June 11, 2021

COVID-19 Weekly Newsletter: Preparing for Post-Pandemic Life

With employers, schools and other organizations considering or carrying out reopening procedures, the focus for health and safety authorities turns to maintaining a low-risk environment for the public. While OSHA addresses new guidelines for the health care sector and researchers explore ways to increase public participation in vaccination programs, the scientific community is keeping a close eye on the highly contagious Delta Variant and new approaches to vaccine design.

Cases of Myocarditis Associated with Vaccines

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will gather on June 18 to better understand why 475 individuals under the age of 30 developed myocarditis, a heart inflammation condition, after getting the mRNA vaccine. Fortunately, most patients have fully recovered with rest and treatment. These findings are consistent with research conducted in Israel, where the incidence of developing myocarditis was one in 20,000 for men between the ages of 18 and 30.

Vaccine Shelf Life Extended

With more than 50% of the American population fully vaccinated and daily vaccination rates down by two-thirds since its peak in April, many vaccination sites worry they may have to throw out vials with expiration dates at the end of the month. Luckily, after reviewing study data, the Food and Drug Administration (FDA) has allowed the one-time dose vaccine to be refrigerated for four and a half months, a 50% jump in its shelf life.

OSHA Issues New COVID-19 Rule for Health Care Sector

On June 10, the Occupational Safety and Health Administration (OSHA) of the Department of Labor announced new COVID-19 safety rules/emergency temporary standard (ETS) for health care settings. The document, more than 900 pages long, requires health care employers to continue social distancing practices, screening of patients for symptoms, and provide paid leave for employees to get vaccinated and recover. Fully vaccinated workers do not have to adhere to social distancing and masking protocol as long as they are in an identified area where all other employees are fully vaccinated as well.

Efficacy Against Delta Variant Demonstrated by Vaccines

The highly contagious Delta Variant (B.1.617.2), first identified in India, has spread to at least 62 countries — with hot spots forming in Africa and Asia. Delta is now associated with 6% of new cases in the U.S. and caused an increase in cases in the U.K. Studies have shown some of current two-dose vaccines provided protection against this strain in fully vaccinated individuals, with efficacy ranging between 60% and 88% depending on which vaccine was administered. Health officials warned that efficacy decreased to 33% for those individuals who had not received their second doses, stressing the importance of completing the full vaccination regimen. With vaccination rates slowing down in the U.S. and more contagious variants such as Delta being discovered, efforts have increased to convince and encourage eligible individuals to get vaccinated.

Public Health Authorities Need Authority to Protect Public Health

A recently published report prepared by the National Association of County and City Health Officials and the Network for Public Health Law highlights local and regional laws that would undermine health authorities’ efforts to protect public health.

Real-World Evidence That Unrestricted Contact Promotes Emergence of New Viral Strains

Based on general biological principles, scientists had been warning that failure to restrict viral circulation in the population would lead to the emergence of new viral strains. Now hard evidence has been published demonstrating the price of relaxed social-contact rules in unvaccinated populations — a surge in COVID-19 cases and wide spread of new SARS-CoV-2 strains.

Call for Germ-Free Indoor Air Standards

An emergency doctor from a medical center in Baltimore, Maryland published a plea for OSHA to establish a public standard for airborne pathogens, which in turn would enable creation of meaningful requirements for safe indoor air. Controlling airborne pathogens is especially important in medical facilities, where the risk of harmful exposure through inhalation is particularly high.

Long-COVID Symptoms Linger for Months

A meta-analysis of thousands of studies looking into effects of “long COVID” found that most patients had one or more persistent symptoms for months. Shortness of breath, loss of smell or taste, cough and fatigue were among the common symptoms.

New Science Adviser in the White House is a Geneticist

Eric Lander has had a distinguished carrier in genomics and related sciences. As a newly confirmed director of the White House Office of Science and Technology Policy (OSTP), he is in a position to ensure that the lessons of the pandemic are not wasted.

Opt-Out Testing Framework Helps Minimize COVID-19 Transmissions

Stories continue to appear reminding us of the importance of keeping schools safe. In addition to general hygiene measures, students and other populations with low vaccination rates could benefit from routine daily testing. This practice can help prevent transmission of COVID-19 by asymptomatic or pre-symptomatic individuals by identifying and isolating virus-carriers early. Success of the testing program depends on high coverage (i.e., proportion of the population undergoing regular testing). A randomized controlled study showed that to increase coverage, an opt-out program (where testing is a default) is more efficient than an opt-in (where not testing is the default). Numerous tests for SARS-CoV-2 are now available, and the FDA holds regular town halls to review development and validation of new tests and the performance of tests against new virus variants.

Persuading to Vaccinate Requires Facts for Some, Emotion for Others

When designing advertising campaigns to target those who have avoided vaccination so far, recognizing the diversity of psychological and life circumstances will help create more effective messaging — according to researchers with expertise in clinical, business, and consumer management. Employing an influential theory of attitude change, these authors explain that for individuals with high involvement in decision-making, presenting facts and data is most effective — while for individuals with low emotional engagement in decision-making regarding vaccinations, presenting short, memorable messages is most powerful.

Preventing Global Pandemics Depends on Global Tracking of Infectious Agents

The Science Academies of the G7 countries have developed recommendations for establishing a fair and effective data-sharing system to detect and prevent future pandemics. These recommendations will be discussed at the G7 summit scheduled to take place this month in the UK . The UK has also been working with WHO to create a “pandemic radar.”

Researchers Design Next-Generation Vaccines

Before 2020, mRNA-based and nanoparticle-based vaccines had been more of an “interesting research topic” than the go-to defenders they have become during the pandemic. Thanks to the proven success of these technologies, similarly novel approaches to vaccine design are now being studied for a variety of promising applications. For example, researchers are demonstrating how to build mRNA-based vaccines that would be effective against several different types of coronaviruses. Others are exploring self-assembling nanoparticles presenting one or more types of receptor-binding proteins, or adding adjuvants to a spike-based vaccine in order to create a potent and long-lasting immune response against SARS-CoV-2. Protein-presenting nanoparticles are also proposed as multivalent influenza vaccine candidates

mRNA Vaccines Significantly Reduce Infections

When the current mRNA vaccines received their Emergency Use Authorizations, indicators of their efficacy were reductions in deaths, hospitalizations, or severe disease. The newly published CDC study reveals that in addition to protection against severe disease, these vaccines are effective at reducing infection with SARS-CoV-2, and therefore also reduce risk of asymptomatic transmission by fully vaccinated individuals. Furthermore, the study showed that COVID-19 cases that did occur despite full vaccination were relatively mild. These results should help ease the “return to normal” anxiety in those who might be feeling apprehensive. Common cleanliness and hygiene measures, as well as rigorous research, should nevertheless continue as SARS-CoV-2 is not the only virus threatening human health.

Reopening Schools Safely This Fall

A new modelling study suggests that with moderate infection-control measures, elementary through high schools could be reopened safely this fall. In this model, some clusters of COVID-19 cases could be expected, albeit rarely, and knowing this in advance should help avoid a universal lockdown in response to each and every such cluster.

Rapid Publishing Requires Rapid Error Correction

A thoughtful analysis published in STAT discusses effects of the pandemic-spurred rapid publishing of scientific information related to COVID-19. The authors conclude that while rapidly sharing insights during a public health crisis is laudable, responsible publishers should establish mechanisms for rapidly correcting errors in publications that may affect public health policies and clinical practice.

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.

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