Posted on 08/23/2021 7:49:22 PM PDT by DoodleBob
--------------------------- INDICATIONS AND USAGE ----------------------------
COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.
...
------------------------------ ADVERSE REACTIONS ------------------------------
• In clinical studies of participants 16 through 55 years of age, the most commonly reported adverse reactions (≥10%) were pain at the injection site (88.6%), fatigue (70.1%), headache (64.9%), muscle pain (45.5%), chills (41.5%), joint pain (27.5%), fever (17.8%), and injection site swelling (10.6%). (6.1)
...
The safety of COMIRNATY was evaluated in participants 16 years of age and older in 2 clinical studies conducted in Germany (Study 1), United States, Argentina, Brazil, Turkey, South Africa, and Germany (emphasis added) (Study 2)... Study C4591001 (Study 2) is a Phase 1/2/3 multicenter, multinational, randomized, saline placebo-controlled, double-blinded (Phase 2/3), dose-finding, vaccine candidate-selection and efficacy study that has enrolled approximately 44,047 participants (22,026 COMIRNATY; 22,021 placebo) 16 years of age or older (including 378 and 376 participants 16 through 17 years of age in the vaccine and placebo groups, respectively)...At the time of the analysis of the ongoing Study 2 with a data cut-off of March 13, 2021, there were 25,651 (58.2%) participants (13,031 COMIRNATY and 12,620 placebo) 16 years of age and older followed for ≥4 months after the second dose.
...
First COVID-19 occurrence from 7 days after Dose 2 in participants without evidence of prior SARS-CoV-2 infection:
COMIRNATY N=19,993; (Covid) Cases: 77
Placebo N=20,118; (Covid) Cases: 833
Vaccine Efficacy %: 91.1%
(Excerpt) Read more at fda.gov ...
This approval was based on studies conducted not just in the US, but also Argentina, Brazil, Turkey, South Africa, and Germany. These countries were included in the studies underlying the EUA.
The inclusion of people in other countries isn't necessarily bad, but given differences in latitude (i.e., differences in ideally over a year to take into account seasonality), differences in each nation's compliance with lockdowns, masks, etc., this seems problematic.
One final thing: based on the surveillance time metrics, the test subjects were observed for about four months. Since the FDA usually conducts clinical trials for years, this is hardly a compelling 'approval' given that prevention effectiveness is usually tracked for a longer period of time.
In sum, clinical trials are like a baseball game, the EUA was akin to calling the game after about 1.5 outs, and this approval is like calling the game after about five outs...in both cases, with players spanning several countries each playing by their own rules.
And it does a piss poor job of prevention. Witness all the “breakthrough” cases of vaxed folks.
See tag.
No word about deaths in their literature.
No word about how the FDA gave approval with no control group.
IMHO, this was a rush job to end all rush jobs. Bad news.
Not true...they had a placebo group as big as the test group.
But the observation period, at about four months, is hardly adequate for assessing efficacy. This is especially true if the untested variants become the dominant form of the bug.
so according to them, not ONE person has died from the shot!
Efficacy is about 90-95 percent. This is with somewhat controlled situation. Actual real life efficacy (i.e.effectiveness)is usually less.
They did not address spike protein tox., whether pcr testing ruled out influenza, types of behaviour which avoided contracting covid. Did not address vaccinated people being carriers.
Still feel uncomfortable with no long term followup and novel pharmacology and mandate madness. As far as package inserts go...
Not too long.
Would be more inclined to get novavax product. Don’t like messing with genetic machinery. Death and case numbers appear to be dropping a bit. I will avoid all approximately 80% safe vaccinated folk as I believe they can be carriers and not know it.
COMIRNATY (COVID-19 Vaccine, mRNA) is a sterile suspension for injection for intramuscular use. COMIRNATY is supplied as a frozen suspension in multiple dose vials; each vial must be diluted with 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine. Each dose of COMIRNATY contains 30 mcg of a nucleoside-modified messenger RNA (mRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2.
Each 0.3 mL dose of the COMIRNATY also includes the following ingredients: lipids (0.43 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2-(polyethylene glycol 2000)-N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.2 mg cholesterol), 0.01 mg potassium chloride, 0.01 mg monobasic potassium phosphate, 0.36 mg sodium chloride, 0.07 mg dibasic sodium phosphate dihydrate, and 6 mg sucrose. The diluent (0.9% Sodium Chloride Injection, USP) contributes an additional 2.16 mg sodium chloride per dose.
[i notice that graphene oxide isn’t an ingredient]
Since the Pfizer vaccine is now “approved,” is Pfizer now responsible for any “unfortunate consequences” experienced by the vaccinated?
Article from which I drew:
IOW, can they be sued now?! :*)
Why didn’t they just go all the way and name it ChiComirnaty?
Plus or minus FOUR MONTHS. Saints preserve us. This is malpractice.
What do you think the “nucleoside-modified” in “30 mcg of a nucleoside-modified messenger RNA” means?
“What do you think the “nucleoside-modified” in “30 mcg of a nucleoside-modified messenger RNA” means?”
it means EITHER that the molecular structure of one or more of the nucleosides (RNA chain components) has been been tweaked from their “natural” or “native” form OR that the chain of nucleosides is not the exact sequence of the “native” antigen spike protein they’re tricking the cells into manufacturing, most likely the latter ...
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