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.
"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.
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.
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.
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.
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...
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):
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.
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.
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.
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.
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.
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
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.
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.
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.
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."
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.
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.
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.
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.
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.
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"
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.
> 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)
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]
"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.
> 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.
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.
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.
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]
> 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.
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.."
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.
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?
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:
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.
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.
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]
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.
> 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.
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.
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.
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.
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.