just thought it would be a good PSA for any who thought it would be a good idea to take this…
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FDA
- Thread starter sami
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just thought it would be a good PSA for any who thought it would be a good idea to take this…
Interesting that they lead with the headline catching tweet, but if you read the article it actually says some initial research is underway, the FDA hasn't even reviewed data and the drug is used in humans for a couple of other conditions.
I wonder if the FDA will use the same approach to dairy products. I’m not a cow. Why am I drinking cows milk? It’s designed for cows, not humans. Probably not at the economic expense of dairy farmers. Thank God for lobbyists.
They may be researching ivermectin, but to date there is no evidence that it helps with Covid. Especially not the tubes of it which are meant for animals. Just absolutely mind boggling that people do not trust a vaccine, but they read some nonsense online and then go ingest medicine meant for a horse.
Uptick in Mississippi poison control calls from people who take livestock dewormer to treat COVID-19
Mississippi’s Poison Control is reporting an alarming uptick in calls from people who took a drug bought at a feed store meant to deworm livestock.
They may be researching ivermectin, but to date there is no evidence that it helps with Covid. Especially not the tubes of it which are meant for animals. Just absolutely mind boggling that people do not trust a vaccine, but they read some nonsense online and then go ingest medicine meant for a horse.
Uptick in Mississippi poison control calls from people who take livestock dewormer to treat COVID-19
Mississippi’s Poison Control is reporting an alarming uptick in calls from people who took a drug bought at a feed store meant to deworm livestock.www.fox8live.com
Epidemiologic Analyses on Ivermectin in COVID-19
The Latest Results of Ivermectin’s Success in Treating Outbreaks of COVID-19 including charts and data by Juan Chamie.
covid19criticalcare.com
India's Ivermectin Blackout: Part II
Delhi Obliterates COVID with Ivermectin
india may hve the evidence
You can't fix stupid and, quite frankly, we shouldn't even try. Thin the herd. Karma.They may be researching ivermectin, but to date there is no evidence that it helps with Covid. Especially not the tubes of it which are meant for animals. Just absolutely mind boggling that people do not trust a vaccine, but they read some nonsense online and then go ingest medicine meant for a horse.
Uptick in Mississippi poison control calls from people who take livestock dewormer to treat COVID-19
Mississippi’s Poison Control is reporting an alarming uptick in calls from people who took a drug bought at a feed store meant to deworm livestock.
Epidemiologic Analyses on Ivermectin in COVID-19
The Latest Results of Ivermectin’s Success in Treating Outbreaks of COVID-19 including charts and data by Juan Chamie.
India's Ivermectin Blackout: Part II
Delhi Obliterates COVID with Ivermectinwww.thedesertreview.com
india may hve the evidence
I'm open to it, but from Delta seems to have a harsher peak in areas where it is spreading if they treat with Ivermectin or not. One of the studies I read on the drug compared infection of those who were treated with Ivermectin vs placebo noting no difference. If a controlled study shows there is a benefit from it, great.
If someone gets infected, I don't care if doctors want to try it. I'm just generally opposed to it as a means to avoid vaccination where people think they don't need the vaccine because we have a cure available.
maybe those peaks would have been greater if not for ivermectin? generally i dont think it should be written off. india isna recipe for disaster for these types of diseases so the correlation with ivermectin is enough to look into. the drs there will say it works.
but who in america wants to admit a cheap drug could be super effective. we already have massive restrictions on the cheap effective drugs in india.
Health is not the primary concern. Profit is. No money to be made in this drug.
A
anon_ezos2e9wn1ob0
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One of the conspiracy theories that was pushed was that Ivermectin was not being talked about because the vaccines would lose their EUA status if there was an effective treatment available.
Now that the FDA has fully approved Comirnaty (odd name) that theory won't really make sense any more.
The studies I saw on using it as a treatment seemed like it didn't really help, though they weren't looking at those who were already infected so maybe it could turn out that there are benefits from prophylactic use?
Now that the FDA has fully approved Comirnaty (odd name) that theory won't really make sense any more.
The studies I saw on using it as a treatment seemed like it didn't really help, though they weren't looking at those who were already infected so maybe it could turn out that there are benefits from prophylactic use?
Invermectin is manufactured by Merck, so that conspiracy theory is just that. And while it's fairly common to have existing drugs prescribed for "off-label" indications, you probably want to wait until clinical trials are completed and the FDA reviews it for treatment.
And yes, there are people dumb enough to take veterinary grade prescriptions (like the dosing for a 2,000 pound cow will translate well to a human). Ketamine is a good example of a drug that used on humans and livestock....but don't buy the latter....but people do.
We have vaccines; we have treatments; we know what we need to do personally (diet/exercise) to significantly reduce our risk. And we have actually done better than most of the world on the first two.
And yes, there are people dumb enough to take veterinary grade prescriptions (like the dosing for a 2,000 pound cow will translate well to a human). Ketamine is a good example of a drug that used on humans and livestock....but don't buy the latter....but people do.
We have vaccines; we have treatments; we know what we need to do personally (diet/exercise) to significantly reduce our risk. And we have actually done better than most of the world on the first two.
Speaking of the FDA, buried in their online FAQ's after today's approval is this (emphasis mine):
Overall, the vaccine was 91% effective in preventing COVID-19 disease, with 77 cases of COVID-19 occurring in the vaccine group and 833 COVID-19 cases in the placebo group.
The most commonly reported side effects by those clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle pain, chills, joint pain and fever.
The FDA conducted a rigorous evaluation of the of post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of Pfizer-BioNTech COVID-19 Vaccine and determined that the data demonstrate increased risks, particularly within the seven days following the second dose. The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support Information is not yet available about potential long-term health outcomes. The Comirnaty Prescribing Information includes a warning about these risks.
But yeah, I'm crazy for being concerned about the risk of side effects and possible unknown long-term issues.
www.fda.gov
Q: How safe and effective is Comirnaty (COVID-19 Vaccine mRNA)?
Overall, the vaccine was 91% effective in preventing COVID-19 disease, with 77 cases of COVID-19 occurring in the vaccine group and 833 COVID-19 cases in the placebo group.
The most commonly reported side effects by those clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle pain, chills, joint pain and fever.
The FDA conducted a rigorous evaluation of the of post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of Pfizer-BioNTech COVID-19 Vaccine and determined that the data demonstrate increased risks, particularly within the seven days following the second dose. The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support Information is not yet available about potential long-term health outcomes. The Comirnaty Prescribing Information includes a warning about these risks.
But yeah, I'm crazy for being concerned about the risk of side effects and possible unknown long-term issues.
Pfizer-BioNTech COVID-19 Vaccine Frequently Asked Questions
Frequently asked questions on the emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine
I would not characterize it as being "buried" on this particular drug. This is SOP package insert stuff that is regulated (ever notice that they have a speed talker on 30 second TV ads rip through the adverse reaction stuff? Not because Pharma wants to do it.Speaking of the FDA, buried in their online FAQ's after today's approval is this (emphasis mine):
Q: How safe and effective is Comirnaty (COVID-19 Vaccine mRNA)?
Overall, the vaccine was 91% effective in preventing COVID-19 disease, with 77 cases of COVID-19 occurring in the vaccine group and 833 COVID-19 cases in the placebo group.
The most commonly reported side effects by those clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle pain, chills, joint pain and fever.
The FDA conducted a rigorous evaluation of the of post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of Pfizer-BioNTech COVID-19 Vaccine and determined that the data demonstrate increased risks, particularly within the seven days following the second dose. The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support Information is not yet available about potential long-term health outcomes. The Comirnaty Prescribing Information includes a warning about these risks.
But yeah, I'm crazy for being concerned about the risk of side effects and possible unknown long-term issues.
Pfizer-BioNTech COVID-19 Vaccine Frequently Asked Questions
Frequently asked questions on the emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine
Virtually every drug has adverse reactions and potential long term side effects that only time and data will uncover. It's up to the individual to make that call and I will continue to support a person's right to be vaccinated or not.
But you see, that’s the problem, more and more a person’s right to be vaccinated or not is being taken away, especially when it comes to these experimental covid “vaccines” where short cuts are being taken so they can ram them through the FDA.
It's not that you're crazy. It's that you tend to overstate the risk of the vaccines and understate the risk of the virus. The risk to you personally is low with both, but certainly higher from the virus than the vaccine.
Long term risks are an unknown for both.
Exactly. Government is actively trying to take away your right to choose whether or not to take it and they're using the private sector to do it. Pure evil.
But the difference between my risk from the virus and the vaccine (both low) isn't that great. It isn't a large enough spread to push me to want to get the vaccine.
If you went to school, you were mandated to take several vaccinations by the government.
The idea that you have the right to not get vaccinated isn't really correct. That's not the debate. If this virus killed 10x the number of people that it does, everyone would be mandated to get it. No exclusions or exceptions other than maybe religious beliefs or allergies.
The debate is really if Covid warrants a mandate. In my opinion we don't need a mandate, but people can opt out if they want to just get tested instead. That seems reasonable when the virus is spreading.
I would agree that mandating a vaccine that is still under an EUA or has very little historic data is not a good tact in my opinion. You can certainly opt out and I was just reading an article today that pointed to law firms who are helping people navigate an opt out option that would allow them to have access to any public event that requires vaccination. Once again the lawyers win....
There is a difference between being FDA approved and experimental. There is also a difference between having to use a vaccine passport to go about your daily business and being free to live your life without sharing part of you medical history with everyone!
Moot point now that is has full FDA approval, no?
I agree. I'm not on board with vaccine cards... but only because I don’t think we need them for Covid. If Covid were significantly more deadly, we would have vaccine mandates and need proof of vaccination everywhere and I’d be fine with that.
That’s not true. You are over generalizing what he has said. He has consistently said that those of his age and health have a minuscule risk of death from Covid and so he rather have a choice whether to get vaccinated based on unknowns.
You and others knees in particular never answered my questions that would compare at a basic level this vax vs others.
I don't get your point. Are you fine with the governor who you voted for in the coming weeks to require vaccine passports similar to NYC? Because we all know its going in that direction.
Because this is unprecedented in any of our lifetimes. None of us have experienced anything like this. You want to compare it to a situation that is not comparable.
Glad you get it or are aware. Seems like you respect it too, which I think both sides of this coin deserve. It remains a personal choice until the science dictates a different course which it hasn’t yet knock on wood and thank God.
as to second point you made above ….So then why use the comparison of “if you went to school you were mandated”?
@Merge Fauci apologizes for his mistake. He predicted America won't be out of the woods until fall of 2022. However he backed out of that prediction and is now saying spring 2022. Shouldn't this guy stop making predictions. He originally said we would be out of the woods by spring of 2021.
Fauci apologizes, says he misspoke about getting COVID-19 under control in 2022
Dr. Anthony Fauci walked back his prediction Monday that it will take the United States more than one year to get control of COVID-19.
news.yahoo.com
Because it’s in the context of personal freedoms with vaccinations. We don’t have personal freedoms with vaccinations (maybe outside of religious beliefs). We are required to get them for school.
There is no compassion to a new vaccine like this because this is unprecedented.
I almost agree with you here. I like the term unprecedented. It’s a good try on your part to frame the issue….to best try to counter the view of an 09 type of person.
