https://dailymed.nlm.nih.gov/dailymed/dailymed-announcements-details.cfm?date=2021-09-13
"SEPTEMBER 13, 2021
Pfizer received FDA BLA license for its COVID-19 vaccine
Pfizer received FDA BLA license on 8/23/2021 for its COVID-19 vaccine for use in individuals 16 and older (COMIRNATY). At that time, the FDA published a BLA package insert that included the approved new COVID-19 vaccine trade name COMIRNATY and listed 2 new NDCs (0069-1000-03, 0069-1000-02) and images of labels with the new tradename.
At present, Pfizer does not plan to produce any product with these new NDCs and labels over the next few months while EUA authorized product is still available and being made available for U.S. distribution. As such, the CDC, AMA, and drug compendia may not publish these new codes until Pfizer has determined when the product will be produced with the BLA labels."
13 comments:
This is a MUST-READ. It may be the FIRST TIME a politician has ever told the truth!
https://off-guardian.org/2021/10/30/watch-meps-protest-vaccine-passports/
The Executive, Legislative and Judicial branches of the Federal Government have all been captured by the CCP and Communists. "We the People with the Constitution are on our own."?
So, per Biden’s edict, Americans who work at a company that employs more than 100 people have no choice but to get vaccinated. The same standard applies to the health care workers who have heroically put their lives on the line treating COVID-19 patients.
But for reasons unexplained, Biden refuses to mandate vaccines for the 59 million Americans who receive welfare benefits.
Put another way, Biden is mandating that the Americans who supply most of the tax revenue to pay for America’s welfare system be vaccinated or lose employment. But the beneficiaries of the welfare state are exempt.
Major Law Firm Confirms FDA Deceived America With Its ‘Approval’ Of Pfizer Vax.
https://rightsfreedoms.wordpress.com/2021/09/26/major-law-firm-confirms-fda-deceived-america-with-its-approval-of-pfizer-vax/
what does BLA stand for?
Hi, Ms. Nass.
Love your blog and follow every day. Good job. Thank you
Could you explain me why Dr. Michael Kurilla said that nobody died from heart problem after vaccine when there is a lot of information of teenagers and young people who died?
He does not read or does not believe?
Thanks
Gail
1.) All you need to know about COVID vaccine safety!
https://www.skirsch.com/covid/All.pdf
2.) US COVID-19 Vaccines Proven to Cause More Harm than Good Based on Pivotal Clinical Trial Data Analyzed Using the Proper Scientific Endpoint, “All Cause Severe Morbidity”. J. Bart Classen, MD*
https://www.scivisionpub.com/pdfs/us-covid19-vaccines-proven-to-cause-more-harm-than-good-based-on-pivotal-clinical-trial-data-analyzed-using-the-proper-scientific--1811.pdf
3.) Sean Hartman: 17-Year-Old Boy Dies Shortly After Receiving The Pfizer COVID-19 Vaccine.
https://thecovidworld.com/sean-hartman-17-year-old-boy-dies-several-weeks-after-receiving-the-covid-19-vaccine/
4.) Healthy 16-year-old boy dies during online class after second Pfizer jab: VAERS database.
https://www.lifesitenews.com/news/healthy-16-year-old-boy-dies-during-online-class-after-second-pfizer-jab-vaers-database/
5.) Police officer and father of four can’t walk after taking mandatory COVID jab,
https://www.lifesitenews.com/news/police-officer-and-father-of-four-cant-walk-after-taking-mandatory-covid-jab/
6.) SHOCKING: Dr. Carrie Madej Releases FIRST LOOK at Pfizer Vial Contents.
https://rumble.com/vnzy9f-shocking-dr.-carrie-madej-releases-first-look-at-pfizer-vial-contents.html
A comparison of official Government reports suggest the Fully Vaccinated are developing Acquired Immunodeficiency Syndrome.
https://theexpose.uk/2021/10/10/comparison-reports-proves-vaccinated-developing-ade/
Latest UK PHE Vaccine Surveillance Report figures on Covid cases show that doubly vaccinated 40-70 year olds have lost 40% of their immune system capability compared to unvaccinated people. Their immune systems are deteriorating at around 5% per week (between 2.7% and 8.7%). If this continues then 30-50 year olds will have 100% immune system degradation, zero viral defence by Christmas and all doubly vaccinated people over 30 will have lost their immune systems by March next year.
FDA Admits MORE Serious Adverse Effects From Pfizer Vaccine ‘May Become Apparent’ With Widespread Use.
https://odysee.com/@AlexJonesChannel:c/FDAAdmitsMORESeriousAdverseEffectsFromPfizerVaccineMayBecomeApparentWithWidespreadUse:2
Adverse Reaction's Covid Vaccine:
https://odysee.com/@Adverse:c/adv34273940:9
Dr. Fauci funded over 60 projects in China related to COVID and all were under the Chinese Military complex. 'Fauci gave funding to the Chinese military to research COVID as a biological weapon.'
https://www.thegatewaypundit.com/2021/10/official-tgp-performs-better-analysis-reporting-bidens-entire-intel-community-claims-covid-not-biological-weapon-created-china/
Estimate is VACCINE FAILURE RATE = 96.11%
VACCINE EFFECTIVENESS = 3.89%
Of 8,086 after-covid shot deaths reported Oct. 29, data through Oct. 22, 2021 via US Centers for Disease Control and Prevention/US Food and Drug Administration Vaccine Adverse Events Reporting System, VAERS:
3,141 died after 2 shots.
Of these:
1,240 in 0-14 days after covid shots
1,782 more than 15 days after covid shots.
This count of 1,782, according to CDC, are those deemed 'fully vaccinated.'
VAERS DATA: 1,782 died more than 14 days after 2 vax
SARS-COV-2 TEST NEGATIVE 25 or 1% [0.0142918]
SARS-COV-2 TEST POSITIVE 618 or 35% [0.34680135]
[[This is 24.265787 TIMES MORE POSITIVE COVID TESTs than NEGATIVE]]
UNKNOWN 1,139 if pos or neg = 64%
Were data on this 1,139 known, that would be one thing. However, as is now widely known, VE = ZERO, or if you prefer, covid shots VE tends toward ZERO. Unlike other vaccines that actually work, we've all heard about the call for 'boosters' -- an acknowledgment that VE = ZERO, or if you prefer tends toward ZERO.
The data shows this as well, from VAERS involving those 15+ days after "fully vaccinated" -- the longer the time span, the more positive covid tests reported, and the less negative test reported.
If this distribution of data in hand holds, given 34% of known data [and given UNKNOWN = 1,139 if is pos or neg] -- then estimate would show and overall:
VACCINE FAILURE RATE = 96.11%
VACCINE EFFECTIVENESS = 3.89%
Measuring those that died more than 14 days after covid shot #2, and were tested for SARS CoV2.
As follows:
25/[618+25]643 = 0.03888
618/643 = 0.9611
VAERS DATA
Breakdown as follows:
316 died 15-30 days after 2 vax
SARS-COV-2 TEST NEGATIVE 12 [23%]
SARS-COV-2 TEST POSITIVE 40 [77%]
COVID-19 50
COVID-19 PNEUMONIA 14
VACCINE BREAKTHROUGH INFECTION 3
363 died 31-60 days
SARS-COV-2 TEST NEGATIVE 6 [9%]
SARS-COV-2 TEST POSITIVE 60 [91%]
COVID-19 70
COVID-19 PNEUMONIA 26
VACCINE BREAKTHROUGH INFECTION 9
330 died 61-120 days
SARS-COV-2 TEST NEGATIVE 2 [2%]
SARS-COV-2 TEST POSITIVE 112 [98%]
COVID-19 143
COVID-19 PNEUMONIA 51
VACCINE BREAKTHROUGH INFECTION 15
773 died more than 120 after 2 vax
SARS-COV-2 TEST NEGATIVE 5 [1%]
SARS-COV-2 TEST POSITIVE 406 [99%]
COVID-19 542
COVID-19 PNEUMONIA 138
VACCINE BREAKTHROUGH INFECTION 73
119 died unknown how long after 2 vax
SARS-COV-2 ANTIBODY TEST 2
SARS-COV-2 ANTIBODY TEST NEGATIVE 1
SARS-COV-2 TEST 3
SARS-COV-2 TEST POSITIVE 3
COVID-19 17
COVID-19 PNEUMONIA 1
For above,
Manufacturers
MODERNA 40%
PFIZER\BIONTECH 60%
Female 751 or 42%
Male 985 or 55%
Unknown 46 or 3%
Total 1,782 100%
6-17 years 2 or <1%
18-29 years 14 or 1%
30-39 years 28 or 2%
40-49 years 42 or 2%
50-59 years 92 or 5%
60-64 years 105 or 6%
65-79 years 697 or 39%
80+ years 797 or 45%
Unknown 5 or <1%
Total 1,782 100%
-30-
PS
The 36% is not good, but stratifying above data provide more than double the overall VAERS reporting on covid tests on all after-shot deaths reported to CDC [about 16.1% overall has been reported].
And even with paltry data on this, pattern showing VE tends towards zero holds.
Dec. 2020, first month of shots, 18 deaths after shot, with 1 negative test and zero positive tests, or 5.6% of total. This would "show" VE = 100%
Jan 2021 466 deaths, 66 test reports on VAERS; 25 neg. 41 pos., or 14.1% -- and "show" VE = 38%
Feb, 39 neg 53 pos, 42%
March, 33 and 51, 39%
April, 35 and 59, 34%
May, 26 and 75, 26%
June, 17 and 98, 16%
July, 7 and 73, 9%
Aug., 7 and 176, 4%
Sept., 9 and 303, 3%
Oct., 6 and 191, 3%
Deaths reported by month
Dec., 2020 18
Jan., 2021 468
Feb., 2021 777
Mar., 2021 1,207
Apr., 2021 1,313
May, 2021 725
Jun., 2021 689
Jul., 2021 535
Aug., 2021 731
Sep., 2021 904
Oct., 2021 618
Unknown Date 83
Total 8,068
Meryl--given the fact that the military didn't make the EUA shots mandatory--and only made the vax mandatory after COMIRNATY was approved--how can they now make military service members get this shot?
My Navy son-in-laws religious exemption was denied--he is preparing an appeal--I'm wondering what would be the best course to take?
He was NEVER given the pfizer FDA document that the law requires him to see in order to give informed consent https://www.fda.gov/media/150386/download
see page 6 https://www.justice.gov/olc/file/1415446/download
AND since COMIRNATY isn't available--how can they still force this vax on these men and women?
This article quotes a jag officer--she goes back to the anthrax vaccine fiasco...and shows that servicemembers had very little success in fighting the order...but she also says that the anthrax vax was FDA approved.
https://sites.duke.edu/lawfire/2021/02/18/can-troops-be-ordered-to-take-the-covid-vaccine-a-guest-post-analyzes-the-law/
We are hoping he won't get separatedhe will lose ALL his training (corpsman/degree and certification in optometry) AND may even have to pay the Navy back....Any thoughts or advice would be most welcome.
THANK YOU FOR ALL YOU DO
The CDC flat out lies and says no kids died from myocarditis. We know of several deaths, and more are reported to VAERS.
BLA stands for Biologics license application. A biologic is a vaccine or certain drugs like monoclonal antibodies.
About one of the Anonymous posts: Don’t rely on Steve Kirsch. Though he does offer some good advice he also pushes Fluvoxamine as a treatment for Covid. Maybe it does work in that regard but it is still a psychoactive drug, specifically a Selective Serotonin Reuptake Inhibitor (SSRI). There are much better treatments (which ironically he knows about and mentions). Run like hell from this intelligent idiot.
My last post could have been a little more “nuanced.” If Fluvoxamine fights covid it might be useful if the doctor has to throw everything at a recalcitrant case, used just that one time and with the consent of the patient after telling them it is an SSRI.
In my (non-medical person’s) opinion an SSRI should never be used as a prophylactic. Kirsch sees no problem with Fluvoxamine at all and seems to think it should always be used as part of a “cocktail” when treating covid.
Post a Comment