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.
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.
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".
[0] https://apnews.com/article/coronavirus-pandemic-health-941fc...
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.
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.
Evidence?
> 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.
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.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC300808/
:D
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.
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...
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...
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...
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...
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.
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: 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.
> 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...
Great example.
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...
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.
