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Pfizer for teens?
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It's not fully approved. I'll leave my comments at that.
I get this under normal circumstances, but this is an exceptional situation.
Life really, really sucked here this past winter and spring. We were having close to 5,000 cases per day, our ICUs were full, and our hospitals were basically limited to treating Covid patients and emergencies. I had a friend newly diagnosed with cancer who had her surgery postponed - I can't even begin to imagine how stressful that would be.
Throughout all of it I kept thinking to myself "imagine how much worse this would be if we didn't have a vaccine." Like I can't even wrap my head around where we would be right now without it - we have dropped down to 525 cases here today. Because of the vaccine.
Yes in normal non emergency times I might also choose to wait for full approval. But I will say to you what I said to someone else earlier in the thread - you have the luxury of doing that because other people stepped up and took the small risk upon themselves to try to end this pandemic.
Life does not come with a zero risk guarantee.10 -
cmriverside wrote: »SuzySunshine99 wrote: »cmriverside wrote: »SuzySunshine99 wrote: »YellowD0gs wrote: »On being able to afford the vaccine, at least in the U.S.: from the CDC
Who is paying for the vaccine?
The federal government is providing the vaccine free of charge to all people living in the United States, regardless of their immigration or health insurance status.
COVID-19 vaccination providers cannot:
-Charge you for the vaccine
-Charge you directly for any administration fees, copays, or coinsurance
-Deny vaccination to anyone who does not have health insurance coverage, is underinsured, or is out of network
-Charge an office visit or other fee to the recipient if the only service provided is a COVID-19 vaccination
-Require additional services in order for a person to receive a COVID-19 vaccine; however, additional healthcare services can be provided at the same time and billed as appropriate
COVID-19 vaccination providers can:
-Seek appropriate reimbursement from the recipient’s plan or program (e.g., private health insurance, Medicare, Medicaid) for a vaccine administration fee
-However, providers cannot charge the vaccine recipient the balance of the bill
-Seek reimbursement for uninsured vaccine recipients from the Health Resources and Services Administration’s COVID-19 Uninsured Programexternal icon
No one said anything about not affording the vaccine.
Heath insurance costs came up because the question was asked...is it ethical for a "wealthy" country to vaccinate low-risk individuals when there are developing nations that can't vaccinate their most vulnerable.
Some of us pointed out that even this "weathly" nation has many people that cannot afford to be sick with Covid, so vaccines should not be diverted away from people here, even if they are low-risk.
We can't afford NOT to get the vaccine.
But Suzy, vaccines are now being diverted because people are refusing it.
Anyone in this country (U.S.) who hasn't initiated vaccination at this point doesn't want one.
Send it where it will find a willing arm.
The specific situation being discussed was "should we be vaccinating low-risk children instead of sending the vaccines to other countries who have not yet vaccinated their vulnerable population." It was suggested that we deny the opportunity for parents to get their kids vaccinated.
Also, I think we need to continue efforts to convince hesitant people to get vaccinated. Not everyone is an anti-vaxxer, just scared or misinformed. I don't think we just give up and say, well, if you haven't had it by now, you never will.
Well that's quite a leap.
If people don't want it now they don't lose their lifetime decision. It's not now or never, it's Now or wait till the next round is manufactured. At some point in the not-that-distant future there will be enough doses for the world. If you turn away your place in line right now, well, your decision. Catch it next time around. If you're still here.
The Pfizer in particular has a shelf-life. So we should just leave it *somewhere* until *maybe* people change their minds? Let the rest of the world fend for themselves? Wow.
I understand the issue of expiring vaccines, and if they can be moved somewhere where they will be used before expiration, that would be great. There's logistical problems in doing that, given the sub-zero handling requirements of the Pfizer in particular.
Since the U.S. is already donating 80 million surplus doses to other countries, I don't think there's a "fend for yourself" attitude.
My entire point was in regards to vaccinating children, which is the topic of this thread. Again, it was suggested that it's not ethical to vaccinate children in this country when other countries need vaccines for elderly people. I disagree with that, and think we need to give the opportunity to EVERYONE here to be vaccinated, while at the same time helping people around the world.5 -
It's not fully approved. I'll leave my comments at that.
Pfizer will most likely be approved yet this summer though. Moderna is not that far behind them in the process as well. It will be interesting to see if FDA approval will actually make a difference for those not vaccinated yet though. The handful of people I know in real life who refuse to get the vaccine keep moving the goal posts for why they won't get vaccinated.
Yep, I fully expect that the "it's not fully approved" group will find new reasons to object once it is fully approved.13 -
I was just saying, I wouldn’t take it until it was approved. I’m not using that as an excuse not to get it. I just won’t.
If a couple few rounds of e-coil, meningitis, and the many extremely unsafe things I’ve done in my lifetime hasn’t done me in this won’t.4 -
I was just saying, I wouldn’t take it until it was approved. I’m not using that as an excuse not to get it. I just won’t.
If a couple few rounds of e-coil, meningitis, and the many extremely unsafe things I’ve done in my lifetime hasn’t done me in this won’t.
This makes zero sense. The millions who died of COVID also probably survived illnesses -- some serious -- prior to dying. This is such a perfect parody of anti-vax logic I suspect you're just playing with us.
The vaccine is legally approved for emergency use in the US because it is an emergency. I cannot fathom the thought process of someone who'd rather take their chances with a virus that is currently actively mutating through the population and has a cluster of still not yet fully understood long term health impacts than a legally approved vaccine.17 -
I was just saying, I wouldn’t take it until it was approved. I’m not using that as an excuse not to get it. I just won’t.
If a couple few rounds of e-coil, meningitis, and the many extremely unsafe things I’ve done in my lifetime hasn’t done me in this won’t.
Yeah, since you haven't been hit by a car yet, it's perfectly safe to go play in traffic.17 -
janejellyroll wrote: »I was just saying, I wouldn’t take it until it was approved. I’m not using that as an excuse not to get it. I just won’t.
If a couple few rounds of e-coil, meningitis, and the many extremely unsafe things I’ve done in my lifetime hasn’t done me in this won’t.
This makes zero sense. The millions who died of COVID also probably survived illnesses -- some serious -- prior to dying. This is such a perfect parody of anti-vax logic I suspect you're just playing with us.
The vaccine is legally approved for emergency use in the US because it is an emergency. I cannot fathom the thought process of someone who'd rather take their chances with a virus that is currently actively mutating through the population and has a cluster of still not yet fully understood long term health impacts than a legally approved vaccine.6 -
As far as I can tell from reading material I can find, the key differences between emergency use authorization (EUA) and full FDA approval are that:
* The EUA process can be used only when there's an emergency (there are criteria for this), and when there is no safe/effective alternative already.
* With an EUA process, the safety/efficacy trials and production can occur in parallel. When the trials reach a point where there's statistically significant evidence that the vaccine is safe and effective, the FDA review of the trials happens, and - if the EUA is approved - the already-manufactured vaccine can be distributed. With a full approval, it's a two stage, non-parallel process. The trials happen first, then then the company submits a Biologics License Application (BLA). The FDA reviews the trial results, and if the BLA is approved based on those results, the company can begin manufacturing the vaccine, with distribution to follow as supply becomes available.
* In this case, there was about 3 months' worth of trial results and follow-up, on which the EUA was based. With the full approval process, there would be 6 months of follow-up in the trial phase, and the FDA's review usually takes about 6 months, vs. the expedited time period in this instance. While long-term side effects from vaccines have been very rare, historically, this slower process does include more time when those things could pop up. Also, the longer time period means that more can be known about the duration of protection. (That that's unclear in this case seems to be a point of frustration for some consumers, whose confidence is undermined by that lack of a definitive answer.)
* In my limited understanding, the FDA has some legal discretion about what scientific standards to apply to an EUA, to give them flexibility to weigh relative risks of disease vs. treatment in different kinds of emergencies. In this case, the FDA required “at least one well-designed Phase 3 clinical trial that demonstrates the vaccine’s safety and efficacy in a clear and compelling manner”, which seems to be somewhat at the stronger end of the scale of their discretionary range, similar to a full approval's standards. (According to one source, as a generality, "Under an EUA, regulators must determine that the product “may be effective” and the “known and potential benefits outweigh the known and potential risks.”)
* Much of the difference between the two approval processes is expediting of the administrative steps. There is not a huge difference in the standards used, or the topics considered, when reviewing the vaccines under the two processes in this case, but the longer administrative track for full approval does make a longer time period of data available for review.
Does anyone else know of further differences between the processes, that would be relevant to a consumer's decision-making?
I'm not making this post to say what I think anyone should do, one way or another. (I do have opinions.) I'm just trying to get (for myself) a better understanding of what EUA vs. full approval really means since that's a hot topic now, and to share here what I'm seeing, ask if others have additional information.
These are a couple of articles, not the only sources I looked at, but IMO a fair representation of what I found in multiple places, presented somewhat succinctly in a consumer-friendly form, from what appear (to me) to be reasonably trustworthy/neutral sources:
https://vaccine.unchealthcare.org/science/vaccine-approval/whats-the-difference-between-fda-emergency-use-authorization-and-fda-approval/
https://www.wkyc.com/article/news/health/coronavirus/vaccine/difference-between-emergency-use-authorization-and-full-fda-approval-coronavirus-vaccines/95-f2a7a6ba-eeee-4352-b3c7-8dce70cfba677 -
As far as I can tell from reading material I can find, the key differences between emergency use authorization (EUA) and full FDA approval are that:
* The EUA process can be used only when there's an emergency (there are criteria for this), and when there is no safe/effective alternative already.
* With an EUA process, the safety/efficacy trials and production can occur in parallel. When the trials reach a point where there's statistically significant evidence that the vaccine is safe and effective, the FDA review of the trials happens, and - if the EUA is approved - the already-manufactured vaccine can be distributed. With a full approval, it's a two stage, non-parallel process. The trials happen first, then then the company submits a Biologics License Application (BLA). The FDA reviews the trial results, and if the BLA is approved based on those results, the company can begin manufacturing the vaccine, with distribution to follow as supply becomes available.
A very minor and probably irrelevant point, but the kind of thing that nags at my brain -- this implies that EUAs are only for biologics, but they can also be granted for other medical products, such as drugs, devices, little radioactive pellets they insert in your body near a cancer site ...
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Do I think it's worth it to be Vaccinated at ANY age? - YES! Definitely! Not only for yourself, but for other people too. That's what I kept reading. That's what my husband & I did. That's what our teenage son is in the process of his 2nd dose in tomorrow. Yes, Yes, Yes is my simple answer. 👍 I was even willing to drive people in my community, if they needed a ride to Vaccinate, but no one reached out. Hopefully they already had it done.13
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https://youtu.be/Fq3CG5WvHQU
****1:07-1:12****& 5:22+1 -
My youngest son just turned 12, and he and his teenaged brothers will be getting vaccinated this coming week. They all had Covid back in November, as did my husband. Only my 14-year-old was truly ill. I am not concerned about serious side effects, but I did want to wait until my kids finished the school year, lest they miss final exams due to a day or two of post-vaccine flu-like symptoms. My husband was sick for two days after each vaccine. I had no issues aside from a little injection site soreness.7
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We don’t need a vaccination for a 99.6% survival virus. Everyone is quick to trust and do what they are told. An MRNA is not actually a “vaccine.” It does not fit FDA guidelines to be labeled as such. Real vaccinations take 10+years to develop. Food for thought. Additionally, you won’t see the larger amount of adverse reactions on mainstream news. Check rumble.com. Also, teens are passing away from the vaccinations. Would you be willing to take that chance with your child? How about natural supplements and building the immune system. If you notice, the flue is now non-existent from 2020-2021. Apparently the flu was cured? Lol. No, just everything is being labeled as Covid. My in-laws has two good friends pass away from the Johnson-Johnson and one Pfizer vaccine. One of them I believe had diabetes and was in their 50’s. The other, in their 40’s and no pre-existing conditions. They labeled cod as Covid. This is not to banter, but to throw info out their and warn others to do your research from credible sources. Mainstream does not have your best interest, I promise. https://www.newsweek.com/13-year-old-dies-sleep-after-receiving-pfizer-covid-vaccine-cdc-investigating-16065293
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ElliesDad422 wrote: »We don’t need a vaccination for a 99.6% survival virus. Everyone is quick to trust and do what they are told. An MRNA is not actually a “vaccine.” It does not fit FDA guidelines to be labeled as such. Real vaccinations take 10+years to develop. Food for thought. Additionally, you won’t see the larger amount of adverse reactions on mainstream news. Check rumble.com. Also, teens are passing away from the vaccinations. Would you be willing to take that chance with your child? How about natural supplements and building the immune system. If you notice, the flue is now non-existent from 2020-2021. Apparently the flu was cured? Lol. No, just everything is being labeled as Covid. My in-laws has two good friends pass away from the Johnson-Johnson and one Pfizer vaccine. One of them I believe had diabetes and was in their 50’s. The other, in their 40’s and no pre-existing conditions. They labeled cod as Covid. This is not to banter, but to throw info out their and warn others to do your research from credible sources. Mainstream does not have your best interest, I promise. https://www.newsweek.com/13-year-old-dies-sleep-after-receiving-pfizer-covid-vaccine-cdc-investigating-1606529
Newsweek is not a peer reviewed journal. Neither is anecdotal experience. Credible sources are research studies from reputable journals. Those results are based on large scale data, not “ I know someone who knows 2 people who passed away”.9 -
Well regardless of where you stand on this issue, I think we'd all probably agree that greed and commercialism in the medical field and pharmaceutical industries hurt everyone. I don't just automatically trust peer reviewed research without looking up the researchers and funding, etc. & it's sad.. isn't there such important research that scientists need to do, but can't simply because it's not profitable enough to be funded?2
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ElliesDad422 wrote: »We don’t need a vaccination for a 99.6% survival virus. Everyone is quick to trust and do what they are told. An MRNA is not actually a “vaccine.” It does not fit FDA guidelines to be labeled as such. Real vaccinations take 10+years to develop. Food for thought. Additionally, you won’t see the larger amount of adverse reactions on mainstream news. Check rumble.com. Also, teens are passing away from the vaccinations. Would you be willing to take that chance with your child? How about natural supplements and building the immune system. If you notice, the flue is now non-existent from 2020-2021. Apparently the flu was cured? Lol. No, just everything is being labeled as Covid. My in-laws has two good friends pass away from the Johnson-Johnson and one Pfizer vaccine. One of them I believe had diabetes and was in their 50’s. The other, in their 40’s and no pre-existing conditions. They labeled cod as Covid. This is not to banter, but to throw info out their and warn others to do your research from credible sources. Mainstream does not have your best interest, I promise. https://www.newsweek.com/13-year-old-dies-sleep-after-receiving-pfizer-covid-vaccine-cdc-investigating-1606529
mRNA vaccines have been in development for “10+ years”.8 -
It always make me laugh when people assume they won't be one of the (*supposed) .4% of those who die from Covid, but they won't get the vaccine because they fear being the one in a million person who reacts to it.
*the actual rate is more like 1.8%10 -
*the actual rate is more like 1.8%
Sure, if you count all of the people killed in car wrecks, construction accidents, or died of other legitimate causes that were labeled as "Covid" deaths because they may have tested positive after death. Hospitals everywhere are using the "Covid" cause of death for everything they can because covid insurance claims are paying at a higher rate and are not being scrutinized as closely for fraud.
Actual deaths caused by Covid alone are probably much lower than what @ElliesDad422 noted.4 -
*the actual rate is more like 1.8%
Sure, if you count all of the people killed in car wrecks, construction accidents, or died of other legitimate causes that were labeled as "Covid" deaths because they may have tested positive after death. Hospitals everywhere are using the "Covid" cause of death for everything they can because covid insurance claims are paying at a higher rate and are not being scrutinized as closely for fraud.
Actual deaths caused by Covid alone are probably much lower than what @ElliesDad422 noted.
Hospitals everywhere? Our hospitals are publicly funded and non-profit so I can't imagine a scenario where a Covid death would be more beneficial to them than a death by any other cause.
Or do you mean life insurance claims? Maybe I'm not following exactly what "covid insurance claims" you are referring to.3 -
*the actual rate is more like 1.8%
Sure, if you count all of the people killed in car wrecks, construction accidents, or died of other legitimate causes that were labeled as "Covid" deaths because they may have tested positive after death. Hospitals everywhere are using the "Covid" cause of death for everything they can because covid insurance claims are paying at a higher rate and are not being scrutinized as closely for fraud.
Actual deaths caused by Covid alone are probably much lower than what @ElliesDad422 noted.
What fraud??
Not following what you are claiming is happening??
And does it apply to all countries?? Are you claiming covid deaths are being misdiagnosed in all countries - if not, how do you a count for the death rate world wide ??5
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