Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Merck’s molnupiravir for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate. Molnupiravir is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset.
Molnupiravir is not authorized for use in patients younger than 18 years of age because molnupiravir may affect bone and cartilage growth. It is not authorized for the pre-exposure or post-exposure prevention of COVID-19 or for initiation of treatment in patients hospitalized due to COVID-19 because benefit of treatment has not been observed in people when treatment started after hospitalization due to COVID-19.
The Covid vaccines really do work
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Re: The Covid vaccines really do work
https://www.fda.gov/news-events/press-a ... 19-certain
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Re: The Covid vaccines really do work
https://www.defenseone.com/technology/2 ... ts/360089/
Early days yet on this. Need Phase 2 and Phase 3 trials.Within weeks, scientists at the Walter Reed Army Institute of Research expect to announce that they have developed a vaccine that is effective against COVID-19 and all its variants, even Omicron, as well as previous SARS-origin viruses that have killed millions of people worldwide.
The achievement is the result of almost two years of work on the virus. The Army lab received its first DNA sequencing of the COVID-19 virus in early 2020. Very early on, Walter Reed’s infectious diseases branch decided to focus on making a vaccine that would work against not just the existing strain but all of its potential variants as well.
Walter Reed’s Spike Ferritin Nanoparticle COVID-19 vaccine, or SpFN, completed animal trials earlier this year with positive results. Phase 1 of human trials, wrapped up this month, again with positive results that are undergoing final review
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Re: The Covid vaccines really do work
Published December 16:
https://www.army.mil/article/252890/ser ... t_strategy
A SARS-CoV-2 Ferritin Nanoparticle Vaccine Elicits Protective Immune Responses in Nonhuman Primates
http://www.science.org/doi/10.1126/scitranslmed.abi5735
Efficacy and breadth of adjuvanted SARS-CoV-2 receptor-binding domain nanoparticle vaccine in macaques
https://www.pnas.org/content/118/38/e2106433118
SARS-CoV-2 ferritin nanoparticle vaccine induces robust innate immune activity driving polyfunctional spike-specific T cell responses
https://www.nature.com/articles/s41541-021-00414-4
A SARS-CoV-2 spike ferritin nanoparticle vaccine protects against heterologous challenge with B.1.1.7 and B.1.351 virus variants in Syrian golden hamsters
https://www.nature.com/articles/s41541-021-00392-7
SARS-CoV-2 ferritin nanoparticle vaccines elicit broad SARS coronavirus immunogenicity
https://www.cell.com/cell-reports/fullt ... 21)01639-9
This is a link to the human Phase 1 trial. Very small study population of 72, but it is Phase 1 after all.
SARS-COV-2-Spike-Ferritin-Nanoparticle (SpFN) Vaccine With ALFQ Adjuvant for Prevention of COVID-19 in Healthy Adults
Clinical Trials.gov: https://clinicaltrials.gov/ct2/show/NCT04784767
https://www.army.mil/article/252890/ser ... t_strategy
Links to published articles about the preclinical studies from that page:Pre-clinical studies published today in Science Translational Medicine indicate that the SpFN vaccine protects non-human primates from disease caused by the original strain of SARS-CoV-2 and induces highly-potent and broadly-neutralizing antibody responses against major SARS-CoV-2 variants of concern including the SARS-CoV-1 virus that emerged in 2002.
SpFN entered Phase 1 human trials in April 2021. Early analyses, expected to conclude this month, will provide insights into whether SpFN’s potency and breadth, as demonstrated in preclinical trials, will carry over into humans. The data will also allow researchers to compare SpFN’s immune profile to that of other COVID-19 vaccines already authorized for emergency use.
A SARS-CoV-2 Ferritin Nanoparticle Vaccine Elicits Protective Immune Responses in Nonhuman Primates
http://www.science.org/doi/10.1126/scitranslmed.abi5735
Efficacy and breadth of adjuvanted SARS-CoV-2 receptor-binding domain nanoparticle vaccine in macaques
https://www.pnas.org/content/118/38/e2106433118
SARS-CoV-2 ferritin nanoparticle vaccine induces robust innate immune activity driving polyfunctional spike-specific T cell responses
https://www.nature.com/articles/s41541-021-00414-4
A SARS-CoV-2 spike ferritin nanoparticle vaccine protects against heterologous challenge with B.1.1.7 and B.1.351 virus variants in Syrian golden hamsters
https://www.nature.com/articles/s41541-021-00392-7
SARS-CoV-2 ferritin nanoparticle vaccines elicit broad SARS coronavirus immunogenicity
https://www.cell.com/cell-reports/fullt ... 21)01639-9
This is a link to the human Phase 1 trial. Very small study population of 72, but it is Phase 1 after all.
SARS-COV-2-Spike-Ferritin-Nanoparticle (SpFN) Vaccine With ALFQ Adjuvant for Prevention of COVID-19 in Healthy Adults
Clinical Trials.gov: https://clinicaltrials.gov/ct2/show/NCT04784767
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Re: The Covid vaccines really do work
Well, we're all quarantined in this house. One of us tested positive using a rapid test from the drug store. No serious symptoms. The person who tested positive had a sore throat and a bit of a phlegm cough, mild fever. Five other people at the store he works at have gotten sick, including one antivax guy who is as sick as the proverbial dog.
We are all vaccinated, with boosters. No, the vaccines weren't claimed to prevent infection, they help to prevent severe illness.
"...and that's that."
We are all vaccinated, with boosters. No, the vaccines weren't claimed to prevent infection, they help to prevent severe illness.
"...and that's that."
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Re: The Covid vaccines really do work
https://www.fda.gov/media/144434/download
8. Benefit/Risk Assessment in the Context of Proposed Indication and Use Under EUA
8.1 Known Benefits
The known benefits among recipients of the proposed vaccine relative to placebo are:
• Reduction in the risk of confirmed COVID-19 occurring at least 14 days after the second
dose of vaccine
• Reduction in the risk of confirmed severe COVID-19 occurring at least 14 days after the
second dose of vaccine
The 2-dose vaccination regimen was highly effective in preventing PCR-confirmed COVID-19
occurring at least 14 days after receipt of the second dose. Secondary efficacy analyses
showed consistency with outcomes in the primary efficacy analysis; the vaccine was effective in
preventing COVID-19 using a less restrictive definition of the disease and considering all cases
starting 14 days after the first injection. Efficacy findings in the interim analysis were also
consistent across various subgroups, including racial and ethnic minorities, participants ages 65
years and older, and those at risk for severe COVID-19 disease due to obesity, diabetes,
cardiac disease, liver disease, chronic lung disease, mild to severe asthma, and infection with
HIV, although the efficacy estimate in participants ages 65 years and older was slightly lower in
the primary efficacy analysis.
...
As shown in Table 9, in participants ≥18 years of age, there were 5
COVID-19 cases in the vaccine group and 90 COVID-19 cases in the placebo group, with a VE
of 94.5%, a lower bound of the 95% CI of 86.5%, and a one-sided p-value of <0.0001 for testing
H0: VE ≤30%, which met the pre-specified success criterion. In participants ≥65 years of age in
the Per-Protocol Set, there were no COVID-19 cases in the vaccine group and 15 COVID-19
cases in the placebo group.
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Re: The Covid vaccines really do work
Fine, whatever. At this point I'll just refer to my previous posts in this thread.
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Re: The Covid vaccines really do work
I fear you misunderstand me. I did not mean to imply that you moved the goal posts. Merely that it was inherent on the part of anti vaxxers.
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Re: The Covid vaccines really do work
I apologize. I'm old, I'm tired, my mental faculties are not what they used to be, and they weren't all that good to begin with.
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Re: The Covid vaccines really do work
https://www.texaschildrens.org/texas-ch ... -emergency
Twitter thread from Dr. Peter Hotez:
Details at the link. It's late and I'm not up to hunting for data outside of the press release.Texas Children’s Hospital and Baylor College of Medicine announced today that CORBEVAX™, a protein sub-unit COVID-19 Vaccine, whose technology was created and engineered at its Center for Vaccine Development (CVD), has received Emergency Use Authorization (EUA) approval from the Drugs Controller General of India (DCGI) to launch in India with other underserved countries to follow.
Twitter thread from Dr. Peter Hotez:
Link: https://twitter.com/PeterHotez/status/1475838044318183425
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Re: The Covid vaccines really do work
Same for an isolated person, with a condition that means they can’t get Covid, or they will die. If the vaccinated spread Covid, how does that work for them?robinson wrote: ↑Wed Oct 13, 2021 8:56 am … it doesn't answer the question, or questions. Island nations (and isolated communities/individuals), who have no exposure to any of the novel C19 strains, really want to know the answers.
In case it's too complicated, here is a simple version.
If everyone is vaccinated, and everyone has no exposure to the virus, and the country opens up for travel, and vaccinated people now show up, and they carry the virus, and infect vaccinated people, and then people get sick and die, how the fuck do you spin that?
And how the fuck can you claim the 'vaccines' work?
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Re: The Covid vaccines really do work
I refer you to pyrrho's previous post that referred to previous posts.
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Re: The Covid vaccines really do work
If the mRNA treatments don’t stop infection or the spread, then “work” means something else now
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Re: The Covid vaccines really do work
I'll stipulate that with Omicron they no longer seem to be effective at stopping the infection or the spread.
However, that's not the only issue to consider. They still seem to be effective at preventing severe illness. That means fewer people will need to be hospitalized, and fewer people will die. It also mitigates the burden on hospitals.
https://www.nejm.org/doi/full/10.1056/NEJMc2119270 (New England Journal of Medicine; this was published Dec. 29)
So they are finding that it still reduces the risk of hospitalization by 70%, which could make a big difference in whether hospitals become overwhelmed with too many patients all at once. And ultimately, a reduction in the risk of hospitalization also implies a reduced risk of death.Effectiveness of BNT162b2 Vaccine against Omicron Variant in South Africa
. . .
Using data from Discovery Health, a South African managed care organization, we estimated the vaccine effectiveness of two doses of the BNT162b2 vaccine (i.e., full vaccination) against hospitalization for Covid-19 caused by the omicron variant by analyzing data sets that included the results of polymerase-chain-reaction (PCR) assays, preauthorization admission data, a full history of members’ medical records, registrations regarding chronic diseases, and data regarding body-mass index to obtain the number of Covid-19 risk factors per patient, according to the guidelines of the Centers for Disease Control and Prevention (CDC).3
. . .
During the proxy omicron period, we found a vaccine effectiveness of 70% (95% confidence interval [CI], 62 to 76), a finding that was supported by the results of all sensitivity tests. This measure of vaccine effectiveness was significantly different from that during the comparator period, when the rate was 93% (95% CI, 90 to 94) against hospitalization for Covid-19 (Table 2).
Thus, during the proxy omicron period, we saw a maintenance of effectiveness of the BNT162b2 vaccine (albeit at a reduced level) against hospital admission for Covid-19 that was presumed to have been caused by the omicron variant as compared with the rate associated with the delta variant earlier in the year. The addition of a booster dose of vaccine may mitigate this reduction in vaccine effectiveness.5
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Re: The Covid vaccines really do work
Anax, your facts do not match the wanted political and religious illusion!
– J.D.
– J.D.
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Re: The Covid vaccines really do work
What did the animal studies show for mRNA treatments?
You know, the years long studies to see if they are effective, and safe?
You know, the years long studies to see if they are effective, and safe?
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Re: The Covid vaccines really do work
https://www.fda.gov/news-events/press-a ... 19-vaccine
Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to:
Expand the use of a single booster dose to include use in individuals 12 through 15 years of age.
Shorten the time between the completion of primary vaccination of the Pfizer-BioNTech COVID-19 Vaccine and a booster dose to at least five months.
Allow for a third primary series dose for certain immunocompromised children 5 through 11 years of age.
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Re: The Covid vaccines really do work
https://www.nytimes.com/2021/12/21/heal ... icron.html
Hospitals Scramble as Antibody Treatments Fail Against Omicron
The single remaining monoclonal antibody therapy effective against the variant is now in short supply in the U.S., imperiling an option that doctors and hospitals have relied on.
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Re: The Covid vaccines really do work
I have to take that bolded part back. The vaccines were claimed to prevent infection, on the basis of the clinical trial results, which were measured during specific post-innoculation time periods.Pyrrho wrote: ↑Tue Dec 28, 2021 8:05 pm Well, we're all quarantined in this house. One of us tested positive using a rapid test from the drug store. No serious symptoms. The person who tested positive had a sore throat and a bit of a phlegm cough, mild fever. Five other people at the store he works at have gotten sick, including one antivax guy who is as sick as the proverbial dog.
We are all vaccinated, with boosters. No, the vaccines weren't claimed to prevent infection, they help to prevent severe illness.
"...and that's that."
For the Moderna vaccine:
https://www.fda.gov/news-events/press-a ... cond-covid
FDA Evaluation of Available Effectiveness Data
The effectiveness data to support the EUA include an analysis of 28,207 participants in the ongoing randomized, placebo-controlled U.S. study who did not have evidence of SARS-CoV-2 infection prior to the first dose of vaccine. Among these participants, 14,134 received the vaccine and 14,073 received placebo. The vaccine was 94.1% effective in preventing COVID-19 disease among these clinical trial participants with 11 cases of COVID-19 in the vaccine group and 185 in the placebo group. At the time of the analysis of these 196 COVID-19 cases, none in the vaccine group and 30 in the placebo group were classified as severe. After the analysis of these 196 cases was completed, one severe case in the vaccine group was identified and is awaiting confirmation. At this time, data are not available to determine how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person.
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Re: The Covid vaccines really do work
What an idiotic question. Every day of delay cost thousands of lives. You want to spend years making sure a life-saving vaccine is totally safe before using it and let hundreds of thousands of people die in the meantime?
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Re: The Covid vaccines really do work
Yes, and originally they did prevent infection as well as severe illness. That was before Omicron, and to some extent Delta before that. As the vaccine mutated into new variants, and we learned that the effectiveness waned over time (which was always an open question), they became less effective at preventing a positive test, but they still are effective at preventing severe illness, and shortening the duration of illness and infectivity.Pyrrho wrote: ↑Tue Jan 04, 2022 3:09 amI have to take that bolded part back. The vaccines were claimed to prevent infection, on the basis of the clinical trial results, which were measured during specific post-innoculation time periods.Pyrrho wrote: ↑Tue Dec 28, 2021 8:05 pm Well, we're all quarantined in this house. One of us tested positive using a rapid test from the drug store. No serious symptoms. The person who tested positive had a sore throat and a bit of a phlegm cough, mild fever. Five other people at the store he works at have gotten sick, including one antivax guy who is as sick as the proverbial dog.
We are all vaccinated, with boosters. No, the vaccines weren't claimed to prevent infection, they help to prevent severe illness.
"...and that's that."
And so-called natural immunity doesn't seem to provide permanent immunity either. The fact remains that many thousands of people, probably hundreds of thousands in the US and millions worldwide are alive today thanks to vaccines who would otherwise have died.
The situation has changed but claims that were true at the time don't become untrue later because the situation is now different.
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Re: The Covid vaccines really do work
Journal article about Preclinical data, from June 2020:
https://www.nature.com/articles/s41577-020-0377-3
https://pubmed.ncbi.nlm.nih.gov/28457665/
This one from 2019 discusses human clinical trials that took place in 2015-2017, using mRNA vaccines for "bird flu":
https://pubmed.ncbi.nlm.nih.gov/31079849/
https://www.nature.com/articles/s41577-020-0377-3
This journal article from 2017 discusses preclinical and clinical data for an mRNA vaccine for what is commonly called "bird flu":Reflecting the urgency to develop prophylactic approaches against COVID-19, several vaccine candidates have entered clinical trials before showing efficacy in animal models. In this preprint, Corbett et al. describe a preclinical study evaluating an mRNA vaccine candidate by Moderna. Immunization of mice with mRNA encoding stabilized prefusion SARS-CoV-2 spike trimers elicited dose-dependent neutralizing antibody and CD8+ T cell responses. Two doses given in prime–boost combination (2 x 1 µg/mouse) protected mice against infection of the nasal mucosa and lungs after challenge with mouse-adapted SARS-CoV-2. Importantly, there was no indication of enhanced immunopathology in animals that received sub-protective doses. A phase III efficacy trial in humans (using a single 100 µg dose regimen) is set to start in July.
https://pubmed.ncbi.nlm.nih.gov/28457665/
This one from 2019 discusses human clinical trials that took place in 2015-2017, using mRNA vaccines for "bird flu":
https://pubmed.ncbi.nlm.nih.gov/31079849/
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Re: The Covid vaccines really do work
I had my booster today. I've started getting a craving for small flies and my shits are a bit rough.
Skin's a bit dry too.
Skin's a bit dry too.
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Re: The Covid vaccines really do work
"Flies? Flies? Who wants to eat flies? Not when I can have fat juicy spiders!"
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Re: The Covid vaccines really do work
Given the post-nasal drip and a "tickle" just behind my uvula, I am assuming that I have "it". Stores are out of stock for rapid tests.
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Re: The Covid vaccines really do work
How it started
March 10 2021
Dec. 23, 2021 (last update)
March 10 2021
How it's goingVaccines currently approved for use in the United States are effective at preventing COVID-19.
Large-scale clinical studies found that COVID-19 vaccination prevented most people from getting COVID-19.
All COVID-19 vaccines available in the United States are effective at preventing COVID-19.
Dec. 23, 2021 (last update)
For extra credit, guess what date they removed the claims about prevention and preventingAll currently approved or authorized COVID-19 vaccines are safe and effective and reduce your risk of severe illness.
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Re: The Covid vaccines really do work
https://twitter.com/disclosetv/status/1 ... 49540?s=21
At some point reality will be more important than the propaganda
(and tweets will vanish)
At some point reality will be more important than the propaganda
(and tweets will vanish)
Last edited by robinson on Fri Jan 07, 2022 5:49 am, edited 1 time in total.
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Re: The Covid vaccines really do work
And yes, I hope the treatment reduces the deaths
If animal studies had been done we would already know what is likely to happen
It’s a major reason you don’t experiment on people with out first testing this shit on animals
If animal studies had been done we would already know what is likely to happen
It’s a major reason you don’t experiment on people with out first testing this shit on animals
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Re: The Covid vaccines really do work
And if you are looking for the mRNA vaccine studies using primates, you won’t find any
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Re: The Covid vaccines really do work
Unfortunately the speakers are long gone. They were crap speakers from Gold Circle anyway.
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Re: The Covid vaccines really do work
Maybe we can bequeath playlists? Stereos seem so passé. :dunno:
:worship:
:worship: