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[__ Science __ ] Turns out Covid Vaccine was not tested. Phizer lied.
- Thread starter JLB
- Start date
jasonc
Member
Lol I remember him
Barbarian
Member
The Pfizer/BioNTech COVID-19 vaccine was the first to be granted emergency use authorization by the Food and Drug Administration on Dec. 11, 2020. The EUA was based on the interim results from the phase 3 randomized controlled trial involving 36,523 participants — about half receiving the vaccine and the other half getting a placebo — showing the vaccine “was 95% effective in preventing COVID-19 disease among these clinical trial participants with eight COVID-19 cases in the vaccine group and 162 in the placebo group,” the FDA said at the time.
Months later, on Aug. 23, 2021, the vaccine received full FDA approval, after a review of the manufacturing process, ongoing results from the clinical trial and safety monitoring. At that point, the FDA reviewed updated trial results on about 20,000 vaccine and 20,000 placebo recipients showing the vaccine was 91% effective in preventing symptomatic COVID-19.
Yet, various social media posts in May have claimed that “just released” Pfizer documents show the vaccine is “12% effective.” That appears to be a misunderstanding of the Pfizer FDA briefing document released in December 2020, before the EUA was granted.
Hundreds of thousands of pages of Pfizer documents on its vaccine trial have been released as part of a Freedom of Information Act request, but two experts who have looked into the 12% claim — a biostatistician and an epidemiologist — have said those FOIA documents don’t appear to be the source of the claim.
“FDA Approves First COVID-19 Vaccine.” Press release. FDA.gov. 11 Dec 2020.
Public Health and Medical Professionals for Transparency. Pfizer’s Documents. accessed 13 May 2022.
Siri Glimstad letter to FDA. Freedom of Information Act Request Expedited Processing Requested. 27 Aug 2021.
Public Health and Medical Professionals for Transparency v. Food and Drug Administration. U.S. District Court for the Northern District of Texas. No. 4:21-cv-1058-P. Order. 6 Jan 2022.
Vaccines and Related Biological Products Advisory Committee Meeting. “FDA Briefing Document, Pfizer-BioNTech COVID-19 Vaccine.” FDA.gov. 10 Dec 2020.
“Vaccines and Related Biological Products Advisory Committee December 10, 2020 Meeting Announcement.” FDA.gov. 10 Dec 2020.
Morris, Jeffrey. “Do the recent 80k pages of Pfizer documents released really show vaccine efficacy was only 12%?” COVID-19 Data Science. 5 May 2022.
Elijah, Sonia. “Was Pfizer’s 95% vaccine efficacy fraudulent all along?” Substack. 3 Apr 2022.
Meyerowitz-Katz, Gideon. “Covid-19 Vaccines Are Still Effective.” Medium. 6 May 2022.
“A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals.” Clinical Protocol. Pfizer. Nov 2020.
Xpert Xpress SARS-CoV-2. Instructions for Use. FDA.gov. 2021.
Centers for Disease Control and Prevention. “Science Brief: COVID-19 Vaccines and Vaccination.” 15 Sep 2021.
Lopez Bernal, Jamie et al. “Effectiveness of Covid-19 Vaccines against the B.1.617.2 (Delta) Variant.” New England Journal of Medicine. 21 Jul 2021.
Tenforde, Mark W. et al. “Effectiveness of mRNA Vaccination in Preventing COVID-19–Associated Invasive Mechanical Ventilation and Death — United States, March 2021–January 2022.” Morbidity and Mortality Weekly Report. 18 Mar 2022.
Months later, on Aug. 23, 2021, the vaccine received full FDA approval, after a review of the manufacturing process, ongoing results from the clinical trial and safety monitoring. At that point, the FDA reviewed updated trial results on about 20,000 vaccine and 20,000 placebo recipients showing the vaccine was 91% effective in preventing symptomatic COVID-19.
Yet, various social media posts in May have claimed that “just released” Pfizer documents show the vaccine is “12% effective.” That appears to be a misunderstanding of the Pfizer FDA briefing document released in December 2020, before the EUA was granted.
Hundreds of thousands of pages of Pfizer documents on its vaccine trial have been released as part of a Freedom of Information Act request, but two experts who have looked into the 12% claim — a biostatistician and an epidemiologist — have said those FOIA documents don’t appear to be the source of the claim.
Sources
“FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine.” Press release. FDA.gov. 11 Dec 2020.“FDA Approves First COVID-19 Vaccine.” Press release. FDA.gov. 11 Dec 2020.
Public Health and Medical Professionals for Transparency. Pfizer’s Documents. accessed 13 May 2022.
Siri Glimstad letter to FDA. Freedom of Information Act Request Expedited Processing Requested. 27 Aug 2021.
Public Health and Medical Professionals for Transparency v. Food and Drug Administration. U.S. District Court for the Northern District of Texas. No. 4:21-cv-1058-P. Order. 6 Jan 2022.
Vaccines and Related Biological Products Advisory Committee Meeting. “FDA Briefing Document, Pfizer-BioNTech COVID-19 Vaccine.” FDA.gov. 10 Dec 2020.
“Vaccines and Related Biological Products Advisory Committee December 10, 2020 Meeting Announcement.” FDA.gov. 10 Dec 2020.
Morris, Jeffrey. “Do the recent 80k pages of Pfizer documents released really show vaccine efficacy was only 12%?” COVID-19 Data Science. 5 May 2022.
Elijah, Sonia. “Was Pfizer’s 95% vaccine efficacy fraudulent all along?” Substack. 3 Apr 2022.
Meyerowitz-Katz, Gideon. “Covid-19 Vaccines Are Still Effective.” Medium. 6 May 2022.
“A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals.” Clinical Protocol. Pfizer. Nov 2020.
Xpert Xpress SARS-CoV-2. Instructions for Use. FDA.gov. 2021.
Centers for Disease Control and Prevention. “Science Brief: COVID-19 Vaccines and Vaccination.” 15 Sep 2021.
Lopez Bernal, Jamie et al. “Effectiveness of Covid-19 Vaccines against the B.1.617.2 (Delta) Variant.” New England Journal of Medicine. 21 Jul 2021.
Tenforde, Mark W. et al. “Effectiveness of mRNA Vaccination in Preventing COVID-19–Associated Invasive Mechanical Ventilation and Death — United States, March 2021–January 2022.” Morbidity and Mortality Weekly Report. 18 Mar 2022.
Barbarian
Member
It turns out, it's about 83% effective at stopping transmission of the newer variants. That's an additional benefit; the intent is to keep the vaccinated person from dying or becoming seriously ill with the virus.
More lies from the left. The world is already burning their stores of vaccines because it’s dangerous and is useless.
Gold-Standard” RCT from Gates-Funded Company Proves Ivermectin Works Against COVID
For nearly two years, Dr. Pierre Kory has been trying to tell the United States and the world that Ivermectin is highly effective in preventing COVID-19. On January 5, following the release of “the 16th positive, statistically significant trial” reinforcing the effectiveness of the affordable drug, Kory reiterated that same message. Indeed, the latest study proving Ivermectin’s effectiveness was a gold-standard randomized clinical trial (RCT) conducted by MedinCell.
The study, conducted on 399 patients, met its primary efficacy endpoint with a reduction of 75 percent of COVID-19 infection in the group treated with daily oral administration of Ivermectincompared to the placebo group. All participants were unvaccinated adults and had been exposed to the virus within five days of screening after documented close contact with a person who had a PCR-confirmed SARS-CoV-2 infection. After administering Ivermectin for 28 days, the drug showed acceptable safety and tolerability with zero unforeseen safety signals.
The “A Study to Evaluate the Efficacy and Safety of Ivermectin in COVID-19 Prevention” clinical trial, called SAIVE (NCT 05305560), is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical study evaluating the safety and efficacy of Ivermectin tablets taken orally for 28 days under the oversight of a U.S.-based independent Data Monitoring Committee. The study was conducted in Bulgaria between March and November 2022. Participants were given 200 microgram/kg on Day 1, then 100 microgram/kg from Day 2 to Day 28. Speaking of the encouraging results, Christophe Douat, CEO of MedinCell, remarked:
“The SAIVE study provides encouraging data demonstrating efficacy and safety of Ivermectin in prevention of Covid-19 infection in a post-exposure situation. It supports the development of a long-acting injectable. Such a long-acting injectable would provide a complementary tool against COVID-19. Several candidate formulations of Ivermectin are ready for clinical batch manufacturing to start regulatory preclinical and clinical development. We will be reviewing the strategy for this asset based on this top line result and the upcoming comprehensive analysis of the study.”
The undeniably positive trial results for Ivermectin, with no unexpected side effects, should have quickly caught the attention of the FDA, CDC, WHO, and others as significantly as it did Dr. Kory. Especially given the high standards of the trial—it was a parallel-group, double-blinded, randomized, and placebo-controlled trial with little that could be done to improve the rigor of the design. Add that to the fact Ivermectin is a Nobel Prize winner and one of the safest drugs known. In 2017, the Journal of Antibiotics wrote, “Few, if any, other drugs can rival Ivermectin for its beneficial impact on human health and welfare.”
"Gold-Standard" RCT from Gates-Funded Company Proves Ivermectin Works Against COVID - UncoverDC
MedinCell, a Bill Gates-funded company, recently issued a benchmark randomized clinical trial proving Ivermectin successfully treats COVID.
www.uncoverdc.com
atpollard
Member
Why would you burn a liquid that has strict storage guidelines and a naturally limited shelf life?
Who are these fools burning something that they should just not purchase in the first place, or could just throw away?
https://www.stericycle.com/en-us/re...ine-waste-disposal-frequently-asked-questions
They are burning it because it's poison.
There is nothing you can post or say that will change anything.
Individual states are passing laws to ban and make the poisonous Chinese Virus Vaccine illegal.
It does nothing.
It destroys peoples lives, while enriching those whom the Globalists pay off to promote their poison.
JLB
Barbarian
Member
It turns out, it's about 83% effective at stopping transmission of the newer variants. That's an additional benefit; the intent is to keep the vaccinated person from dying or becoming seriously ill with the virus.
November 2021:
The vaccine rollout has affirmed those findings.
Fully vaccinated people made up about 9% of reported COVID-19 deaths in 13 U.S. jurisdictions between April and July, according to the Centers for Disease Control and Prevention. CDC studies have also shown unvaccinated people are 10 times more likely to be hospitalized with COVID-19.
More recent variants are more infectious: From Korea., March 2023
Vaccine effectiveness (VE) of four doses of COVID-19 vaccine against BA.5 infection among COVID-naïve participants was 16.1%, while it was 89.5% and 94.3% among those previously infected with BA.1 and BA.2, respectively.
VE of two doses against critical BA.5 was low in all groups, including COVID-naïve participants (41.5%) and those previously infected with BA.1 (53.1%) and BA.2 (50.0%). But four-dose VE against critical BA.5 was 90.9% among COVID-naïve participants and 93.9% and 92.9% among those with previous BA.1 and BA.2 cases, respectively.
www.cidrap.umn.edu
Still, over 90% effective against infection itself is pretty darn good. It is of course much better at preventing severe illness or death.
That's what the data say. No point in denials:
November 2021:
The vaccine rollout has affirmed those findings.
Fully vaccinated people made up about 9% of reported COVID-19 deaths in 13 U.S. jurisdictions between April and July, according to the Centers for Disease Control and Prevention. CDC studies have also shown unvaccinated people are 10 times more likely to be hospitalized with COVID-19.
Fact check: Vaccines protect against contracting, spreading COVID-19
While vaccinated people can still get COVID-19, experts say the shots provide considerable protection against the virus.
www.usatoday.com
Vaccine effectiveness (VE) of four doses of COVID-19 vaccine against BA.5 infection among COVID-naïve participants was 16.1%, while it was 89.5% and 94.3% among those previously infected with BA.1 and BA.2, respectively.
VE of two doses against critical BA.5 was low in all groups, including COVID-naïve participants (41.5%) and those previously infected with BA.1 (53.1%) and BA.2 (50.0%). But four-dose VE against critical BA.5 was 90.9% among COVID-naïve participants and 93.9% and 92.9% among those with previous BA.1 and BA.2 cases, respectively.
4 COVID vaccine doses best prevent critical Omicron BA.5, even after BA.1/BA.2 infection
Protection of 4 doses of COVID vaccine against BA.5 infection among COVID-naïve participants was 16.1%, while it was 89.5% and 94.3% among those previously infected with BA.1 and BA.2, respectively.
Still, over 90% effective against infection itself is pretty darn good. It is of course much better at preventing severe illness or death.