As reminders…

Alpha–Variant first identified in the UK

Beta–Variant first identified in South Africa

Gamma–Variant first identified in Brazil

Delta–Variant first identified in India

–So before we get into the obvious (which has been blowing up my inbox and phone since last Friday), let me preface everything we are about to discuss with the following.

This is not only the most timely meme a reader has sent, this is the most accurate, and a strong candidate for Meme of The Pandemic:

–Alright, that said, let’s get into the CDC’s reversal of its mask guidance for the fully vaccinated in light of the current delta driven wave in the US.

And patience, grasshopper. We’re just going to go through the facts on it all, and will get to it in order.

First, what the CDC has changed is that vaccinated persons are now recommended to wear masks again when indoors in close contact with others in counties with high sustained levels of coronavirus activity. Two thirds of counties in the US meet this criteria right now, and they are, generally speaking, where people live, so odds are you are affected by this if you are in the US right now.

The CDC cited data that delta is an “unusual variant” in that vaccinated people who test positive for SARS-CoV-2 lately have had Ct values in those PCR tests that are equivalent to those with active infection.

I can anecdotally support this on a collection of PCR “screen positives” we were sent, who, do indeed, pop positive with Ct values that you will see in some known symptomatic patients.

However, vaccinated people testing positive are overwhelmingly asymptomatic or mildly symptomatic at best, and thus many of these are screen positives (like the cluster I was asked to test). The patients are NOT being tested for clinical symptoms of COVID, to arrive at a diagnosis. This, for example, is how the head coach of the Indianapolis Colts popped positive this week. He’s fully vaccinated, but NFL policy was periodic screening, and his screening PCR popped positive.

Now, yes, this does prove the vaccines work. They are preventing hospitalizations in these patients.

As we have said before, many a time, the main threat of SARS-CoV-2 is its hospitalization rate. If it occupies too many beds, too fast, all cause mortality shoots up.

Its secondary threat is an elevated risk of mortality to select patient populations, mainly the elderly, the obese, those with diabetes, and patients with significant immune dysfunction. Those groups have been heavily vaccinated, and the vaccine is protecting them from severe disease right now too.

The key to the medical end of SARS-CoV-2, as we have said before wayyyyyy back at the beginning of these, was effective treatment that reduced the risk of hospitalization to a point where it could not threaten to overwhelm entire healthcare systems.

Yay vaccines, because they, and some of the other treatments available, thus far appear to be accomplishing those goals.

So back to the PCR positive, but asymptomatic vaccinated patients that have caused the CDC to reverse course…

As we have said before, while PCR is the gold standard for proving COVID as a cause of a patient’s symptoms, it is NOT. MEANT. TO. BE. A. SCREENING. TEST. The PCR was designed for symptomatic patients. Strictly speaking, most of them are only approved for symptomatic patients. I know everyone and their brother is using them for screening anyways–realize this is not the intended or labeled use for the vast majority of them.

This is because PCR is really sensitive (also highly specific). But it’s qualitative.

All the PCR tells you is that SARS-CoV-2 RNA is there. If the patient has symptoms consistent with COVID, yeah, pretty good chance the SARS-CoV-2 RNA the PCR found means that active SARS-CoV-2 is there, and the patient likely has legit COVID.

If, on the other hand, the patient does not have symptoms, all it says is that the virus is present.

That’s it. Present.

The CDC, out of apparent preponderance of caution, is recommending masks again for the vaccinated because the vaccine is not stopping the presence of the virus in some vaccinated patients (something the vaccine was never going to be able to stop). The CDC is also assuming, again in preponderance of caution, that the virus detected in asymptomatic, vaccinated patients may be live, and thus transmissible. Hence, masks to reduce transmission from the vaccinated, who may be unknowning carriers of active SARS-CoV-2.

The citation they give for this conclusion is a study from India, which was A) by definition on a population that had less vaccine prevalence than the US, and fewer known recovered patients per capita B) using data for a vaccine not in use in the US and C) was a model, extrapolating from limited real world data.

Again, all models are wrong, but some are useful.

Decide for yourself, given those limitations listed, how useful that model is likely to be for the US.

Stronger data would be patient tracing (I know we are paying a lot of tracers out there) to see how many people are subsequently A) testing positive and B) testing positive AND having symptoms following known contact with one of these asymptomatic PCR screen positive vaccinated patients. That would tell you, real world, what the risks of transmission are from these patients and better inform policy recommendations for vaccinated people regarding mask use.

We do not appear to have this data yet for the delta variant. One presumes it will be forthcoming.

CDC, again in apparent preponderance of caution, has changed policy in advance of that real world tracing data.

Avoid the temptation to ask my opinion on that (see the meme above)–I am just making a statement of fact.

Do we have data that might be applicable? On delta variant specifically, no.

That is an important limitation of what I am about to discuss–not on delta specifically.

But, we do have data on the risk of transmission from asymptomatic, recovered patients who were screening positive by PCR from the pre-vaccine days of COVID. This was when, as you recall, there were “reinfection/reactivation” scares as patients who had previously caught and recovered from COVID were testing positive again a little while later by screening PCR.

First, we have the South Korean study alluded to in the update from 03 December I linked above. If you recall, in that study, the South Koreans attempted to culture virus from some of these asymptomatic positives after the patient had recovered from COVID. In presymptomatic patients, those positive but early into symptoms, you could get live virus. However, in petri dishes, the South Koreans could NOT get live virus from the asymptomatic cases after the patient had already recovered, suggesting the PCR assay was picking up inactive virus particles, and not transmissible virus.

But that’s petri dishes. So secondly, in the real world, Ze Germans did a cohort study, following patients who were asymptomatic and those who were presymptomatic (developing some COVID symptoms later). None, yes, none of the asymptomatic patients in the cohort “successfully” transmitted COVID to another person. The presymptomatic patients did though. While this is a small cohort study, stick around for the discussion section of the article, where the authors mention their finding in asymptomatic patients is consistent with 3 other studies showing similar findings.

Now, BEFORE all the “GOTCHA’ CDC!!!!” moments here, a couple important caveats.

1) This study did NOT involve the delta variant, which is more contagious than the variants circulating when this study was performed. Delta may be infectious enough to transmit at all, or at least more readily, from asymptomatic patients, but no one knows for sure yet.

2) This study did NOT involve vaccinated patients. It’s possible the multi-target response of the immune system (not merely the spike protein only of the vaccine) is more effective at inactivating SARS-CoV-2, and thus making asymptomatic positives who were naturally infected less likely to spread. Certainly, the Israeli data showing that natural resistance from previous infection is 6-7 times LESS likely to screen positive in their current delta wave suggests this is possible. Again, no one knows for sure yet.

I bring these up only because they are the right kind of data, and unless delta and/or vaccination is significantly different from these scenarios, they suggest the possibility that the CDC’s new recommendations are merely an abundance of caution that could be revised back at some point soon-ish.

And yes, Ze Germans did publish in the Emerging Infectious Disease journal run by the CDC. Again, merely statement of fact.

MOST IMPORTANTLY, these data highlight a critical differentiation:

It is VERY difficult to know, on a screen positive result, if the patient is asymptomatic (will never develop symptoms) or pre-symptomatic (will develop some settings).

In the latter setting, there IS evidence they may be infectious to others as well.

Because only time reveals which of those you are, if you ARE positive for PCR for SARS-CoV-2, even with the vaccine, and do NOT have symptoms, YOU SHOULD STILL ISOLATE FROM OTHERS. You might be one of the true, rare breakthroughs who get some symptoms (but will all but certainly not be hospitalized by them). And in that case, yes, you may be infectious to others.

“So should I mask up like the CDC recommends, even if I have gotten the vaccine?” I hear you ask, Hypothetical Reader. “After all, I read those headlines Friday after your update dropped that the Israeli data is that the Pfizer vaccine is only 39% effective against delta!”

I’m glad you brought up the Israeli data and headlines, Hypothetical Reader, because I got that argument from some fellow physicians over the weekend.

Here’s the actual data, direct from the Israelis:

In terms of preventing hospitalization, the vaccine is actually 88% effective, with a confidence interval in line with the data reported by the UK’s NHS. That said, it is only 40.5% effective against symptomatic COVID–but the limitation on this is that their method is to go back to the positives and ask them to remember if they have anything that might qualify as a symptom. That may result in over-reporting. They also count as asymptomatic anything that is NOT fever or respiratory symptoms, so it may be under-reported as well.

So that 39% in the headline is really 39% effective in preventing a PCR screen positive. It’s also worth noting that the numbers of bona fide breakthrough on the vaccine is still quite low–these percentages are not based on high numbers of patients. You only get screened in Israel for returning from travel abroad, symptoms (which may be biasing the “symptomatic” category too), or close contact with a known infected patient.

There are almost certainly a lot more people who were exposed to the delta variant after vaccination, but did not get screened and did not develop symptoms–and why the CDC still has a below 1% risk of serious COVID following vaccination.

But, this is the kind of headline and data that may have influenced the caution of the CDC with its current recommendation.

So, back to your first question Hypothetical Reader, if you have gotten the vaccine, should you wear a mask indoors around others per the new guidelines?

Again, I follow what the business or place I am visiting requests. If they want me to wear a mask in response to CDC guidelines–okay. I’ll respect their wishes or just not go there for the time being.

Otherwise, it comes down to your personal level of risk tolerance. The chances of getting symptomatic or worse COVID following complete vaccination are small (and probably smaller if you already got over COVID once). Would wearing a mask reduce those chances further for you (or even testing screen positive if you are still being screened)? Probably. Is wearing a mask a huge burden? For most people, not really. Do you reduce the odds enough to make a difference that you would notice? Well… they’re already really low… At least with available data, a LOT of vaccinated people would have to wear masks a lot of the time to prevent even one serious infection in an already vaccinated person.

So your call. Do what’s best for you. This is not medical advice and you should speak to your healthcare provider about your personal situation if you have questions.

Now, that’s the personal, onto the public health implications of the CDC guidelines.

Another reason for the preponderance of caution from the CDC is the current increase in cases from the delta variant across much of the US. Epidemiologically (and you can find these charts many places yourself already), the Ro has leveled to starting to fall for the US as a whole. Cases are still going up, but tracking similar to both the UK and India, which saw about 36 days of increase from start to peak, then about a 36 day drop. I would say we have 14-20 days left of likely increases. The final peak will look similar to the alpha wave earlier this spring–maybe a little higher–but hospitalizations are lower than the alpha wave at this point in its wave for delta (again, because you have higher effective vaccination rates).

That is the most probable outcome, regardless of mask policy or adherence. That’s just how delta will go now that it’s already everywhere.

As we have covered before, masks, when used properly, do appear to benefit the individual. However, the data that they do ANYTHING to blunt height or duration of number of cases or hospitalizations from COVID is, well, not exactly in favor of masks from a public health perspective. There is no clear benefit. Again, in just two charts:

I have said it before, and will say it again, for politicians, and political institutions (which, yes, includes CDC), the perception of effectiveness is just as good as being effective. Masks are low burden “intervention” that gives the appearance of soberly responding to a public health threat–and so are low risk from a political perspective. Is it likely to shift case numbers?

It will be impossible to tell, although you might get a “control group” of non-masking states as some governors (mostly Republican, in fairness) have already announced they will not enforce, and other states have banned mask mandates already. But you’ll have confounding variables of vaccination rates and existing natural immunity from previous infection, so expect lots of internet ink arguing utterly inconclusive data for a purely tribal political bend.

Yay. Can’t wait for those. Before you send them to me, please review the meme at the top of this update.

Right now, the most affected people in the current wave are unvaccinated. Plenty of headlines about young people who did not want the vaccine regretting that choice later, mostly to nudge the unvaccinated towards the vaccine. But again, most of your unvaccinated are younger, or in particular demographics we have already mentioned.

–Now, to the other part of the CDC’s recommendations. They recommend children return to in person learning, but elementary kids (5-12) who are not vaccine eligible yet should go back to wearing masks too.

I told you I expected the recommendation to cover that at some point before the fall : )

Nostra-f’ing-damus over here.

There is still no evidence that delta is a particular threat to children. Yes, some kids have died from COVID–every. single. one. had a known high risk condition. The chance that your 5-12 year old child will die in an accident is several orders of magnitude (more than 100x greater) than death from COVID, and its mortality rate is not even much of a flu in that age group. Still.

But the kids are used to masks; I don’t expect that recommendation to last the full school year. I would rather they be back in person, even if it’s masked up a bit longer. No big quibble from me.

What has been interesting is vaccine questions on 5-12 year olds this week, even in discussion with other doctors.

I have had two memorable encounters, just this week!!!!, where other doctors have looked at me like I had a second head suddenly growing when I said I wanted to wait and see the safety data before I rush my kids into the shot.

Day 1 for my peds rotation, and beaten into us every day of it thereafter, was that kids are NOT just little adults. There is a difference in biology between a full grown adult and a growing kid. There are drugs you can give adults that you would never give to kids. They get different kinds of diseases, and can present entirely differently too.

All of the significant side effects of the vaccines thus far, ranging from the Pfizer Flu and Moderna Malaise, through myocarditis and GBS, are immune mediated and more common the younger the patient. I’m also old enough to remember that hot minute where we were all worried about reports of increased incidence of Kawasaki-like disease as a complication of COVID in kids aged 5-12 who caught the virus. That, too, is immune mediated, and was not reported in adults in any appreciable numbers I am aware of. Or maybe it’s just a function of where I currently work, and know that funny things happen when a drug is tried in a new patient population with slightly different biology.

You’re god damn right I want to see safety data on the vaccines before I start mentally signing my kids up for them.

Do I think they will have a significant risk, even at the current doses being used? I think the odds are against it.

But they’re not zero.

Show me the data.

And I am apparently not the only one interested. This week the FDA asked Pfizer and Moderna to add more patients aged 5-12 to their vaccine studies in this age group, undoubtedly to get as robust a safety package as they can for this age group, before the FDA makes a decision.

–“So should the CDC have recommended the vaccinated wear masks indoors, changing their previous policy?”, I hear you ask, Hypothetical (and not so hypothetical from my inbox and texts) Reader.

You’re asking for my opinion.

I guess it’s nice that you care about my opinion to ask, but frankly, no one else does, least of all the CDC, who did not contact me during any part of their decision making process on this.

I’ve laid out the facts up above, what we know, what we know we don’t know (especially regarding delta). I will say I don’t think delta is appreciably different in biological behavior from the other SARS-CoV-2 strains, other than a slightly higher contagiousness. Form your own conclusion.

Unless you have a time machine though, can go back and argue your opinion cogently and convincingly to the CDC, your opinion, or mine, changes nothing. The only question before you is to follow the recommendation, yes or no, and what are the risks/consequences of that.

–Which brings us to, God help us, the politics of all of this.

Again, go view the meme at the beginning of this update, and let that guide you as read you my musings on all of this.

Because everything COVID is now a political litmus test, the dial seems stuck on maximum stupid all around.

Are there Republicans advising against vaccines and mask mandates? Yes. Are there some out there stumping for vaccines though? Yes. Are there democrats against vaccines? At least 12% of them according to the polls–and just today, the American Postal Workers Union, who endorsed Biden, came out against a vaccine mandate (not necessarily against the vaccine though).

Are there media outlets out there doing their level best to make vaccines a political litmus test, and your opinion on them, or decision to get one, a per-requisite for your Official Good Person^TM merit badge? Absolutely. Have I seen other journalists at the same outlets, especially in the week since castigating their insistence on making vaccination choices a political question, actually do some of the work and go ask “why” of those not being vaccinated in a more productive wave? Yes.

The problem is not about who to blame. The medium is the message and the medium is the problem.

And it’s not getting any better. In fact, it was a bipartisan crew on Bill Meyer talking about the righteous indignation that the vaccinated should have towards the unvaccinated, for making this delta wave possible, for putting us all at risk, and now, presumably, for foisting these masks back upon us.

I want you to think for a second about the message that “anger” (direct quote), justified anger, that the vaccinated should have towards the unvaccinated sends…

…considering the many of the unvaccinated are ethnic minorities with good historical and legal reasons to be wary of government sponsored vaccination.

Anger at them is now justified?

Or at rural unvaccinateds, who lacked the ready access to get a vaccine? Their social circumstances are their fault, and we are now justified in blaming them for that?

Those are the messages we want to send–because that will encourage vaccination?

In the past couple weeks you have also had op-eds, with authors from both Team R and Team D, suggesting mandates expand, and cheering them on. Republican, as well as Democrat, governors and legislators have floated those balloons.

I can predict, having been around for a few decades now, the likely persuasive effect of turning vaccination into a matter of raw power and compulsion will be.

For a foreshadowing, look no further than the UK, France and Italy which had prostestors out in their thousands about similar mandates and proposed mandates there this past week.

Again, I will argue that the medium is creating these message problems.

Social and traditional media get paid for attention. Full stop. That’s the business model.

What draws and captures attention anymore are the extremes–because competition has expanded. You used to have just Walter Cronkite, or just a few national papers or channels. Now you have a dizzying array, with little cost barrier to seeking attention on the internet.  How hard is it to start a conspiracy channel on TikTok right now? Even though you have relatively few players in traditional and social media, and relatively few large players for internet news, algorithm driven content changed everything.

Everything.

The battle for your attention, and the financial rewards for it, made companies like Facebook, drawn up on a bar napkin in Harvard, into multi-billion dollar companies so influential they have been dragged before Congress for outsized political influence on elections…

…mostly for being unable to curate facts quickly enough. They reward the flashy, the superficial, the emotionally arresting.

Fear, disgust, anger, anxiety are some of the most captivating emotions. All those “Top 10” and “Top 5” clickbait articles? Look at the headlines. They are trying to trigger an emotion and the “Top” part promises you a quick read. They are getting more extreme. Or look at Epsilon Theory’s AI tracking of “explains the news” articles, where “experts explain” or “we explain” about a news topic. These kinds of articles are starting to outnumber the news they report on–and they are op-eds. Look at trending YouTube and TikTok content–what is dominating, going viral, capturing those sweet, sweet, monetizable views are “reaction to” videos.

The emotional reaction to the thing.

Like Taleb’s “Fat Tony” character would say, that is a function of ‘ting, and the function of ‘ting is NOT the same ‘ting as the ‘ting.

But that’s why everything is politics and everything becomes a litmus test, because your reaction to is your tribal marker now. It’s how you get your “Official Good Person” with “Official Right Opinions” about things from whichever tribe you pick. That is increasingly defined by opposition to whatever the other team is perceived to be stating.

And you will be shown their most egregious examples as typical of that team, and not the outlier they are. Why? Because those extremes are what make for the best “reacts to” videos and best “we explain” articles.

In turn, that dynamic creates the widening gulf of political views over the years–as I am sure you have seen graphically.  That changes the appetite and beliefs of the electorate–on both sides. They start to skew more extreme, as again you have seen over the years. That then feeds into the actual politics, and creates more substrate for the machine via “reacts to” and “explains” articles as vids. Because NOW, to get their legislative goals through the actual legislative process, legislators have to move further to the fringe just get on social/regular media and get their ideas even out there, let alone support for them.  As the politicians move the fringe, that cycles into a wider divide, more extreme antics, more extreme assumptions about the other side, more zero sum behavior.  Since that behavior now gets increasingly rewarded at the polls (because all Team D and Team R see about the other side is their worst and most extreme elements, and meanwhile see justification and normalization of -their- most extreme elements), the vicious circle comes back and that’s what you start to get from elected leaders.  More extreme D and more extreme R and more and more and more politicization of everything and zero sum behavior.

To be clear, -both- sides are guilty.  So is the media.  So are we for letting ourselves get hooked by the anxiety/fear/outrage algorithms, and normalizing extreme feelings about the other side and letting the more extreme elements of our preferred side become more normal and rational—even when they are not.

If you wanted to play politics with the vaccines in a productive way, the way to split the baby was back in December to push the idea through R channels that these are the vaccines that Trump delivered with the accelerated programs he put in place (that’s actually true).  Take one for Team Trump.  Meanwhile, you tell team D that the vaccines -are- the science, the best way to keep people safe and the way we show we can deliver care to marginalized groups at high COVID risk like African Americans and Hispanics by meeting the Biden administration’s more aggressive vaccine rollout plan.  Meanwhile, you ask the “why” questions we went over of groups not getting much traction on vaccines as you do this, and you listen and respond when they tell you what they need to see before they will take the vaccine. You meet them where they are, and fer God’s sake, raw power mandate is the LAST damn thing you ever mention, let alone do.

Instead, we chose a zero sum pissing match.

And continue to do so.

Then we own goal left and right. No matter what you think about the CDC and masks this week, there are a sizeable body of people who you just convinced the vaccine isn’t worth it. If it’s not stopping delta to the point of having to wear masks again, or where vaccinated people can transmit the virus and we must stop that, what is the point of the vaccine they will be, and are, asking. And, CDC, you have just massively raised the hurdle in convincing them.

The Bonfire of the Institutional Credibilities continues unabated.

–Lastly, in other policy changes from CDC this week, some confusion in reporting around the CDC abandoning the EUA designation for its own PCR assay.

This is so the CDC does not have to supply any more of its PCR test to, for example, state labs.  This is NOT because the test does not work, as some of the articles written by those who have clearly never done diagnostic PCR, or learned how it works yet, have suggested. The CDC assay works very well–again, we use the same primers and probes here, and have passed every proficiency test thrown our way with it thus far.  CDC made this change because there are now diagnostic companies who have made multiplex PCR assays that test for SARS-CoV-2, AND influenza A AND influenza B and usually nearly a dozen other “flu like symptom” causing organisms–all at the same time!  This means you don’t need a separate PCR for SARS-CoV-2 AND the flu when you walk into your doctor’s office feeling sick–so the result comes back faster.  And cheaper, since it’s not a la carte testing.

So in summary, not an issue with PCR for SARS-CoV-2 or anything having to do with “inability to distinguish from flu”.  No, the PCR is highly sensitive and highly specific for SARS-CoV-2. 

CDC is just telling the state labs (in particular) “we don’t want to make this kit and ship it any more” and “there are more practical assays out there commercially that will not only tell if it was SARS-CoV-2, but will also, AT THE SAME TIME, in the SAME TUBE, tell you if it was one of the other dozen common viruses and bacteria that can look like SARS-CoV-2/flu clinically–and you should probably buy one of those now.”

–Finally on the week (I am going to skip “around the horn” because this is already a novel), thanks to all those sending in the new “superbug” fungus infection. There is a species of Candida that has been identified in a few cities along the East Coast that is now resistant to all forms of anti-fungal medications. For the vast majority of people, this is no threat. This form of Candida is not especially infectious or dangerous, unless you are profoundly immunocompromised. Like many “superbug” bacteria though, this undoubtedly grew up in transplant ICUs, where the patients are seriously immunocompromised and often seriously infected. They get carpet bombed with every form of heavy hitter antibiotic (or in this case, anti-fungal) until you inevitably select organisms that can survive them all. Bacteria and fungi like this will die in their trillions of trillions to have one lucky mutation that lets them survive–and then rapidly divide to fill that niche. That’s been their survival strategy for eons. What’s novel here is that this is a fungus. What’s more surprising is that it took this long–fungi are closer to human cells than bacteria, so there are fewer drugs (which often have more side effects) to treat serious fungal infections. For example, we can target bacterial ribosomes with many classes of antibiotics. Fungi have ribosomes similar enough to ours that those are not a popular target, and most, but not all, anti-fungals actually work on targets in the cell membrane called sterols that human cells don’t have.

So, scary headline, but not remotely a threat to you unless you are severely immunocompromised.

Just highlights the increasing medical need for new forms of antifungal and antibiotic drugs to stay ahead in the arms race. Public sanitation, antibiotics/anti-infectives, and improved pre-natal and pediatric care are THE reason average life expectancy jumped from the 40s in the Medieval era (mostly infectious deaths of children and around child birth) to the 70s+ it is in most modern countries.

–Your chances of catching coronavirus most places in the world are equivalent to the chances that we will politicize everything, making everything zero sum, and thus the dial will remain cranked to maximum stupid for at least the near future–so if one of the popular global societal collapse hypotheses/fever dreams actually do come to pass, chances are, we won’t be able to argue that we didn’t deserve it.

<Paladin>