Disagreement in the US over the COVID-19 outbreak has intensified, with several states announcing plans to start relaxing some measures, despite leading infectious disease experts warning that such moves are premature and could backfire. Georgia’s governor will be opening up some businesses starting today, 24 April, despite the US President suggesting it was too early to take such steps. Georgia is part of a coalition with other southeastern states, including Florida, Mississippi, Alabama, South Carolina, and Tennessee that plan to reopen businesses in the coming days. The controversy shines a spotlight on the nuances of the administration’s “Opening Up America Again” guidelines and underscores some disparities with the World Health Organisation’s own guidance.
US President Donald Trump has announced the administration’s three phase plan to reopen the economy, which outlines various criteria and guidelines for state officials to transition through the various stages of the mitigation strategy. According to the White House, the phased approach will help mitigate resurgence of an outbreak, and can be implemented at the discretion of individual governors at the state or county level. Before the three-step plan can even begin a set of criteria need to be met including a decline in the number of new infections over a 14-day period, hospitals having sufficient capacity to treat all patients requiring care, and the presence of a robust testing programme for at-risk healthcare workers, including use of newly developed antibody tests. The White House also included a list of requirements for “state preparedness” that in addition to ensuring testing capacity and healthcare system capacity is notably expanded, includes the establishment of “plans” to protect workers in critical industries, those living in high-risk facilities such as nursing homes, and users of mass transit, that could prove notably challenging for governors given the unprecedented nature of the pandemic and the lack of sufficient data to determine how best to protect individuals from the virus in situations where social distancing is simply not possible.
States and regions that meet the “gating criteria” can begin implementing Phase 1, with the aim of transitioning to Phase 2, then gradually to Phase 3, assuming the gating criteria is met at each step. If there is resurgence in cases, governors should consider restarting the phase or potentially returning to an earlier phase, if necessary, depending on severity. This may leave some states that prematurely remove lockdowns perpetually stuck in Phase I for much longer than intended. A summary of the phases is included below.
US plan sets lower bar for lifting lockdowns relative to WHO guidance
Although the phased approach to “re-opening America” aligns with the WHO’s own recommendation that measures “should be lifted in a phased, step-wise manner”, the guidelines appear to set a lower bar for embarking on that phased process. Details regarding precise methods and markers for assessing “epidemiological risks”, upon which the WHO states lifting restrictions should be based, are absent from the document.
The WHO’s guidance for “transitioning to and maintaining a steady state of low-level or no transmission” focuses on six main elements – controlling transmission; enabling health systems to detect, test, isolate, trace, and treat contacts; minimising threats in hospitals and nursing homes and other key settings; taking preventative steps in workplaces and schools and other public spaces; controlling imported cases; and ensuring that communities are informed and empowered. The guidance, which was contained in the WHO’s “Covid-19 Strategy Update” on 14 April, warns that “without careful planning, and in the absence of scaled up public health and clinical care capacities, the premature lifting of physical distancing measures is likely to lead to an uncontrolled resurgence in COVID-19 transmission and an amplified second wave of cases”. The six criteria, which have been widely interpreted by countries as conditions to be met for lifting restrictions, are summarised below:
- Transmission is controlled to a level of sporadic cases and clusters of cases from known contacts or importations. New cases should be maintained at a level that health systems can manage with substantial clinical care capacity in reserve.
- Sufficient health system and public health capacities are in place to enable the shift from detecting and treating mainly serious cases to detecting and isolating all cases – detection, testing, isolation and quarantine.
- Outbreak risks in high-vulnerability settings are minimized, this requires major drivers of COVID‑19 transmission “to have been identified, with appropriate measures in place to minimize the risk of new outbreaks and of nosocomial transmission (e.g. appropriate infection prevention and control, including triage, and provision of personal protective equipment in health care facilities and residential care settings)”.
- Workplace preventive measures are established to reduce risk. This includes “appropriate directives and capacities to promote and enable standard COVID-19 prevention measures in terms of physical distancing, hand washing, respiratory etiquette and, potentially, temperature monitoring”.
- Risk of imported cases managed through analysis of the likely origin and routes of importations; “measures would be in place to rapidly detect and manage suspected cases among travelers (including the capacity to quarantine individuals arriving from areas with community transmission)”.
- Communities are fully engaged and “behavioural prevention measures must be maintained”.
The US guidelines converge with the WHO guidance by stating the need to ensure that sufficient health system capacity is in place, workplace preventive measures are established, and that testing, isolating, and contact tracing activities are functioning, in order to thwart the risk of resurgence. However, they do not set these standards as actual conditions under the “proposed state or regional gating criteria” that should be satisfied before proceeding to phased re-opening. Instead, they are listed separately as “core state preparedness responsibilities”. This suggests that verified capabilities for testing, treating, prevention and controlling transmission are not criteria for starting relaxations. This may, for political reasons, place a disproportionate responsibility on governors to address national problems such as testing capacity, personal protective equipment (PPE) availability, and ability to surge intensive care unit (ICU) capacity, among other things, as they potentially compete for limited resources
The US guidelines’ requirement for 14 day periods of downward trajectories in reported symptoms, reported case, and in positive tests as a percent of total tests are set as “gating criteria” for starting the implementation of Phase 1. This takes heed of the WHO’s estimation of a 14-day incubation period and the agency’s recommendation that there should “be a minimum of two weeks between each phase of the transition, to allow sufficient time to understand the risk of new outbreaks and to respond appropriately”. However, it falls far short of the WHO’s criteria for transmission to be “controlled to a level of sporadic cases and clusters of cases, all from known contacts or importations and the incidence of new cases should be maintained at a level that the health system can manage with substantial clinical care capacity in reserve.” Details pertaining to patterns of community transmission and the contact tracing activities needed to identify clusters of cases do not feature in the US Plan’s “gating criteria”.
The US Plan specifies that hospitals should be able to “treat all patients without crisis care” before relaxing measures, and this represents another area of convergence; it correlates with the WHO’s recommendation that incidence of new cases should be maintained at a level that does not overwhelm health systems. However, the US plan does not establish requirements for spare capacity, and the guidelines do not elucidate on methods for measuring health system capabilities.
Beyond the “gating criteria” the US plan’s “core state preparedness responsibilities” urge authorities to monitor and contain transmission through testing, contact tracing and to set up screening for syndromic asymptomatic cases. However, there are no guidelines for quarantining close contacts and isolating all confirmed cases, as called for under the WHO’s second criterion: “Sufficient health system and public health capacities are in place to enable the major shift from detecting and treating mainly serious cases to detecting and isolating all cases, irrespective of severity and origin”. With no geographical reference to where testing and screening sites should be located, measures to prevent transmission of infections across state borders, and to monitor routes of impetrated cases – as recommended under criteria five in the WHO guidance – are lacking.
The US plan includes guidelines for employers and individuals and these do strongly reiterate the importance of the behavioral prevention measures recommended by the WHO. In some respects, these sections elaborate instructions with greater detail than that afforded to state preparedness responsibilities for testing, contact tracing, and healthcare system capacity, despite the fact that the WHO guidance prioritises assessment of “epidemiological risks” as the foundation of any phased process to lift restrictions on work, travel and socialising. The US Administration’s “Opening Up America Again” guidelines delegate responsibility for key aspects of the phased process to state and regional authorities. This approach does not in theory contradict WHO guidance, which states that plans for “sustaining low level transmission while society and economic activity resumes” should be flexible enough to respond to fast changing epidemiological situations in different parts of a country, and should consider local contexts.
The guidelines’ most fundamental divergence from the WHO recommendations emanates from the thinly detailed “gating criteria” for starting relaxations, particularly with respect to thresholds for satisfying requirements on transmission control. Notably, there is limited mention of antibody testing or immunity in the US plan, although the overwhelming consensus is that this data will be critical to guiding policies for removing lockdowns and the WHO guidance states that “risk assessments may eventually benefit from serological testing, when reliable assays are available, to inform understanding of population susceptibility to COVID-19”. For now, there remains a significant gap in epidemiological models in the US, because there is no definitive answer as to how many people have actually been infected, especially as there are numerous records of many confirmed COVID-19 positive cases that remained asymptomatic or only had mild cold-like symptoms.
Although most aspects of the WHO’s guidance are mirrored in the US’s guidelines, they are essentially watered down by the absence of clarity, detail and methods for implementation. The majority of the measures recommended by the WHO do not feature in the US guidelines as mandatory criteria for starting to lift restrictions. Instead, responsibility for ensuring most measures are in place is transferred to state authorities, and decisions on when to start the process are ultimately left for state governors. This could undermine the purpose of the guidelines and the ability of the government to prevent an escalation in transmission. Georgia’s governor clearly made his decision to relax lockdowns even without meeting the gating criteria. According to Johns Hopkins data around 1,300 new cases of COVID-19 were confirmed in the state on 22 April, a notable increase from 474 new cases recorded on 21 April. The low level of federal involvement in specifying and verifying conditions for a safe loosening of lockdown measures falls short of the WHO guidance, which emphasises the importance of strong national and sub-national coordination and management.