COVID-19 Thread [V2.0]

[igor67]

Early in trials they will tend to pause for any rare event occurring while they try and establish the cause and if it is plausibly related to the trial in question or something else. Roughly speaking the idea there is that the chances of some kind of rare event early in a trial while the sample is small are relatively low. By the end of a trial though a single rare event does not have any real predictive power.

[CheezWizHed]

We need to be careful not to let a, thus far, one in a million occurrence rate with limited details (again thus far) give fuel to the 'vaccines are dangerous' crowd.

 

By "we", I'm assuming you mean the FDA and vaccine manufacturers and not BF.net. I can see the headlines now "BF.net online forum openly questions the safety of J&J vaccine!"

 

But seriously, I think pausing to examine the evidence (especially while under emergency approval use) is the best course of actions. You will always have the two extremes of people ("it will turn us into zombies" and "Just take it. Its safe!") that no action will sway their opinion. For the rest of us, there are four possible action/outcome combinations:

- Don't pause it, No Issue - People will question why they aren't looking at it (even if they are) and trust will go down.

- Don't pause it, Find Issue - Obviously the worst outcome - Trust in future medicines goes way down. [sarcasm]Plus, we end up with the largest populations of zombies![/sarcasm]

- Pause it, No Issue, report it, restart it - People might still be skeptical, but at least it is visible that the FDA and J&J took action. This action should build trust in most people.

- Pause it, Find Issue - Well, obviously why you pause it in the first place. Maybe a very minimal chance, but better safe than sorry. Public trust might be impacted, but at least they can show that the system works.

 

Pausing it now is really the best way to build trust in the consuming population.

 

And it isn't just "vaccines are dangerous". Remember there are the general anti-vax, there are people cautious about new technology or medicines, there are people cautious about being experimented on (i.e. historical wounds)... There are a variety of good and bad reasons why people are cautious about the vaccine.

[PeaveyFury]

We need to be careful not to let a, thus far, one in a million occurrence rate with limited details (again thus far) give fuel to the 'vaccines are dangerous' crowd.

 

By "we", I'm assuming you mean the FDA and vaccine manufacturers and not BF.net. I can see the headlines now "BF.net online forum openly questions the safety of J&J vaccine!"

 

I guess I was referring more to the general populace, and by extension, BF.net posters. We need to be careful in general that the narrative doesn't become 'the vaccine is dangerous' when these instances of clotting, statistically at least, are less prevalent than than women taking birth control, women following pregnancy, etc.

[CheezWizHed]

We need to be careful not to let a, thus far, one in a million occurrence rate with limited details (again thus far) give fuel to the 'vaccines are dangerous' crowd.

 

By "we", I'm assuming you mean the FDA and vaccine manufacturers and not BF.net. I can see the headlines now "BF.net online forum openly questions the safety of J&J vaccine!"

 

I guess I was referring more to the general populace, and by extension, BF.net posters. We need to be careful in general that the narrative doesn't become 'the vaccine is dangerous' when these instances of clotting, statistically at least, are less prevalent than than women taking birth control, women following pregnancy, etc.

 

I'd say it isn't wise for the general populace to say it is neither "safe" nor "dangerous" as it would generally be speaking out of ignorance. Knowing that this process (pausing the roll-out to examine the evidence) is normal is helpful and builds confidence, however.

[Machu Peach]

Pausing a clinical trial is normal. I would not call pausing use of a vaccine already administered to 6-7 million people normal.

[PeaveyFury]

I'd say it isn't wise for the general populace to say it is neither "safe" nor "dangerous" as it would generally be speaking out of ignorance. .

 

I think that's perfectly fair. But my post was in direct response to someone that was seemingly implying that the vaccine is more dangerous than COVID due to this issue, but when again, clotting instances statistically here are less than other far more common situations for women in this age group and no details are known about medical history beyond age and gender.

[Machu Peach]

The issue isn't just clotting. It's clotting in a specific location, specifically the brain's venous sinuses. Looking at the overall rate of clotting per person to the rate of clotting in the brain post vaccination is not a good comparison.

 

Notably, the cerebral venous sinus thrombosis is getting all the attention, but these patients also all apparently had low platelet levels. That, to me, is far more significant than just the CVST. It's much easier to hypothesize links from vaccination to thrombocytopenia than it is to clots in the brain.

[CheezWizHed]

Pausing a clinical trial is normal. I would not call pausing use of a vaccine already administered to 6-7 million people normal.

 

True. But how often are vaccines given emergency approval for use? If we compare this to a normal vaccine roll-out, we would still be in the clinical trial phase, right?

 

I'd say it isn't wise for the general populace to say it is neither "safe" nor "dangerous" as it would generally be speaking out of ignorance. .

 

I think that's perfectly fair. But my post was in direct response to someone that was seemingly implying that the vaccine is more dangerous than COVID due to this issue, but when again, clotting instances statistically here are less than other far more common situations for women in this age group and no details are known about medical history beyond age and gender.

 

But technically it could be. The truth is that we (general public) don't know if it is safe or not. Based on what I've heard, I don't think it should be a concern, but I'm glad the experts decided to pause it and look deeper.

[Machu Peach]

Pausing a clinical trial is normal. I would not call pausing use of a vaccine already administered to 6-7 million people normal.

True. But how often are vaccines given emergency approval for use? If we compare this to a normal vaccine roll-out, we would still be in the clinical trial phase, right?

Yes, these are much larger and much shorter duration than standard vaccine trials. ...yet another reason why I would not call it 'normal'.

 

But technically it could be. The truth is that we (general public) don't know if it is safe or not. Based on what I've heard, I don't think it should be a concern, but I'm glad the experts decided to pause it and look deeper.

It is perfectly acceptable to ask questions about decisions made by scientists or "the experts." The pause could have real-world negative consequences; it is also OK to discuss them.

[CheezWizHed]

But technically it could be. The truth is that we (general public) don't know if it is safe or not. Based on what I've heard, I don't think it should be a concern, but I'm glad the experts decided to pause it and look deeper.

It is perfectly acceptable to ask questions about decisions made by scientists or "the experts." The pause could have real-world negative consequences; it is also OK to discuss them.

 

Agreed on both points. I was just saying that the general public should avoid jumping to the conclusion that it was either safe or dangerous.

[igor67]

Worst thing I saw last night was a CBS report that made it sound like it was a big disappointment that the FDA or CDC panel (can't remember which) had met and didn't have any answers so it was continuing the pause. It was a terrible example of how movie and TV scientist heroes can really mess with actually understanding what is reasonable. Given the rarity of the events I would guess that they will need some new type of experimental data to actually sift through the various hypotheses. Maybe super detailed clinical comparisons will settle it, but that seems rather optimistic. And while any slow down in vaccination is not ideal having decided to pause this one doing a really definitive look at the issue is the best for public health. Lots of people watching, so getting it right is way better than getting it fast.

[CheezWizHed]

Seems like supply and demand at the moment are pretty close. People that want a vaccine are getting them, so there certainly shouldn't be pressure to be fast (though J&J is going to be losing $$).

 

Slightly different topic... My work started the policy that someone that has recovered from COVID or had the COVID vaccine (plus 2 weeks for effectivity) no longer needs to quarantine if they have been exposed to someone with COVID (unless they show symptoms).

 

I'm wondering how a policy like that might be used in the MLB? If I heard right, Milwaukee was fully vaccinated.

[PeaveyFury]

Slightly different topic... My work started the policy that someone that has recovered from COVID or had the COVID vaccine (plus 2 weeks for effectivity) no longer needs to quarantine if they have been exposed to someone with COVID (unless they show symptoms).

 

I believe this policy is consistent with current CDC guidelines for vaccinated people in general as well.

[igor67]

So no comparison to the risk of other types of events is remotely perfect, but for some sense of comparison about 800,000 people have developed peanut allergies as adults. Each of those represents an out of the blue event with frequent exposures and all the dangers that anaphylactic reactions bring.

https://www.healthline.com/health-news/adults-are-developing-peanut-allergies-after-age-18-heres-what-we-know

I'm not sure if that is useful at all for helping others understand risks.

[adamb100]

Got my second Pfizer shot yesterday at the Wisconsin Center. Super smooth process. Anyway coming at this from a 32 YO male that is slightly overweight...

 

The second dose definitely hit me a little hard. The typical arm pain had onset within a few hours, gradually getting worse. Had some restless sleep and sense of chills. Running a fever around 100 degrees. Also have a headache. I ended up using a sick day at work since I have driving job and a few places I visit do a temperature check, and they’d probably refuse me, thinking I have COVID.

 

Hopefully these vaccines can get reformulated eventually to cause less of an immune system response.

[Zad Fnark]

Getting number 2 tomorrow. Hopefully won't get hit too bad, but number one had me miserable for a day.

[Jimbo]

Injected with Moderna #1 on 2:30 pm Wednesday and at 10:30 the arm was getting sore. Slept fine through the night. Woke up at 5:30 am and otherwise felt great. Around 9:30 am all at once felt like I got hit by a Mack truck and spent most of the rest of the day flat on my back with aches, chills and no energy nor appetite. Friday morning was 80% better with a bit of a headache and by evening was fine. Ran twelve miles Saturday morning.

[OldSchoolSnapper]

I had my 2nd Pfizer on Friday and got pretty sick through Saturday night, then it vanished. Fever, chills, and was just REALLY tired all of Saturday.

[Hopper]

I wonder since the vaccine effects so many differently, if you have severe reaction, does that mean that COVID would have effected you severely too?

I don't know the answer, just wondering.

It seems that there are a lot of people that have no problem with the vaccine, and there are a lot of people that do.

[tmwiese55]

Feel like only people chiming in have been having side effects. I had my 2nd last week and had no reaction to either shot, as if nothing had happened to me at all. So just adding in that it can happen, cross your fingers. For info, I'm upper 30s, never had covid, and I'm someone who never gets sick (which had me thinking my body would have a reaction). ETA: It was pfizer

[Machu Peach]

I wonder since the vaccine effects so many differently, if you have severe reaction, does that mean that COVID would have effected you severely too?

I don't know the answer, just wondering.

It seems that there are a lot of people that have no problem with the vaccine, and there are a lot of people that do.

There should be little to no correlation between the reaction to the immunization and severity of a hypothetical infection.

[PeaveyFury]

I'll defer to Machu's knowledge about whether it's actually a plausibly theory, but there has been a lot of 'presumption' that those that HAD a COVID infection previously are having more severe reactions to the vaccine, and more notably to the 1st shot than non-previously infected persons.

[adamb100]

Update to my earlier post. Going to try to make this without cursing...I’ve only felt worse one time in my life after getting the second shot. Fever is hovering at 101 degrees. The headache reminds me of the awful migraines I used to have as a child. Throbbing pain in the front of my head along the crown. Arm still hurts a bit but that’s the least of my pain. Lost all my appetite, trying to drink lots of water. Still got chills. Little sensitive to light and sound. If this is what actual COVID feels like, only longer...yeesh, screw this virus.

[homer]

Feel like only people chiming in have been having side effects. I had my 2nd last week and had no reaction to either shot, as if nothing had happened to me at all. So just adding in that it can happen, cross your fingers. For info, I'm upper 30s, never had covid, and I'm someone who never gets sick (which had me thinking my body would have a reaction).

 

My wife didn't feel a thing after either shot. I get my second on friday. Hopefully I'm in that camp

[TURBO]

I had no stmptoms other than a slight sore arm with both shots.

 

Wife had a headache after #1, nothing after #2.

 

My daughter just got shot #2, and is going through fever, chills, fatigue.

 

Son getting #2 tomorrow, but had no symptoms after #1.

 

All phfizer.