Covid-19 and SARS-CoV-2 Pandemic and Pandemic Management

An insufficiently appreciated impact of the COVID-19 pandemic has been to reveal tension within the CDC and FDA between doing science and making policy. The CDC and FDA often have compromised science for politics. The time has come to examine critically the missions of CDC and FDA to see if they embody untenable conflicts. If they do, maybe the time has come to separate the agencies’ health protective functions from their medical innovation promotion functions. Maybe, in short, the time has come to restructure the CDC and the FDA.

Eric Topol's Science Magazine Editorial of 21 January 2022 attributes the Biden Administration’s disappointing Covid-19 pandemic response largely to failure of data collection: “during the Omicron wave, we haven’t a clue as to whether and to what extent hospitalizations are being prevented by vaccinations and boosters.” I agree, but I would apply Topol’s criticism more broadly, most notably to an important metric that has garnered less attention than it deserves: mild or non-symptomatic Covid-19. Topol’s criticism that “not a single word has been uttered about fixing the profoundly deficient data systems” applies to this metric, which would not be captured by better hospitalization data.

With surging COVID-19, New York City Mayor Eric Adams defended his policy of retaining in-person schooling: “Fear not sending them back. … The safest place for children is inside a school.” This statement might have a grain of truth, but it should be taken with a shaker full of salt.

I recently published the hypothesis that SARS-CoV-2 might enter organs, such as the brain, where immune surveillance is ineffective. An NIH study soon confirmed this. The virus could persist, reactivating when we become old, sick, or weak. The weight of evidence now suggests that 'Covid' and 'long Covid' could become 'lifelong Covid'. Opportunistic virus reactivation is common. Childhood chicken pox becomes adult shingles. ‘Cured’ Ebola re-emerges years later, without external reinfection. Yet, the US FDA and CDC have remained overly restrictive regarding vaccine boosters. Our overriding priority should be on preventing as many COVID-19 cases as feasible, not tolerating them because they tend to be mild. Even mild cases might impose future health and economic burdens. We therefore must adopt the 'precautionary principle'.

Pandemic Covid-19 has exposed tension between personal choice and public health policy. Vaccination has damped pan� demic inertia in the U.S., but emergence of highly infectious variants such as delta and omicron has increased infection of fully vaccinated people. This worrisome trend justifies vaccine booster eligibility and access for all vaccinated people in a timeframe responding to waning protection. In restricting booster eligibility, US FDA and CDC statements indicate failure to consider that SARS-CoV-2 might be persistent, meaning that it might remain dormant in immune-privileged “refugia” such as the central nervous system of previously infected peo� ple, even if their Covid-19 symptoms had been mild or non� existent. Opportunistic re-activation of dormant viruses can cause severe illness, as in childhood chickenpox producing adult shingles decades later. External re-infection is unneces� sary. Consistent with the “precautionary principle,” the overrid� ing FDA and CDC public health priority should be to prevent as many SARS-CoV-2 infections as possible, not tolerate them, assuming optimistically that they will not impose major public health and associated economic burdens in the future. We naturally have focused upon our tragic past losses. We also must focus upon the future, learning from Covid-19 to man� age pro-actively the inevitable next pandemic.

In our brave new pandemic world, risks of Covid-19 virus infection have skyrocketed. We missed the opportunity to limit U.S. cases mainly via isolating travelers from China and other hotbeds of infection, and their contacts. Further risk management now is urgent. The pandemic might end in the U.S. with less impact than flu, but only if we implement effective risk reduction strategies now. It may be calamitous otherwise. In the 2019/’20 flu season, reports the U.S. Centers for Disease Control, we had 13 million cases; 120,000 hospitalizations; and 6,600 to 30,000 flu-related deaths. Manyfold more of each were averted by vaccination. Likewise, personal Covid-19 infection risk estimates have meaning only in a specified risk management context.

The need to adopt effective strategies to suppress our surging COVID-19 pandemic lends urgency to the question of whether schools should be open or closed. Infection risks at schools may be lower than at students’ homes. Many New Yorkers therefore advocate keeping non-residential elementary, middle and high schools open. This reasoning is simplistic and invalid. Non-residential schools might be kept open if incremental risks are acceptably low, and if the benefits are deemed to justify the infection risks. They should not be kept open simply because school risks are lower than home risks. Infection risks at residential schools versus homes differ in being independent. Those risks can be compared to decide whether instruction should be on-campus or remote. If risks are lower on campus, students living there would be safer, and colleges could hold in-person classes. Analogous reasoning is invalid for non-residential schools. Their students attend school for only part of the day, but they live at home. This nexus brings school risks to homes, and home risks to schools. Non-residential schools cannot be opened or closed based upon risk comparison, because the risks are entangled, and are therefore (at least) additive. Such co-mingling promotes risk enhancement and community spread.

Serology testing for antibodies induced by Covid-19 may indicate past exposure without past infection.

In the Fall of 2021, the US FDA and CDC expanded eligibility for Pfizer Covid-19 booster shots but imposed inadvisable restrictions. Two issues support unrestricted booster eligibility: SARS-CoV-2 is strongly selected for exploiting personal immunological weaknesses, resulting in weakened immune protection and slower immune response with increasing viral adaptation. Further, the virus might be persistent, which means that it might remain dormant in immune-privileged 'refugia' such as the central nervous system of previously infected people, even if their Covid-19 symptoms had been mild or non-existent. Opportunistic re-activation of dormant viruses can cause severe illness, as in childhood chickenpox producing adult shingles decades later. External re-infection is unnecessary. Consistent with the 'precautionary principle', the overriding FDA and CDC public health priority should be to prevent as many SARS-CoV-2 infections as possible, not tolerate them, assuming optimistically that they will not impose major public health and associated economic burdens in the future.