COVID VACCINE - The Megathread

[Summit]

Coronavirus (COVID-19) Update: FDA Limits Use of Janssen COVID-19 Vaccine to Certain Individuals

The FDA has limited the authorized use of the Janssen COVID-19 Vaccine to individuals 18 older for whom other available COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 and older who elect to receive it because they would otherwise not receive a COVID-19 vaccine.

www.fda.gov

Turns out there may have been cause for worry

Hardly.

"Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals"

Basically, the benefit of the J&J vaccine has fallen DRASTICALLY with new variants. It already no longer recommended because of this. Its effectiveness has fallen to the point where it is now limited to people who literally can't or won't use one of the effective vaccines.

Why is this shocking or scandalous?

Love the way they keep calling it a 'vaccine'....

What a bizarre post. It presents or generates antigen to "train" the immune system without causing the risk of infection/toxin exposure it is design to protect against. All the COVID vaccines fall under that definition. That meets the definition of vaccine in my book, much more so than the original concept of variolation. So what would you like to call it?

 

[E tank]

What a bizarre post. It presents or generates antigen to "train" the immune system without causing the risk of infection/toxin exposure it is design to protect against. All the COVID vaccines fall under that definition. That meets the definition of vaccine in my book, much more so than the original concept of variolation. So what would you like to call it?

Good question....quasi immune-therapy? Mechanism of action aside, when a fully immunized (and boosted) person can both become ill (as ill as some people that have not rec'd the shot) and transmit the infection, the traditional understanding of a vaccine is not that...this is the only 'vaccine' I'm aware of that is encouraged by the message, "this will reduce the severity of the infection should you get it."

Splitting hairs? Maybe. But truth in advertising would go a long way in getting on top of the virus, not that natural immunity and getting the shot hasn't mostly already. We've gone from being told "you be able to stop wearing masks" to "we don't know how many shots you'll need, so everyone will need multiple." The confident, authoritative declarations of 'what we know' are becoming tiresome.

 

[Summit]

Good question....quasi immune-therapy?

Trying to split the hairs on the immunotherapy vs vaccine is first needlessly confusing and secondly I cannot categorize it as anything other than wrong.

While immunologists love to say "it's complicated," training the immune system to respond to an antigen is not the mechanism of immunotherapy, except when viral vectors are used to stimulate antigen presentation which is then referred to as "vaccination." That is the mechanism for vaccines whether you present the antigen directly by subunit, cellular, or killed virus, generate it through alternative pathogen exposure like live virus, variolation, or supplying ephemeral snippets of genetic code to get human ribosomes to temporarily generate the antigen.

The trope that these vaccines aren't actually vaccines has been presented almost exclusively by the antivaxxers who are typically peddling other falsehoods (usually they like to falsely call mRNA or viral vector vaccines "gene therapy"). Thus, I'm pretty shocked that you think that definition is so far off from correct that you'd trot it out in this thread. None of my colleagues in epidemiology, immunology nor infectious disease think that is an accurate or necessary distinction in common medical professional discourse, much less public discourse.

 

[MonkeyArrow]

Good question....quasi immune-therapy? Mechanism of action aside, when a fully immunized (and boosted) person can both become ill (as ill as some people that have not rec'd the shot) and transmit the infection, the traditional understanding of a vaccine is not that...this is the only 'vaccine' I'm aware of that is encouraged by the message, "this will reduce the severity of the infection should you get it."

Uh, the flu vaccine? It doesn't fully prevent infection, transmission, or death, and is likely far less effective than the Pfizer/Moderna vaccines at each of those things.

 

[E tank]

Trying to split the hairs on the immunotherapy vs vaccine is first needlessly confusing and secondly I cannot categorize it as anything other than wrong.

While immunologists love to say "it's complicated," training the immune system to respond to an antigen is not the mechanism of immunotherapy, except when viral vectors are used to stimulate antigen presentation which is then referred to as "vaccination." That is the mechanism for vaccines whether you present the antigen directly by subunit, cellular, or killed virus, generate it through alternative pathogen exposure like live virus, variolation, or supplying ephemeral snippets of genetic code to get human ribosomes to temporarily generate the antigen.

The trope that these vaccines aren't actually vaccines has been presented almost exclusively by the antivaxxers who are typically peddling other falsehoods (usually they like to falsely call mRNA or viral vector vaccines "gene therapy"). Thus, I'm pretty shocked that you think that definition is so far off from correct that you'd trot it out in this thread. None of my colleagues in epidemiology, immunology nor infectious disease think that is an accurate or necessary distinction in common medical professional discourse, much less public discourse.

Sorry the topic makes for so much angst. To be honest, I've never heard anyone 'trot' out the distinction before, just an observation of who still gets so sick despite being vaccinated. Sue me. There another 'vaccine'...uh, vaccine that has that distinction?

But, whatever... when I read terms like 'trope, antivaxxer, peddling and shocked', I get the sense there's more at stake for the poster than just disagreeing...

 

[Summit]

when a fully immunized (and boosted) person can both become ill (as ill as some people that have not rec'd the shot) and transmit the infection, the traditional understanding of a vaccine is not that...this is the only 'vaccine' I'm aware of that is encouraged by the message, "this will reduce the severity of the infection should you get it."

The effectiveness of every vaccine is less than 100%. Some are always left fully vulnerable and effectiveness falls to its lowest if you only measure VEi.

With respect to spread, the degree to which infection is seen in the vaccinated is dependent on their proportion of vulnerable population, VEi, prevalence, and base reproduction number of pathogen. Since current variants in this novel viral pandemic seem to have a R0 approaching or meeting that of Measles, the erstwhile most contagious non-vector borne disease known to mankind, we should hardly be shocked with what we are seeing: a lowered VEi due to antigenic drift because the vaccine against the undrifted wildtype virus hasn't been updated thus results in significant infection amongst the vaccinated. This happens with influenza each year! Nevertheless, the vaccinated are still protected at least somewhat against infection, moreso against transmission, to a greater extent against severe illness, and even moreso against hospitalization and death.

Risk is nonbinary so proper communication is absolutely that the vaccine is not proof against infection!

Even with one of the most effective vaccines known to humanity, MMR2, you get some wild effects. Remember the Disneyland measles outbreak about 8 years ago where the index case was an unvaccinated Californian returning form foreign travel in an endemic area? Over 300 measles cases resulted in over 3 countries. There were over 100 in CA and >50% of those cases were in VACCINATED persons despite the fact that the VEi is 97-99%. Is that not the same alarming situation that you are identifying present day? Now why did that happen? This is all Epi 101.

I'll be blunt. I would imagine that you would know the above... not to the point where you would compose such off the top of your head, but conceptually it should be understood. As it apparently is not, I find disheartening the apparent strength in your conviction on your controversial points: that this is some novel situation for a vaccine and thus perhaps these vaccines are not actually vaccines. I encourage you to seek knowledge and hope I have helped.

 

[Summit]

I guess I'd add to the above point about antigenic drift from the wild type virus on which the vaccines are based: that cellular immunity is most preserved against antigenic drift and is least prone to waning vs humoral immunity, and neither are going to be super effective against preventing infection from an incredibly infectious RV that happily infects and replicates in the epithelium of the nasopharynx, the latter propensity along with the increased infectiousness are even more pronounced in the latest variants. You need mucosal immunity to prevent that infection, get some good IgA in the NELF. Remember "warp speed" was meant to stop the collapse of the healthcare system by deploying vaccine to reduce first and foremost the number of people who were getting severely ill, thus the types of vaccines pursued.

So four points we see:
1. the utility of boosters for some to ensure sufficient immune response and to counter waning,
2. the desirability of an updated multivalent vaccines (under testing) to tackle the newer antigenically drifted variants
3. the potential desirability of an intranasal vaccine (some are under study) to reduce infection through mucosal immunity
4. cellular immunity from vaccination and infection is what continues to prevent most of the severe disease which is why hospitals are fine and we don't need costly transmission controls.

 

[Carlos Danger]

But, whatever... when I read terms like 'trope, antivaxxer, peddling and shocked', I get the sense there's more at stake for the poster than just disagreeing...

Things get weird quickly when you start to question religion.

Remember "the population bomb" (1968), "the next ice age" (1975), "coastal cities will be underwater within a handful of years" (1994), "Saddam has weapons of mass destruction" (2002), "The Hunter Biden laptop doesn't exist / President Trump is a Russian agent" (2015 / 2019)?

"Masks don't work". "Masks are the only thing that work". "You can't be outside on the beach even if you are the only person in a 100 meter radius". "Kids don't get sick with COVID". "Kids have to be vaccinated against COVID". "This stimulus won't cause inflation".

We weren't allowed to question any of those things either. And of course that's just a sampling.

 

[E tank]

Things get weird quickly when you start to question religion.

Remember "the population bomb" (1968), "the next ice age" (1975), "coastal cities will be underwater within a handful of years" (1994), "Saddam has weapons of mass destruction" (2002), "The Hunter Biden laptop doesn't exist / President Trump is a Russian agent" (2015 / 2019)?

"Masks don't work". "Masks are the only thing that work". "You can't be outside on the beach even if you are the only person in a 100 meter radius". "Kids don't get sick with COVID". "Kids have to be vaccinated against COVID". "This stimulus won't cause inflation".

We weren't allowed to question any of those things either. And of course that's just a sampling.

Right...and I guess it has ever been thus...and neither right nor left is immune (tho I have my biased opinions on which is more prone to bias narratives ) To wit: what is so wrong about admitting honestly that what we're facing is unprecedented and while what we've done so far is not unremarkable (Operation Warp Speed, DJT) it just isn't the same product as the MMR, flu or polio vaccines? There is just no equivalency and to suggest as much is at best, not accurate and at worst, dishonest.

 

[Summit]

Right...and I guess it has ever been thus...and neither right nor left is immune (tho I have my biased opinions on which is more prone to bias narratives ) To wit: what is so wrong about admitting honestly that what we're facing is unprecedented and while what we've done so far is not unremarkable (Operation Warp Speed, DJT) it just isn't the same product as the MMR, flu or polio vaccines? There is just no equivalency and to suggest as much is at best, not accurate and at worst, dishonest.

The situation is unprecedented and has precedent. COVID isn't the first global pandemic. This won't be the last. If you know the history of pandemics most of what we faced, we as humans have faced before. It just isn't as much of the living memory nor in most professional knowledge spaces. But it is resident in the written history and specialty knowledge spaces. It was niche stuff, and in a lot of ways it still is. So much of what happened recently, including the mistakes made, all happened before, ALL OF IT, the fear and panic, the multiple waves, reinfections, debates about transmission, denialism, ****ty and misleading communication from authorities, civil liberties versus public health, just in time policies that were just too late, preliminary studies that didn't pan out, pseudoscience, sham cures, solid science that was shunned, and emotional reactions from all quarters... it happens almost every time.

What is unprecedented is the science and technology of today.

Warp Speed was an unprecedented mind boggling success thanks specifically to mRNA technology and entrepreneurship, a medical Manhattan Project or Apollo Program, but faster. From patient zero to deployment of vaccine in under 12 months, while a pandemic is only part way through, is an unprecedented triumph of medical science. The speed was only possible because of the shortened development cycle of vaccines based on supplying ephemeral snippets of genetic code to get human ribosomes to temporarily generate the antigen, that code sources by rapid sequencing, them distributing the pathogen's code to labs worldwide (once some scientists went around the delaying CCP government to share it).

In a world wide competition of over 100 simultaneous vaccine development efforts, only two were the fastest and worked. The Chinese and other attenuated virus vaccines didn't work well even to begin with and all the protein subunit vaccines were slow to refine and produce.

Nobody said that's the same as MMR.

BUT This isn't politics, it is psychology.

Remember the goal of Warp Speed: VE 50% reduction in hospitalizations.

What we started with at the end of 2020 was so far beyond anyone's wildest dreams, VEi in the 90s, VE for reduction of death and hospitalizations of nearly 100%... it felt like a miracle. Well, the promise of panacea faded before the reality of viral evolution. And yet, despite all that, with a booster, the Warp Speed requirements are still vastly exceeded by these vaccines.

The issues you brought up that there is breakthrough and decreasing efficacy, particularly against infection, in the face of a rapidly changing pathogen is not shocking for all the reasons I described above. We have seen those before. We see them all the time. It happens in many pandemics, even when there is no vaccine. 1918 H1N1 variants caused the pandemic to come in multiple waves around the world due to antigenic drift and the pandemic lasted years (and then 1918 H1N1 variants persisted as the dominant H1N1 strain until 2009). That's not new. Vaccine breakthrough isn't new. Immune escape isn't new. But for most people, it is a new concept to them.

 

[Summit]

BTW anyone looking for reading materials to reflect that past upon the present, I can recommend many, some exciting histories, some interesting ID, some extraordinarily dry epi. But if I was going to give two here, it would be:

The Great Influenza

Amazon.com

I read this before the pandemic, and it was mind-blowing how history repeats itself.

The Psychology of Pandemics

The Psychology of Pandemics: Preparing for the Next Global Outbreak of Infectious Disease - Kindle edition by Taylor, Steven. Reference Kindle eBooks @ Amazon.com.

The Psychology of Pandemics: Preparing for the Next Global Outbreak of Infectious Disease - Kindle edition by Taylor, Steven. Download it once and read it on your Kindle device, PC, phones or tablets. Use features like bookmarks, note taking and highlighting while reading The Psychology of...

www.amazon.com

This was supposed to be a brief text for a small audience, in fact the publisher in 2019 wasn't really interested because they thought nobody would purchase such a boring niche topic. It is less gripping than Barry's compendium above, and at the same time mindblowing.

 

[Summit]

And this thread needs some levity:

If you haven't watched Dr. Glaucomflecken, you are missing out!

 

[ffemt8978]

Why is this shocking or scandalous?

Frequently Asked Questions | HRSA

Frequently asked questions about HRSA’s Countermeasures Injury Compensation Program (CICP)

www.hrsa.gov

Maybe because of the one year limitation on filing a claim for injuries due to the vaccine? The same vaccine that went through abbreviated clinical trials and emergency use authorization and was then mandated (briefly). The same vaccine that had its side effects downplayed with the argument that the disease was worse than the vaccine. Of course that only happened after it was undeniable that the vaccines have side effects, which would have likely come out in full length clinical trials.

Yes, the statistical occurrences of these adverse effects are extremely minimal especially in light of the risks from COVID at the time they were rushed into approval and use.

 

[Summit]

Frequently Asked Questions | HRSA

Frequently asked questions about HRSA’s Countermeasures Injury Compensation Program (CICP)

www.hrsa.gov

Maybe because of the one year limitation on filing a claim for injuries due to the vaccine? The same vaccine that went through abbreviated clinical trials and emergency use authorization and was then mandated (briefly). The same vaccine that had its side effects downplayed with the argument that the disease was worse than the vaccine. Of course that only happened after it was undeniable that the vaccines have side effects, which would have likely come out in full length clinical trials.

Yes, the statistical occurrences of these adverse effects are extremely minimal especially in light of the risks from COVID at the time they were rushed into approval and use.

I think you've answered you own question.

Anyone denying the existence of side effects is living in an alternate reality. But as you point out, they are comparatively very rare versus the benefit... but once the benefit falls to drastic lows, miniscule but non-zero risks are no longer so well balanced. Decreased benefit is something that changed from time of approval to current time. So it makes sense to consider that updated risk v benefit. It seems to me like it is the right thing to do to restrict the EUA for the low benefit vaccine when there are vaccines with full approval, higher efficacy, and better safety profiles.

Personally I was never a fan of the J&J except for people who wouldn't/couldn't get Pfizer/Moderna. I always recommended the mRNAs over J&J. I only ever gave J&J once and that was for a patient who was explicit that they would never do two shots.

As far as the 1 year limit, I get it scientifically, as it is beyond extremely unlikely that a vaccine adverse reaction would present after a year, or really after a few weeks. I hope the year limit is for demonstrated onset of injury, not for filing the claim, because that seems draconian if it is a filing limit.

 

[ffemt8978]

I think you've answered you own question.

Anyone denying the existence of side effects is living in an alternate reality. But as you point out, they are comparatively very rare versus the benefit... but once the benefit falls to drastic lows, miniscule but non-zero risks are no longer so well balanced. Decreased benefit is something that changed from time of approval to current time. So it makes sense to consider that updated risk v benefit. It seems to me like it is the right thing to do to restrict the EUA for the low benefit vaccine when there are vaccines with full approval, higher efficacy, and better safety profiles.

Personally I was never a fan of the J&J except for people who wouldn't/couldn't get Pfizer/Moderna. I always recommended the mRNAs over J&J. I only ever gave J&J once and that was for a patient who was explicit that they would never do two shots.

As far as the 1 year limit, I get it scientifically, as it is beyond extremely unlikely that a vaccine adverse reaction would present after a year, or really after a few weeks. I hope the year limit is for demonstrated onset of injury, not for filing the claim, because that seems draconian if it is a filing limit.

The one year limit starts from the date of the vaccine administration. Since the vaccine manufacturers are immune from lawsuit over the vaccines, that means the CICP and its one year limit is the only means of redress for affected individuals.

 

[ffemt8978]

US can’t afford fall boosters for all—even after cuts to test and PPE spending

"These were incredibly painful decisions."

arstechnica.com

This was only a matter of time in coming.

 

[DrParasite]

At my full-time job, we have taken down all of the plastic barriers. I took my son to his swim lessons, and none of the instructors are wearing face shields in the water. at the FD, we haven't worn masks in months, but do have them on the apparatus should the need arise.

I'm seeing reports on LinkedIn that people who went to the RSA conference (infosec conference) are testing positive for covid. and my response is Duh; this happens every time people go to conferences. people come home with colds, STDs, and all types of illnesses; it happens any time you put a large number of people in a relatively small area, especially if you throw in alcohol. It's happened like this for decades.

Get vaccinated if you want. don't get vaccinated if you won't want to. you're going to get covid; it's not a matterr of if, but when, even if you are triple vaxed and live in a level A hazmat suit, or if you refuse to ever leave your home.

Lets all be adults, and go back to living our lives. I don't care if you want to wear an n95 for the rest of your life (that's your choice, and I support you), but I'm treating this pandemic as being over. Is Covid gone? nope, nor do I think it ever will be, but the pandemic is over, and this is now endemic, just like the common cold. Move on with your lives, get back to work, and lets stop expecting the government to do everything for us

 

[Summit]

I think for the general public it is mostly over: endemic. No transmission controls. People will suffer and die from it, but it won't be a million dead in 2 years as we experienced. Some industries will require vaccination/boosters just as they do with other vaccines.

Healthcare will have to deal with the disease as it does with others, annoying isolation and restriction from work issues, but is still more in the deceleration phase. There will be more variants and they may cause staffing disruptions. Right now many places we are dealing with staffing issues from ba.2.1.12.1, ba.4 and ba.5

I hope culturally more people are OK with the idea of don't go to work while sick. I hope more people will mask during flu season at busy places like airports and grocery stores, just as they do in Asia.

 

[Tigger]

Where are folks at with masks at work? We’re still in surgical masks for all calls, and the ED requires everyone be in a mask. N95 for respiratory calls.

Many of the crews are “done” with masks so we look kinda dumb sometimes. Having half the guys in surgical masks kind of defeats the point of reducing transmission by healthcare providers.

 

[E tank]

Where are folks at with masks at work? We’re still in surgical masks for all calls, and the ED requires everyone be in a mask. N95 for respiratory calls.

Many of the crews are “done” with masks so we look kinda dumb sometimes. Having half the guys in surgical masks kind of defeats the point of reducing transmission by healthcare providers.

When you see an engine company on a scene with everyone wearing masks and then in the grocery store buying dinner with no one wearing masks it does beg the question....