More Inconvenient Facts

One size doesn’t fit all

Everyone is aware of the current surge of COVID disease in the US and around the world. XBB.1.5 has probably just about peaked in the New York and the Northeast, and is quickly ramping up in the heartland. This variant, which was first identified in New York, has also begun early expansion in Europe. Similar to the predictions about the “very mild” Original Omicron B.1, a fair number of articles in the lay press have presented the hopeful opinion that we would not see any significant increase in hospitalizations, similar to Singapore. That prediction has unfortunately been laid to rest with the Jan.10th US daily deaths of 727 and a 7 day average of 615, which represents more than a doubling from October. The current national COVID hospitalizations by age group are shown in the following CDC graph. Inconvenient facts which are easily ignored, when it suits relaxed personal behavior or political proclamation. The red line of course are the folks over 65 yo.

One more US graph, before I move on, is the CDC data modeler’s projections of likely near term hospital admissions. You will note the very wide potential outcome range over the next two weeks. This is primarily the result of the uncertain impact of XBB.1.5. My guess is that the actual hospitalizations will be well above the consensus line, which is basically flat, but well below the projected upper bound.

Let’s quickly check the eastern half of the world. Top Chinese officials met with the leadership of the WHO yesterday to deliver the message in person that the data coming out of China is honest, accurate and timely. This week, as they reported 40 COVID deaths, we were treated to satellite images of newly expanded parking lots around crematoriums, reports on social media of waits up to 2 weeks for cremations, five minute funerals, and photographs of caskets lined up in alleyways outside hospitals. Despite my previously expressed confidence in the CCP to stage-manage this, I get the feeling their censors are understaffed. Maybe some former Twitter employees will smell a job opportunity? Mr. Xi, who spent the last 3 years mocking the decadent Western democracies for their handling of the Pandemic has changed his tone to, “the Pandemic has been hard for everybody”. Seems he too may be having doubts about the ultimate effectiveness of their lying campaign.

Next on the list is some scientific data I wish we could have seen go the other way. That is the following very large scale study from the Cleveland Clinic system just posted to the medRxiv server.

Effectiveness of the Coronavirus Disease 2019 (COVID-19) Bivalent Vaccine https://www.medrxiv.org/content/10.1101/2022.12.17.22283625v1

This appears to be a robust study of 51,000 actively employed health care workers looking at the effectiveness of various numbers of mRNA COVID vaccinations over a defined time period. The vast majority of this group were under 65, and by and large healthy. The groups, based on the number of prior vaccine doses they had received, were well matched for all the usual demographics and other propensity confounders. The study was commenced only in September, when the bivalent booster became available, and the enrollment date for the surprisingly small percentage taking the booster was 2 weeks after the shot. They found the booster to have an efficacy of 30% in the short term prevention of infection verses no bivalent booster. Although not directly comparable studies, this result is similar to the findings of the recent CDC sponsored MMWR report on the under 65 yo. group, which I discussed in my Dec. 17th post. We are well versed now in quickly acknowledging that the vaccine does very little to prevent infection against the current variants (likely even less against XBB.1.5 than against BA.5 which was dominant during both studies), and the real value of the vaccine is the enhanced protection from more severe disease. This is well established, but here the inconvenient findings of this study come into play. These researchers found that there was a direct correlation (dose response) between how many doses of vaccine the person had received (from 1- 4) and the risk of contracting COVID. The authors describe the results as extremely surprising and unexpected. In fact it seems likely the study was designed to prove just the opposite. This is not the first study to find a higher risk of contracting COVID with more doses of vaccine, but others have been smaller with more obvious methodological problems, which have allowed them to be pooh-poohed by people who are convinced they know everything about a virus which has proven them wrong time and again. You know the drill here, this is a preprint not yet peer reviewed. I could speculate on alternative explanations to the measured results, but I will wait for people more versed in epidemiology studies to weigh in. In the meantime, I have no doubt that many, with no more expertise than me in this field, will be offering their learned and heated opinions. Just to be clear, this study says nothing about potential value of ongoing updated shots for individuals who are truly at risk for severe disease. It does however raise doubts about the wisdom of the current approach of repeated vaccination of individuals at extremely low risk.

Paul Offit, one of the deans of American vaccinology, appears to agree with me. In a perspective published on Jan.11th in the NEJM, he concluded the following: Bivalent Covid-19 Vaccines — A Cautionary Tale

• Paul A. Offit, M.D. 

• January 11, 2023 DOI: 10.1056/NEJMp2215780Bivalent Covid-19 Vaccines — A Cautionary Tale

“Although boosting with a bivalent vaccine is likely to have a similar effect as boosting with a monovalent vaccine, booster dosing is probably best reserved for the people most likely to need protection against severe disease -- specifically, older adults, people with multiple coexisting conditions that put them at high risk for serious illness, and those who are immunocompromised," Offit argued. "In the meantime, I believe we should stop trying to prevent all symptomatic infections in healthy, young people by boosting them with vaccines containing mRNA from strains that might disappear a few months later.”

Professor Offit discounts the improvement offered by the bivalent booster compared to the original. He was one of two members on the FDA advisory board to vote against the plan for the bivalent. For a somewhat different perspective, I recommend Eric Topol’s Substack “Ground Truths” this week. I agree with Dr. Topol, that there is some evidence of slightly better response to the bivalent vaccine (against current variants) compared to the original vaccine boosters, but in this case I think he is missing the forest for the trees. His admirable goal is to encourage more people to take the updated booster, but his detailed summary of the evidence pointing to the small advantage of the bivalent vaccine isn’t going to convince those who should, but haven’t taken a booster— and besides at this point the bivalent is the only game in town.

The closing thoughts today veer into the political—my editor is already shaking her head and job posting now on LinkedIn. Could there be subtle signs of some meeting of the minds between our political parties? My first suggestion of this was the fact that only 15% of the eligible American populace has stepped forward for a new bivalent booster—my basic math skills tell me there must be a significant number of Democrats joining Republicans in the abstaining group. Next, there is the Congressional formation of a bipartisan Committee to investigate and provide oversight on Chinese spying and influence on American Universities and Industry. All the Republicans voted in favor, but so did 2/3 of the Democratic caucus. The only question I have about that is, if virtually everyone in both parties is in favor of this; who was preventing it from happening quite a while ago? Anyway, we can remain hopeful for some moderation in sentiment going forward into the New Year.

Thanks as always for reading here. This marks number 52 in the series and I certainly was not anticipating doing this every week for a year when I wrote, in a paroxysm of frustration, “Masks in Schools Reduce COVID Transmission”. Omicron was the second Black Swan event in this Pandemic, and it has spawned much to analyze and discuss. Certainly you are sick of this 3 year hiatus from normalcy; perhaps you’re tired of reading about Pandemic fatigue. During this past year another 241,222 Americans died directly from COVID, and an unknown number from: delayed diagnosis, lack of follow up for chronic medical conditions, drug addiction linked to depression and isolation, and suicide. Let’s hope we truly are seeing some light at the end of the variant tunnel, but remain realistic. Hit the Like Button if you feel moved, but I am no longer receiving the previous consideration from the IRS, and neither will you. Apparently there is some dust up about secret documents from my time in the Masonic Lodge now found in my old locker in the Cincinnati YMCA, and also the attendant’s closet at the Port Authority men’s room.