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December 03, 2021

COVID-19 Weekly Newsletter: What Do We Know About the Omicron Variant?

The Omicron variant has prompted considerable concern and uncertainty in the COVID-19 response, as public health leaders continue to advocate for vaccines and booster shots and researchers make progress in the development of new treatment options.

New Variant: Omicron 

A new COVID-19 variant – Omicron, identified first in South Africa, has now been detected in five states: California, Minnesota, Colorado, New York, and Hawaii. Since being first identified, it has been found in over 30 countries. Severity of the disease is not fully understood, as the cases in South Africa have been of young people and those infected in the United States have been vaccinated. Omicron has the potential to cause more havoc than previous variants of concern, including Delta. This worry is based on the large number of genetic changes observed in Omicron, some of which had also been seen in other variants, but many are unique. What those changes mean, however, is largely a matter of speculation right now, because factual data about impacts of Omicron on human health are still missing.  Epidemiological and clinical data are being actively collected. While it may take a few weeks before anyone can know with any certainty what Omicron’s effects really are, and how effective the immunity generated by available vaccines would be, World Health Organization (WHO) Chief Scientist Soumya Swaminathan noted that vaccines will likely protect against severe COVID-19, a sentiment Dr. Fauci shared as well. According to CDC data, about 63% of eligible people, and 71% of adults, are fully vaccinated in the U.S. However, executives of one of the mRNA COVID-19 vaccine manufacturers has voiced some doubts that the vaccine in current form will be as protective and has already started to work on a multi-variant vaccine that would include the Omicron variant. While that investigative work is ongoing, the U.S. Food and Drug Administration (FDA) urges vaccinations and boosters, which not only protect against severe COVID-19 disease, but also limit the circulation of the virus and thereby the emergence of yet newer variants. In addition, as more and more studies confirm, hand-washing, distancing and especially masking, further cut the risk of catching respiratory viruses such as SARS-CoV-2 in all their variant manifestations.

Past Infection May Not Be Fully Protective One Year Out 

A study of the immune responses in survivors of COVID-19 one year past infection found that while some immune components remained active, the level of multifunctional T-cells was low. The authors therefore recommended vaccination even to those who recovered from COVID-19, to protect them from reinfection.  

CDC Recommends Boosters for All 18+ Individuals 

More and more experts are recommending boosters as necessary to maintain adequate protection against SARS-CoV-2. Several studies, as well as real-world evidence, by now indicate that the original vaccine protection might be weakening with time. In the U.S., boosters are administered free of charge, and you can find the closest booster site location here. On Monday, Centers for Disease Control and Prevention (CDC) tweaked their guidance for booster doses, advising that all adults should get boosters as opposed to merely noting that they can get boosted. CDC Director Dr. Rochelle Walensky said in a statement the change is a reaction to the emergence of the Omicron variant. 

200 Million Doses To Be Shipped Worldwide 

In President Biden’s strategy to curb the pandemic, he announced during this Thursday press conference that 200 million doses will be sent abroad in 100 days. To date, the U.S. has donated 280 million doses and shipped to 110 countries. These efforts come as the Biden administration implements new travel requirements for inbound travelers to get a negative test within one day of departure for the U.S., as opposed to the three-day requirement currently in effect, in addition to proof of full vaccination against COVID-19. 

Repeated Tests Are More Accurate Than Any Single Test 

Tests “for COVID-19” abound, and the CDC, FDA and European Commission have each provided breakdowns of diagnostic options and their use cases. Some tests work by detecting bits of the virus’ genetic material in the blood or on mucosal surfaces, whereas others look for the presence of a person’s antibodies to the virus. Some require sophisticated equipment, others are as simple as home pregnancy tests. Results are available after a few days for some tests, and within a few minutes for others. Only a few of the existing tests can reveal the full genetic sequence or identify the specific variant of the virus. Finally, the meaning of the results differ — some tests indicate an ongoing infection, while others point to a past infection.  

One aspect that is true of all tests, however, is that none of them is 100% accurate 100% of the time. False readings (either false positive or false negative) could arise due to a number of various reasons — including incorrect sampling technique and equipment errors, the specifics of a SARS-CoV-2 variant, the specifics of a person’s immune responses, and the time dependence of antibodies in the blood. For improved overall accuracy, therefore, it is recommended that tests be repeated. The recommended frequency of re-testing depends on the situation (including the reason for testing) and the particular testing methods involved. 

For an illustrated description of how the various tests work, see the American Society for Microbiology's COVID-19 Testing FAQs. And for a practical guide on tests and easy-to-understand explanations, check out this guide from Yale Medicine.

Daily Testing Prevents Transmission as Effectively as 10-Day Isolation 

By comparing the transmission of SARS-CoV-2 in schools with known exposure to infected individuals, researchers concluded that daily testing using antigen lateral flow devices was as effective as 10-day isolation in preventing the spread of the virus. 

Lung Autopsies of COVID-19 Patients Reveal Treatment Clues

Along with recent advances and authorizations of new SARS CoV-2 treatments, scientists continue to make progress in research to develop more types of effective treatments. A recent study of lung autopsy and plasma samples from high risk patients who died from COVID-19 provides valuable information about the mechanisms of the disease in the lung, much of which is still not known. The research demonstrates how the virus affects specific lung regions and cell types, shedding light on how the virus can impact, for example, specific types of lung function and natural repair processes. Better understanding of these mechanisms can inform development of more and varied virus treatments. Further, since samples were from high risk patients, such as the elderly, obese or diabetic, the study could provide useful information in developing effective treatments for such patients. 

A Boost for the U.S. Health Care Workforce Size, Diversity

The U.S. administration is planning an injection of grants to fund the expansion of the health care workforce, which was hit hard by the pandemic, especially in the most vulnerable communities.

Remote Monitoring Saves Lives

In a study on the impact of remote monitoring based on text messaging, researchers found that twice-daily check-ins with those who had tested positive for COVID-19 significantly reduced mortality. When the subjects’ responses indicated worsening symptoms, the automated communication was handed over to human physicians who could further assess the situation and promptly recommend appropriate treatment.

Global Quality Guidelines for mAbs

The WHO prepared a draft guideline for quality control in manufacturing of monoclonal antibodies (mAbs). Several of the current treatments recommended for treating COVID-19 are mAbs. Their safety and effectiveness depend on their quality.

COVID-19 Almost Doubles Risk of Stillbirth

In a sobering report the CDC exhorts expectant mothers to get vaccinated and follow other infection-prevention measures because having COVID-19 leads to an increased risk of stillbirth, especially in those with the Delta variant of SARS-CoV-2.

Hand-Sanitizer Manufacturers To Comply With Current Good Manufacturing Practices (cGMPs)

The FDA announced the planned withdrawal of temporary policies that allowed non-pharmaceutical manufacturers to produce alcohol-based hand sanitizers to meet the public demand during the pandemic. Those who wish to continue to manufacturer hand sanitizers after December 31, 2021, will need to meet the requirements of the over-the-counter antiseptics monograph and comply with current Good Manufacturing Practices.

In the meantime, researchers studied the microbe-killing activity of various types of hand sanitizers based on either ethanol or isopropanol, with or without vitamins, moisturizing oils, antiseptics and other components. The authors concluded that each formulation has upsides and downsides, that an “all-purpose” universal hand sanitizer does not exist, and that the best type should be selected based on the specific purpose and particular circumstances for hand sanitizing. 

Proposals Invited for Research into Advanced Manufacturing

FDA is inviting proposals for research into advanced manufacturing methods and other innovations to bolster medical countermeasures and pandemic preparedness. The deadline for submissions is January 21, 2022 

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.

The material contained in this communication is informational, general in nature and does not constitute legal advice. The material contained in this communication should not be relied upon or used without consulting a lawyer to consider your specific circumstances. This communication was published on the date specified and may not include any changes in the topics, laws, rules or regulations covered. Receipt of this communication does not establish an attorney-client relationship. In some jurisdictions, this communication may be considered attorney advertising.

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