COVID-19 Weekly Newsletter: Positive Signs on Path to Normalcy, Teenagers Approved for Vaccines

The Centers for Disease Control and Prevention (CDC) made waves this week with its announcement that fully vaccinated individuals can begin congregating indoors. Coupled with the announcement that teenagers are eligible for the COVID-19 vaccine, it has been an encouraging week in the path back to normalcy, though concerns about variants and the need for more sophisticated and responsive testing remain top of mind for researchers and public health authorities.

Getting Back to Normal for Fully Vaccinated Individuals

On Thursday, May 13, CDC Director Dr. Rachelle Walensky announced that fully vaccinated individuals can congregate in groups indoors or outdoors without wearing a mask and begin to resume activities that individuals did prior to the pandemic — except where required by federal, state, local, tribal, or territorial laws, rules or regulations, including local business and workplace guidance. This is an expansion of previous guidance released at the end of last month that stated fully vaccinated Americans can safely meet outdoors with other fully vaccinated individuals without wearing a mask. Shortly after, President Biden echoed Walensky’s sentiments in his Thursday speech from the White House. Many recognize it will take time for people to feel comfortable returning to a pre-pandemic, no-mask world, but it is an encouraging sign on the path back to normalcy.

CDC Recommends Vaccine for 12- to 15-Year-Olds

With parents eager to send their children back to school in the fall, allowing 12- to 15-year-olds to get the vaccine could not have come at a better time. This week, providing COVID-19 vaccines to teenagers was endorsed by the CDC Advisory Committee on Immunization Practices (ACIP), and the Food and Drug Administration’s (FDA) issued an emergency use authorization (EUA) for the practice, as well. In other good news for children, guidance instructing doctors to wait two weeks after their patients got the COVID-19 vaccine before administering any other vaccines has changed. Patients may now get multiple vaccines during one doctor visit, which will help getting children who fell behind on regular vaccinations this past year back on track. Safety studies for children younger than 12 are still underway, and it is predicted vaccination of younger children will be approved before the end of the year, hopefully in the early fall.

Businesses Are Ready to Reopen — How Will Employees and Customers Get There?

Although the proportion of vaccinated individuals is growing, it may never reach 100%, and no vaccine so far has claimed to be 100% protective. On the other hand, the CDC and other authorities have now admitted that SARS-CoV-2 is spread through exhalation-inhalation at a distance — and not limited to close-contact or surface-based transmissions. In light of this enhanced understanding, the studies of distribution of airborne infections take on an added significance and relevance, especially as businesses are considering timelines and safe ways of reopening in the coming months.

For example, the London Underground was previously linked to the airborne spread of respiratory illness resembling influenza. Mathematical modeling — see abstract and full text — of airborne infection spreading in Japan’s commuter trains concluded that “surgical masks are somewhat effective,” but the biggest impact on stopping the spread of contagion comes from doubling the air-exchange rate to over 26 ventilation cycles per hour. For reference, the New York City subway cars replace air only 18 times per hour and the Boston trains and buses have between 10 and 28 air exchanges per hour. A U.S.-based modeling study found that airborne contaminants can spread quickly through a complex subway system, mainly through the action of air rushing in and out of train cars when the train doors open at the stations. A 2020 literature review of subway’s role in spreading airborne infections concluded that risks are real, and more focused research is needed to quantify all the effects and scenarios. The authors advise that ventilation systems in subways should introduce clean fresh air, and also that these systems should be controlled zonally and adjusted in real time. Until such systems are in place, public transportation systems are predicted to be major sources of the continued spread of COVID-19 in large cities. Personal vehicles could be an alternative to mass public transport in some situations, but personal cars vary in their air-recirculation system design. If one of the car travelers is a virus carrier, the risk of airborne infection could be as high as 99.9% for a 90-minute trip with closed windows.

As More Adults Get Immunized, Children’s Proportion of New COVID-19 Cases in the U.S. Is Growing

The American Academy of Pediatrics reports that the proportion of children with COVID-19 is increasing, representing 24% of the new weekly cases as of May 6, 2021. AAP holds free online townhall meetings to answer parents’ and pediatricians’ questions about the disease and its prevention.

Testing Goals Shift to Detecting Current Infectivity Rather Than Past Infection With SARS-CoV-2

A wide roll-out of conveniently administered testing for SARS-CoV-2 with rapidly available results has long been recommended as a critical component of safe re-opening of schools and businesses. Besides logistical and financial challenges, however, there is a scientific and technical challenge: What exactly various types of tests can tell you. For example, antibody testing (also known as serological assays) can tell you if you had a SARS-CoV-2 infection two weeks ago — but not if you are having one right now. In fact, to determine if someone is shedding infectious virus currently, a combination of at least two (each rather complex) tests is needed, such as:

• a combination of antibody testing and real-time quantitative viral-genome testing (also known as RT-PCR or PCR)
• “early and frequent” repeated antigen testing
• a combination of lateral-flow antigen testing (LFT) and PCR

The complexity, cost and limited usefulness of today’s commercial tests might be contributing to their underutilization, which in turn leads to the continued community spread of COVID-19. A recent review of available technologies presented a hopeful picture of what might be possible — if and when promising ideas such as nanomaterials-based virus detection — become commercial products. Simple-to-administer, cost-effective, readily available, highly sensitive and specific tests are needed not only to stop transmissions but also to diagnose suspected cases early, which is critical to improving patients outcomes, since most current effective interventions (such as monoclonal cocktails) work best when administered early. Once “the golden hours” opportunity has passed, treatment becomes more expensive and less effective. A good test could prevent much human suffering.

Whole Viral Genome Sequencing Needed to Get Ahead of SARS-CoV-2 Variants

In addition to the test or tests diagnosing a current infection, as discussed above, even more demanding tests are needed to track — and hopefully stop — the emergence of new SARS-CoV-2 variants. Whole genome sequencing (WGS) of the virus can distinguish between variants, but these tests are resource-intensive and mainly conducted in advanced academic centers or through collaborations of large institutions. More accessible and wider-spread WGS tests are needed because new variants represent new threats. Without knowing the intimate build-up of the infecting virus, it would be difficult to upgrade or develop new countermeasures. Against some studied variants, existing vaccines are less effective compared to the original type, and breakthrough infections with new variants are observed in vaccinated individuals. Furthermore, without broad-based genomic surveillance, new variants get a chance to emerge and spread unchecked. In worst case-scenarios, this can cause devastating new waves of COVID-19, especially if preventative public health measures and restrictions are relaxed or ignored.

More COVID-19 Insights

COVID-19 Response — 2020 Hindsight and 2021 Vision Podcast

• Episode 01: Introduction
• Episode 02: Labor and Employment
• Episode 03: Litigation
• Episode 04: Advocacy
• Episode 05: Health Care

Additional Resources

Global COVID-19-Related Patent Office Status and Deadline Extension Updates
Information regarding the status of each foreign patent office and the availability of extensions of time in each jurisdiction.

Government Actions: COVID-19
Tracking executive orders, legislation, and other government actions related to COVID-19 by state and major locality across the U.S.

Tracking Fraud Related to the COVID-19 Pandemic
Tracking federal and state law enforcement and regulatory actions taken against bad actors who have exploited the COVID-19 emergency to defraud consumers and payers.

Faegre Drinker’s Coronavirus Resource Center is available to help you understand and assess the legal, regulatory and commercial implications of COVID-19.