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

Also as a reminder:

Marburg:

–The Marburg outbreak has been declared officially over. Among 170 known contacts, there was not a single additional case. One poor farmer just got -really- unlucky.

Nipah:

–No new confirmed cases reported, and most of the contacts with even the slightest of symptoms have ruled out for Nipah virus. We are getting close to the end of the incubation period for those contacts as well, so on track for this most recent Nipah outbreak in India to end soon.

Coronavirus:

–The big news over the weekend is that the FDA advisory committee (AdComm) decided AGAINST universal SARS-CoV-2 vaccine boosters, and recommended boosters only for patients 65 and older and specific high risk subgroups like the immunocompromised. Yesterday, the FDA accepted these recommendations.

Before you ask the obvious, given that has been my exact take for like the last 4 weeks: no, I am not on the FDA AdComm, I did not advise the AdComm or its members, and to the best of my knowledge, they are not readers of these updates.

But they did have access to the exact same data we have been Sciencepalooza’ing during that period, and their conclusions were clearly similar to ours.

–The other interesting AdComm take was some concern raised about the safety of the mRNA vaccines, particularly considering myocarditis after the second dose particularly in younger men. In short, the concern of some committee members was that a booster dose into a locked and loaded immune system might see an even higher rate of myocarditis in some patients. So they preferred additional studies of the safety of the booster for this specific outcome before they would be comfortable recommending a booster in younger patients.

In my humble opinion, I am not opposed to collecting this data. The current data shows there is no rush for boosters for this age group, and thus time to collect this safety data, if we think booster recommendations might change for younger patients in the future.

–Speaking of younger patients and vaccines, Pfizer press released the topline of their study for their mRNA vaccine in ~elementary age kids, claiming efficacy and safety endpoints were reached in children down to age 5.

To be clear, that is a press release and not a published paper. Both we and the FDA are waiting for the more complete report, particularly to look at safety data.

That said, this study was done using a reduced dose of the vaccine (1/3rd the adult dose), and was looking to see if that would generate antibody amounts similar to levels already known to be protective in adults. Based on the press release, that seems to have happened. So that’s good news. It also involved about 2200 kids, so there should be some good safety data.

That said, even 2200 patients is not enough to catch lottery level events like the known risk of myocarditis for the adult dose in younger patients. So there may still be a few rare side effect surprises.

Regardless, let’s see what the actual publication says (or what the data submitted to the FDA says).

–And yes, the Monday after a late Friday FDA Ad Comm blew up your-previous announcement for your shareholders and the market-to expect revenue from universal vaccine-boosters-for-ever-and-ever-amen the recommendation for universal boosters was a timely read out for Pfizer’s stock price.

–In other vaccine booster news, J&J, whose claim to fame was a one shot COVID vaccination has new data from a continuation of its Phase 3 study showing that patients who got a booster J&J shot two months after their “one and done” vaccine dose had >90% efficacy against COVID hospitalization. While fewer people have gotten the J&J, there certainly have been hints and whispers, innuendo and insinuation in the data that the one shot J&J was not quite as effective as two doses of the mRNA vaccines. So this is no real surprise, and I suspect the J&J eventually gets this two dose approach.

So much for differentiation based on administration, though.

–Around the horn, delta waves appear to have peaked and are coming down in the US, Canada, and much of Southeast Asia (including Vietnam, Malaysia, Thailand and the Philippines).

In the US, the epiforecasts Rt for the nation is currently <0.9, and nearly every state has falling case numbers. This includes new hospital admissions and hospital census appears to be falling in many places as well. As delta abides despite the College Football and Met Gala/Emmy experiments in close quarter masklessness, if the pattern over the last 18 months holds, we should see at least a couple months of low activity coming up. Yes, despite colder weather. Where things will next turn interesting is November/December. In general, but not as a hard rule, SARS-CoV-2 has been moving in a pattern of about 2 months of high activity, followed by 2 months of low activity, followed by 2 months of high activity etc. No real great biological explanation for that, but if Nov.-Dec. cold weather plus holidays can’t crack the now far greater than 83% vaccine/recovered resistance in the US with a new wave I may finally get a break from these weekly updates we will have strong evidence that herd immunity is reached and we will settle into endemic SARS-CoV-2.

Israel, source of much headline vaccine angst, is also peaking its current wave and numbers there are falling. In the UK, numbers appear to be pretty much steady–the bigger news there is on the socioeconomic front as small to mid-size energy companies are getting nuked by higher natural gas prices, and there are some odd supply chain strains, like availability of CO2 for soft drinks. China just closed another city of 10 million people for a single positive reported case, but again, bigger news there this week is the challenges in their property market. China has long kept some “social distancing” from the financial system of the rest of the world, so the biggest reason to watch the unfolding Evergrande story is the Chinese economy continuing to try to recover from the pandemic, balancing these periodic “entire city” closings, with a managed deflation of a real estate bubble–in the most populous country on earth where that population keeps ~70% of its net worth in real estate of one kind or another. It already appears as if the CCP is printing new Yuan to keep Evergande and other overleveraged property developers a controlled detonation…

…the biggest risk to most of you readers is what more printed money does for the intensity and duration of inflation. Inflation is already global; everyone and their brother is warning about it (including delivery companies like UPS and FedEx earlier this week); and if China really has to crank the printer, then other major currencies are probably going to have to as well, just to keep from losing too much of their already delicate post-pandemic economic recovery from losing competitive cost advantage to a cheaper Yuan.

–But before we get further into socioeconomic issues, yes, I saw the article in The Telegraph about other gain of function ideas proposed for the Wuhan lab. To be fair, these were merely grant proposals from 2018 up to the pandemic by US based and Dr. Petere Daszak led EcoHealth Alliance. They were not accepted as near as I can tell, mostly because the grant reviewers (including DARPA) felt the gain of function work proposed was too risky. These included a $14 million request to create even more chimeric bat/human coronaviruses to make them more infective for humans, and release nanoparticles containing novel chimeric spike proteins into bats around Wuhan as what would essentially be a “bat vaccine.”

The idea here would be to prevent natural selection of these more dangerous coronavirus spike proteins by priming the bat immune systems to kill them before they were created.

The problem, of course, is you have to create them first. Which means they exist, even before you have immunized the bats to them. And if they escape your lab, by accidentally jumping into an already existing coronavirus, well, then, yes, that is one possible way to land on SARS-CoV-2. You can go back a couple weeks to our discussion on why the idea that you can control what you created is a popular misconception based on misunderstanding time versus ensemble probabilities. One that makes gain of function research look like great potential benefits for controllable risk, when really, the risk of ruin is far more probable than you think and this research is often, if not always, unacceptably risky.

Don’t take my word for it! As The Telegraph reports, even DARPA, when reading this grant proposal, said this seems like an unnecessarily risky proposal that could back fire as an accidental creation or release of a nasty human infective coronavirus.

They did NOT fund this research, and to be crystal clear, there is NO evidence that these experiments were ever carried out.

But turns out EcoHealth Alliance was just full of questionable gain of function ideas. One of their other unfunded proposals was to try to make MERS, a cousin of SARS-CoV-2 with a 30% mortality rate among confirmed cases, more contagious in the lab. Just to know how it might become more contagious, so you could have a treatment or vaccine to the more contagious elements already set to go.

–Speaking of things that sound like a good idea, but come with predictable, though unintended, consequences we have this story.

Which will only get more frequent, I’m afraid.

The socioeconomic indicator to watch around November/December in the US, in addition to SARS-CoV-2 disease activity around then, will be around the fallout from employer vaccine mandate policies. A healthy chunk, including some large employers, have opted for “no jab, no job” policies. The deadline for vaccination for many of them will have hit by November. The scale of layoff will be interesting to see. There have been some lawsuits already; those will only pick up the pace once the “no vaccine” layoffs commence. I also suspect that someone, somewhere will be sued for discrimination and a hostile environment for measures required by the company for those who got exemptions from vaccination, but now feel ostracized or mistreated by the “scarlet mask” or testing requirements. On the flip side, how OSHA handles the executive order for vaccine mandates for employers over 100 employees will be interesting. Violations, and then lawsuits about those alleged violations from cited companies, seem likely. How defensible those are when exemptions for certain categories, like the Postal Service and Congress, have already been politically carved out, will be tested in the courts.

No idea how those lawsuits will turn out, but I know one thing…

Dollar, dollar bill y’all.

–Your chances of catching coronavirus, in most places in the world, remain equivalent to the chances that the lawyers were always going to win.

–Your chances of catching Marburg or Nipah virus are equivalent to the chances coronavirus research would result in actual, “Jurassic Park” velociraptors. So it’s unlikely, in fact, spectacularly unlikely, that you will find yourself in a classic velociraptor distraction ambush, and the pack leader is waiting beside you right now, for the final rush of the hunt.

But it’s not impossible either…

<Paladin>