Navigating the New Normal in the Pandemic in the United States
Revised CDC Recommendations for Fully Vaccinated
On May 16, 2021, the Centers for Disease Control and Prevention (CDC) issued revised recommendations for persons fully vaccinated against COVID-19 that they may forego wearing a face covering and physical distancing in nearly all indoor and outdoor settings. This change was made based on data showing that COVID-19 vaccines are highly effective at protecting fully vaccinated persons from severe infection, hospitalization, and death.
Overall, the vaccines appear to be effective against variants too. Recent data from Public Health England demonstrate that both the Pfizer/BioNTech and AstraZeneca/Oxford vaccines are 96% and 92% effective against the Delta variant among people who have received both doses however, they were much less effective (33–60%), against the Delta variant among people who had only received one dose of vaccine. The Moderna vaccine also has been shown to have neutralizing antibodies against all variants tested (Beta, Kappa, Delta, and Eta). This demonstrates both the importance of becoming fully vaccinated and the potential risk that emerging variants present until vaccination rates across the globe are much higher.
On the heels of the changing CDC stance and rapidly declining case counts in the U.S., many states, including New York, California, and more than 20 others, abandoned all mask mandates and many other COVID-19 requirements. However, the percentage of the population in the US that is fully vaccinated is not even close to reaching herd immunity in most communities and is likely not high enough to protect us from having ongoing outbreaks and possibly even surges in some states in the late fall and winter when activities move indoors, and respiratory virus season is upon us. By December 2021, when the population travels for holiday celebrations, many people who are fully vaccinated will be approaching one year since they were fully vaccinated.
The revised CDC guidelines focus on recommendations for individuals, so different industries have been left to navigate situations where fully vaccinated, partially vaccinated, and unvaccinated persons mix. As of July 6, 2021, only 47.5% of the United States population is fully vaccinated. Even in Vermont, with the highest percentage of fully vaccinated persons at 66.1%, 3 out of 10 people are not fully protected from COVID-19 and may be able to transmit the virus. New York State reached an important milestone on June 15, 2021, with 70.2% of adults 18 and older receiving one dose of a vaccine, but only 50.6% of the total population was fully vaccinated at that time.
What should businesses do to protect their employees and patrons from COVID-19 now that states are relaxing their public health mitigation strategies under pressure to fully open the economy? Essentially, they are left with three options (Table 1);
1. Option 1 — Masks for All — Continue to require all patrons to mask and distance regardless of their vaccination status;
2. Option 2 — Honor System — Allow patrons to mask or distance based on the honor system; or
3. Option 3 — Immunity Certificate — Allow patrons to mask or distance but only based upon a method of ascertaining vaccination such as an immunity certificate or recent testing results.
With Option 1, 100% of patrons who are fully vaccinated (approximately 40–60% in the U.S. in June) will be wearing masks and distancing unnecessarily. Businesses that have tried to implement this have faced criticism. With Option 2, which is what most businesses are doing because it is the least burdensome and problematic to implement, some unknown percentage (y) of patrons who are unvaccinated will fail to wear masks and distance, and some who are fully vaccinated will mask and distance (x) because they remain uncomfortable without the added protection. With Option 3, both groups will use the appropriate protective measure, except for an unknown percentage (z; hopefully small) of unvaccinated individuals who find a way to falsify their immunity certificate.
Of the unknowns in the table above, the percentage of unvaccinated individuals who do not appropriately mask and distance under the honor system (y) is a key variable because it is a group that is at increased risk for transmission of the virus. There are some other examples in public health that may be instructive for estimating this percentage. In a study from HHANES, more than 6% of individuals who self-reported being a non-smoker had serum cotinine levels indicating that they were active smokers. In a study from Cancer Epidemiology, Biomarkers & Prevention, a similar percentage of adults misclassified their cancer screening histories on self-report, 5%, 6% and 7% for mammogram, clinical breast exam and Pap test, respectively, and a much higher percentage misclassified their history for the prostate-specific antigen (29%) and digital rectal exam (25%). Utilization of the honor system varies by individual and may not always reflect true numbers.
Immune Certificates
Immunity digital certificates have been used in Israel, which issues “green passes” to vaccinated persons to allow entry to hotels, gyms, and restaurants. New York State collaborated with IBM to develop the “Excelsior Pass” and encouraged private sector partners to use the digital certificate to gain entry to mass gatherings in sports, arts, and entertainment venues. The New York Yankees initially required the Excelsior Pass or a CDC vaccination card for guests to sit in fully vaccinated seating sections at full capacity without face coverings or physical distancing between seats. However, they dropped the requirement after New York State relaxed all of its COVID-19 requirements. Now, in New York only a small number of businesses have decided to use the Excelsior Pass. Outside of professional sports or large outdoor venues, most industries are opting not to use it. And in some states, the government is prohibiting businesses from using these certificates at all.
Meanwhile, the federal government has decided not to get involved and leave the private sector on its own. But for an immune certificate to be issued and contain valid data, a third-party must establish access to at least 50 different state, territorial, and local immunization information systems to verify vaccination status, exchanges that are challenging to establish, and open up questions of ethics and privacy. This leaves industries to fend for themselves and it is unclear to many what risks remain and what incentives there are to do the right thing.
Are fully vaccinated individuals placed at increased risk when unvaccinated people fail to appropriately mask and distance?
It is unlikely that they are placed at increased risk because the mRNA vaccines are highly effective. In fact, a larger number of studies demonstrate that fully vaccinated persons have a lower nasal viral load rendering them unlikely to transmit the infection even if it is present in their nasal passages. However, the probability of a variant developing that evades our vaccines remains a possibility, the longer the virus has unvaccinated hosts to infect. Therefore, it is imperative that we vaccinate as many people as possible around the world to protect us all.
Will we need a booster dose in the future?
It remains to be seen but companies are already engaged in testing and producing a booster, if necessary. There are two factors that will help determine whether a booster dose is needed. The first is how long our bodies maintain high enough levels of B and T cells from vaccination to continue to protect us if we are exposed to the virus in the future. The second is how stable the virus is over time and whether the virus mutates enough to impact the fit that the vaccines have with the viruses that are currently circulating.
It may also be that those who received a viral-vector based vaccine (Janssen/Johnson & Johnson) may require an mRNA booster dose to help improve immunity against the variants — particularly the Delta variant. Canada’s National Advisory Committee on Immunization has already issued guidance for people to receive a 2nd dose of an mRNA vaccine after 1 dose of AstraZeneca which is also a viral-vector based vaccine.
So where are businesses and individuals left?
Public health agencies are not going to tell us which activities are safe and not safe; the onus is on each of us to make an educated decision. This decision must be based on our own individual medical histories (vaccinated vs. unvaccinated, high risk vs. low risk) and of those around us as well as the levels of community transmission. We must work together as individuals as part of a broader community that wants to keep citizens safe while keeping industries and our economies open and prosperous.
With most countries across the globe struggling to increase vaccination rates for many reasons, the risk that variant strains will emerge remains a valid concern. To date, while variant strains have thus far been more transmissible and slightly more severe, they have not yet substantially evaded protection from our vaccines. Unfortunately, this may not be the case in the coming months. Fully vaccinated individuals will likely continue to have partial protection against even variant strains of high concern and even persons with breakthrough infections may experience milder disease. Unvaccinated or partially vaccinated individuals, though, could remain at high risk for severe outcomes due to COVID-19, especially if they have comorbidities that have been shown to increase risk. Businesses or other entities that either serve clients that are more likely to be at high risk (e.g., long term care facilities, healthcare providers), or that have indoor venues with large crowds of people (e.g., banquet halls and religious organizations), or that have visitors that come from many different countries around the world (e.g., Walt Disney World, Broadway theaters, or other tourist destinations) are at increased risk for ongoing outbreaks and higher transmission of COVID-19 at their venues and may want to consider incentivizing or mandating vaccination for their staff and patrons. These entities also would be the most logical ones to implement immunity digital certificates.
The pandemic brought out the best in some of us. Watching friends help elderly neighbors get vaccinated and buy groceries for one another so that only one community member would be exposed was noble and based on principles of public health. We can continue to approach the post-pandemic world with a public health mindset, thinking beyond the four walls of our own households and behaving in a manner that protects one another as we interact, socialize, and get back to living well.
If you need expert assistance with your how your business should navigate the new normal, you can contact us at: https://www.trivediconsults.com/contact .
