The Conservative Cave
Current Events => The DUmpster => Topic started by: Texacon on November 04, 2022, 12:01:50 PM
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https://www.democraticunderground.com/100217317848
Believe what you want. Myself, I'm thinking these vaccines are causing some of this, and I have anecdotal evidence. SVP feel free to light me up, I don't mind. I know we have differing opinions on this and that's fine. I've been watching this for awhile and I'm still watching.
Nittersing (5,171 posts)
Strokes, heart attacks, sudden deaths: Does America understand the long-term risks of catching COVID
"A 35-year-old acquaintance drops dead from a hemorrhagic stroke. A friend in her 40s, and another in his 70s, experience recurrent spells of extreme dizziness, their hearts pounding in their chests when they stand. A 21-year-old student with no prior medical history is admitted to the ICU with heart failure, while a 48-year-old avid tennis player, previously healthy, suddenly suffers a heart attack. A relative is diagnosed with pericarditis, an inflammation of the protective sac surrounding the heart.
I can’t confirm the exact etiology of all these cases. But every one of the people I mentioned had a history of COVID either days or months beforehand–and all of them experienced only mild cases of infection at the time.
Is it possible, despite everything we know, that we still underestimate COVID’s reach and danger? It is not normal for me to know so many people with severe conditions. Not normal at all.
Lengthy social media threads have begun compiling lists of people much like those mentioned above, and while there are many possible causes for their health misfortunes, the sheer volume of cases speaks to something more worrisome than just a Twitter phenomenon."
https://fortune.com/2022/10/06/strokes-heart-attacks-sudden-death-america-long-term-risks-catching-covid-carolyn-barber/
Per usual, the DUmmies don't read the article. The article actually states the vaccinated are experiencing the same things. But you still get this;
Wounded Bear (53,589 posts)
5. Anti-vaxxers are blaming them all on the vaccines...
Initech (93,955 posts)
15. No, and the MAGA lunatics would rather drop dead than "comply".
It's going to be interesting to see how this shakes out in the years to come. There are many, many, of us who are not vaccinated. The comparisons over the years should be easy.
KC
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:panic:
A coward dies a thousand times before Death finally comes for them. The courageous face Death only once.
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Strokes, heart attacks, sudden deaths: Does America understand the long-term risks of catching COVID
DUchebag that describes the VERS reports on the covid jab not on covid.
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1. One would have to search to find someone who does not believe Covid exists or that Covid is never serious. So DUmmie Nittersing is whaling away at a straw man.
2. Vaccination does not prevent infection.
3. Recovery from Covid does not prevent infection.
4. Moronic shutdowns and panic - people unable or too afraid to obtain medical treatment for non-Covid diseases - have killed tens or hundreds of thousands, i.e. non-Covid "excess deaths".
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Anecdotally, people who get the kung flu seem to be suffering more health issues, sometimes fatally. Anecdotally, people who got shots seem to be suffering more health issues, sometimes fatally. My two bits is that the virus itself is insanely random, possibly due to the gain of function research done on it, and the shots are equally random, both in their effectiveness and their side effects, short and long term.
It's all anecdotal, and is going to be nearly impossible to actually track, which is fuel for crazy vaccine worshipers as well as crazy anti-vaxxers. Whatever China (and Faucci?) invested in creating COVID-19, they got back a hundred fold in chaos around the world.
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Anecdotally, people who get the kung flu seem to be suffering more health issues, sometimes fatally. Anecdotally, people who got shots seem to be suffering more health issues, sometimes fatally. My two bits is that the virus itself is insanely random, possibly due to the gain of function research done on it, and the shots are equally random, both in their effectiveness and their side effects, short and long term.
It's all anecdotal, and is going to be nearly impossible to actually track, which is fuel for crazy vaccine worshipers as well as crazy anti-vaxxers. Whatever China (and Faucci?) invested in creating COVID-19, they got back a hundred fold in chaos around the world.
I don’t know about it being hard to track. I think there is enough of a control to see what’s going on, BUT I think it will be years, if not decades before we know if the vaccines were the cause or the virus was the cause.
It’s definitely going to be interesting to watch. Especially as you have families growing.
This is science. You watch and compare.
I didn’t knock anyone getting the shot nor anyone not getting it. It was an individual decision that should never have been made as difficult as it was.
KC
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Perhaps in some cases, it's karma:
(https://images2.imgbox.com/c7/bb/e7Njz9mW_o.jpg)
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I would have to agree.
If someone wants the Vaccine, go for it. Hell, if you want to wear a mask, knock yourself out. I had Covid twice. The first time was at the beginning of the Pandemic. So, original strength if you will. Yeah, it sucked. Not going to lie. But recovered. Not once did I consider even consider the Vaccine when it was available for me. Then, I got it again around June of this year. I barely remember the symptoms.
But something strange is going on with what appears to be reasonably healthy people, falling over dead.
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I was very suspicious of these vaccines from day one. After bird flu scares, mad cow scares, Sars scares, covid suspicious too for that matter. Anyway, no reasonable person can expect a full and viable medicine to reach market in 3 months. It just doesn't happen. It takes at minimum a decade of study for r&d (this is from reading countless prospectus on medical stocks) my concern was met with scorn from family that still refuses to apologize after the j&j vaccine almost killed my father.
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I was very suspicious of these vaccines from day one. After bird flu scares, mad cow scares, Sars scares, covid suspicious too for that matter. Anyway, no reasonable person can expect a full and viable medicine to reach market in 3 months. It just doesn't happen. It takes at minimum a decade of study for r&d (this is from reading countless prospectus on medical stocks) my concern was met with scorn from family that still refuses to apologize after the j&j vaccine almost killed my father.
I'm about 99 percent sure it took my mother, early in the year this year.
One thing you learn from such a thing:
There is no dealing with left leaning true believers who are convinced that government always has your best interests in mind. They literally have to face death and either die or come very close to it, to be disabused of that notion.
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It’s why I’m still watching. It will take time to figure out what’s going on since even the vaccinated are getting, and passing the virus. It will be difficult to determine if the virus caused the damage and death, or if it was the vaccine.
I’m glad there’s a huge control group.
None in my family got vaccinated. My son in law died. He had complicating issues. Would he have died if he was vaccinated? I don’t know.
KC
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... Anyway, no reasonable person can expect a full and viable medicine to reach market in 3 months. ...
* BioNTech was founded in 2008, specifically to study and develop mRNA- based vaccines and treatments. Moderna was founded in 2008, specifically to study and develop mRNA- based vaccines and treatments.
* Janssen Research/Johnson & Johnson
February 18, 2020 - HHS to work with Janssen Research to develop a Covid-19 vaccine; https://www.hhs.gov/about/news/2020/02/18/hhs-janssen-collaborate-to-develop-coronavirus-therapeutics.html ; obviously, Janssen began their development research and work before HHS became involved, probably in January.
March 30, 2020 - HHS accelerated clinical trial of a potential coronavirus vaccine developed by Janssen Research & Development; https://www.hhs.gov/about/news/2020/03/30/hhs-accelerates-clinical-trials-prepares-manufacturing-covid-19-vaccines.html
March 30, 2020 - Johnson & Johnson announced selection of a lead COVID-19 vaccine candidate and an expansion of the partnership between the Janssen Pharmaceutical and BARDA; https://www.jnj.com/johnson-johnson-announces-a-lead-vaccine-candidate-for-covid-19-landmark-new-partnership-with-u-s-department-of-health-human-services-and-commitment-to-supply-one-billion-vaccines-worldwide-for-emergency-pandemic-use
July 30, 2020 - Janssen Research (Johnson & Johnson) COVID-19 vaccine began Phase I/IIa clinical trial in the US and Belgium; https://www.jnj.com/single-dose-of-johnson-johnson-covid-19-vaccine-candidate-demonstrates-robust-protection-in-pre-clinical-studies ; these tests are with human volunteers, not with cells in Petri dishes or with animals.
September 23, 2020 - Johnson & Johnson announced the start of its Phase III trial for its COVID-19 vaccine candidate developed by its Janssen Pharmaceutical Companies; the trial will enroll up to 60,000 volunteers across three continents; https://www.jnj.com/johnson-johnson-initiates-pivotal-global-phase-3-clinical-trial-of-janssens-covid-19-vaccine-candidate ; https://www.janssen.com/johnson-johnson-initiates-pivotal-global-phase-3-clinical-trial-janssens-covid-19-vaccine-candidate
February 28, 2021 - Johnson & Johnson Covid vaccine receives Emergency Use Authorization; https://www.cbsnews.com/news/covid-vaccine-johnson-and-johnson-authorized-emergency-use/
Moderna - Phase III
January 7, 2020 - NIH and Moderna agreed to work on developing a vaccine against what came to be called Covid-19; https://www.hhs.gov/about/news/2020/12/18/hhs-dod-statements-fda-authorization-moderna-vaccine.html
January 13, 2020 - Moderna produced its first prototype sample of its vaccine; https://nymag.com/intelligencer/2020/12/moderna-covid-19-vaccine-design.html
March 16, 2020 - Phase I testing begins of Moderna's experimental coronavirus vaccine; at Kaiser Permanente Washington Health Research Institute, https://www.kpwashingtonresearch.org/news-and-events/recent-news/news-2020/kaiser-permanente-launches-coronavirus-vaccine-study-seattle , https://www.hhs.gov/about/news/2020/03/16/hhs-secretary-azar-statement-on-launch-of-phase-1-covid-19-vaccine-trial.html , https://www.nih.gov/news-events/news-releases/nih-clinical-trial-investigational-vaccine-covid-19-begins
April 16, 2020 - Enrollment was completed for Moderna's Phase I trial and additional test groups were added to the trial; https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-award-us-government-agency-barda-483-million
May 6, 2020 - The FDA approved the start of Phase II testing of Moderna's vaccine; https://investors.modernatx.com/news-releases/news-release-details/moderna-receives-fda-fast-track-designation-mrna-vaccine-mrna
May 12, 2020 - Moderna receives FDA Fast Track designation for coronavirus vaccine; https://investors.modernatx.com/news-releases/news-release-details/moderna-receives-fda-fast-track-designation-mrna-vaccine-mrna
May 29, 2020 - Moderna announces first participants dosed in Phase II study of coronavirus vaccine; https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-first-participants-each-age-cohort-dosed-phase
June 11, 2020 - Enrollment of the younger adults group of Moderna's Phase II trial was completed; https://investors.modernatx.com/news-releases/news-release-details/moderna-advances-late-stage-development-its-vaccine-mrna-1273
July 8, 2020 - Enrollment of the older adults group of Moderna's Phase II trial was completed; https://investors.modernatx.com/news-releases/news-release-details/moderna-completes-enrollment-phase-2-study-its-mrna-vaccine
July 26, 2020 - Moderna announced a modification to its contract with BARDA for additional funding to support late development, including the expanded Phase III study of its COVID-19 vaccine; https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-expansion-barda-agreement-support-larger-phase
July 27, 2020 - Moderna announced announced that the Phase III study of its COVID-19 vaccine has begun dosing participants; the randomized, placebo-controlled trial will include some 30,000 US participants; https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-phase-3-cove-study-mrna-vaccine-against-covid
October 22, 2020 - Moderna announced that it has completed enrollment of 30,000 participants in the Phase 3 study of its COVID-19 vaccine candidate, in collaboration with NIAID (part of NIH) and BARDA (part of the US Department of HHS); to date, more than 25,650 participants have received their second vaccination; https://investors.modernatx.com/news-releases/news-release-details/moderna-completes-enrollment-phase-3-cove-study-mrna-vaccine
November 16, 2020 - Moderna announced that the independent, NIH-appointed Data Safety Monitoring Board for the Phase 3 study of its vaccine candidate against COVID-19 has informed Moderna that the trial has met the statistical criteria in the study protocol for efficacy, with a vaccine efficacy of 94.5%; https://investors.modernatx.com/news-releases/news-release-details/modernas-covid-19-vaccine-candidate-meets-its-primary-efficacy
December 18, 2020 - Moderna's vaccine received Emergency Use Authorization from the FDA; https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-fda-authorization-moderna-covid-19-vaccine-us , https://www.fda.gov/news-events/press-announcements/fda-takes-additional-action-fight-against-covid-19-issuing-emergency-use-authorization-second-covid
Novavax
February 26, 2020 - Novavax announced it is testing several possible Covid vaccine candidates using animals; https://ir.novavax.com/2020-02-26-Novavax-Advances-Development-of-Novel-COVID-19-Vaccine
April 8, 2020 - Novavax announced it has selected a vaccine candidate for clinical trials; https://ir.novavax.com/2020-04-08-Novavax-Identifies-Coronavirus-Vaccine-Candidate-Accelerates-Initiation-of-First-in-Human-Trial-to-Mid-May
May 25, 2020 - Novavax Began Phase I/II Clinical Trial of COVID-19 Vaccine; https://ir.novavax.com/news-releases/news-release-details/novavax-initiates-phase-12-clinical-trial-covid-19-vaccine
August 17, 2020 - Novavax announced the beginning of a Phase IIb clinical trial in South Africa of its COVID-19 vaccine candidate; https://ir.novavax.com/news-releases/news-release-details/novavax-initiates-efficacy-trial-covid-19-vaccine-south-africa
August 24, 2020 - Novavax announced that the first volunteers have been enrolled in Phase II of its clinical trial of its Covid-19 vaccine; https://ir.novavax.com/news-releases/news-release-details/novavax-initiates-phase-2-portion-phase-12-clinical-trial-covid
September 24, 2020 - Novavax announced that it has initiated its first Phase 3 study in the UK to evaluate the efficacy, safety and immunogenicity of Novavax’ COVID-19 vaccine along with Novavax’ adjuvant; https://ir.novavax.com/news-releases/news-release-details/novavax-initiates-phase-3-efficacy-trial-covid-19-vaccine-united
November 09, 2020 - Novavax announced that the FDA has granted Fast Track Designation for the Company’s COVID-19 vaccine; https://ir.novavax.com/news-releases/news-release-details/novavax-covid-19-vaccine-granted-fast-track-designation-us-fda
In December 2020 or January 2021 I stopped updating my source file from which I'm C&P-ing selected events/dates, hence this time gap.
July 13, 2022 - Novavax Covid vaccine receives Emergency Use Authorization; https://covidblog.oregon.gov/novavax-becomes-fourth-covid-19-vaccine-authorized-by-fda/
Pfizer/BioNTech
March 16, 2020 - Pfizer announced partnership to develop BioNTech’s mRNA-based COVID-19 vaccines; https://www.pfizer.com/news/press-release/press-release-detail/pfizer_and_biontech_to_co_develop_potential_covid_19_vaccine ; Pfizer and BioNTech are two separate companies; the purpose of this partnership (and the partnership with Fosun Pharma in China) is production and distribution, capabilities BioNTech lacks; obviously, BioNTech started their development of a Covid vaccine in February or January 2020.
April 22, 2020 - Pfizer and BioNTech announced approval to begin Phase I/II trial of BioNTech’s COVID-19 vaccines in Germany; https://www.pfizer.com/news/press-release/press-release-detail/biontech_and_pfizer_announce_regulatory_approval_from_german_authority_paul_ehrlich_institut_to_commence_first_clinical_trial_of_covid_19_vaccine_candidates
April 29, 2020 - Pfizer and BioNTech announced that the first cohort of BioNTech’s Phase I/II clinical trial has been dosed; https://www.pfizer.com/news/press-release/press-release-detail/biontech-and-pfizer-announce-completion-dosing-first-cohort
May 5, 2020 - Pfizer and BioNTech announced that the first participants have been dosed in the US in the Phase I/II clinical trial; https://www.pfizer.com/news/press-release/press-release-detail/pfizer_and_biontech_dose_first_participants_in_the_u_s_as_part_of_global_covid_19_mrna_vaccine_development_program
July 13, 2020 - Pfizer Inc. and BioNTech announced that two of the companies’ COVID-19 vaccine candidates received Fast Track designation from the US FDA; both are currently undergoing Phase 1/2 clinical studies; https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-granted-fda-fast-track-designation-two
July 27, 2020 - Pfizer and BioNTech announced the start of a global Phase II/III clinical study of its COVID-19 vaccine, which will include up to 30,000 participants; https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-choose-lead-mrna-vaccine-candidate-0
August 12, 2020 - Pfizer and BioNTech announced that they have submitted an amended protocol to the FDA to expand the enrollment of their Phase III COVID-19 vaccine trial to up to approximately 44,000 participants, allowing for the enrollment of new populations; the company expects to reach its initial target of up to 30,000 participants next week; https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-propose-expansion-pivotal-covid-19
November 18, 2020 - Pfizer and BioNTech announced that, after conducting the final efficacy analysis in their ongoing Phase 3 study, their COVID-19 vaccine candidate met all of the study’s primary efficacy endpoints; analysis of the data indicates a vaccine efficacy rate of 95% (p<0.0001) in participants without prior SARS-CoV-2 infection; the companies also announced that the safety milestone required by the FDA for Emergency Use Authorization (EUA) has been achieved; Pfizer and BioNTech plan to submit a request within days for an EUA; https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine
December 11, 2020 - The FDA granted Emergency Use Authorization to the Pfizer/BioNTech vaccine; https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19 ; https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-celebrate-historic-first-authorization
Unlike traditional dead & weakened virus vaccines, mRNA vaccines (Moderna and Pfizer) and viral vector vaccines (Johnson & Johnson) do not require culturing the target virus, now experimentation with weakened or intact dead target viruses. Developing mRNA vaccines and viral vector vaccines requires knowledge and use of of the DNA sequence of the target virus. This saves considerable time in both development (months) and testing (more months). For example, Moderna had developed its prototype sample within 2 or 3 days of the DNA sequence of the SARS-CoV-2 virus. Similarly, in time savings, Moderna was dosing Phase 1 test participants in March 2020, and BioNTech was dosing Phase 1 test participants in April 2020.
IOW, while Trump's Operation Warp Speed did accelerate the testing process and Emergency Use Authorization accelerated bringing the vaccines into use, a significant amount of R & D and testing time was saved by the nature of the vaccine technologies used by J&J, Moderna, and Pfizer.
Novavax uses the traditional protein sub-unit technology (in use about as long as dead & weakened virus technology). This technology requires culturing the target virus or bacterium to identify characteristic proteins intrinsic to the target, altering cells (bacterium, animal cells, yeast cells, etc.) to produce that protein, culturing those altered cells, and then producing the target protein. Immune response to a protein sub-unit vaccine is less strong than, e.g., a dead or weakened virus, so an adjuvant, a general immune system stimulant, is needed and had to be selected. This probably is reflected in Novavax's slower vaccine development and slower time to testing with human volunteers. Being months behind even J&J probably resulted in Novavax becoming lower in priority, and thus delaying authorization into mid 2022.
Where "reach market in 3 months" came from mystifies me.
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* BioNTech was founded in 2008, specifically to study and develop mRNA- based vaccines and treatments. Moderna was founded in 2008, specifically to study and develop mRNA- based vaccines and treatments.
* Janssen Research/Johnson & Johnson
February 18, 2020 - HHS to work with Janssen Research to develop a Covid-19 vaccine; https://www.hhs.gov/about/news/2020/02/18/hhs-janssen-collaborate-to-develop-coronavirus-therapeutics.html ; obviously, Janssen began their development research and work before HHS became involved, probably in January.
March 30, 2020 - HHS accelerated clinical trial of a potential coronavirus vaccine developed by Janssen Research & Development; https://www.hhs.gov/about/news/2020/03/30/hhs-accelerates-clinical-trials-prepares-manufacturing-covid-19-vaccines.html
March 30, 2020 - Johnson & Johnson announced selection of a lead COVID-19 vaccine candidate and an expansion of the partnership between the Janssen Pharmaceutical and BARDA; https://www.jnj.com/johnson-johnson-announces-a-lead-vaccine-candidate-for-covid-19-landmark-new-partnership-with-u-s-department-of-health-human-services-and-commitment-to-supply-one-billion-vaccines-worldwide-for-emergency-pandemic-use
July 30, 2020 - Janssen Research (Johnson & Johnson) COVID-19 vaccine began Phase I/IIa clinical trial in the US and Belgium; https://www.jnj.com/single-dose-of-johnson-johnson-covid-19-vaccine-candidate-demonstrates-robust-protection-in-pre-clinical-studies ; these tests are with human volunteers, not with cells in Petri dishes or with animals.
September 23, 2020 - Johnson & Johnson announced the start of its Phase III trial for its COVID-19 vaccine candidate developed by its Janssen Pharmaceutical Companies; the trial will enroll up to 60,000 volunteers across three continents; https://www.jnj.com/johnson-johnson-initiates-pivotal-global-phase-3-clinical-trial-of-janssens-covid-19-vaccine-candidate ; https://www.janssen.com/johnson-johnson-initiates-pivotal-global-phase-3-clinical-trial-janssens-covid-19-vaccine-candidate
February 28, 2021 - Johnson & Johnson Covid vaccine receives Emergency Use Authorization; https://www.cbsnews.com/news/covid-vaccine-johnson-and-johnson-authorized-emergency-use/
Moderna - Phase III
January 7, 2020 - NIH and Moderna agreed to work on developing a vaccine against what came to be called Covid-19; https://www.hhs.gov/about/news/2020/12/18/hhs-dod-statements-fda-authorization-moderna-vaccine.html
January 13, 2020 - Moderna produced its first prototype sample of its vaccine; https://nymag.com/intelligencer/2020/12/moderna-covid-19-vaccine-design.html
March 16, 2020 - Phase I testing begins of Moderna's experimental coronavirus vaccine; at Kaiser Permanente Washington Health Research Institute, https://www.kpwashingtonresearch.org/news-and-events/recent-news/news-2020/kaiser-permanente-launches-coronavirus-vaccine-study-seattle , https://www.hhs.gov/about/news/2020/03/16/hhs-secretary-azar-statement-on-launch-of-phase-1-covid-19-vaccine-trial.html , https://www.nih.gov/news-events/news-releases/nih-clinical-trial-investigational-vaccine-covid-19-begins
April 16, 2020 - Enrollment was completed for Moderna's Phase I trial and additional test groups were added to the trial; https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-award-us-government-agency-barda-483-million
May 6, 2020 - The FDA approved the start of Phase II testing of Moderna's vaccine; https://investors.modernatx.com/news-releases/news-release-details/moderna-receives-fda-fast-track-designation-mrna-vaccine-mrna
May 12, 2020 - Moderna receives FDA Fast Track designation for coronavirus vaccine; https://investors.modernatx.com/news-releases/news-release-details/moderna-receives-fda-fast-track-designation-mrna-vaccine-mrna
May 29, 2020 - Moderna announces first participants dosed in Phase II study of coronavirus vaccine; https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-first-participants-each-age-cohort-dosed-phase
June 11, 2020 - Enrollment of the younger adults group of Moderna's Phase II trial was completed; https://investors.modernatx.com/news-releases/news-release-details/moderna-advances-late-stage-development-its-vaccine-mrna-1273
July 8, 2020 - Enrollment of the older adults group of Moderna's Phase II trial was completed; https://investors.modernatx.com/news-releases/news-release-details/moderna-completes-enrollment-phase-2-study-its-mrna-vaccine
July 26, 2020 - Moderna announced a modification to its contract with BARDA for additional funding to support late development, including the expanded Phase III study of its COVID-19 vaccine; https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-expansion-barda-agreement-support-larger-phase
July 27, 2020 - Moderna announced announced that the Phase III study of its COVID-19 vaccine has begun dosing participants; the randomized, placebo-controlled trial will include some 30,000 US participants; https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-phase-3-cove-study-mrna-vaccine-against-covid
October 22, 2020 - Moderna announced that it has completed enrollment of 30,000 participants in the Phase 3 study of its COVID-19 vaccine candidate, in collaboration with NIAID (part of NIH) and BARDA (part of the US Department of HHS); to date, more than 25,650 participants have received their second vaccination; https://investors.modernatx.com/news-releases/news-release-details/moderna-completes-enrollment-phase-3-cove-study-mrna-vaccine
November 16, 2020 - Moderna announced that the independent, NIH-appointed Data Safety Monitoring Board for the Phase 3 study of its vaccine candidate against COVID-19 has informed Moderna that the trial has met the statistical criteria in the study protocol for efficacy, with a vaccine efficacy of 94.5%; https://investors.modernatx.com/news-releases/news-release-details/modernas-covid-19-vaccine-candidate-meets-its-primary-efficacy
December 18, 2020 - Moderna's vaccine received Emergency Use Authorization from the FDA; https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-fda-authorization-moderna-covid-19-vaccine-us , https://www.fda.gov/news-events/press-announcements/fda-takes-additional-action-fight-against-covid-19-issuing-emergency-use-authorization-second-covid
Novavax
February 26, 2020 - Novavax announced it is testing several possible Covid vaccine candidates using animals; https://ir.novavax.com/2020-02-26-Novavax-Advances-Development-of-Novel-COVID-19-Vaccine
April 8, 2020 - Novavax announced it has selected a vaccine candidate for clinical trials; https://ir.novavax.com/2020-04-08-Novavax-Identifies-Coronavirus-Vaccine-Candidate-Accelerates-Initiation-of-First-in-Human-Trial-to-Mid-May
May 25, 2020 - Novavax Began Phase I/II Clinical Trial of COVID-19 Vaccine; https://ir.novavax.com/news-releases/news-release-details/novavax-initiates-phase-12-clinical-trial-covid-19-vaccine
August 17, 2020 - Novavax announced the beginning of a Phase IIb clinical trial in South Africa of its COVID-19 vaccine candidate; https://ir.novavax.com/news-releases/news-release-details/novavax-initiates-efficacy-trial-covid-19-vaccine-south-africa
August 24, 2020 - Novavax announced that the first volunteers have been enrolled in Phase II of its clinical trial of its Covid-19 vaccine; https://ir.novavax.com/news-releases/news-release-details/novavax-initiates-phase-2-portion-phase-12-clinical-trial-covid
September 24, 2020 - Novavax announced that it has initiated its first Phase 3 study in the UK to evaluate the efficacy, safety and immunogenicity of Novavax’ COVID-19 vaccine along with Novavax’ adjuvant; https://ir.novavax.com/news-releases/news-release-details/novavax-initiates-phase-3-efficacy-trial-covid-19-vaccine-united
November 09, 2020 - Novavax announced that the FDA has granted Fast Track Designation for the Company’s COVID-19 vaccine; https://ir.novavax.com/news-releases/news-release-details/novavax-covid-19-vaccine-granted-fast-track-designation-us-fda
In December 2020 or January 2021 I stopped updating my source file from which I'm C&P-ing selected events/dates, hence this time gap.
July 13, 2022 - Novavax Covid vaccine receives Emergency Use Authorization; https://covidblog.oregon.gov/novavax-becomes-fourth-covid-19-vaccine-authorized-by-fda/
Pfizer/BioNTech
March 16, 2020 - Pfizer announced partnership to develop BioNTech’s mRNA-based COVID-19 vaccines; https://www.pfizer.com/news/press-release/press-release-detail/pfizer_and_biontech_to_co_develop_potential_covid_19_vaccine ; Pfizer and BioNTech are two separate companies; the purpose of this partnership (and the partnership with Fosun Pharma in China) is production and distribution, capabilities BioNTech lacks; obviously, BioNTech started their development of a Covid vaccine in February or January 2020.
April 22, 2020 - Pfizer and BioNTech announced approval to begin Phase I/II trial of BioNTech’s COVID-19 vaccines in Germany; https://www.pfizer.com/news/press-release/press-release-detail/biontech_and_pfizer_announce_regulatory_approval_from_german_authority_paul_ehrlich_institut_to_commence_first_clinical_trial_of_covid_19_vaccine_candidates
April 29, 2020 - Pfizer and BioNTech announced that the first cohort of BioNTech’s Phase I/II clinical trial has been dosed; https://www.pfizer.com/news/press-release/press-release-detail/biontech-and-pfizer-announce-completion-dosing-first-cohort
May 5, 2020 - Pfizer and BioNTech announced that the first participants have been dosed in the US in the Phase I/II clinical trial; https://www.pfizer.com/news/press-release/press-release-detail/pfizer_and_biontech_dose_first_participants_in_the_u_s_as_part_of_global_covid_19_mrna_vaccine_development_program
July 13, 2020 - Pfizer Inc. and BioNTech announced that two of the companies’ COVID-19 vaccine candidates received Fast Track designation from the US FDA; both are currently undergoing Phase 1/2 clinical studies; https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-granted-fda-fast-track-designation-two
July 27, 2020 - Pfizer and BioNTech announced the start of a global Phase II/III clinical study of its COVID-19 vaccine, which will include up to 30,000 participants; https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-choose-lead-mrna-vaccine-candidate-0
August 12, 2020 - Pfizer and BioNTech announced that they have submitted an amended protocol to the FDA to expand the enrollment of their Phase III COVID-19 vaccine trial to up to approximately 44,000 participants, allowing for the enrollment of new populations; the company expects to reach its initial target of up to 30,000 participants next week; https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-propose-expansion-pivotal-covid-19
November 18, 2020 - Pfizer and BioNTech announced that, after conducting the final efficacy analysis in their ongoing Phase 3 study, their COVID-19 vaccine candidate met all of the study’s primary efficacy endpoints; analysis of the data indicates a vaccine efficacy rate of 95% (p<0.0001) in participants without prior SARS-CoV-2 infection; the companies also announced that the safety milestone required by the FDA for Emergency Use Authorization (EUA) has been achieved; Pfizer and BioNTech plan to submit a request within days for an EUA; https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine
December 11, 2020 - The FDA granted Emergency Use Authorization to the Pfizer/BioNTech vaccine; https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19 ; https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-celebrate-historic-first-authorization
Unlike traditional dead & weakened virus vaccines, mRNA vaccines (Moderna and Pfizer) and viral vector vaccines (Johnson & Johnson) do not require culturing the target virus, now experimentation with weakened or intact dead target viruses. Developing mRNA vaccines and viral vector vaccines requires knowledge and use of of the DNA sequence of the target virus. This saves considerable time in both development (months) and testing (more months). For example, Moderna had developed its prototype sample within 2 or 3 days of the DNA sequence of the SARS-CoV-2 virus. Similarly, in time savings, Moderna was dosing Phase 1 test participants in March 2020, and BioNTech was dosing Phase 1 test participants in April 2020.
IOW, while Trump's Operation Warp Speed did accelerate the testing process and Emergency Use Authorization accelerated bringing the vaccines into use, a significant amount of R & D and testing time was saved by the nature of the vaccine technologies used by J&J, Moderna, and Pfizer.
Novavax uses the traditional protein sub-unit technology (in use about as long as dead & weakened virus technology). This technology requires culturing the target virus or bacterium to identify characteristic proteins intrinsic to the target, altering cells (bacterium, animal cells, yeast cells, etc.) to produce that protein, culturing those altered cells, and then producing the target protein. Immune response to a protein sub-unit vaccine is less strong than, e.g., a dead or weakened virus, so an adjuvant, a general immune system stimulant, is needed and had to be selected. This probably is reflected in Novavax's slower vaccine development and slower time to testing with human volunteers. Being months behind even J&J probably resulted in Novavax becoming lower in priority, and thus delaying authorization into mid 2022.
Where "reach market in 3 months" came from mystifies me.
If they were so confident in it, they wouldn't have offered legal amnesty from litigation for these companies. The 3 months is a bit of hyperbole, but clinical trials still take much longer than what happened here.
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If they were so confident in it, they wouldn't have offered legal amnesty from litigation for these companies. ....
You have an anachronism problem with this claim. The Public Readiness and Emergency Preparedness Act was invoked in March 2020, https://www.phe.gov/emergency/events/COVID19/COVIDvaccinators/Pages/PREP-Act-Immunity-from-Liability-for-COVID-19-Vaccinators.aspx . As documented in my previous post, this was before testing of the several vaccines approved or authorized for use in the US started testing. IOW, Sec HHS invoked the PREP Act before any level of or lack of "confidence" in the Covid vaccines could be conceived. And before anyone thinks to ask, the Public Readiness and Emergency Preparedness Act was signed into law in 2005, which means it was not created just for Covid vaccines.
The 3 months is a bit of hyperbole 1, but clinical trials still take much longer than what happened here 2.
1 :bs:
2 The authority to Fast Track meds was given the FDA in 1997. Covid vaccines were far from unique in Receiving Fast Track status, and were tested in accordance with Fast Track protocols. Don't like that? Take it up with the FDA who Fast-Tracked the vaccines and treatments and designed the testing protocols.
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I’ve said it before and I’ll say it again; it’s not a vaccine. Therapeutic? Possibly but the jury is still out as far as I’m concerned.
I’m still watching, learning.
KC
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I’ve said it before and I’ll say it again; it’s not a vaccine. Therapeutic? Possibly but the jury is still out as far as I’m concerned.
I’m still watching, learning.
KC
Precisely right.
It is NOT a vaccine, unless one buys the leftist redefinition of the word.
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Perhaps in some cases, it's karma:
(https://images2.imgbox.com/c7/bb/e7Njz9mW_o.jpg)
But vaccines always work! This gios against the lefty narrative! How DARE she! Well, her lefty cred has been REVOKED! REVOKED I tell you!
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You have an anachronism problem with this claim. The Public Readiness and Emergency Preparedness Act was invoked in March 2020, https://www.phe.gov/emergency/events/COVID19/COVIDvaccinators/Pages/PREP-Act-Immunity-from-Liability-for-COVID-19-Vaccinators.aspx . As documented in my previous post, this was before testing of the several vaccines approved or authorized for use in the US started testing. IOW, Sec HHS invoked the PREP Act before any level of or lack of "confidence" in the Covid vaccines could be conceived. And before anyone thinks to ask, the Public Readiness and Emergency Preparedness Act was signed into law in 2005, which means it was not created just for Covid vaccines.
1 :bs:
2 The authority to Fast Track meds was given the FDA in 1997. Covid vaccines were far from unique in Receiving Fast Track status, and were tested in accordance with Fast Track protocols. Don't like that? Take it up with the FDA who Fast-Tracked the vaccines and treatments and designed the testing protocols.
Suit yourself. But my first hand account of it had my dad in a medically induced coma for months along with "covid" pneumonia and caught it again despite vaccines and boosters. Guillian-barre syndrome is real and though it may not have affected others as much as him, it affected multitudes. This is directly related to improper trials.
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...
1 :bs:
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I've been seeing variants of the "untested" "experimental vaccine" BS for almost two years. The "3 months" claim is just a variant. I compiled my source files regarding Covid vaccines, treatments, tests, equipment, DPA usage, etc. starting in very early 2020 in anticipation that the Dems would use Covid to attack Trump. One avenue of attack I anticipated was to attack the safety, etc. of Covid vaccines, which LIEden, Kammie, and several Dem goobernors did. Facts, like money, can be used in a wide variety of contexts.
I’ve said it before and I’ll say it again; it’s not a vaccine. Therapeutic? Possibly but the jury is still out as far as I’m concerned.
I’m still watching, learning.
KC
You keep claiming that. By what reasoning have you decided that the Covid vaccines are not vaccines?
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I've been seeing variants of the "untested" "experimental vaccine" BS for almost two years. The "3 months" claim is just a variant. I compiled my source files regarding Covid vaccines, treatments, tests, equipment, DPA usage, etc. starting in very early 2020 in anticipation that the Dems would use Covid to attack Trump. One avenue of attack I anticipated was to attack the safety, etc. of Covid vaccines, which LIEden, Kammie, and several Dem goobernors did. Facts, like money, can be used in a wide variety of contexts.
You keep claiming that. By what reasoning have you decided that the Covid vaccines are not vaccines?
A better question is:
By what reasoning have you decided that they are?
They certainly are not by the definition we all grew up using, because words have meanings.
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Suit yourself. But my first hand account of it had my dad in a medically induced coma for months along with "covid" pneumonia and caught it again despite vaccines and boosters. Guillian-barre syndrome is real and though it may not have affected others as much as him, it affected multitudes. This is directly related to improper trials.
1. Did you read my post above, specifically these two statements?
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2. Vaccination does not prevent infection.
3. Recovery from Covid does not prevent infection.
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* Guillain–Barré syndrome was first identified in 1916 and is named for French neurologists Georges Guillain and Jean Alexandre Barré, who described it. Covid vaccines were developed at the beginning of 2020, over a century later.
* Guillain–Barré syndrome has been known to be a possible side effect of some vaccines since at least 1976 and the vaccination campaign in response to Swine Flu. 1976 is almost 45 years before Covid vaccine development started. Also, Flu vaccines are weakened or dead virus technology, not mRNA or viral vector vaccine technology. Guillain–Barré syndrome has also been associated with the Shingrix shingles vaccine.
* The National Vaccine Injury Compensation Program covers injuries and/or conditions associated with some covered vaccines, https://www.hrsa.gov/vaccine-compensation/covered-vaccines .
Guillain–Barré syndrome is a covered condition for influenza vaccines, https://www.hrsa.gov/sites/default/files/hrsa/vicp/vaccine-injury-table-01-03-2022.pdf . Guillain–Barré syndrome is not, among vaccines, peculiarly associated with Covid vaccines.
* Looking around a bit, I found that Guillain–Barré syndrome has been observed after vaccination with Pfizer, Moderna, J&J, and AstraZeneca (not authorized in the US, but used in the UK and many other countries), These vaccines use two very different technologies, mRNA and viral vector. This is an indication that the Guillain–Barré syndrome is a result of recipients' immune systems' stimulation, not a specific type of vaccine.
* Guillain–Barré syndrome has also been found in Covid patients who had not been vaccinated, e.g. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7182017/ . Note the April 2020 publication date of that report and its first phrase, "From February 28 through March 21, 2020 ...". Those cases observed in Italy predated testing of any Covid vaccine (possibly except for a couple of Chinese companies' vaccines).
Guillain–Barré syndrome is not peculiarly caused by Covid vaccines or vaccines. Guillain–Barré syndrome is caused by a person's immune system being stimulated by something - virus, bacteria, vaccine, etc. - and the immune system attacking normal body tissue, just like many auto-immune diseases (e.g. Langerhans Cell Hystiocytosis). Covid vaccine trials were not done "improperly".
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A better question is:
By what reasoning have you decided that they are?
They certainly are not by the definition we all grew up using, because words have meanings.
Nice evasion attempt. What is your "definition", and from what specific source?
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Nice evasion attempt. What is your "definition", and from what specific source?
Knock it off. Nothing you said previously was addressed to me, so *I* am evading nothing.
You on the other hand, have been asked questions, directly, by me. Answer them instead of attempting to evade them by nonsensically accusing me of evading a question you asked of a poster that isn't me.
What is your "definition", and from what specific source?
*I* asked *you* first. You did *not* ask *me* first.
Fair warning, bud, anything but being strait forward and fair about this and in this discussion isn't going to go well for you, All i need is your permission to savage you, and you've just taken the first of two steps that give it. Don't double down and take the second.
Be reasonable and keep it fair and level headed.
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https://www.democraticunderground.com/100217317848
Believe what you want. Myself, I'm thinking these vaccines are causing some of this, and I have anecdotal evidence. SVP feel free to light me up, I don't mind. I know we have differing opinions on this and that's fine. I've been watching this for awhile and I'm still watching.
Per usual, the DUmmies don't read the article. The article actually states the vaccinated are experiencing the same things. But you still get this;
It's going to be interesting to see how this shakes out in the years to come. There are many, many, of us who are not vaccinated. The comparisons over the years should be easy.
KC
Tex, this is for you:
https://spectator.com.au/2022/11/wots-in-the-shots/
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This is from a personal incident that occurred early this year. In January 2022 I had open heart surgery to correct two clogged arteries. I have not suffered a heart attack but it there was a consensus between my cardiologist and my surgeon that one was inevitable. I have never taken a covid shot. I went through the surgery and in April I started in hospital physical therapy. While there I meet a man who also had the surgery I did. He told me that for his whole life he had no issues with clogged arteries, had low cholesterol tests, and never experienced any heart issues. His doctor suggested he get the covid shot and so he did. One month later he had a heart attack and was told two of his arteries were almost completely blocked and needed a CABG +2. Same surgery as me. When I asked him what his doctor said about this coincidence and he told me I could ask the doctor myself as he was also in rehab with us. The doctor experienced a heart attack due to blockage six weeks after getting the covid shot. Before the shot, the Dr. also had a clean bill of health as far as his heart was concerned. His doctor advised that I not take the shot after I recovered.
Draw your own conclusions.
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This is from a personal incident that occurred early this year. In January 2022 I had open heart surgery to correct two clogged arteries. I have not suffered a heart attack but it there was a consensus between my cardiologist and my surgeon that one was inevitable. I have never taken a covid shot. I went through the surgery and in April I started in hospital physical therapy. While there I meet a man who also had the surgery I did. He told me that for his whole life he had no issues with clogged arteries, had low cholesterol tests, and never experienced any heart issues. His doctor suggested he get the covid shot and so he did. One month later he had a heart attack and was told two of his arteries were almost completely blocked and needed a CABG +2. Same surgery as me. When I asked him what his doctor said about this coincidence and he told me I could ask the doctor myself as he was also in rehab with us. The doctor experienced a heart attack due to blockage six weeks after getting the covid shot. Before the shot, the Dr. also had a clean bill of health as far as his heart was concerned. His doctor advised that I not take the shot after I recovered.
Draw your own conclusions.
After my dad's time in the hospital, he went back to his doctor who said..." let's just forget about that Johnson and Johnson shot. Let's get you the Moderna one instead." Believe it or not, he actually did it and got boosters to boot.