As discussed in April’s FSMA Friday on Covid-19: The Next Phase, presented by TAG President Dr. David Acheson MD and Dr. Ben Miller, PhD, MPH, the COVID-19 pandemic is a rapidly evolving situation with recommendations changing daily. Thus, the information in this presentation provides the best knowledge as of the end of April. For continuing updates on TAG recommendations, and a free daily e-newsletter, please visit https://achesongroup.com/covid-19.

The U.S. is currently moving from coronavirus mitigation to suppression, in most cases through a phased approach (though there are exceptions in some jurisdictions). This phased approach is important because many are still in the thick of it, plants are still facing closures, areas are seeing increasing illness, and many challenges remain. It is for that reason that we have to continue with the basics, and determine the effective role of testing in the long term.

As such, next steps should be based on an adaptive response, such that how and when areas move forward are based on adequate testing capacity.

To safely reopen, we need to have a testing infrastructure in place with contact tracing and be able to test a sufficient number of people per day. Testing matters so that we can isolate those that are sick and their close contacts to reduce rate of transmission and start down the other side of the curve. Every person that is infected currently infects about 1.5 people; we need to bring that to below 1. Until then, opening non-essential businesses may be premature. And even once we begin to reopen, we will need to rely on foundational measures, which we expect will be needed for at least the next 6 to 12 months.

Reopening is being phased-in in many local, state, and regional jurisdictions. In the best-case scenarios, it will be data-driven, including US Federal Government recommended “gating” criteria with:

• Reduction in Covid-like symptoms over 14 days
• Reduction in Covid-cases over 14 days
• Enough hospital capacity to treat all patients and test healthcare workers, so the system isn’t overwhelmed if a surge is seen after opening

As we have seen during both COVID-19 and the 1918 influenza outbreak, there is a logical link between public health and the economy. In 1918, cities in the U.S. that had stricter nonpharmaceutical interventions (NPIs) fared better economically after the outbreak. Mortality causes significant economic disruption, as those who die aren’t able to contribute to the economy. Although today’s supply chains are different, the data show that a more conservative approach from a public health aspect initially brings greater economic benefit in the long run.

To understand why testing and screening matter so much with COVID-19, it is important to understand the role of pre-symptomatic transmission. Not only is there pre-symptomatic transmission with COVID-19, there is a long timeframe from which time the patient was exposed to the time they became symptomatic. Additionally, as we continue to learn more about the virus, CDC’s list of the symptoms to check for have expanded.

As such, TAG recommends the following be included in daily (and more frequent) Employee Wellness Screenings:

• Fever
• Cough
• Shortness of breath or difficulty breathing
• Chills
• Repeated shaking with chills
• Muscle pain
• Headache
• Sore throat
• New loss of taste or smell (anosmia)
• O2 levels < 90% (as a pre-symptomatic indicator)

As such, this forms the base of the pyramid which sets the foundational protection against the virus and needs to be continued, to include:

• Employee wellness checks – to keep symptomatic out of the workplace
• Social Distancing – with the facility reworked to increase employee distance and reduce close contacts
• Enhanced cleaning and disinfection as added protection
• Face mask usage, for which CDC has shifted to recommend more usages so the infected are not spreading droplets

And, as offices reopen, similar strategies to those that have been used in the food industry will still apply with the same risk mitigation considered in other aspects of society. These should include:

• The basics (employee wellness screening, social/physical distancing, cleaning and disinfection, mask usage)
• Continued teleworking, as able to reduce risk
• Return to work in phases
• Close off common areas
• Incorporate split shifts in the office settings, no more than 50% of employees at a time
• Minimize non-essential travel

As jurisdictions begin to reopen restaurants, TAG recommends that seating be at least 6 feet apart. Because mask usage is difficult while eating, social distancing is key to limiting transmission. There are questions that remain, particularly whether people will come back or will continue to order for pick-up or delivery. At what point will we be comfortable going back to restaurants, getting haircuts? There will be different metrics for different people, and the levels of confidence will likely vary based on the amount of testing being conducted and the number of cases still being detected in various jurisdictions. Another question is whether we will start to see customer health screening – as has become prevalent in some countries.

Regardless of what new initiatives are begun, though, it will be critical to continue the basics of employee wellness screenings, social/physical distancing, cleaning and disinfection, and mask usage.

Picking up from Dr. Miller, Dr. Acheson spoke on the role and challenges of testing for which the science and knowledge continues to evolve, and a lot of questions remain. Because of that, before conducting testing, the first question should always be: “What will I do with this data?” There are various opinions on the value of testing, as there needs to be a determination of what the results will actually say and what actions would be taken based on that.

Additionally, it is critical to thoroughly understand the test to be administered and ensure it is accurate. Through its Emergency Use Authorization Process (EUA), FDA has “approved” certain tests through an expedited process. But even with those, TAG recommends you review the details of a test you wish to use particularly in relation to its sensitivity (false negatives) and specificity (false positives), as these may not be well evaluated. You don’t want to rely on a test and find out it is not accurate, as that could lead you to hold people out that don’t need to be or, worse, letting in people with the virus.

There are two kinds of tests

• Molecular (RT-PCR) tests which look for the presence of the virus, evidence it is there. These are used to determined active infections, as they detect viral RNA (genetic material). While this could be useful as part of the Employee Wellness Screening, it must be realized that this test tells you only of infection at the time of testing. So if you’re not getting results for two days, there is little value. The value is in getting a rapid response that is accurate, widely available, and cost-effective. And we’re not there yet.
• Serological (antibody) tests provide an indication that a person has had the virus. These determine past infection, as they detect IgM or IgG response. However, we do not yet know what it means to show an antibody response. We don’t know how protective the immunity is or how long it lasts. If it is used too soon, we could be creating an incentive to be immune, e.g., if those who are immune are perceived as having privileges because of immunity. So we have to be very thoughtful before we use as back-to-work tool

Other challenges continue to exist in COVID-19 reduction, one of which is the uneven public health response nationally, although there is a lot of attention being paid to food settings by public health authorities and the media. And, with restaurants being closed, to food manufacturing in particular. Although you should be doing the right thing regardless, and protecting your workers, that attention is something to be aware of.

While CDC Interim Guidance for Essential Workers has allowed those with close-contact exposure to continue to work, this is not “science-based.” The initial guidance was for close contacts to stay home for 14 days, as, if one were going to get sick, it would be within that timeframe. But CDC has now said that if you want to bring these people back, go ahead. We, at TAG, don’t agree as it can create additional risks and does not account for asymptomatic/pre-symptomatic transmission.

But there can be a balance. We recommend the following three steps for close contacts:

1. If that person is not essential, have them stay at home. If they are essential, bring them back with the following criteria:
2. Determine the level of contact, for example if they are in a household with someone with the virus, bringing them back would pose a high risk. If they were within six feet of a person with the virus, the risk is lower and you may want to allow them back.
3. In all cases, make sure you are following CDC guidance for temperature, 6-foot distancing, masks, etc. If you don’t, you will have issues.

Remember as well that exposure extends beyond the workplace. Employees can be infected outside of work, so you should ask and consider questions such as: Who lives with whom? Who carpools or rides to work together? Do employees know to practice social distancing outside of work? And workers are scared and worried. There is a lot of anxiety, and you have a responsibility to manage that too.

Much of this anxiety comes from mixed messages, the misinformation, and fake news. You need to continually communicate with and educate your workforce, have a plan to keep them informed. Always consider the validity of your information sources, avoid sharing doubtful or misinformation, and be mindful of pictures taken out of context. To do this, you need to have access to reliable and credible information – a good source of with is the TAG COVID-19 webpage and daily e-newsletter. We’re not just managing disease we’re managing people’s mental well-being.

What is the long-term expectation for COVID-19? We have turned a corner with states beginning to reopen, but regions may also move in and out of stay-at-home orders if they reopen too quickly. Serological testing – providing information on the percent of the population that has been infected – could be helpful to get a broad view, but we need a better understanding of immunity and whether, and how long, it is protective. Measles provides lifelong immunity while pneumonia is only yearly because immunity doesn’t last and the virus changes. We don’t know where COVID-19 may lie along these plains.

The next phase of COVID-19 will be taking us into the “new normal.” What that looks like we can only guess at this point, but we will be discussing it on future FSMA Fridays – what it is and how to adjust.

A recording of the full webinar is available online.