COVID-19 vaccines: medical concerns and recommendations

[Dog Guy]

Not trying to be an ass. If it's that well studied why did the CDC say the only way to know what will happen is to give the shots. This should be already known, no?

There is no one Aha moment. More like a lot of these little things that when add up don't amount to a lot of trust in this new vaccine or the push to get them

Also, any thoughts on the new concerns out of Israel?

Sent from my moto z4 using Tapatalk

If we're being honest though, isn't that statement true for the rollout of almost any new drug or gizmo or car or rifle or military gear or ??? We like to think we've checked all the possibilities and then it hits truly widespread use and wait, they did what? Or this population has what interaction? The only way to know what not launching the vac would do was to not launch the vac and see how things worked out for a few years, or a generation, or however long our preferred time line reaches. Kind of a Hobson's choice.

The same question will hold true for the various therapeutics: they're not the vac so they'll carry less political baggage but again, we won't know everything they'll do until they hit truly widespread use. No testing regime can reveal everything.

My other concern with holding off on wide vac release until we had all the possible answers is that we still don't know, and can't know for a while, is what's the long term impact on patients who recovered after just a runny nose. I asked way back at the start, what are the chances that people who are getting just a little sick now will end up with some downstream impact 20 years on that we have no way of knowing about right now. The general response was that this wasn't a worry because respiratory corona viruses don't work that way. With the impact on the vascular system and other organs, I'm not convinced that this answer still holds true. Holding the vac long enough to gather a lot more data would increase the number of not dead but still sick people. We'd still be lab rats, just in a different lab. But with the widespread vac refusal, we'll have a population to watch over time and see what happens.

[MickAK]

It was a leaked video of discussing vaccines for kids. I'm paraphrasing but what was said was we don't know whats going to happen to kids and there's only one way to find out and that's to start vaccinating.

It wasn't leaked. Every one of those meetings is recorded and posted online for everyone to read, in mind numbingly boring detail.

That one is here: https://www.fda.gov/advisory-committ...vent-materials

In full context the statement is much less sinister.

[Nephrology]

It was a leaked video of discussing vaccines for kids. I'm paraphrasing but what was said was we don't know whats going to happen to kids and there's only one way to find out and that's to start vaccinating.

New observations out of Israel suggest that MAYBE the mRNA vaccines are destroying immune systems. Enough of a worry that the new round of boosters is only for those who really need it. Their CDC equivalent guy said they cannot stop even though there may be health issues down the road. They have to look into this and give vaccines at the same time.

Again, I'm paraphrasing

Sent from my moto z4 using Tapatalk

to repeat myself more succinctly, there is no way around the fact that when a new drug or device is developed, it has to be tested on people in order to prove that it works. It is a leap of faith by definition. The trials process is designed in such a way to minimize the odds of harm (eg starting with small phase I trial geared to closely monitor safety before enrolling more patients for phase 2/3)but there is no way around the fact that it starts with a leap of faith every time. Trials can and will be stopped mid-process if there is a significant enough concern for safety.

For this reason, they did launch a separate clinical trial to investigate the vaccines in kids but only after very favorable safety results in adults had been demonstrated. They repeated essentially the same basic study design in kids, the results of which can be found here. The relevant safety results are below. TLDR, quite safe.

On the basis of phase 1 safety and immunogenicity results, 10 μg of BNT162b2 was selected as the dose level to be studied in 5-to-11-year-olds in the phase 2–3 trial. This dose level was associated with mainly low-grade local and systemic adverse events lasting 1 to 2 days; the frequency and severity of fever were low. As compared with adults and adolescents in the pivotal trial, 5-to-11-year-olds reported a higher incidence of injection-site redness (15 to 19%, vs. 5 to 7%) and swelling (10 to 15%, vs. 5 to 8%), but a generally lower incidence of systemic events, including fever (3 to 7%, vs. 1 to 20%) and chills (5 to 10%, vs. 6 to 42%).3,4 Lymphadenopathy was reported in 0.9% of 5-to-11-year-old BNT162b2 recipients, an incidence similar to that in 12-to-15-year-olds (0.8%) but higher than that observed in adults (0.3%).3,4 Four potentially vaccine-related rashes were reported, too few to determine whether the pattern was similar to that observed in adult BNT162b2 recipients.31 No MIS-C cases were reported, although surveillance continues. Neither myocarditis nor pericarditis was observed, a finding consistent with the low frequency of these adverse events with real-world use of BNT162b2 in other age groups.32

New observations out of Israel suggest that MAYBE the mRNA vaccines are destroying immune systems. Enough of a worry that the new round of boosters is only for those who really need it. Their CDC equivalent guy said they cannot stop even though there may be health issues down the road. They have to look into this and give vaccines at the same time.

That's not something I have heard of before. if you can find a link to a study of some kind I could give you more incisive commentary. Israel is fairly famous for being very aggressive in vaccination rollout and were the earliest to warn that the effectiveness of the vaccine wanes over time. Maybe that is what you are referring to? To my knowledge significant immunocompromise is not a side effect of the vaccines. The most common serious adverse effects of the mRNA vaccines are myocarditis, but in relative terms, this is a very rare, and the cases are largely mild and treatable with oral steroids.

There's no way around the fact that if you give a drug/treatment to enough people somebody will do badly, just like if you give enough people strawberries eventually someone will have a severe allergic reaction and die. That is why every medical decision is a careful weighing of the potential risks and potential benefits. In the case of the vaccine, this ratio is substantially more favorable than a great number of things that we do to people all the time that receive far less public scrutiny to be honest.

I could give you countless examples of this, e.g., lots of new fancy and expensive chemo drugs that are basically designated only for salvage therapy in patients who have not responded to first, second or third line treatment. Patients with terminal cancer do not want to die, and when they are offered a new treatment that a physician sells as having a slim margin of hope they will jump all over it. What they do not consider is the exorbitant cost, significant side effects, and the fact that going to hospice is often more likely to prolong their life and increase its quality than some of the chemo drugs that have hit the market in the last 5-10 years.

In my opinion the latter is a controversy that deserves far more public scrutiny and does not, for reasons that I could ramble about but will stop for now. Hopefully that gives you some context with which to interpret the way we think about the risk/benefits of new drugs in the context of clinical trials.

[HeavyDuty]

…Xigris...

Shit, this just made my blood run cold. My late wife rode the sepsis train multiple times, and the one time they used Xigris she developed a severe GI bleed that almost killed her.

[Nephrology]

Shit, this just made my blood run cold. My late wife rode the sepsis train multiple times, and the one time they used Xigris she developed a severe GI bleed that almost killed her.

I am sorry to hear that. The drug was pulled off the market for a reason. @ccmdfd has probably a lot more historical perspective on this than I do ... but it was a bad drug that should never have approved.

I'm sorry.

[peterb]

What they do not consider is the exorbitant cost, significant side effects, and the fact that going to hospice is often more likely to prolong their life and increase its quality than some of the chemo drugs that have hit the market in the last 5-10 years.

In my opinion the latter is a controversy that deserves far more public scrutiny and does not, for reasons that I could ramble about but will stop for now.

*thread drift*
100% with you on that. There’s an increasing body of data that hospice care improves the quality and duration of life for patients with terminal cancer. Continuing chemo to try to buy time often had the opposite effect.

[ccmdfd]

I am sorry to hear that. The drug was pulled off the market for a reason. @ccmdfd has probably a lot more historical perspective on this than I do ... but it was a bad drug that should never have approved.

I'm sorry.

Yeah, never seen anyone bleed out of their eyeballs before until I gave that drug one time.

[HeavyDuty]

Scary shit.

[4RNR]

If we're being honest though, isn't that statement true for the rollout of almost any new drug or gizmo or car or rifle or military gear or ??? We like to think we've checked all the possibilities and then it hits truly widespread use and wait, they did what? Or this population has what interaction? The only way to know what not launching the vac would do was to not launch the vac and see how things worked out for a few years, or a generation, or however long our preferred time line reaches. Kind of a Hobson's choice.

The same question will hold true for the various therapeutics: they're not the vac so they'll carry less political baggage but again, we won't know everything they'll do until they hit truly widespread use. No testing regime can reveal everything.

My other concern with holding off on wide vac release until we had all the possible answers is that we still don't know, and can't know for a while, is what's the long term impact on patients who recovered after just a runny nose. I asked way back at the start, what are the chances that people who are getting just a little sick now will end up with some downstream impact 20 years on that we have no way of knowing about right now. The general response was that this wasn't a worry because respiratory corona viruses don't work that way. With the impact on the vascular system and other organs, I'm not convinced that this answer still holds true. Holding the vac long enough to gather a lot more data would increase the number of not dead but still sick people. We'd still be lab rats, just in a different lab. But with the widespread vac refusal, we'll have a population to watch over time and see what happens.

Probably is true but I don't take drugs and wouldn't take one if it was new. I'm very much not into the latest and greatest. I let others be beta testers. I've had a few prescriptions for athlete's foot cream over the years and for some kind of antibacterial mouth wash after minor dental surgery. Thats it. Just this summer I had a minor concern about something and the doctor didn't want to even finish hearing me out. He straight up wrote a prescription for some new medication that's not really for what I was talking about but has shown to potentially work. No thanks! With this concern I'll deal with it a different way.

We don't know what's going to happen in 20 years. I couldn't control getting covid but I can control what is put in my body.


Sent from my moto z4 using Tapatalk

[Borderland]

Probably is true but I don't take drugs and wouldn't take one if it was new. I'm very much not into the latest and greatest. I let others be beta testers. I've had a few prescriptions for athlete's foot cream over the years and for some kind of antibacterial mouth wash after minor dental surgery. Thats it. Just this summer I had a minor concern about something and the doctor didn't want to even finish hearing me out. He straight up wrote a prescription for some new medication that's not really for what I was talking about but has shown to potentially work. No thanks! With this concern I'll deal with it a different way.

We don't know what's going to happen in 20 years. I couldn't control getting covid but I can control what is put in my body.


Sent from my moto z4 using Tapatalk

I think you believe that you can control what you put into your body but by just breathing you inhale things that you don't know about. Do you drink tap water? If so have you seen a chemical analysis of that. Food is even worse. How do you know for sure what chemicals are used on certain crops? Unless you grow your own food and filter your own water you don't have as much control as you think you do.