Changing Vaccine Guidelines

Further explorations in building public confidence

There are now three RSV vaccines available in the US—Moderna received approval for their mRNA vaccine this past week. That joins the offerings from Glaxo-Smith-Kline and Pfizer, which were approved last year. Simultaneous with the new vaccine is a major change in the recommendations of the ACIP (Advisory Committee on Vaccination Practices). Throughout my career in medicine I frequently was treating diseases which were novel, or had quickly evolving treatment paradigms, and I followed a path of ignoring official recommendations and treatment guidelines if they differed from my reading of what the basic and clinical science dictated. I operated under the belief that the guidelines would eventually catch up to my practice. Until this week, the recommendations from the ACIP and CDC have been that everybody over the age of 60 should receive the RSV vaccine, “based on shared decision making with their physician”. Since these vaccines were approved, I have advised that in my opinion healthy people in their mid 70”s should receive the vaccine, and that those 60-74 should receive the vaccine ONLY if they have a variety of significant health problems or immune compromising conditions. This week the ACIP changed their guidelines to completely omit the notion of “shared decision making”, and are now recommending only that healthy people age 75 and up get the vaccine, and people age 60-74 take the shot if they have significant medical co-morbidities or immune compromise. They further state that healthy people 60-74 do not need to take the vaccine. If you are healthy, in your sixties, and already took the the vaccine following the CDC’s advice you might have some questions about what fundamental scientific information caused this reversal—the answer is NONE. If you are younger than Medicare age and had to pay out of pocket for your vaccine, try contacting the CDC to cover your expense. Apparently part of their change of heart was based on feedback from doctors complaining that “shared decision making”, was too difficult and time consuming. In my world important medical decisions were always based on informing the patient of risks versus benefits, alternative options and potential side effects, and reaching a mutual shared decision. Between the low uptake of the first two RSV vaccines and this change in ACIP guidelines, the bean counters at the Pharma companies must be having fits. You may have read about the very low occurrence rate of Guillain-Barre syndrome following the GSK and Pfizer vaccines, and now a very low level signal of thrombocytopenia—these are extremely rare events and clearly outweighed by the benefit received when people truly at risk for serious RSV outcomes are vaccinated.

As far as COVID goes, if it seems like a lot of people you know have it yet again, (despite many people refusing to test) you would be pretty accurate. The predicted summer ramp up is underway across the country with wide regional variations. The FDA threw another curveball 2 weeks ago when their vaccine advisory committee of outside experts recommended a new vaccine targeted at the JN.1 variant, which had dominated all winter, but Peter Marks the head FDA vaccine regulator differed, and ordered Moderna and Pfizer to produce vaccine targeting KP.2—the variant which recently became the most common viral mutant. So much for listening to the advice of outside experts with a great deal more in depth knowledge of immunology, virology and vaccine science than the bureaucrat—follow that science stuff. From a practical point of view the biggest issue was that Novavax, which makes the only protein based more traditional vaccine, will not have time to change from JN.1 (which the FDA was originally signaling as the highly likely choice), and thus will continue production of the JN.1 vaccine. So you will be able to take a non-RNA vaccine this fall if that matters to you. There is every reason to believe that the vaccines will be equally effective at what they do now—temporarily reduce your risk of infection by about 50% for say 2 months and more significantly reduce the risk of severe disease for those at risk. Below are the CDC graphs showing the uptick in COVID.

We are still learning about the effects of the gargantuan social and biologic experiment of prolonged social distancing triggered by the SAR2-CoV19 Pandemic. Short term social isolation to “flatten the curve” made logical sense to prevent collapse of the hospital system in the most hard hit areas, and there was no biologic or psychologic reason to assume very significant adverse effects. On the other hand, dragging out the program of social isolation beyond the very limited time frame when the health system was truly at risk of collapse: had no basis in established scientific data, was based on some people’s narrow focus on trying to limit the spread of a disease which was destined ultimately to infect virtually every human on the planet, and for the most part gave zero consideration to the multitude of secondary effects when gigantic groups of humans are socially isolated for prolonged periods. Sure hind-sight is 20/20; but wasting time emphasizing the blame game, or for that matter countering by defending policies that were clearly counter-productive and ultimately damaging, in an attempt to justify your favorite hero, will not help to insure that we come away from this episode with an improved approach to Public Health policies that need to perform more successfully against the next pandemic.

That brings us to the next unexpected complication of the prolonged social distancing—at least that is by far the most likely explanation. Japan is experiencing a huge increase in invasive streptococcal disease with a dire complication of Streptococcal Toxic Shock Syndrome. This result of group A (occasionally B, C, or G) Strep infection has a 30% mortality despite the most advanced medical care. Last year Japan had the greatest number of cases and deaths on record 941 and 97, has already surpassed that case number halfway through the current year. Why blame pandemic social distancing? Group A Strep is an endemic and commensal organism of humans for eons—we all contract it as young children and are frequently re-exposed re-boosting immunity, which fades with time. Five European countries reported to the WHO in late 2022 that they were experiencing surges in this infection, with children under 10 years old primarily affected, (while the current Japanese outbreak is affecting an older population on average). Social distancing was more strictly adhered to in Japan and for longer than in the US or Europe. There is no vector which generally spreads the disease other than humans (ok, rare cases from family dog) so climate change can’t be invoked for once. Furthermore, there does not appear to be any identifiable genetic change in the organism giving it greater virulence. Also the vast majority of cases in Japan have nothing to do with an increase in injection drug use. This is analogous to the massive surge in RSV disease in children seen in the US and Europe in 2022 following relaxation of all social distancing. Yes, correlation is not causation, but when there is a good scientific rational to explain the likely mechanism of causation, and a variety of evidence ruling out other possible reasons, the chances of this being the correct explanation are much greater.

Wearing masks outside on a cold winter day with low humidity and a breeze—then taking them off for a nice restaurant meal, with the risk you might get thrown out if you tried to walk from the door to your table without the mask.

https://www.niid.go.jp/niid/images/cepr/RA/STSS/240329_STSS_2023-2024_Eng.pdf. Risk Assessment of Streptococcal Toxic Shock Syndrome In Japan

https://www.cnn.com/2024/06/17/asia/japan-record-spike-stss-bacterial-infection-intl-hnk/index.html

How about the surge in measles around the world, is that due to the same phenomenon? The answer of course is no, but Pandemic social restrictions did play a role. We do not get fading immunity from Measles Virus—the protection is life long and no period of social isolation will make you susceptible to another infection. Prolonged pandemic restrictions did however, have the unintended consequence of directly delaying measles vaccination for millions of children around the world during their most vulnerable period for severe disease or death (this was particularly acute in the poorest, medically underserved regions); and I will extend this to suggest that various poorly thought out, and even more ineptly communicated, public health dictums worsened the climate of vaccine hesitancy, and have contributed something to the dismal rates at which children in first world settings like Europe and America are getting vaccinated. If you don’t vaccinate your children for measles you should get checked to see if perhaps the same type of worm which “ate”part of RFK’s brain is doing some gnawing on you.

The National Academies of Engineering, Science and Medicine (NAESM) just released a document meant to be a guideline for defining who has Long COVID. Honestly I can’t think of a more useless piece of “official guidance”. In addition to the endless list of symptoms already acknowledged as possible consequences of Long COVID, they conclude that people with essentially any set of symptoms after any infection be considered as Long COVID. Chronic Fatigue Syndrome, Chronic Symptoms Post Lyme, POTS (postural orthostatic hypotension syndrome), it’s all the same as far as these new guidelines are concerned. No requirement for documentation of COVID infection, even people who were asymptomatic with no diagnostic testing will henceforth be “Long COVID” sufferers. The doctors who run Long COVID clinics of course are cheering what a breakthrough this is, how “equitable and inclusive”, allowing they hope, the vast majority of people who feel unwell to visit their clinic with a reimbursement guarantee. How this will advance clinical investigations of the cause and development of therapeutics, as the NASEM suggests, is well beyond me. It seems likely people will be enrolled in studies of a disease called, “I think I had an Infection and I feel very bad”. Four years into this and billions of dollars “wasted” (as Professor Eric Topol says), on collecting lists of patient reported symptoms, and this is the best the scientific community can do. I await rebuttal from any Long COVID researchers with different opinions!

That’s the infectious disease summary for today. You will have noticed that since the mass exodus of the Editorial staff that I was forced to slip some into the body of the report. We are less than 24 hours away from the scintillating prospect of watching two intellectual Titans combat on the debate stage. Visions of Daniel Webster, Theodore Roosevelt, Abraham Lincoln, Socrates, Winston Churchill come to mind….so I will probably skip it. I’m sure you know at least one person you would like to enlighten or annoy so go ahead and share this.