January 28, 2022

COVID-19 Weekly Newsletter: “Mix-and-Match” Vaccinations Safe, Effective

This week, early findings of an NIH-backed study were released — showing that a combination of doses from any authorized vaccines is safe and effective. Meanwhile, the Department of Labor shifts focus to a traditional rulemaking process to pursue a vaccine or test requirement policy for employers.

Findings of Mix and Match Study

Early results of a study published on Wednesday by the New England Journal of Medicine supports the decision the advisory committees of FDA and CDC advisory made in the fall allowing individuals to get a COVID-19 booster dose of any of the authorized vaccines, irrespective of which dose was originally administered. This NIH-backed study showed that doing combinations, or “mix-and-match” doses, was safe and effective.

OSHA Emergency Temporary Standard Withdrawn

This week the Department of Labor withdrew its emergency temporary standard that instated a vaccine or test requirement policy for businesses with 100 or more employees. This action comes after the Supreme Court blocked enforcement of the ETS on January 14. However, the department is still pursuing a vaccine policy through the traditional rulemaking notice-and-comment process rather than the expedited emergency process.

FDA Limits Use of Two Antibody Treatments Due to Omicron

Based upon recent studies demonstrating only one of the three authorized monoclonal antibody treatments are effective against the Omicron variant, which is estimated to account for 99% of all COVID-19 cases in the U.S., the FDA has limited the use of the remaining two treatments only when treating a variant susceptible to that treatment. This leaves only one monoclonal antibody treatment available to treat Omicron COVID-19 infections. This guidance is aligned with the recent recommendation by the NIH COVID-19 Treatment Guidelines Panel.

Passive Air Sampler Developed to Assess Personal Exposure to SARS-CoV-2

As SARS CoV-2 is spread via airborne aerosol droplets, much research has focused on improving air sampling, virus detection and filtration. A recent publication describes a wearable air sampler that can provide information on personal exposure to SARS CoV-2. The sampler consists of a polydimethylsiloxane material that can absorb the virus on its surface. The small devices, which were clipped to shirt collars, were worn for five days by people in a variety of occupations and situations, including health care and restaurant work. The study found significant viral loads in some of the samples from restaurant workers and no viral samples from those worn by healthcare workers, consistent with other studies of hospital settings and likely due to the consistent use of personal protective equipment and good ventilation. Viral loads detected were also significantly lower than the estimated inhalation dose for SARS CoV2, suggesting the ability to detect sub-infectious virus levels. The work suggests potential use of these personal, wearable passive samplers as a way to gauge risk of SARS CoV2 exposure in specific locations and situations, along with potential early detection of cases.

Is Omicron Infection Inevitable?

Despite the Omicron variant’s high virulence, experts and infectious disease doctors note that there are proven ways to protect yourself from getting infected with the virus, key among these is to get vaccinated and to wear a mask — preferably KN95, which are similar to the standard of N95s used by health care workers. Recent studies show that Omicron multiplies about 70 times faster in the upper airways but replicates much more slowly in the lungs than the Delta variant, which some think may explain its rapid spread but lower disease severity. Although breakthrough infections have occurred with the Omicron variant, doctors are stressing the importance of vaccinations not only to protect against disease but also to protect again severe symptoms and hospitalization, a proven result of vaccinations demonstrated in several large studies. Vaccination is also much more effective in building longer immunity than trying to build immunity by getting infected with the variant, with the additional possibilities of suffering from severe disease or long Covid.

Vaccines Provide Sustained Protection

A large study from the U.K. found that vaccinations protect against symptomatic COVID-19 for up to 10 weeks post-second dose, after which their effectiveness against symptomatic disease decreased. Nevertheless, vaccinations remained highly protective against hospitalization and death for up to 20 weeks post-second dose.

Many COVID-19 ICU Survivors Struggle with Health Issues a Year Later

A study using data from 11 hospitals in the Netherlands explored the current condition of patients a year after they were admitted to an intensive care unit (ICU) for COVID-19. Three out of four patients continued to experience physical symptoms, one in four had mental symptoms, and one in six faced ongoing cognitive symptoms. More than half of the patients reported difficulty returning to work. The mean age of patients in the study was 61 years and 71% were male.

Fine-Tuning Recommendations for Testing

A Viewpoint article in JAMA recommends that in health care settings boosters should be mandated, frequency of testing increased, and N95 masks used universally in order to limit transmission of highly contagious SARS-CoV-2 variants. For situations outside of health care, however, more and more experts are calling for a more judicious approach to testing so that asymptomatic fully vaccinated individuals, who are associated with a lower risk of transmission or serious disease, are released from any mandatory testing requirements. Discontinuing the testing of fully vaccinated asymptomatic individuals could save valuable lab resources and testing kits.

Proactive Machine Learning Needed for Timely Extraction of Actionable Data

In a JAMA Viewpoint article by medical and bioinformatics experts, the authors remind us that the flood of data generated during the pandemic needs sophisticated algorithms to analyze the information in order to discern patterns through a process called machine learning (ML). They further explain that due to the dynamic and diverse nature of the data collected in relation to COVID-19, the ML methods need to be upgraded from the traditional static to proactive models. A proactive model reduces the need for human input through automation of some steps. As a result, data is transformed into usable knowledge much more quickly.

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.

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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