FDA Releases Pfizer COVID Vaccine Safety Data: Should You Take It?
WHO'S IN CHARGE
Before discussing it, I want to emphasize that making this vaccine mandatory is evil, the work of tyrants. There is nothing in the government-driven coronadoom crisis that warrants forcing people under the point of a gun---or starvation, or joblessness, or shunning---to take a vaccine most don't necessarily need, especially those under about 40 years old and otherwise healthy.
Risk is the first consideration about whether to take a vaccine. Safety and efficacy follow. See this, at bottom, for who is most at risk of the virus. It's small for most people.
Some have said you need a driver's license to drive therefore....you need a vaccination to breathe? To live? The minds of the people who say this are clouded by irrational fear.
Too, we cannot and must not let medical experts decide these questions for us. Doctors don't know what is ideal for a culture any more than astrophysicists. Memorizing bones or stars does not mean you know what is best for a people.
We must not allow the precedent of giving government all control of citizens unless they submit to whatever fanciful medical treatment is in current fashion. The history of medicine alone is sufficient argument for this.
One last qualification, about cause, well known to regular readers. We can't read cause out of the data, but we can, do, and must read it into it. For instance, we assume the side effects (mentioned later) were caused by vaccine in the vaccine group, and were caused by something else beside the placebo in the placebo group. And we either assume that whatever this cause or these causes were in the placebo group, they weren't operating in the drug group (which isn't likely), or they were, but to an unknown extent.
Meaning not all the adverse events (AEs) in the vaccine group were caused by the vaccine, but by it and other things. The numbers of both can be guessed at using probability models.
With those provisos, onto the data---which I, like you, have to take as given to us.
ADVERSE EVENTS
The most important AE is death. Only 2 in the vaccine arm, 4 in the placebo. The Ns were 21,621 vaccine and 21,631 placebo, two doses for both, three weeks apart. Deaths were heart attacks, strokes, and two unknowns in the placebo group. All older than 55. This data is, of course, in favor of the vaccine.
Others (S is "serious"): "The most common SAEs in the vaccine group which were numerically higher than in the placebo group were appendicitis (0.04%), acute myocardial infarction (0.02%), and cerebrovascular accident (0.02%), and in the placebo arm numerically higher than in the vaccine arm were pneumonia (0.03%), atrial fibrillation (0.02%), and syncope [passing out] (0.02%)."
The placebo AEs can be put down to anxiety, if you like, or usual disease with the pneumonia. Appendicitis is indeed serious, as are heart attacks (MIs); and "cerebrovascular accident" is a nice euphemism for stroke.
Next, tables of "solicited" and "unsolicited" AEs. The difference is those the experimenters thought to ask about and those they didn't. This opens the possibility that unsolicted AEs are under-counted.
With our assumption about cause, the vaccine has been confirmed to produce more AEs.
Note that this table (above) is 18-55 only, but a chart for 55+ is similar. Pain, swelling, and redness, while greater with vaccines, are minor.
I won't show it, but there are similar charts showing vaccines produce in 18-55 year olds more fever (15.8% vs. 0.5%) fatigue (59.4% vs. 22.8%), headaches (51.7% vs. 24.1%), chills (35.1% vs. 3.8%), vomiting (1.9% vs. 1.2%), diarrhea (10.4% vs. 8.4%), muscle pain (37.3% vs. 8.2%), joint pain (21.9% vs. 5.2%), and use of antipyretic or anti-pain meds (45 vs. 12.6%). Results are similar for 55+.
Whether these are important is a question for you, and not anybody else. Meaning the answer will vary depending on person.
More infrequent events:
Reports of lymphadenopathy [swollen lymph nodes] were imbalanced with notably more cases in the vaccine group (64) vs. the placebo group (6), which is plausibly related to vaccination. Bell's palsy [in which you make a face like the Joker] was reported by four vaccine participants and none in the placebo group. These cases occurred at 3, 9, 37, and 48 days after vaccination. One case (onset at 3 days postvaccination) was reported as resolved with sequelae within three days after onset, and the other three were reported as continuing or resolving as of the November 14, 2020 data cut-off with ongoing durations of 10, 15, and 21 days, respectively. The observed frequency of reported Bell's palsy in the vaccine group is consistent with the expected background rate in the general population, and there is no clear basis upon which to conclude a causal relationship at this time, but FDA will recommend surveillance for cases of Bell's palsy with deployment of the vaccine into larger populations.
They say so.
The next point of interest were unsolicited AEs in the 65+ group.
Again, the importance is up to you. Not the government, not your doctor.
Besides all that, this: "Two serious cases of suspected but unconfirmed COVID-19 were reported, both in the vaccine group, and narratives were reviewed...Among 3410 total cases of suspected but unconfirmed COVID-19 in the overall study population, 1594 occurred in the vaccine group vs. 1816 in the placebo group."
Data about effect of pregnancies is incomplete, thought I read elsewhere a handful of vaccinated women later became pregnant.
Finally, the study will continue for two years after injection to check for mid-term AEs. These are now unknown. Long term, i.e. 2+ years, adverse effects are also unknown. For instance, nobody knows how this vaccine could interact with a mutated virus.
EFFICACY
The experiment itself and disposition has a few important points, such as that it "excluded participants at high risk of SARSCoV-2 infection or with serological evidence of prior or current SARS-CoV-2 infection". So the results only apply to those not at high risk.
Testing, if I understand it correctly, was not uniform, but driven by symptoms: "Efficacy is being assessed throughout a participant's follow-up in the study through surveillance for potential cases of COVID-19. If, at any time, a participant develops acute respiratory illness, an illness visit occurs" then a PCR test was done---if this was after the second dose.
If that's right, then mild infections will have gone unnoticed. This isn't necessarily against the vaccine, because a mild infection is better than a serious one. But it will skew the efficacy numbers, perhaps by a lot.
Here's the main efficacy table:
There are others by age, sex, and comorbidity that you can look up. The efficiency is high (I'd use a beta-binomial with 1 and 1, which would widen the intervals).
As I've said before, trial numbers in medical experiments always look better than real-life numbers, and I'd bet good money these numbers will shrink. I have no idea by how much. I'd be (pleasantly) surprised if in real life it was much north of 50%.
How? Easily: the people who jump at the chance of these trials might not look like, in a COVID causal sense, those in the general population. Recall it skews against serious infections. Plus, routine testing is increase, meaning the mild infections the study missed will be picked up.
Plus, just like that Danish mask study, this trial represents the ideal: the vaccines were likely handled with great care, the shots, too, and the follow ups, and so on. Real life is much messier.
Double plus, we don't know how long the vaccine will last, even if it works.
No idea yet of the progress of those who got the doom even after being vaccinated. Too early. Interestingly---and you should have noticed this---there were only 2 deaths in the vaccine group and 4 in the placebo. Even though 9 people in the vaccine group and 169 people in the placebo group got it.
Too early for deaths to be noticed---or the doom isn't that deadly? The deaths in the placebo group were not doom deaths.
There is another most remarkable thing. How many of these infections are false positives? Any false negatives?
We've seen lots of reports of PCR tests giving false positives around ~0.1-1%. That means we'd see around 20 to 200 or so positives in each group. That's near the number of placebo positives. That's if testing were routine----which is wasn't.
So either there are no false positives on this sensitive test as we normally see----or these experimenters were exceedingly careful in the vaccine group at identifying positives, and maybe not so good in the placebo group. Could the data have been unblinded?
Feel free, as always, to dismiss my opinion. Also feel free to reject Pfizer's and the FDA's opinion, too.
CONCLUSION
There isn't one. As I started, I end. Whether you take this vaccine should be up to you.
First, are you at risk of dying from the coronadoom? Not really; not if you're young and healthy. If you're old and not, then you have a higher risk, but there's still at least a 10 times chance you'll croak of something else.
Their numbers are: 9/18,559 = 0.05% got the doom in the vaccine group, and 169/18,708 = 0.9% got the doom in the placebo group. Rather, were measured to have it after symptoms developed. Nobody in the roughly 40,000 people studied died of the doom.
For 19-55, it was 5/9897 = 0.05% in the vaccinated and 114/9955 = 1% in the placebo.
For 55+, it was 3/7500 = 0.04% in the vaccinated and 48/7543 = 0.6% in the placebo.
So it's about the same for any age. The younger are slightly more likely to get the bug without the vaccine, but then they're also more likely not to suffer from it, as other stats show.
My prediction, which you may dismiss, is that that ~0.05% rises, while the 0.9% (1% or 0.6%) won't change much.
Suppose it doubles, which I believe to be the minimum increase. Then, if you're 55+, it's 0.1% versus 0.6%. My best guess is it will be closer to to 0.2% to 0.3% versus the higher number.
Is that 0.5% reduction enough for you, given the adverse events you might suffer? Is the test as sharp as they said in the experiment, seemingly with no error? If not, the differences between groups will be even smaller.
Do you trust them enough?
I can't answer for you. You have to answer yourself. The government must not be allowed to decide for you.
Other ethical questions, such as whether the vaccine was derived using the bodies killed by Planned Parenthood, I leave out.
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