...

Re:FDA Approves First Covid-19 Vaccine by mrcarruthers on Monday August 23, 2021 @12:50PM (#28278676)
One aspect of the time element is not "this much time has past" but rather "the subjects have had enough exposures to the virus". For some viruses, like HIV, this may take a long time to accomplish. But for COVID, in the middle of a pandemic, it doesn't take that long to accomplish.
Re:FDA Approves First Covid-19 Vaccine by ethbr0 on Monday August 23, 2021 @01:25PM (#28279166)
> political pressure on expedited drug approvals

I feel like people keep forgetting the definition of "public health crisis."

Time is lives. And economic dollars.

The standard process is designed around limiting harm. Not rapid delivery. Not maximizing good.

In times of business as usual, that's fine. In times of public health crises, it's not.

If we'd rapid approved HIV / AIDS treatments in the 1980s, the world as a whole would have been better.

Re:FDA Approves First Covid-19 Vaccine by mike00632 on Monday August 23, 2021 @12:56PM (#28278754)
This is wrong in two big ways:

1. The FDA requires six months of clinical data to establish safety before FDA approval. The normal requirements for FDA approval absolutely were followed

2. With longer-term studied it's not like we don't know anything about them until it's complete. Data is released on a rolling basis so we know how the results of the studies so far, and (surprise!) data so far say it's safe.

Re:FDA Approves First Covid-19 Vaccine by mikepurvis on Monday August 23, 2021 @01:41PM (#28279364)
And in the cases where there have been question marks that have come up about safety (AZ, JJ), even with miniscule likelihood, those have quickly been withdrawn.
Re:FDA Approves First Covid-19 Vaccine by anonuser123456 on Monday August 23, 2021 @01:01PM (#28278820)
>That process isn't being followed

Evidence?

Re:FDA Approves First Covid-19 Vaccine by walterbell on Monday August 23, 2021 @01:29PM (#28279221)
Why did the FDA not hold the expected public meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC), to review the latest data prior to this approval? The last public meeting was in October 2020. In the intervening 10 months, tens (hundreds?) of millions of doses of EUA vaccine were administered, generating an enormous data set which has not been through VRBPAC review, https://www.bmj.com/content/374/bmj.n2086

> Transparency advocates have criticised the ... (FDA) decision not to hold a formal advisory committee meeting to discuss Pfizer’s application for full approval of its covid-19 vaccine ... Kim Witczak ... a consumer representative on the FDA’s Psychopharmacologic Drugs Advisory Committee, said the decision removed an important mechanism for scrutinising the data ... "The public deserves a transparent process, especially as the call for boosters and mandates are rapidly increasing. These meetings offer a platform where questions can be raised, problems tackled, and data scrutinised in advance of an approval" ... She warned that without a meeting “we have no idea what the data looks like.”

“It is already concerning that full approval is being based on 6 months’ worth of data despite the clinical trials designed for two years,” she said. “There is no control group after Pfizer offered the product to placebo participants before the trials were completed. “Full approval of covid-19 vaccines must be done in an open public forum for all to see. It could set a precedent of lowered standards for future vaccine approvals.”

... Joshua Sharfstein ... former FDA deputy commissioner during the Obama administration, said that advisory committee meetings were more than just a way of receiving scientific input from outside experts. “It’s also an opportunity to educate the public about the important work that the FDA has done reviewing an enormous amount of data about a product,” he told The BMJ. “It’s a chance for questions to be asked and answered, building public confidence."

Re:FDA Approves First Covid-19 Vaccine by axus on Monday August 23, 2021 @12:37PM (#28278480)
So the people opposed to vaccination are helping science by being the control group?
Re:FDA Approves First Covid-19 Vaccine by criticaltinker on Monday August 23, 2021 @12:50PM (#28278672)
> the Pfizer vaccine works and is safe

Yes the vaccine has been proven to be safe for most adults in the short-term. But blanket statements like this over-simplify the reality of the situation.

People need to be aware that for certain sub-populations (eg pediatrics & pregnant women), there is insufficient scientific evidence - in terms of clinical trials and longitudinal studies - to conclude that the benefits of vaccination always and universally outweigh the risks.

Until consensus has been established in the scientific literature - and even after that - everyone should be making their own decisions based on personal risk evaluation with the consultation of doctors and other medical professionals.

Re:FDA Approves First Covid-19 Vaccine by handoflixue on Monday August 23, 2021 @01:04PM (#28278858)
Just to be clear, by the standard you're proposing there's also no scientific evidence that posting on Hacker News is safe. There is no scientific evidence that the internet is safe. There is no scientific evidence that wearing a mask is safe.

There is, of course, an INCREDIBLE amount of EVIDENCE for all of these things being safe (including the vaccine). There has simply never been a 100% complete full evaluation of safety to the rigorous standards of an academic paper.

But it's really important to understand that we know TONS of things without having that rigor, and we don't hold the vast majority of our life to that standard.

Heck, we outright know that driving IS dangerous, ridiculously so compared to taking a vaccine, but we still allow that.

Re:FDA Approves First Covid-19 Vaccine by dhanvanthri on Monday August 23, 2021 @01:18PM (#28279055)
Parachutes have not been subjected to rigorous evaluation by using randomized controlled trials.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC300808/

:D

Re:FDA Approves First Covid-19 Vaccine by criticaltinker on Monday August 23, 2021 @01:33PM (#28279265)
Had to up-vote because this is hilarious, thanks for sharing. As a critique of evidence based medicine they've clearly demonstrated their point, but it's obviously philosophical and the tradeoffs of practical medical interventions are no where near as clear cut as the case of falling from the sky without a parachute.
Re:FDA Approves First Covid-19 Vaccine by handoflixue on Monday August 23, 2021 @02:01PM (#28279637)
We have a known-safe vaccine that has been tested on millions of people. We have a known-deadly pandemic that has killed almost 4.5 million people.

While we are not QUITE as clearcut as parachutes, this is still an area where we can reasonably conclude that the vaccine is vastly safer than being unvaccinated.

Re:FDA Approves First Covid-19 Vaccine by criticaltinker on Monday August 23, 2021 @01:51PM (#28279507)
Just to be clear, you're arguing against evidence based medicine and instead advocating for hasty generalization and jumping to conclusions based on the absence of evidence.

Somewhere between our two points is an optimal middle ground. The holy grail of exclusively evidence based interventions is lofty no doubt, and we'll have to do the best with what we know right now, but to aim for anything less is quite difficult to defend.

Re:FDA Approves First Covid-19 Vaccine by handoflixue on Monday August 23, 2021 @01:58PM (#28279601)
I can't fathom how you could misinterpret a post saying "there's a difference between evidence and peer reviewed academic standards" to conclude that I've abandoned the idea of evidence entirely.

I don't need an academic, peer-reviewed study to tell me that using this site is safe. I don't need one to tell me that masks are safe. It's NICE to have such things, and I'm NOT opposed to them, but they are also NOT necessary for day-to-day reasoning.

I do think we should continue vaccine trials, because we might uncover subtle risks. But until we do, we are in fact at a point where we can conclude that the vaccine is significantly safer than going unvaccinated. What we expect to find going forward is small refinements like "X group should prioritize Y vaccine", not "Y vaccine is in fact more dangerous than Covid"

Re:FDA Approves First Covid-19 Vaccine by criticaltinker on Monday August 23, 2021 @02:30PM (#28280015)
You're attacking a straw man here, my original comment was about the lack of evidence for vaccine safety in certain understudied sub-populations.

> we are in fact at a point where we can conclude that the vaccine is significantly safer than going unvaccinated

You keep coming back to "vaccinated versus unvaccinated" rhetoric and using irrelevant logical reasoning to argue that we should hastily generalize safety results to these sub-populations without citing any scientific literature supporting your claim.

The reality of the situation is a lot more complex, and it's obvious you're neglecting these nuances because for example, you fail to acknowledge how immunity acquired through natural infection is a major factor in the tradeoffs of vaccinating these understudied sub-populations.

I'm open to further debate, but I won't continue responding if you continue to raise the same unsupported arguments.

Re:FDA Approves First Covid-19 Vaccine by handoflixue on Monday August 23, 2021 @02:41PM (#28280160)
> You [...] argue that we should hastily generalize safety results to these sub-populations

I never argued for "hasty" or "generalization."

Simple question: which sub-population are you talking about? Please exclude any sub-population where a statistically significant sample of vaccinated individuals already exists, unless your concern is limited solely to long-term side effects.

If you are concerned about long-term side effects, please cite at least one scientific study explaining why you are concerned about that PARTICULAR sub-group being vulnerable to that PARTICULAR side effect - we wouldn't want to waste time if you can't cite any scientific literature supporting your claim

(P.S. I've only made a single comment about vaccinated -vs- unvaccinated, so you might have me confused with someone else in this thread)

Re:FDA Approves First Covid-19 Vaccine by criticaltinker on Monday August 23, 2021 @03:08PM (#28280528)
Children and pregnant women are the two sub-populations I mentioned previously.

> Given that COVID-19 disease is far milder in the majority of children than in adults, the risk–benefit of a pediatric SARS-CoV-2 vaccine must be carefully weighed [0]

> The prognostic significance, long-term implications and mechanism of this myocardial injury needs to be studied further, especially as vaccination efforts are rolled out to younger children. [1]

> While the safety, immunogenicity, and efficacy data for the 4 authorized vaccines are reassuring so far, none of these vaccines has been systematically studied in pregnant and breastfeeding people [2]

> it is important to remain transparent about the lack of information, acknowledge concerns, and support those who decide to defer vaccination until more data are available [2]

[0] SARS-CoV-2 vaccine testing and trials in the pediatric population: biologic, ethical, research, and implementation challenges (Feb 2021) https://www.nature.com/articles/s41390-021-01402-z

[1] COVID-19 Vaccination-Associated Myocarditis in Adolescents (August 2021) https://pediatrics.aappublications.org/content/pediatrics/ea...

[2] SARS-CoV-2 Vaccination During Pregnancy: A Complex Decision (April 2021) https://academic.oup.com/ofid/article/8/5/ofab180/6220034

Re:FDA Approves First Covid-19 Vaccine by handoflixue on Monday August 23, 2021 @04:25PM (#28281428)
"Even so, given the reassuring safety and efficacy profiles of the SARS-CoV-2 vaccines that have gained UK/US regulatory authorization to date, the known risks of COVID-19 likely outweigh the unclear risks of SARS-CoV-2 vaccines for pregnant and breastfeeding people."

What are you advocating for? Your own Source Two backs me up here - we have plenty of reason to conclude that Covid is the bigger risk despite the lack of studies. It's right there in the "Conclusion" section.

Re:FDA Approves First Covid-19 Vaccine by criticaltinker on Monday August 23, 2021 @04:48PM (#28281719)
> the known risks of COVID-19 likely outweigh the unclear risks of SARS-CoV-2 vaccines for pregnant and breastfeeding people

Emphasis on "likely" - the authors do not conclude with any certainty, they're speculating based on the available evidence, just like you.

I guess your personal threshold for "plenty of reason to conclude" is lower than mine, and that's okay - to each their own.

But it's very clearly spelled out in the sources I cited: currently there is limited evidence demonstrating the safety and benefit profiles needed to conclude that every child and every pregnant woman should be vaccinated.

Re:FDA Approves First Covid-19 Vaccine by handoflixue on Monday August 23, 2021 @06:31PM (#28282847)
Yeah, but in the absence of better information, we make do with what we have, and pregnant people get vaccinated, right?

I see your point that more research is better, but given the current uncertainty you still have to decide whether Covid or Vaccine is the bigger risk, and all the science says that Covid is the bigger risk.

I'm honestly not sure where we disagree.

Re:FDA Approves First Covid-19 Vaccine by taurath on Monday August 23, 2021 @01:29PM (#28279222)
There are no doctors that will tell you not to get the vaccine unless you go looking for one who will tell you not to. Covid sucks and is filling up the hospitals, and it’s crazy to me that someone decides for themselves that a potential unknown about a vaccine is worse to them than the real virus taking out people left and right. You’re basically saying that the medical establishment is incompetent in the extreme, yet the evidence for that is extremely low.
Re:FDA Approves First Covid-19 Vaccine by mike00632 on Monday August 23, 2021 @12:59PM (#28278785)
1. If "long term" is a matter of years, then yes, the vaccines have been shown to be safe long term.

2. New data shows that the vaccine is indeed safe for pregnant women and it's not recommended that everyone 12 and older get a vaccine.

https://www.cdc.gov/media/releases/2021/s0811-vaccine-safe-p...

Re:FDA Approves First Covid-19 Vaccine by XorNot on Monday August 23, 2021 @12:56PM (#28278744)
For pregnant women the conclusion has been in for a while that COVID-19 leads to a higher incidence of hospitalizations and complications and it has been advice from OBGYN's to get vaccinated with Pfizer ASAP: source - my wife is currently pregnant and we were told this by our OBGYN, who also suggested Astrazeneca would be unlikely to be harmful but couldn't professionally recommend it as their were no formal studies (but a large number of pregnant women have been vaccinated with it not knowing they were pregnant).

For pregnant women the current data is that vaccination is conclusively necessary because they cannot possibly hope to avoid COVID-19 infection when giving birth and while pregnant are much more likely to be severely impacted by COVID-19.[1]

[1] https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/spec...

Re:FDA Approves First Covid-19 Vaccine by criticaltinker on Monday August 23, 2021 @01:14PM (#28279009)
> The conclusion has been in for a while that COVID-19 leads to a higher incidence of hospitalizations and complications

Yes just about any symptomatic illness is going to lead to hospitalization and complications during pregnancy.

I understand how the language on the CDC page you cited may lead you to believe that vaccines are conclusively recommended, but take a look at this page from the CDC [1] (updated August 11th) for a more balance appraisal. They say that evidence about the safety is "limited" but "early data" is reassuring. Almost all of the links on the page you cited are to ongoing trials. It's a misrepresentation of science to say that the recommendation to vaccinate pregnant women is conclusive.

And if we're trading anecdotes, my wife's OBGYN advised her not to get vaccinated yet, because it's unclear what the long-term risks are for mother and baby, and because it's unclear if vaccination provides any additional benefits for mothers who have acquired immunity through natural infection.

If you can provide any citations to primary sources supporting your claim that vaccination is conclusively recommended I would appreciate it - I'm keeping an open mind here.

[1] https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommend...

Re:FDA Approves First Covid-19 Vaccine by XorNot on Monday August 23, 2021 @01:24PM (#28279153)
If your wife has had COVID before she got pregnant, or during and recovered just fine, then that's a very different proposition to my wife who has not had COVID. You're burying the lead hard and frankly if you want to argue against the CDC and ATAGI[1] (the Australia advisory board) then the onus is on you to provide the extraordinary evidence that they shouldn't be believed.

Your proposition is "a virus many times deadlier then the flu in a target group who have more serious outcomes from anything, what could go wrong?"

And your evidence is: "well for someone who currently has effective natural immunity.."

[1] https://www.health.gov.au/sites/default/files/documents/2021...

Re:FDA Approves First Covid-19 Vaccine by AuryGlenz on Monday August 23, 2021 @06:10PM (#28282633)
I think he’s arguing against absolutism. If you’re pregnant and have had COVID or can keep your chances of catching it low by staying/working from home the potential risks probably outweigh the benefit of the vaccine.

But that’s not what’s being communicated.

Re:FDA Approves First Covid-19 Vaccine by orblivion on Monday August 23, 2021 @01:11PM (#28278964)
It seems reasonable to argue that the control group should have access to the vaccine, but it still makes them not really a control group anymore right?
Re:FDA Approves First Covid-19 Vaccine by mikepurvis on Monday August 23, 2021 @01:44PM (#28279421)
I'm in a phase 3 study in Canada for a not-yet-approved vaccine called Medicago. It was a crossover study where you would either get the vaccine now or later, but there were some administrative issues with the second half of it. Between the delays associated with that and the sooner-than-expected availability of the mRNA vaccines in Canada, they ended up agreeing to unblind everyone with the thought that anyone who was in the placebo-first group would drop out and get an approved vaccine.

Those of us who got that vaccine first were encouraged to remain in, though, which I did. Though that may change depending on mandate/passport stuff, since for official purposes, I'm still considered unvaccinated. There have been a number of other issues like this that have come up, for example:

https://www.thestar.com/news/canada/2021/08/13/vaccine-passp...

https://www.cbc.ca/news/canada/newfoundland-labrador/covid-1...

Re:FDA Approves First Covid-19 Vaccine by La1n on Monday August 23, 2021 @01:19PM (#28279092)
Yes, that's why they no longer in the control group. Informed consent can be withdrawn at any time during a trial, and people are not obligated to not take a vaccine when in the control group. The only thing you can do is remove someone from the study, or possibly move them to the other study arm.
Re:FDA Approves First Covid-19 Vaccine by collias on Monday August 23, 2021 @12:43PM (#28278565)
It definitely hasn’t been clear “for a while now” that the vaccine is safe. They do seem to be effective, though.

It really depends on what your definition of “safe” is. The vaccines have stated side effects, some of which can severe. The side effects are relatively rare, but non-zero.

The other component is time. We’ve proven that the vaccine is mostly safe…for at least a year out. After that, we have no data.

You don’t have to look that far back to find things that were deemed safe at one time have disastrous consequences years down the line. Cigarettes, asbestos, etc.

Re:FDA Approves First Covid-19 Vaccine by azinman2 on Monday August 23, 2021 @12:53PM (#28278709)
Getting Covid is not safe, like at all, so it’s so bizarre to me that anyone would look at the safety profile of a vaccine in a vacuum. Any medication has rare side effects. Tylenol has rare side effects that can be severe. Covid has direct effects that are common and severe.

Cigarettes and asbestos are not vaccines and are thus evaluated totally differently (and at a totally different point in time). In past vaccines monitoring, bad things happen right away versus long term:

“Serious side effects that could cause a long-term health problem are extremely unlikely following any vaccination, including COVID-19 vaccination. Vaccine monitoring has historically shown that side effects generally happen within six weeks of receiving a vaccine dose. For this reason, the FDA required each of the authorized COVID-19 vaccines to be studied for at least two months (eight weeks) after the final dose. Millions of people have received COVID-19 vaccines, and no long-term side effects have been detected.” [1]

[1] https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/sa...

Re:FDA Approves First Covid-19 Vaccine by collias on Monday August 23, 2021 @01:03PM (#28278841)
I never claimed getting covid was safe, only that we don’t have long-term data on the vaccines.

Re: things like Tylenol, the difference is we have a ton of long term data on that, and the interactions with things like alcohol or other drugs are well known.

The fact that the FDA made a point to say that the vaccine was studied for eight whole weeks is worrisome, for something that most of the population will be forced or at least coerced into taking.

Re:FDA Approves First Covid-19 Vaccine by leesalminen on Monday August 23, 2021 @12:49PM (#28278650)
Don’t forget Vioxx!
Re:FDA Approves First Covid-19 Vaccine by nanis on Monday August 23, 2021 @01:06PM (#28278898)
> Shortly before the FDA approved Vioxx in 1999, drug maker Merck launched a study it hoped would prove that Vioxx was superior to older painkillers, because it caused fewer gastrointestinal problems. Instead, the study would eventually show Vioxx could be deadly, causing heart attacks and strokes.

> Five years after Vioxx's launch, Merck withdrew the drug from the market. By that time, Merck had sold billions of dollars of the drug worldwide.

[1]: https://www.npr.org/2007/11/10/5470430/timeline-the-rise-and...

Re:FDA Approves First Covid-19 Vaccine by collias on Monday August 23, 2021 @12:53PM (#28278711)
I have never heard of Vioxx and just looked it up…wow.

Great example.

Re:FDA Approves First Covid-19 Vaccine by jhayward on Monday August 23, 2021 @01:01PM (#28278826)
Only someone totally ignorant of the difference between a vaccine and a pain drug, in terms of how they are tested and approved, would use 'what about vioxx' as an indictment of vaccines.
Re:FDA Approves First Covid-19 Vaccine by nanis on Monday August 23, 2021 @01:18PM (#28279054)
> ... as an indictment of vaccines.

Nothing here is an indictment of vaccines per se. However, it is legitimate to have concerns over a process the rules stated at the outset were thrown out, possibly for personal profit and political motivations.

Also, see https://news.ycombinator.com/item?id=28280087 for a link to an articulate consideration of a number of concerns regarding this approval.

Re:FDA Approves First Covid-19 Vaccine by nanis on Monday August 23, 2021 @12:48PM (#28278644)
>> And Pfizer doesn't "make" 1.9b of 100m doses.

True.

> Pfizer's COVID-19 vaccine generated $7.8 billion in revenue in the second quarter[1].

Note that with Pharma, there is a fixed cost up front. After that, the marginal cost is relatively small and every extra dose prints money.

Also, there are people in other countries who are being called back for a fourth dose right now.

[1]: https://www.marketwatch.com/story/pfizers-covid-19-vaccine-g...

Re:FDA Approves First Covid-19 Vaccine by Lochleg on Monday August 23, 2021 @01:39PM (#28279337)
There hasn't been a virus in the past that needed a 100% vaccination rate. This one isn't that special. We just have different standards.

There are going to be some people and even large swathes of some countries that are never going to get vaccinated. If everyone took safety and science seriously, there probably would still be a control group in place. There were probably numerous people in the control group that had little to no risk of death nor complications even if they caught the virus and had to be quarantined. Ultimately, the vaccines will never meet the "gold standard" that Fauci and others applied to all other potential treatments.

Also, if vaccines become mandatory, the systems in place to address vaccine damage and liability need to be reformed. The excuse about scary yet isolated incidents having a disproportionate impact on vaccine adoption rates would no longer be valid.

Re:FDA Approves First Covid-19 Vaccine by lkbm on Monday August 23, 2021 @12:40PM (#28278523)
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/modern...

[1] https://www.cidrap.umn.edu/news-perspective/2020/07/phase-3-...

Re:FDA Approves First Covid-19 Vaccine by jedmeyers on Monday August 23, 2021 @02:46PM (#28280232)
> Moderna was approved on December 18, 2020

Moderna was not "approved" on December 18. Your own source says it was "authorized for emergency use".

Re:FDA Approves First Covid-19 Vaccine by andrew_ on Monday August 23, 2021 @12:25PM (#28278297)
Having to preface a comment with vaccination status is truly unfortunate.
Re:FDA Approves First Covid-19 Vaccine by spiderice on Monday August 23, 2021 @12:43PM (#28278562)
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.
Re:FDA Approves First Covid-19 Vaccine by bmarquez on Monday August 23, 2021 @12:52PM (#28278702)
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.

Re:FDA Approves First Covid-19 Vaccine by spiderice on Monday August 23, 2021 @01:03PM (#28278851)
> 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.

Re:FDA Approves First Covid-19 Vaccine by criticaltinker on Monday August 23, 2021 @12:57PM (#28278762)
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.
Re:FDA Approves First Covid-19 Vaccine by chipotle_coyote on Monday August 23, 2021 @02:09PM (#28279766)
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?
Re:FDA Approves First Covid-19 Vaccine by skyde on Monday August 23, 2021 @01:02PM (#28278832)
He could have simply said I believe the vaccine work and is safe bug .. pharma have predatory contract.

I think his goal was to make it clear that he was not an anti-science or conspirationist himself.

Re:FDA Approves First Covid-19 Vaccine by dr_dshiv on Monday August 23, 2021 @12:05PM (#28277983)
>1.9bn off of 100m doses

20 bucks? Cheep! Hopefully this drives up vaccine investment.

Re:FDA Approves First Covid-19 Vaccine by Grim-444 on Monday August 23, 2021 @12:01PM (#28277911)
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?
Re:FDA Approves First Covid-19 Vaccine by ivanbakel on Monday August 23, 2021 @12:10PM (#28278075)
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/alzhei...

Re:FDA Approves First Covid-19 Vaccine by h_anna_h on Monday August 23, 2021 @12:25PM (#28278289)
Re:FDA Approves First Covid-19 Vaccine by CogitoCogito on Monday August 23, 2021 @12:05PM (#28277980)
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/emerge...

Re:FDA Approves First Covid-19 Vaccine by ramesh31 on Monday August 23, 2021 @12:21PM (#28278237)
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.
Re:FDA Approves First Covid-19 Vaccine by bratcomplex on Monday August 23, 2021 @12:58PM (#28278783)
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.
Re:FDA Approves First Covid-19 Vaccine by myWindoonn on Tuesday August 24, 2021 @11:36AM (#28290248)
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.
Re:FDA Approves First Covid-19 Vaccine by h_anna_h on Monday August 23, 2021 @12:27PM (#28278321)
Citation needed. This to me seems like an attempt to group various people who disagree with you and classify them as lunatics.
Re:FDA Approves First Covid-19 Vaccine by nitrogen on Monday August 23, 2021 @12:39PM (#28278504)
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.

Re:FDA Approves First Covid-19 Vaccine by hannob on Monday August 23, 2021 @12:45PM (#28278600)
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.

Re:FDA Approves First Covid-19 Vaccine by stathibus on Monday August 23, 2021 @01:11PM (#28278956)
> 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.

Re:FDA Approves First Covid-19 Vaccine by sixstringtheory on Monday August 23, 2021 @02:00PM (#28279617)
> 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.

Re:FDA Approves First Covid-19 Vaccine by stathibus on Monday August 23, 2021 @03:50PM (#28281049)
Its not my job to figure out "how safe" or "how certain", but I can definitely say with confidence that "more safe than harmful" and "more likely than not" are both really bad answers.
Re:FDA Approves First Covid-19 Vaccine by sixstringtheory on Monday August 23, 2021 @07:32PM (#28283400)
Unfortunately that is how the world works. It is not all or nothing, it is sets of probabilities and tradeoffs. You will rarely be able to solve complicated problems if your criteria are all or nothing. Few medicines are 100% safe. Nobody can predict the future. I'm sorry you're scared, so are many people, but this is the best option we have right now. I struggle to think of a better choice.
Re:FDA Approves First Covid-19 Vaccine by 015a on Monday August 23, 2021 @01:35PM (#28279289)
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').

Re:FDA Approves First Covid-19 Vaccine by purple_ferret on Monday August 23, 2021 @01:44PM (#28279420)
Medicare pays $40 per dose, no matter the vaccine[0].

[0]https://www.cms.gov/medicare/covid-19/medicare-covid-19-vacc...

Re:FDA Approves First Covid-19 Vaccine by ruffrey on Monday August 23, 2021 @12:06PM (#28277996)
Is $19 per dose expensive? Not knowing anything about pharma costs, it seems about what it'd expect. Especially compared to the economic savings.
Re:FDA Approves First Covid-19 Vaccine by OJFord on Monday August 23, 2021 @01:00PM (#28278806)
I don't really know how to determine a fair price other than letting them compete with Moderna et al.

Traditional flu jabs apparently [0] cost the NHS £5-8 (<$11) per dose; the Astrazeneca Covid-19 vaccine seems in-line with that charging $2-5 non-profit for the duration of the pandemic [1]. But I don't know how comparable that is to Pfizer's given that the latter's different, newer (mRNA) tech AIUI? (Perhaps that's a disservice to the researchers at AZ/Oxford, I don't know.)

[0] - https://www.telegraph.co.uk/news/2018/01/17/nhs-attempts-sav...

[1] - https://www.theguardian.com/world/2021/aug/11/covid-19-vacci...

Re:FDA Approves First Covid-19 Vaccine by albatross13 on Monday August 23, 2021 @12:12PM (#28278103)
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-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/...)

Re:FDA Approves First Covid-19 Vaccine by nitrogen on Monday August 23, 2021 @12:42PM (#28278550)
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?

Re:FDA Approves First Covid-19 Vaccine by parineum on Monday August 23, 2021 @12:57PM (#28278763)
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.
Re:FDA Approves First Covid-19 Vaccine by giarc on Monday August 23, 2021 @12:51PM (#28278693)
>Governments have to pay, regardless of whether or not the shipment arrives: on time, damaged, or at all

Wouldn't this be standard language in any contract? If I buy a widget and they ship it to me, if it gets damaged in transit, or lost in transit I still have to pay the producer, I then go after the delivery company (and/or their insurance) for compensation.

Re:FDA Approves First Covid-19 Vaccine by OJFord on Monday August 23, 2021 @01:06PM (#28278888)
I've never handled such things for a business, but I'd assume it'd be the same as in my personal life - that's the seller's problem?

If something arrives (late, if I care) damaged, or not at all, from Amazon or whatever, I tell them and they refund me or ship a replacement.

Re:FDA Approves First Covid-19 Vaccine by 55555 on Monday August 23, 2021 @01:52PM (#28279515)
It depends. Sometimes you buy EXW, sometimes FOB, sometimes delivery is guaranteed. Just depends on the deal. But mostly, yes, you're right.
Re:FDA Approves First Covid-19 Vaccine by alostpuppy on Monday August 23, 2021 @12:09PM (#28278048)
Wow, I agree. That seems like a deal given all the special extra cold handling you have to do with it.
Re:FDA Approves First Covid-19 Vaccine by OJFord on Monday August 23, 2021 @12:45PM (#28278596)
That's not $19 administered, that's $19 to acquire it and the privilege of having 'all the special extra cold handling' to do.
Re:FDA Approves First Covid-19 Vaccine by neither_color on Monday August 23, 2021 @12:41PM (#28278538)
>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.

Re:FDA Approves First Covid-19 Vaccine by 3l3c7r1c on Monday August 23, 2021 @01:05PM (#28278869)
Body takes repeat threat way more seriously. That's the reason second dose of vaccine mRNA creates about 10x more antibodies. Almost all kids vaccine require a second or even 3 shots with months of gap in between to create stronger immunity. (https://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolesc...)

If you keep a tab on the news you might have seen antibody level from covid vaccines drops significantly over time. Actually same is true for people already have covid; natural protection wanes off within few months.

Re:FDA Approves First Covid-19 Vaccine by mrkramer on Monday August 23, 2021 @01:52PM (#28279517)
But how are Spanish Flu survivors still immune after 90 years?

https://www.nationalgeographic.com/science/article/flu-survi...

Re:FDA Approves First Covid-19 Vaccine by giarc on Monday August 23, 2021 @12:49PM (#28278656)
Boosters are aptly named, they boost your antibody levels.

You are correct the flu shot targets different strains, but the H1N1 strain has been part of the annual flu shot since 2009 simply because it has continued to circulate. So just like you get an H1N1 shot every year (to boost your antibody levels), you will likely get a COVID shot every year to boost those antibodies.

Re:FDA Approves First Covid-19 Vaccine by azinman2 on Monday August 23, 2021 @12:56PM (#28278748)
It’s only currently approved for those who are immunocompromised, for which data show that vaccines don’t result in the same level of antibodies for them.

For others, it seems that with Pfizer the antibody level drops over time.

Re:FDA Approves First Covid-19 Vaccine by random314 on Monday August 23, 2021 @12:45PM (#28278590)
The research is out there. CDC does not arrive at policy based on whims or fancies. Trust the process rather than your "vibe".
Re:FDA Approves First Covid-19 Vaccine by thrwawydeadbeef on Monday August 23, 2021 @12:55PM (#28278734)
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.

Re:FDA Approves First Covid-19 Vaccine by random314 on Monday August 23, 2021 @02:53PM (#28280318)
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.

Re:FDA Approves First Covid-19 Vaccine by pkaye on Monday August 23, 2021 @01:25PM (#28279162)
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.
Re:FDA Approves First Covid-19 Vaccine by jdavis703 on Monday August 23, 2021 @12:21PM (#28278226)
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?
Re:FDA Approves First Covid-19 Vaccine by RcouF1uZ4gsC on Monday August 23, 2021 @12:57PM (#28278770)
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.

Re:FDA Approves First Covid-19 Vaccine by SV_BubbleTime on Monday August 23, 2021 @12:08PM (#28278019)
> 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?

Re:FDA Approves First Covid-19 Vaccine by nanis on Monday August 23, 2021 @12:13PM (#28278122)
> 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-spee...

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

Re:FDA Approves First Covid-19 Vaccine by singhrac on Monday August 23, 2021 @12:40PM (#28278510)
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.

Re:FDA Approves First Covid-19 Vaccine by jpollock on Monday August 23, 2021 @12:22PM (#28278250)
Once you have evidence the treatment works, it becomes unethical to not offer it to the control group. This happens in a lot of medical trials.

In this specific situation, they would have been condemning through a choice to not treat, a fraction of the control group to die.

Re:FDA Approves First Covid-19 Vaccine by breck on Monday August 23, 2021 @01:06PM (#28278890)
From the December FDA report: "The expected duration of study participation is approximately 25 months".

At the time they dissolved the control group, the fatality rate in control and placebo were the same. By their very own data they did not have a strong case that they would be "condemning...a fraction of the control group to die.". One would have to make a leap. A plausible leap, but a leap nonetheless.

Let's assume though that the fatality rate across the population for COVID was 1%, a very high number, to be conservative. So in that case you'd expect ~150 preventable fatalities in the control group. We now have ~that many fatalities, in a single state (Massachusetts), from COVID-19, in people who were "fully vaccinated".

You can do the math and extrapolate that there are now orders of magnitude more deaths from "breakthrough infections" than might have been in the placebo control group. If we had known that the efficacy of these vaccines was going to fall significantly, might some of those deaths have been prevented? I think there's an argument to be made there.

Now we have statisticians scrambling over themselves with complex methods to figure out what the hell is going on, when we could have had the gold standard which would be quite simple to interpret, if we had kept those control groups.

Now some argue it would have been completely impractical to maintain that control group amidst a mass vax campaign (I think we should have tried, regardless). I think there's room to debate that. But in that case I think we need a vast upgrade to our data infra, because giving up the placebo control group was a huge loss (for truth and science, at least).

Re:FDA Approves First Covid-19 Vaccine by SV_BubbleTime on Monday August 23, 2021 @02:06PM (#28279718)
> Once you have evidence the treatment works

That doesn’t actually seem right though. You have control groups at least through all phases of trials to make sure “the treatment works”. That’s literally the point of the control.

Especially now that we know the vaccines don’t completely work to stop infection or prevent symptoms or spread.

I’m all for the vaccines, but it seems crazy that they didn’t even wait until phase3 was over for a new type that has never been tested on humans before.

If the argument is “the control petiole were at risk”, they should have been told their vaccine was placebo and ask for volunteers to remain in control, seems like flat out offering them real shot defeats the point, doesn’t it?

Re:FDA Approves First Covid-19 Vaccine by tracyshaun on Monday August 23, 2021 @12:36PM (#28278461)
But a good chunk of them would survive... and it would be really valuable to know why they survived without a vaccine.
Re:FDA Approves First Covid-19 Vaccine by shadowgovt on Monday August 23, 2021 @12:42PM (#28278545)
But that's the crux of medical ethics of human trials. You can't treat people like mice, no matter how valuable the data gained would have been.
Re:FDA Approves First Covid-19 Vaccine by DangerousPie on Monday August 23, 2021 @12:17PM (#28278175)
You can't force people not to get vaccinated for several years in the middle of a pandemic.
Re:FDA Approves First Covid-19 Vaccine by all2 on Monday August 23, 2021 @01:07PM (#28278903)
No. Quite the opposite.

It seems you can force people to get a vaccine in the middle of a pandemic. France is dealing with massive unrest [0] and are hemorrhaging medical staff [1] because they mandated vaccines for medical professionals (which doesn't make sense, the vaccine doesn't prevent a person from spreading the virus [2]).

[0] https://spectator.org/french-health-pass-riots/

[1] https://www.reuters.com/world/europe/we-have-rights-french-h...

[2] https://www.realclearpolitics.com/video/2021/08/06/cdc_direc...!

Re:FDA Approves First Covid-19 Vaccine by vikingerik on Monday August 23, 2021 @01:47PM (#28279454)
If you justify imposing authoritarian measures because of an emergency, what you get is the authoritarians creating a perpetual emergency.