Physician's message: Let's focus on what works against COVID
[Editor's note: This story originally was published by Real Clear Science.] By Buzz Hollander, M.D. Real Clear Science The new year has arrived, and with it the opportunity to reflect on what is and isn’t working in our lives and in the world at large. In case you haven’t noticed, there is one huge thing…
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An Air Force medical technician draws a dose of the COVID-19 vaccine to inoculate Air Force reservists at Joint Base Lewis McChord, Washington, Sept. 12, 2021. (U.S. Air Force photo by Staff Sgt. Paolo Felicitas)
[Editor's note: This story originally was published by Real Clear Science.]
By Buzz Hollander, M.D.
Real Clear Science
The new year has arrived, and with it the opportunity to reflect on what is and isn’t working in our lives and in the world at large. In case you haven’t noticed, there is one huge thing that falls in the “isn’t working” category right now: America’s collective Covid-19 response. Despite mandates, passports, masks, and various other restrictions, Omicron has spread with remarkable speed. The near-vertical epidemic curve of Omicron towering above Delta’s prior peak appears almost everywhere.
Most of our response in the public health realm is creating a lot of heat, but not much light. With the Omicron siege underway, and the promise of truly effective treatments finally close at hand, it is time to take stock of the situation. It is time to change nearly everything about what we’re doing; to focus on what has been shown to work, and transition away from the practices that don’t. A new year - with a new variant, new treatments, and a new vaccine - is the perfect time for change.
Enough Signaling That We Can Stop the Spread of SARS-CoV-2
The first shoe fell in this regard with the CDC’s rather shocking announcement that it was halving the time for isolation after diagnosis to 5 days if symptoms are resolving, followed by 5 days of mask wearing. Whatever you think of this recommendation — and rapid test authority, Dr. Michael Mina, was not a fan of the implication that a positive rapid test 5 days after symptom onset is no real cause for concern — the more telling shift regarded quarantine after exposure: 5 days for those un-boosted or not recently vaccinated (followed by 5 days of masking) or just 10 days of masking for the recently vaccinated/boosted or all those for whom actual quarantine is not “feasible.”
While this does not exactly constitute waving the white flag at Omicron, it marks a huge shift from the days of aggressive “test/trace/isolate” campaigns with the goal of controlling transmission. Think of all we have done in this country over the past twenty months — universal mask wearing, routine testing on college campuses, required temperature checks — and we are now allowing people with the actual disease, or with known exposures, to go about their business, protecting us with what CNN medical analyst, Dr Leana Wen, termed a mere “facial decoration” while they may well still be infectious.
The CDC asserts its decision was “motivated by science,” but more likely it was motivated by necessity. When (conservatively) 1 in 30 Londoners have Covid in a week, it is simply impractical to ask everyone exposed to one of those 3% to hunker down for 10 days and still have a functional society.
With this tacit acknowledgment that controlling the spread of Omicron is well-nigh impossible, and what appears to be a nationwide distaste for reintroducing more austere restrictions, one thing is crystal clear: we are not going to “stop” Omicron. Those places making the most strenuous efforts to do so, like New York, California, and Hawaii, are being hit just as hard as the laxest states. We will live with Omicron, and have to tolerate what is essentially an unavoidable explosive growth in cases. So let’s get real about what that means.
Enough of the Weekly Testing
This common practice on school campuses, as well as the lone option for employees eschewing vaccination under Biden’s federal vaccine mandate for large companies, never made much sense. A negative test on Monday says little about anyone’s contagion on Tuesday, not to mention Friday. With Omicron — in which symptoms often start before a rapid antigen test will even show positive, and viral load rises remarkably swiftly — weekly testing becomes theater of the absurd.
Daily tests for nursing home workers? This I can get around. Readily available rapid tests so that people can make better and swifter decisions (without going to the ER for a test!) about seeking treatment and avoiding contacts? Fine, especially if done properly. But elite universities still doing weekly tests for their fully vaccinated, often boosted, extremely low risk students? A ridiculous use of resources. Enough already.
Enough of the Mask Mandates
I know the arguments for masks: they’re cheap, non-invasive, and just might work. They have a cost, though, aside from the developmental, social, and psychologic cost of asking people to interact with their primary organ of communication covered. I’ll also refrain from discussing the environmental disaster created by disposable masks…
Of course, if I was convinced mandating people to wear masks was an effective policy intervention, I might think it still worth it, at least at high-impact times as hospitals fill. However, positive clinical data on mask-wearing is entirely based on observational studies with high risk of bias (people who wear masks might tend to be more careful than those who don’t, and places which enforce mask mandates might have more cautious people than those which do not). Most prospective studies that have actually looked at the effectiveness of mask policies have failed to deliver significant findings, though one randomized controlled trial conducted last year in Bangladesh led by researchers at Stanford Medicine and Yale University found that mask interventions reduced spread by about 11%.
Whether my mask protects me, or you, I still do not know (and not for lack of combing through data). I am not convinced that your mask mandate protects anyone, though. Despite the Institute for Health Metrics and Evaluation (IHME) still modeling massive reductions in epidemic curves for places with 80+% mask wearing, I can report from the very throne of mask-wearing, Hawaii, that our epidemic curves for Delta and Omicron look just like those anti-mask-mandate red state curves. A review of the states with highest grades for mask wearing reads like a Who’s Who of Covid-afflicted states.
People with genuine concerns for infection for any of many good reasons can wear N-95s or similarly protective respirators when around other people. Proper masks in appropriate situations help reduce disease burden. Requiring ineffective masks in all situations, especially when mis-worn or partially-worn, is probably just safety theatre. It’s time to move on.
Enough of Vaccine Passports
Two reasons exist for vaccine passports: one, to “protect” everyone in an establishment; the other, to encourage vaccination, which both protects individuals and reduces strain on hospitals. I’ll revisit the second justification shortly. The first has become farcical in the Omicron age.
Reports from South Africa and the U.K. suggest that vaccine protection against symptomatic Omicron infection dips down under 30% relative to an unvaccinated person within 3-4 months of full vaccination. Presumably it is even lower against all infections when asymptomatic infections are included. While effectiveness climbs up to around 70% in the weeks after a booster shot, data from those early adaptors in Israel suggests that this effect, too, will wane within 4 months.
So, what exactly are we doing here? I have to show my January 2021 vaccine card to walk into the local library, despite the fact that I am marginally less likely to spread Omicron to the other book-lovers compared to an unvaccinated/prohibited patron. If the idea is for my vaccine to actually protect others, my low-risk self would need to be boosted every three or four months. I trust — or at least hope — this is not the plan.
I am sometimes asked by patients: “Is it okay to see Darlene? You know, she’s… unvaccinated.” The question is spoken in a tone of abhorrence mixed with fear. In the Omicron era, in which only very recent vaccination significantly reduces infection risk, the answer is another question: “How social is Darlene?” The primary determinant of one’s threat to infect another is not their vaccination status; it is their sociability. In this one way, vaccine passports have real value: if a person has a “vaccine passport” and puts it to regular use for entry to shows, restaurants, and public buildings, that passport is a useful warning of someone with a higher risk of Covid infection.
Enough of Vaccine Mandates
The current White House plan for mandatory vaccination — or weekly testing, if offered, for those who are not federal contractors — was a well-meaning effort to increase vaccination rates under the disingenuous guise of being necessary for “workplace safety” under the auspices of OSHA. Again, to protect your coworkers, avoiding bars, restaurants, concerts, and parties is far more critical than getting vaccinated. So, too, is staying home at the first sign of illness. A workplace vaccine mandate does little to actually protect workers, but it certainly fires up a lot of opposition.
The end result has been a predictable mess. Court challenges have delayed implementation. Has the looming requirement for mandatory vaccination increased vaccination rates? This, after all, is the one reasonable justification for government measures which require vaccination: to increase the number of people with immunity and thereby reduce disease, suffering, death, and hospital strain. Noble goals, all. But do measures of this sort substantially increase the number of non-immune, high-risk people gaining immunity? I don’t know. In the 3 months since Biden announced the plan, another 7% of Americans have become fully vaccinated. The 3 months before: an increase of 11%. I suspect any benefit is marginal; but the costs could be high.
I have already aired my feelings about mandated vaccines for school children. With no hope of achieving herd immunity with an incredibly transmissible, immune-evading variant like Omicron, the usual justification for school vaccination requirements simply does not apply. These vaccines protect the vaccinated. Pushing vaccine rates up for the lowest risk age cohort (ages 5-17) is a counter-intuitive priority. Clear messaging to maximize vaccine uptake in children and adolescents at moderate and high risk of severe disease is a more sensible priority. With the recent well-designed pre-print study from Hong Kong revealing a 1/2700 risk of myocarditis among male adolescents after their second mRNA shot; and last month’s German study, also a pre-print, showing a hospitalization rate in healthy adolescents for the duration of the pandemic to be in the 1/3850 range; it is not just poor public health policy and inappropriate medical guidance to require healthy boys to be vaccinated with an mRNA vaccine — it is madness.
The same can be said of mandating boosters, which is happening even in low-risk settings like universities. A good indication that boosters are a low yield public health initiative is when the clinical trial for Pfizer boosters with 10,000 subjects over 2 months of a smoking hot Delta wave did not have any Covid-19 related hospitalizations in the placebo group to compare with the booster group. Well - not quite. One of the 78 adolescents was hospitalized, but for post-vaccine myocarditis. The science is clear that elderly and higher risk individuals benefit from boosters; the young and healthy, not so much.
This sort of disconnect between science and policy sows confusion and discontent between public health figures and the public. A universal booster recommendation that was not based on solid science but rather political pressure led to the heavily publicized resignation of two top FDA officials. When the poster child for vaccine advocacy, Vaccine and Related Biologic Products panel member, Dr Paul Offit, writes an op-ed decrying the focus on universal boosters, it’s normal for the public to question the guidance. If recommendations and policies make scientific sense, a certain harmony among experts and institutions can arise; these policies, however, are scientific nonsense.
Enough of Doing What Doesn’t Work — Do What Works!
We have new treatments that work. There are three highly effective, long-awaited pharmaceutical options: Evusheld long-acting monoclonal antibodies for pre-exposure prevention, and Sotromivab monoclonals and Paxlovid, the oral antiviral, for early treatment. Unfortunately, we have very little of all three. (We also have a fourth, Remdesivir repackaged as a 3 day IV outpatient infusion, with similar efficacy to the others but serious access issues.)
The immunocompromised and medically frail face the greatest threat in a world in which public health is giving up the battle against broad transmission. I might lose my libertarian readers here, but getting the supply and demand match right for those at highest risk of severe disease is a great use of federal coordination. I do not know how or why one of my patients found a boutique MD in Florida willing to send her a dose of Regeneron with a Sotromivab chaser despite being 7 days into a mild disease course. The White House team could brand itself as a champion of getting the right meds to the right people while supply is low; and despite the difficulties noted by chemists in ramping up Paxlovid production, do everything possible on that front to improve supply, and take all the credit they can for any successes.
Besides medication, ventilation works. Instead of schools and businesses spending millions on testing, money which is effectively dumped in a hole (or a Ferrari dealership), they could be improving their HVAC systems. Healthier air is a gift that keeps giving to building inhabitants for decades.
Immunity also works. Despite barely putting a dent in Omicron infection rates, both vaccination and prior infection have made the Omicron surges in other parts of the world — thus far, at least — far less lethal than prior Covid-19 waves. Since we do not want to promote infection, we should focus on improving vaccination rates via clear messaging, ready availability, and a justified sense of optimism (rather than implying the inevitability of booster after booster).
We are about to get another tool in our Covid tool box, and that is the impending FDA approval of the Novavax vaccine. Medically, I don’t find it superior to our other options, except perhaps in filling that niche for young men with higher myocarditis risks from the mRNA vaccines. Societally, however, it holds the huge benefit of being more traditional than our other Covid vaccine options, and one without all the conspiracist and fear-based baggage that comes with Pfizer, Moderna, and J&J in our country (at least for now).
The opportunity it presents is an easy join for some vaccine hold-outs, a chance to save face and get vaccinated despite perhaps strongly-held social media positions against these “experimental” mRNA and adenovirus-vector jabs. The soft sell should be savvy and immediate, and needs to avoid any trappings that sound like the medical-industrial complex at work, pie-in-the-sky promises, or threats against livelihood or freedom. In other words, no mandates, “horse dewormer”-type dismissals, or platitudes about being “completely safe.” Honesty sells when the product is good.
Summing Up a Hard Situation
I don’t want to sound callous. I don’t want anyone to die or suffer from Covid-19 unnecessarily. But I do think we are over-rating the benefits of our marginally-useful public health interventions, and underestimating their true costs. It’s hard to know what will come next in this pandemic; if Omicron will indeed prove milder and stay a while, or whether France will export its new B.1.640.2 variant, or if something new and different comes along. At some point, we are likely to need a central disease response that inspires confidence.
The U.S. has become a nation divided. To the red states, the blues are oppressive; to the blue states, the reds are reckless. Everyone is angry at the CDC, for either being too easy on Covid-19 transmission or too hard on society. Accelerating the geographic clumping of our populace by political belief is a destructive force — socially, politically, and economically.
I don’t know if the problem is fixable. I do think we should do what we can to slow the process, by only moving to limit personal freedoms when there is convincing evidence of necessity. A softer approach to managing the pandemic might cost little in terms of lives and suffering, but save greatly in terms of our ability to function as a nation.
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