The statement by White House Chief of Staff, Mark Meadows, in a CNN interview on Sunday, October 25th is cause for concern. He averred, “we are not going to control the pandemic, instead we will focus on vaccines, therapeutics and other mitigation areas.” In the week running up to the November 2020 election, the U.S. has recorded 9.0 million diagnosed cases and 230,000 fatalities. Incident cases rose to 80,000 per day with more than 1,000 fatalities. Both the incidence and mortality rates are understatements given deficiencies in testing and assigning the cause of death. Worldwide there have been 44 million diagnosed cases with over 1.4 million deaths. It is evident that the U.S. is experiencing an upsurge in cases with daily reports of new cases approaching 80,000 with close to 50,000 currently hospitalized. The COVID pandemic has profoundly impacted the economy of our nation as evidenced by high unemployment, low and fluctuating earnings reported by public companies and a stock market that shed close to six percent of shareholder value over four consecutive trading days.
The actions of the Administration have been widely criticized, both by public health specialists within the U.S. and by the World Health Organization. Effectively, the Administration has adopted the Swedish model and has embraced the Great Barrington Declaration. Simply put, this approach involves relaxation of most restrictions but with attempts to protect the elderly and those with predisposing conditions, including diabetes, obesity, and immunosuppression. These demographics unfortunately represent close to a third of our population.
Although politically comforting and expedient, science does not support the principle of “herd immunity” with respect to COVID. Herd immunity has never been achieved with any disease absent an effective vaccine stimulating durable immunity. Evidence from Stockholm suggests that the level of antibodies in the population is far lower than the threshold of at least 50 percent of the population required to meaningfully control the infection. There is insufficient knowledge concerning the antibody status of those recovering from COVID-19 irrespective of whether they were asymptomatic or required supportive treatment. The proponents of herd-immunity appear to ignore the long-term consequences of infection. The virus is pantropic in its effect with both cardiac and neural changes in addition to fatigue in the so-called “long haulers”.
Prominent epidemiologists have calculated that without currently-known measures including masking, maintaining social distance, and avoiding large gatherings, cases from COVID-19 will be measured in the millions over the coming year with a proportional rise in fatalities. It is a disquieting thought that correcting for the relative sizes of the U.S. population, the 1918 outbreak of H1N1 influenza resulted in as many fatalities expressed as a rate by October 1918 as the U.S. has experienced with COVID.
Epidemiologists and public health specialists have issued the John Snow Memorandum to counter the fallacies and illogic of the Great Barrington Declaration. They characterize the approach to ignoring known preventive measures to create herd immunity as a gigantic gamble, hoping for a rapid return to pre-COVID social and economic activities.
It may be inferred from the statement by Chief of Staff Mark Meadows that the Administration will depend on protection from an as yet unavailable and unapproved vaccine. Despite the efforts of the major pharmaceutical manufacturers, a vaccine will not be generally available until the beginning of 2021. Pfizer, the apparent leader in the race, has yet to conclude the evaluation of their Phase-3 trial involving 40,000 participants conducted in the U.S., Brazil, Argentina, South Africa, Germany, and Turkey. Results of the trial should be available by the end of November, after which statistical analysis and peer review will be required before approval by the FDA. Pfizer anticipates 164 cases of COVID in their trial but an interim evaluation will consider efficacy after 35 cases have been diagnosed in the trial population. If 26 are in the placebo group, the vaccine could be approved by the FDA on the basis of 50 percent efficacy. Moderna will evaluate their vaccine after 53 cases and AstraZeneca after 75 COVID diagnoses in their respective trial groups.
Even if a vaccine is approved at the beginning of January 2021 only sufficient quantities will be available to commence distribution to priority groups including first responders, the elderly, and those with predisposing conditions. Two doses with a month interval will be required to stimulate durable immunity. Appropriate monitoring will be required for at least three months after initiating mass vaccination to distinguish between any possible adverse vaccine reactions and the large number of spontaneous but unrelated clinical conditions and mortalities that are sure to occur among recipients of the vaccine.
Mass vaccination will impose logistic challenges in distributing and administering a biological product that requires a critical cold chain. Simply stating that “the Army will do it” is more an aspiration than a specific plan. The reluctance of a high proportion of the U.S. population to receive a vaccine will obviously reduce the proportion of those that become immune within the population. It is yet unknown whether development of antibodies will actually provide protection from clinical effects or reduce the extent of virus shedding. An additional unknown is the durability of antibody levels in the face of ongoing challenge and the possible mutation of SARS-CoV-2 over time. It is possible that as with other coronavirus infections, annual re-vaccination may be required, but this challenge is in the future.
It is accepted that there will be a delay in obtaining sufficient quantities of presumably effective vaccines, logistic complications associated with distribution and administration and reluctance to be immunized. This suggests that we must continue to adopt measures that have been shown to be effective in nations such as South Korea, Taiwan, and even China. These nations adopted rapid testing for antigen with strict quarantine of those shown to be exposed, contact tracing, masking, and social distancing. The countries that have achieved the greater success in controlling COVID have followed the advice of scientists and have a culture that accepts masks and are willing to conform to health directives.
From the perspective of our industry, we must apply scientific principles, eschewing quick fixes and false prophets. With the onset of winter we must ensure a high level of immunity against seasonal influenza, that will be a complicating factor both with respect to the diagnosis and clinical response to COVID infection. We must increase the efficiency of testing with quarantine and contract tracing and apply common sense in our business and social activities.
Experience over the past nine months has shown that COVID cannot be ignored. There is no evidence that the infection will spontaneously disappear and without appropriate control measures, we could experience a replay of the 1918-1920 influenza pandemic. We have yet to receive an effective vaccine, there is no consistently effective or specific therapeutic agent (the Administration ‘cure’). We are relying on the stretched resources of our medical community who are reducing mortality by administering supportive therapy and a high level of care.
COVID-19 dominates all aspects of our life at present and we will not return to normality until it is controlled. We have a collective responsibility to respond to sound scientific advice and over the intermediate term, suppress the incidence rate especially in rural areas where our farms and packing plants are located.