Coronavirus

[AlanSubie4Life]

They can't start human trials without FDA approval. If they do so, the FDA will literally show up with a court order and law enforcement on their doorstep and send everyone home and close down the company

Wait, what? How did they do the first trials?

What approval are you referring to? I definitely agree approval is required but is that what is being discussed here?

They completed BA.1 trials (antibody levels only), and there is no “approval” (of the type being discussed).

It's reasonable that they haven't pushed the booster as hard as you would like.

I don’t care if they don’t push the booster as long as I can get it ASAP. In fact that is what I would prefer. More for me.

But because COVID is less deadly

I’m super curious to see how much less deadly it was, in a couple years, after analysis is complete. Definitely a lot of studies but the exact reduction in virulence was very unclear. Seemed like maybe a factor of two vs. Delta, apples to apples. A very tough analysis.

 

[bkp_duke]

Wait, what? How did they do the first trials?

What approval are you referring to? I definitely agree approval is required but is that what is being discussed here?

They completed BA.1 trials (antibody levels only), and there is no “approval” (of the type being discussed).


I don’t care if they don’t push the booster as long as I can get it ASAP. In fact that is what I would prefer. More for me.

You are missing my point. It took so long to get a reformulated booster b/c of the reasons I mentioned.


Regarding first trials - you must have FDA TRIAL approval (not use approval). I.e. Phase 1, 2, 3 clinical trials. That's what I'm referring to. You start injecting humans without that, you are going to jail, and your company shut down.

 

[Daniel in SD]

Pfizer is strong enough for me. It’s crazy that Moderna is still authorized for teenagers.

You are missing my point. It took so long to get a reformulated booster b/c of the reasons I mentioned.


Regarding first trials - you must have FDA TRIAL approval (not use approval). I.e. Phase 1, 2, 3 clinical trials. That's what I'm referring to. You start injecting humans without that, you are going to jail, and your company shut down.

I don’t think they’ve done a phase 3 trial for this booster have they?

 

[AlanSubie4Life]

Regarding first trials - you must have FDA TRIAL approval (not use approval). I.e. Phase 1, 2, 3 clinical trials. That's what I'm referring to. You start injecting humans without that, you are going to jail, and your company shut down.

Sure. It’s a very good question - when did that approval occur (obviously not the article being discussed)? Presumably it was approved at the time the FDA requested the vaccine in June/July. But I don’t know. Reporting has really failed on this stuff.

 

[bkp_duke]

Sure. It’s a very good question - when did that approval occur (obviously not the article being discussed)? Presumably it was approved at the time the FDA requested the vaccine in June/July. But I don’t know. Reporting has really failed on this stuff.

They are public record. It's been a long time since I looked that up, the there is a trials website (clinicaltrials.gov ?).

 

[AlanSubie4Life]

I don’t think they’ve done a phase 3 trial for this booster have they

Yeah, seems like they are not going to. As you have said, should have done that for the BA.1 with a large group.

As I said reporting has failed so no idea what has actually happened.

 

[bkp_duke]

Pfizer is strong enough for me. It’s crazy that Moderna is still authorized for teenagers.

I don’t think they’ve done a phase 3 trial for this booster have they?

It will likely be a phase 2/3 combo, no phase one would be needed in this case.

 

[AlanSubie4Life]

They are public record. It's been a long time since I looked that up, the there is a trials website (clinicaltrials.gov ?).

Yep. Not my job. I agree it is knowable.

 

[bkp_duke]

Yep. Not my job. I agree it is knowable.

ClinicalTrials.gov

clinicaltrials.gov

1334 items in that search. It's a rabbit hole I'm not going down.

 

[AlanSubie4Life]

ClinicalTrials.gov

clinicaltrials.gov

1334 items in that search. It's a rabbit hole I'm not going down.

I’ve done that exact search recently and I also did not go down that hole. The search sucked too.

 

[AlanSubie4Life]

It's reasonable that they haven't pushed the booster as hard as you would like. It comes down to a risk/benefit ratio. When COVID death rates were higher, and there were no vaccines, that was an easy call. But because COVID is less deadly AND the original vaccine confers decent immunity (enough to prevent death and long-term complications in most), a booster has much more stringent requirements for both safety and efficacy.

It’s remarkable about how much this lukewarm approach to vaccine necessity has hurt the US.

The vaccination program here has been a disgrace. There had to be a better way to convince people to protect themselves.

The myth about COVID getting less deadly is pretty silly too (seems about as deadly as it was originally based on the data available). Unfortunately people now actually believe the “not a concern” myth now that tons of people get it and are fine. It’s true if you have already had it! But that’s completely irrelevant of course.

It just keeps on killing, exacerbated by overdose and accidental deaths. What an epic disaster.

 

[JRP3]

Since I'm only about 4 months from my last booster I'll probably wait a month or so before getting the new one.

 

[AlanSubie4Life]

Since I'm only about 4 months from my last booster I'll probably wait a month or so before getting the new one.

Yeah I have that issue too. I have heard 4 months is ok (but no shorter), but perhaps 5 months would be slightly better.

Realistically I probably will get it in late September anyway which would be 4.5 months.

It’ll be interesting what the guidance will end up being there, since there are definitely going to be people in this situation.

Looks like two months:
“

• Individuals 18 years of age and older are eligible for a single booster dose of the Moderna COVID-19 Vaccine, Bivalent if it has been at least two months since they have completed primary vaccination or have received the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.

“

 

[Daniel in SD]

It will likely be a phase 2/3 combo, no phase one would be needed in this case.

Ok, Pfizer did a phase 2/3 trial for the BA.1 vaccine with 1234 participants the preliminary results of which were released June 25th. For unknown reasons (to me) they did not do a larger trial to determine efficacy. Maybe because they didn't want to risk a bad headline if it didn't work against BA.4/5?
As far as I can tell the BA.5 vaccine has only been tested on mice and will be available to humans on Tuesday or so.

Pfizer and BioNTech Announce Omicron-Adapted COVID-19 Vaccine Candidates Demonstrate High Immune Response Against Omicron | Pfizer

Omicron-adapted monovalent candidate given as a fourth booster dose elicited a 13.5 and 19.6-fold increase in neutralizing geometric titers against Omicron BA.1 at 30 µg and 60 µg dose levels; bivalent vaccine candidate exhibited a 9.1 and 10.9-fold increase against Omicron Geometric mean ratios...

www.pfizer.com

I think this is the study for the BA.1 vaccine:

ClinicalTrials.gov

clinicaltrials.gov

This looks like the study for the BA.5 vaccine (BNT162b2 OMI):

ClinicalTrials.gov

clinicaltrials.gov

Yeah I have that issue too. I have heard 4 months is ok (but no shorter), but perhaps 5 months would be slightly better.

Realistically I probably will get it in late September anyway which would be 4.5 months.

It’ll be interesting what the guidance will end up being there, since there are definitely going to be people in this situation.

Looks like two months:
“

• Individuals 18 years of age and older are eligible for a single booster dose of the Moderna COVID-19 Vaccine, Bivalent if it has been at least two months since they have completed primary vaccination or have received the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.

“

Been a year for me. My body is ready.

 

[Dave EV]

It's reasonable that they haven't pushed the booster as hard as you would like. It comes down to a risk/benefit ratio. When COVID death rates were higher, and there were no vaccines, that was an easy call. But because COVID is less deadly AND the original vaccine confers decent immunity (enough to prevent death and long-term complications in most), a booster has much more stringent requirements for both safety and efficacy.

This is not my opinion, this is how the vaccine testing system is setup.

There's still 300+ people dying a day from COVID - I'd love to see the breakdown in terms of age / vaccination status, but with that many people dying daily, it sure seems like there should be more urgency.

Since I'm only about 4 months from my last booster I'll probably wait a month or so before getting the new one.

My booster was back in November, so over 9 months for me. Definitely about time for a booster, though I would probably consider waiting a few months for things to start trending worse.

But on the other hand, I expect another variant to take hold over the winter and waiting to take a booster now might mean having to wait longer for the next one - assuming that Pfizer/Moderna start releasing booster updates more frequently...

 

[Doggydogworld]

There's still 300+ people dying a day from COVID - I'd love to see the breakdown in terms of age / vaccination status, but with that many people dying daily, it sure seems like there should be more urgency.

300/day is similar to flu season, which doesn't create much urgency. COVID is still 3x worse since it's year round vs. seasonal, but it doesn't "feel" worse than what we're used to.

My booster was back in November, so over 9 months for me. Definitely about time for a booster, though I would probably consider waiting a few months for things to start trending worse.

But on the other hand, I expect another variant to take hold over the winter and waiting to take a booster now might mean having to wait longer for the next one - assuming that Pfizer/Moderna start releasing booster updates more frequently...

I get a booster when a wave is about to hit locally. You can see them coming here in TX.

 

[AlanSubie4Life]

With booster rollout coming very shortly, how long before they break it to us that actually these vaccine boosters will work better against Omicron if they are themselves boosted (assuming no prior Omicron)?

And how long before they actually study this? I’ve seen discussions that this may indeed be a good idea but obviously some data would be nice!

Other…
While the CDC and FDA recommendation is two months since last shot, it seems that many studies and immunology experts indicate four months to be a better interval. I guess it depends on your risks and risk tolerance when deciding what to do. The two months is probably a good idea for high risk individuals, for sure. It just may not yield an optimal immune response. But sub-optimal may be better than minimal if infected and at risk.

 

[heltok]

Here we go again:

Mystery pneumonia kills three and infects nine in Argentina

Doctors rule out Covid, influenza and hantavirus as culprits but continue to run more tests

www.telegraph.co.uk

Three people have died and five are in hospital after developing a “pneumonia of unknown origin”, Argentinian health authorities have announced.

According to the Ministry of Health in Tucumán – a small region in the northwest of the country some 800 miles from the capital, Buenos Aires – nine people in the sameprivate clinic unit have contracted mystery pneumonia.

Authorities are concerned about the deadly outbreak because the usual suspects – including Covid, influenza and hantavirus – have been ruled out. Five of the six affected, and both of those who so far died, are also health care workers, suggesting an infectious agent may be involved.

“What these patients have in common is the severe respiratory condition with bilateral pneumonia and compromise in [x-ray] images very similar to Covid, but that is ruled out,” Luis Medina Ruiz, Tucumán’s minister of health, said on Wednesday, according to local media.

He added that the six patients have had a series of tests for “Covid, cold, influenza of both types A + and B +, Hantavirus and 25 other germs” but no virus has yet been identified.

 

[AlanSubie4Life]

Here we go again:

Mystery pneumonia kills three and infects nine in Argentina

Doctors rule out Covid, influenza and hantavirus as culprits but continue to run more tests

www.telegraph.co.uk

Three people have died and five are in hospital after developing a “pneumonia of unknown origin”, Argentinian health authorities have announced.

According to the Ministry of Health in Tucumán – a small region in the northwest of the country some 800 miles from the capital, Buenos Aires – nine people in the sameprivate clinic unit have contracted mystery pneumonia.

Authorities are concerned about the deadly outbreak because the usual suspects – including Covid, influenza and hantavirus – have been ruled out. Five of the six affected, and both of those who so far died, are also health care workers, suggesting an infectious agent may be involved.

“What these patients have in common is the severe respiratory condition with bilateral pneumonia and compromise in [x-ray] images very similar to Covid, but that is ruled out,” Luis Medina Ruiz, Tucumán’s minister of health, said on Wednesday, according to local media.

He added that the six patients have had a series of tests for “Covid, cold, influenza of both types A + and B +, Hantavirus and 25 other germs” but no virus has yet been identified.

It’ll likely be fine, but if it is not, it would likely be appropriate to start a new thread.

 

[madodel]

It’ll likely be fine, but if it is not, it would likely be appropriate to start a new thread.

Why not just create a general plague thread? That's where we seem to be headed.