General COVID vaccination thread

[KeithKSR]

I really need to up my Vitamin D. Just did blood work and I know it's low. Probably b/c I never see the sun.

My brother is an MD, turned me on to Vitamin D3 a few years ago. He had read a study that indicated that most people are D deficient. That makes a lot of sense considering our species lived outdoors for most of its existence and now spend a lot more time indoors.

[dan_bgblue]

FDA in an uproar over the booster vaccine.

The Biden administration’s decisions over when to administer coronavirus vaccine boosters are triggering turmoil within the Food and Drug Administration, frustrating regulators and sparking fear that political pressures will once again override the agency’s expertise.

FDA officials are scrambling to collect and analyze data that clearly demonstrate the boosters' benefits before the administration’s Sept. 20 deadline for rolling them out to most adults. Many outside experts, and some within the agency, see uncomfortable similarities between the Biden team's top-down booster plan and former President Donald Trump's attempts to goad FDA into accelerating its initial authorization process for Covid-19 vaccines and push through unproven virus treatments.

[KeithKSR]

FDA in an uproar over the booster vaccine.

The Biden administration’s decisions over when to administer coronavirus vaccine boosters are triggering turmoil within the Food and Drug Administration, frustrating regulators and sparking fear that political pressures will once again override the agency’s expertise.

FDA officials are scrambling to collect and analyze data that clearly demonstrate the boosters' benefits before the administration’s Sept. 20 deadline for rolling them out to most adults. Many outside experts, and some within the agency, see uncomfortable similarities between the Biden team's top-down booster plan and former President Donald Trump's attempts to goad FDA into accelerating its initial authorization process for Covid-19 vaccines and push through unproven virus treatments.

Biden really began pushing hard on a booster after the Afghanistan debacle.

[dan_bgblue]

Biden's presidency has been awesome and incredible.

[dan_bgblue]

https://www.wsj.com/articles/where-t...pos_5#cxrecs_s

[PedroDaGr8]

So I will make a few comments about this without being too political:

1. The White House should not have said a damn thing about booster shots being available until the FDA/CDC had a chance to do their review. The fact that they jumped the gun (even if they end up being right) is absolutely unacceptable. All they had to do was keep their mouth shut and say they are relying on the experts. This is why several of the FDA committee members are resigning at the end of the year.
2. The data on whether we need boosters is a VERY complicated picture and partly depends on what we set as our end-point for efficacy. This is further complicated by the fact that R0/efficacy/% fully vaccinated are all intertwined variables.
   
   1. If the end point is preventing hospitalization/severe cases/death then there is very very little evidence that boosters are needed for those who aren't immunocompromised or 60+ years old. For those in those two categories then booster shots are DEFINITELY warranted.
   2. If the end point is preventing infection. There is a notable case that a booster dose could be beneficial based on decreasing efficacy numbers against outright infection. These numbers are not nearly as bad as some are indicating but have declined.
3. It will be very telling how the debate at the FDA and CDC go. It would not surprise me if they decide that it is not necessary for those under 60.

[bigsky]

FDA punted today. CDC and White House way out ahead of science here.

[CitizenBBN]

FDA punted today. CDC and White House way out ahead of science here.

I think you can call that "ignoring the science" as well.

CDC is obviously political, and have just about ruined their standing with a lot of Americans. They had a ton of credibility with most people, but I think most of it is now gone.

[PedroDaGr8]

FDA punted today. CDC and White House way out ahead of science here.

I think you can call that "ignoring the science" as well.

CDC is obviously political, and have just about ruined their standing with a lot of Americans. They had a ton of credibility with most people, but I think most of it is now gone.

Honestly, they didn't really punt as much as state the current state of the science: things are murky and NOT fully definitive. Science isn't always clean with a pretty picture when you are in the midst of the "fog of war".

As I mentioned before, if our target end point is preventing severe infection/hospitalization/death then the need for boosters is very debatable at this time.

There is some strong evidence that efficacy against severe cases/hospitalization is dropping over time but this is heavily aliased with age/risk profile/variant/etc. Furthermore, there is conflicting data across many of the studies with some showing steeper drops than others. Previous studies including the one to which I linked had some notable difficulties teasing out what deviation is due to age versus how long ago one was vaccinated. As older patients are more likely to have been vaccinated early versus younger patients, there is the possibility that the reduced efficacy seen in older patients is due to time since vaccination and not due to age itself.

Now on the other hand, if the end goal is to prevent infection/spread, then there is a notable case that boosters are needed.

In particular, there is evidence that across all age strata the risk of a breakthrough infection increased approximately 50% for people vaccinated around 6-8mo ago versus those vaccinated <6mo ago. Per the data, this results in efficacy against infection dropping from around 80% to around 50%. On a slightly good note, there is no statistical difference in the efficacy rates between Delta and the other variants. On the bad side, this means the efficacy against infection/severe COVID/hospitalization/etc. is waning due to length of time. Depending on your view point on the unvaccinated, this could indicate that a booster is the best way to get out of this mess or you could feel that those doses are better served going to other countries.


As for the booster doses, some of the recent data is showing that a booster shot at 6-8 months is producing over 3x the antibodies we saw after Dose 2. Based on what we know about post-Dose2 efficacy against infection this is FAR more than enough to generate complete immunity against infection in over 90% of the population.

Based on the above data, we can summarize: there is some degree of waning in efficacy over time and the booster increases efficacy against infection to higher than it was at the end of dose 2. The questions which remain are 1) is this waning efficacy enough of a risk to warrant another booster or could it reach that level in the near future (could it be bad enough 6 mo from now), 2) is this waning efficacy occurring across all ages, 3) does this waning efficacy warrant the risk of a booster dose, 4) does it warrant redirecting doses which could be used to provide first doses to other countries.

The FDA has a lot of options here, they could not authorize any booster doses, they could authorize a booster dose for those above a certain age and/or with specific comorbidities (as they did for the immunocompromised), or they could authorize a booster dose for anyone (plus pretty much every variant between those points). To be clear, the FDA also has the bias that their job is to protect the American public, meaning that concerns about other countries will weigh less than concerns about Americans directly.

None of this excuses Biden et al from opening their damn mouth before the data was readily available. The fact it appears they might be right does not excuse them from speaking before they could speak truthfully. I view it the same way I view Russia skipping Phase III trials for the Sputnik vaccine. Yes, they made at best an educated guess and they are lucky it worked out in their favor but it is still a **** move and is totally unacceptable.

[KeithKSR]

I think you can call that "ignoring the science" as well.

CDC is obviously political, and have just about ruined their standing with a lot of Americans. They had a ton of credibility with most people, but I think most of it is now gone.

The CDC has jumped the shark. Once you jump the shark your audience never views you the same way.

[CitizenBBN]

Pedro, I don't think the CDC is political b/c of the booster situation, though they are allowing themselves to be painted that way.

It's really the now almost 2 year long behavior at CDC that has undermined confidence. Some of it is their fault, some not, but it has really undermined the public confidence in the institution.

First among those is the eviction moratorium. It's really unclear (and now per SCOTUS completely clear) that it was ever constitutional, but it was very political. The basis for it was very tenuous and using the CDC to implement it in order to find some legal basis for it only hurt them. The same thing with OSHA and testing/vaccinations now. Otherwise generally non-political entities implementing very politically charged orders.

They also really messed up on the mask recommendations. They first said only those with symptoms need them, then tried to split the baby with saying others should wear "non-medical, cloth masks". The only reason to qualify that is b/c the entire early recommendation to NOT wear masks (which included Fauci at NIH and the Surgeon General) was b/c of the mask shortage.

So instead of the truth, which was "masks will help but we don't have enough pre-made N95 masks so they must be held for front line workers", they just basically lied, then backed off and told a half lie, then finally the truth.

Notice that's non-political, b/c that happend during Trump. The way it should have been handled is the US government basically seizing or otherwise rationing all retail inventories of those masks, tellling everyone else to cover their face as best they can, and explain why. It wouldn't make people happy, but you wouldn't lose credibility either.

Reminds me of the history of eggs and potatoes. When I was much younger they were both hailed as superfoods, then they were both evil, and then back to good in moderation, which of course is what we all thought before all the hoopla started in the first place.

You can't go back and forth like that much without people just tuning you out, even if it's the science taking you back and forth. That, as you know far better than I, is why scientists don't draw conclusions before there is a conclusion to draw. The CDC has has to make decisions without perfect information, but they didn't do a good job of communicationg the reality of their situation.

It's OK to say "we don't really know, so this is our best advice right now, but it's going to change as we find out more." There were a few of those instances, but too few.

That's not to mention Fauci mugging for every appearance he can get, and being FAR too definitive for a scientist.

Combine that with all the other lies our leaders tell us on a daily basis, and people are understandably jaded. The CDC was used for political purpose in this, and let themselves be used, and it has hurt them.

Now when we need that credibility so when the booster data comes out they can say "do this", it's not there.

[PedroDaGr8]

I have been watching the proceedings and the FDA is absolutely HAMMERING Pfizer on the data and the lack of clarity to so many questions.

We will see how the voting is going but it really sounds like they are not going to approve the booster for the general population.

A very important procedural issue just happened:

The question in front of the FDA can be summized as follows: "Is a 3rd dose is warranted for the general population?" The question contains no sub-groups based on age/risk/etc. One of the voting members just asked if there is a "no" vote on the question, will there be the ability to propose modifications to the question and the answer was a resounding yes.

This would allow them to change the question to include sub-groups which would benefit from a booster.

[PedroDaGr8]

The question is rejected: 16 no votes and only 2 yes votes for the booster for the general population (16+).

General consensus is that there isn't enough data to demonstrate need, benefit, and safety across the entire population.

They will now take comments and propose modifications to the original questions.



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[PedroDaGr8]

The new question is same as before but for those 65 and older and those at high risk due to occupational exposure or underlying disease. General viewpoint seems to be that there are too many questions remaining from the data to warrant it in the general population right now. They all agree that it is something to revisit in the future but the data isn't there at this time.

[PedroDaGr8]

Booster recommended for 65+ and those at high risk of contracting COVID (such as front-line workers).

[bigsky]

In addition to all the other blood tests looking for elusive monocytes, I got tested for covid antibodies and I’m positive, which may mean I’m makin em (after 7 months gone and slayin the dragon) and then again maybe not. I choose to think I am.

[suncat05]

My wife, my son, my daughter and I are all fully vaccinated now.

I still am not 100% convinced about the vaccines and their effectiveness, especially long term. Every day it seems like there is a new report that the vaccines work, or they don't, or they're only partially effective, or they don't work that well. All of these reports are all over the place, coming from different sources that may or may not be dependable.

We chose to take the vaccine because of the information our daughter has passed on to us from her experiences in her trauma ICU unit in the hospital she works in. She related to us that she wasn't keen on getting the vaccine, but after what she has seen at work that she concludes that it is better to have it and not need it than to need it and not have it. And she urged the Boss and me to get it simply because of our ages, although neither of us has any serious health problems.

[KeithKSR]

In addition to all the other blood tests looking for elusive monocytes, I got tested for covid antibodies and I’m positive, which may mean I’m makin em (after 7 months gone and slayin the dragon) and then again maybe not. I choose to think I am.

A friend of mine, and ironically the former mayor of our small town, had Covid in January. He was in the hospital and on a vent. In August he still had a lot of antibodies.

[dan_bgblue]

J&J says COVID-19 vaccine booster 2 months after first shot increases protection

[PedroDaGr8]

J&J says COVID-19 vaccine booster 2 months after first shot increases protection

I thought the more interesting part was they evaluated antibody levels at two different booster intervals. The two month booster gave a four-fold increase in antibody levels. Just extending the time between doses to six months showed a TWELVE-fold increase in antibody levels.

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[dan_bgblue]

COVID-19 has now killed about as many Americans as the 1918-19 Spanish flu pandemic did — approximately 675,000.

The U.S. population a century ago was just one-third of what it is today, meaning the flu cut a much bigger, more lethal swath through the country. But the COVID-19 crisis is by any measure a colossal tragedy in its own right, especially given the incredible advances in scientific knowledge since then and the failure to take maximum advantage of the vaccines available this time.

"Big pockets of American society — and, worse, their leaders — have thrown this away," medical historian Dr. Howard Markel of the University of Michigan said of the opportunity to vaccinate everyone eligible by now.

Like the Spanish flu, the coronavirus may never entirely disappear from our midst. Instead, scientists hope it becomes a mild seasonal bug as human immunity strengthens through vaccination and repeated infection. That could take time.

Linkage

[KeithKSR]

COVID-19 has now killed about as many Americans as the 1918-19 Spanish flu pandemic did — approximately 675,000.

The U.S. population a century ago was just one-third of what it is today, meaning the flu cut a much bigger, more lethal swath through the country. But the COVID-19 crisis is by any measure a colossal tragedy in its own right, especially given the incredible advances in scientific knowledge since then and the failure to take maximum advantage of the vaccines available this time.

"Big pockets of American society — and, worse, their leaders — have thrown this away," medical historian Dr. Howard Markel of the University of Michigan said of the opportunity to vaccinate everyone eligible by now.

Like the Spanish flu, the coronavirus may never entirely disappear from our midst. Instead, scientists hope it becomes a mild seasonal bug as human immunity strengthens through vaccination and repeated infection. That could take time.

Linkage

I expect us to have one more big wave after this one.

[Padukacat]

Here's an interesting one that i've not really heard. My boss said he had a breakthrough infection and was sick for a few days, the usual flu like sickness with Covid. He is on about week 3-4 i believe, and said he is suffering from depression/anxiety. He said he noticed it really gets crazy bad when he drinks a few beers, like 2-3, so he said he's stopped drinking. He thought it was odd because he had never had that happen pre-covid and isnt the kind that would be scared of covid per se. Said he had to get some anxiety meds and popped them a few times then realized its only happening to that degree when he has a few drinks so has stopped.

[PedroDaGr8]

Here's an interesting one that i've not really heard. My boss said he had a breakthrough infection and was sick for a few days, the usual flu like sickness with Covid. He is on about week 3-4 i believe, and said he is suffering from depression/anxiety. He said he noticed it really gets crazy bad when he drinks a few beers, like 2-3, so he said he's stopped drinking. He thought it was odd because he had never had that happen pre-covid and isnt the kind that would be scared of covid per se. Said he had to get some anxiety meds and popped them a few times then realized its only happening to that degree when he has a few drinks so has stopped.

Definitely interesting, I know some of the lingering aspects can take as long as 6 months to abate. Good on him to recognize the trigger.

[dan_bgblue]

FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations

Linkage

Who should get COVID-19 boosters first? CDC committee set to vote Thursday – but only on Pfizer vaccine


Linkage

[CitizenBBN]

Whoa. You mean if I get this I may have to stop drinking??????!!!!!!

Man, I am not leaving the house. You guys let me know when this is over.

[bigsky]

Talked to a neighbor I had not seen out for a while. He had Covid last year. Got the pfizer shots. Got Covid three weeks ago again. Still has no senses of taste and smell and was miserable, "like my head was on fire" for almost a week. Hospital is getting positive cases in patients who weren't positive when admitted and also staff so it is semi locking down. It ain't goin away.

[dan_bgblue]

CDC director recommends COVID-19 booster for younger at-risk workers, defying advisory panel

[KeithKSR]

CDC director recommends COVID-19 booster for younger at-risk workers, defying advisory panel

The CDC director is assuming Biden knows more than science… That sure makes the CDC continue to look unbiased.

[CitizenBBN]

Biden's medical advice is likely as high quality as his advice on how to deal with home intrusions.