Yes, Omicron is Here but No Need for Panic

Key Points:

• In today’s Recommendations for Industry, we discuss the Omicron variant. Read more below.
• On Sunday Jan 09, the CDC updated its “Quarantine and Isolation” webpage to allow readers to better understand what to do. The updates have extra charts for readers to better understand when to test and when traveling can be allowed.
• Omicron is sweeping the nation and across the globe. On one hand, the WHO is warning that over half of all Europeans may become infected with the Omicron variant in the next 6 – 8 weeks; there’s a push to strengthen mask rules (Euronews). In the U.S., there is an increasing number of young children (<4 years old, who aren’t able to be vaccinated) being hospitalized and testing positive for COVID-19. However, officials say there is “no sign of an increase in severe cases” (NYT1).  Similarly, the COVID-19 variant is also spreading across hospitals and “a quarter of hospitals are reporting critical staffing shortages due to workers being sick or off work for quarantine” (CIDRAP). However, it also seems that “Omicron activity has already peaked in some Mid-Atlantic states, with Omicron now setting its sights on the Midwest, where the pace is picking up.” Additionally, with the rise of cases, the CDC has recommended that “[s]ome people with a weakened immune system can get a fourth dose of the coronavirus vaccine as early as this coming week” (NYT2).
• Two studies in South Africa have found that the Omicron variant “has a much higher rate of ‘asymptomatic carriage’ than earlier variants, which could explain why it has spread so rapidly across the globe” (Reuters).
• The U.S. has issued a “Do Not Travel” warning for Canada admist the rise of COVID-19 cases. The CDC elevated its travel recommendation for Canada to “Level 4: Very High” (NBC). 
• From the FDA:
  • On Dec. 21, the FDA published the webpage: Wastewater Surveillance for SARS-CoV-2 Variants describing how the FDA has developed the capacity to sequence SARS-CoV-2 RNA from wastewater samples, which is useful for detecting and monitoring SARS-CoV-2 at the population scale. Monitoring for both known and unknown variants of the virus can provide information about the evolution of the virus, which is critical to evaluating the effectiveness of FDA-regulated COVID-19 vaccines, therapeutics and diagnostics.
  • On Dec. 29, the FDA implemented temporary changes to its inspectional activities to ensure the safety of its employees and those of the firms it regulates as the agency further adapts to the evolving COVID-19 pandemic and the spread of the Omicron variant. Through Jan.19, the agency intends to continue mission-critical work but has temporarily postponed certain inspectional activities with the hopes of restarting these activities as soon as possible
  • The FDA has authorized 24 antigen tests and nine molecular tests for serial screening programs. The FDA has also authorized 747 revisions to EUA authorizations.

Influenza

• China is reporting another H5N6 avian flu case, along with another H9N2 infection in a child.
• A retrospective study shows worse outcomes from patients hospitalized with COVID-19 than the flu.
• A handful of co-infections of flu and COVID-19 are reported in Israel, the US and Brazil.
• In the U.S., the flu positivity rate is 3.8%. Seasonal influenza activity in the United States is increasing, including indicators that track hospitalizations. Influenza activity is increasing, with the eastern and central parts of the country seeing the majority of viruses reported and the western part of the country reporting lower levels of influenza virus circulation. The majority of influenza viruses detected are A(H3N2). Earlier in the season, most influenza A(H3N2) infections occurred among children and young adults ages 5-24 years; however, in recent weeks, the proportion of infections occurring among other age groups, especially adults age 25 years and older, has been increasing. The amount of activity varies by region. 10 jurisdictions experience moderate and 31 experience high or very high activity.
• Globally: The majority of influenza viruses detected are A(H3N2).

Public Health & Food Safety News

• Giant rats are being used in Tanzania to rapidly screen sputum samples for TB. Once trained, they can screen 100 samples in 20 minutes at a cost of as little as $0.20 per sample – this is much faster than the traditional microscopic analyses by technicians.
• MRSA starins may have originated in hedgehogs, long before antibiotics. From CIDRAP, “A new study led by researchers in Denmark and the United Kingdom has identified hedgehogs as a reservoir of a well-known antibiotic-resistant pathogen. The study, published last week in Nature, suggests that a strain of methicillin-resistant Staphylococcus aureus (MRSA) that has become one of the predominant livestock-associated MRSA lineages in Europe likely originated in hedgehogs. Furthermore, the particular strain of MRSA appears to predate, by more than 100 years, the advent of the antibiotic era. The authors of the study say the findings are inconsistent with the view that widespread antibiotic resistance in bacterial pathogens is solely driven by antibiotic use in human and veterinary medicine, and highlights the importance of a One Health perspective on antimicrobial resistance.”
• FDA will be holding public meetings to discuss proposed changes to agricultural water requirements in the Produce Safety Rule. The first virtual meeting will be February 14^th, while the second virtual meeting will be February 25^th. Register for the first meeting here.
• According to Food Safety News, “Fruit juices, cantaloupe, papayas [are now] listed in FDA’s import enforcement report update.”
• Canada’s Food Inspection Agency has conducted a study on Undeclared Allergens in Bakery Products between 2019 to 2021. “A targeted survey tested 182 bakery products for the presence of undeclared allergens. 91.2% (166) of samples did not contain any undeclared allergens. 8.8% (16) of samples were positive for undeclared allergens such as milk protein (beta-lactoglobulin and casein), egg, peanut and sesame. Positive results were forwarded to the CFIA’s Office of Food Safety and Recall to determine if the levels found would pose a health concern to allergic individuals. There were 5 product recalls in this survey.”
• Former Blue Bell’s president’s trial is delayed until Summer 2022.

Recommendations for Industry

Yes, Omicron Is Here but No Need for Panic

While the Omicron variant of COVID-19 is continuing to spread, the trends are showing that there is not a need for panic or for anyone to be overly fearful. Not only is Omicron proving to have low severity, particularly for those without other health conditions, its fast spread is also showing that it has a fast decline.

The US has traditionally followed the trends of the UK, which has shown high rates of case counts for about four weeks, followed by a flattening. Additionally, even while case counts are high, hospitalization and death rates are relatively low.

In the US, some of the east coast states seem to be peaking – rates are not yet coming down, but are following the same pattern as the UK. This trend is tracking east to west across the US, with the Midwest starting to see increases, and the west coast beginning to see a start of cases.

But it is important to understand that we are not seeing the severity of previous variants. The severe outcomes that do exist are generally related to a co-morbidity issue, especially if the person is unvaccinated. Vast majority of people are at very low risk of severe infection. With all this, TAG does not see the Omicron case counts as a reason to keep students out of school, expand work from home, etc. for most people.

In case you missed it

• In Thursday’s Recommendations for Industry, we discussed the updated CDC isolation guidelines (coupled with antigen testing) while reflecting on how long this new COVID wave might last. Read more here.
• COVID-19 cases in the U.S. are at the highest level recorded through the pandemic. This can be reflected and seen in this week’s risk matrix with some states’ case rates exceeding 200 or 300 cases per 100,000 persons.
• European countries are now reporting post-holiday COVID-19 surges due to the Omicron variant. In many countries, hospitalizations are rising; however, the rise in hospitalizations is not as high as the rate of COVID-19 infections.
• A large multistate cohort study of over 40,000 pregnant women continues to support COVID-19 vaccination safety in pregnant women; there are “no links between use of mRNA vaccine or immunization during the first trimester to the two birth outcomes.” [preterm birth or small-for-gestational- age births].
• Additionally, as the influenza season is underway, an additional study in Denmark has found no interaction between the flu vaccine and “COVID-19 hospitalization or influence [on] the development of SARS-CoV-2 antibodies.”