Omicron in the US: Likely in the Calm before a Surge

• In today’s Recommendations for Industry, we discuss the rise of Omicron. Read more here.
• COVID deaths in the US surpass 800,000 (NYT). It is the highest known number of any country. Known virus cases in the US rose above 50 million and more than 1,200 people are dying from COVID-19 each day. The worldwide death toll has topped 5 million (JH). The last 100,000 deaths in the US occurred in less than 11 weeks as the pace picked up, moving faster than at any time other than last winter’s surge. The current uptick is being driven by the Delta variant.
• Canada reimposes advisory against all non-essential international travel (immigration.ca). Canada has reimposed its advisory against all non-essential international travel as it looks to stop the spread of Omicron. The new advisory was announced on Wednesday by Health Minister Jean-Yves Duclos, saying “To those who were planning to travel I say very clearly: now is not the time to travel.” He added that those who do travel abroad risk being stranded, due to the rapidly evolving situation with Omicron and the likelihood that Canada and other countries could impose new restrictions.
• New laboratory studies indicate that vaccines, especially boosters, may protect against the worst outcomes of Omicron, but will still cause breakthrough infections. (NYT). At a World Health Organization meeting, scientists reported on research suggesting that T cells in vaccinated people can put up a tough defense against the variant, which could help prevent severe disease, hospitalization, and death. On Wednesday, Dr. Anthony Fauci said preliminary data from his institute’s analysis of the Moderna vaccine showed that two shots produced a negligible antibody response in the laboratory, but protection shot up after a third dose. He added that “at this point, there is no need for a very specific booster” to fight Omicron. Others presented similar results, showing that mRNA boosters raised antibodies to levels believed high enough to offer strong protection against infection. “Breakthrough” COVID-19 Hospitalizations Among Fully Vaccinated Patients (KFF) occur most often among older adults, involve people with chronic health conditions, involve shorter hospital stays and appear more likely to be hospitalized primarily for non-COVID ailments, as found in a new analysis of hospital data from June through September by KFF and Epic Research.
• Tests Expected to Fail to Detect the SARS-CoV-2 Omicron Variant (FDA). Due to the inability of these tests to detect the SARS-CoV-2 Omicron variant, the FDA recommends that these tests should not be used until these issues are resolved.
  • Meridian Bioscience, Inc. Revogene SARS-CoV-2
  • Tide Laboratories DTPM COVID-19 RT-PCR Test
  • Applied DNA Science Linea COVID-19 Assay Kit
• Ontario researchers have created chemical compounds that can neutralize SARS-CoV-2 and several of its variants. (CTV News/Canada). Detailing their findings in a paper published in the Journal of Medicinal Chemistry, researchers at the University of Toronto created “D-peptides” that can neutralize the virus and stop infection of cultured human cells. D-peptides, also known as “mirror-image peptides” are chemical compounds that have properties that allow them to be developed into low-cost antiviral therapeutics.

Food Safety & Public Health:

• VQIP Application Portal to Open for FY 2023. On January 1, 2022, the U.S. Food and Drug Administration (FDA) will open the Voluntary Qualified Importer Program(VQIP) application portal for fiscal year (FY) 2023. The portal will close May 31, 2022.

Omicron in the US: Likely in the Calm before a Surge

Throughout the pandemic, the US has tended to follow the trends of the UK in case and transmission rates. Currently, the UK is leading the world in confirmed Omicron cases, with UK Health Security Agency data showing that cases are doubling every 2-3 days, and the variant being 3.2-fold more likely to be transmitted to household contacts than Delta, with close contacts having a 2.1-fold increased risk of becoming infected.

The case rate statistics are being proven with the numbers being seen in the country, as the 4,713 Omicron cases of December 13 has increased to more than 10,000 cases as of December 16. And, with only a sampling of positive tests checked to see which variant is involved, the true total for Omicron is likely much higher. On the positive side, there were only 10 recorded hospitalizations and one death recorded as of December 13 and that has not increased, even with the increase in cases.

From all this, the US should expect that COVID cases will be increasing due to Omicron, and in the coming weeks potentially surpassing the daily high of nearly 300,000 cases which the US hit last December. All data is showing that transmissibility is significantly higher, though that from the UK and South Africa seems to show an encouragingly lower severity rate.

While it also is imperative that businesses continue to maintain all protections, we don’t see lockdowns, travel restrictions, etc., as being particularly effective, especially with European data showing that most Omicron cases are being seen in non-travelers with only 13% of Omicron being found in travelers. So be prepared. COVID-19 is not passing quietly (or at all) into the night; rather we’re likely just in a calm before a next surge.

Risk Matrix:

TAG’s weekly matrix is currently showing a bit of stability across the US, in that case rates are not getting worse … but they’re also not getting better. Delta remains the dominant variant at this point and is continuing to work its way across states in which it had not previously had a significant impact. But as noted in Recommendations, Omicron is beginning, and all signs show that its crest will be high.

Table 1.

Figure 1.

Table 2.

Table 3.

• In Tuesday’s Recommendations for Industry, we discussed COVID protection strategies in food manufacturing. Read more here.
• The C.D.C. found 43 Omicron cases in the first week of December. Almost all cases were mild (NYT). One individual, who was vaccinated, required a brief hospital stay, but there were no deaths. The most common symptoms were cough, fatigue and congestion or runny nose, but the report warned that “as with all variants, a lag exists between infection and more severe outcomes.”
• Pfizer said trials of its COVID pill Paxlovid confirmed that it helped stave off severe disease. If given within three days of the onset of symptoms, it reduced the risk of hospitalization and death by 89 percent. Pfizer has applied to the FDA for authorization.
• Across the U.S.
  • New York State will require masks in indoor public spaces that do not ask for proof of vaccination (NYT), due to the state’s spike in cases and hospitalizations. Businesses could face civil and criminal penalties, and fines of up to $1,000, for failing to comply; local health departments are tasked with checking on them.
  • Philadelphia to require COVID-19 vaccination for indoor dining establishments. Proof of a COVID-19 vaccine will be required to eat inside a food establishment beginning January 3.
  • Companies of all sizes are rethinking return-to-office plans due to Omicron, with Google and Ford delaying plans and other businesses whose employees have returned are considering adding extra precautions, like masks.
  • As U.S. nears 800,000 virus deaths, 1 of every 100 older Americans has died. Those 65 and older are among the most vaccinated groups but make up about 3/4 of the nation’s coronavirus death toll.
• Global news
  • In Europe: Germany is mandating vaccination for health workers, effective mid-March and has announced a lockdown on those who are unvaccinated. France is expected to be hit by a sixth COVID wave in January, fueled by Omicron – even while still in the midst of the current, Delta-fueled, fifth wave. Officials in the United Kingdom, Denmark, Norway and Sweden have asked people to work from home if they can.
  • Chinese workers are urged not to travel home for Lunar New Year as nearly 80 percent of the country’s latest locally infected COVID-19 cases are found in the manufacturing powerhouse province of Zhejiang.
  • Experts warning that Papua New Guinea is a potential breeding ground for new COVID variants, as less than 5% of the adult population is vaccinated, causing opportunities for the virus to spread and mutate.

Food Safety & Public Health:

• FDA Issues Improvement Plan Focused on Modernizing Foodborne Illness Outbreak Responses. The plan is designed to help enhance the speed, effectiveness, coordination, and communication of foodborne outbreak investigations. It focuses on four priority areas expected to have the most impact on outbreaks of human food:
  • Tech-enabled product traceback.
  • Root-cause investigations (RCIs).
  • Strengthen analysis and dissemination of outbreak data.
  • Operational improvements.

Flu Update:

In the US (CDC, etc.)

• Seasonal influenza activity in the U.S. remains low but continues to increase.
  • The dominant strain remains H3N2, an Influenza A
  • Flu vaccine rates are lower than normal in some places
  • Illness rates also are lower than would be typical, largely attributed to COVID precautions (e.g., mask wearing, hand washing) that are still in place.
• Norovirus cases are also increasing, particularly in group settings – schools, a homeless shelter, etc.

WHO/globally:

• National Influenza Centres (NICs) and other national influenza laboratories from 102 countries, areas or territories reported data to FluNet for Nov 8-21, 2021. Of more than 335,864 specimens tested in WHO GISRS laboratories, 3,844 were positive for influenza viruses, of which 1,658 (43.1%) were typed as influenza A and 2,186 (56.9%) as influenza B.
• Globally, influenza activity continued to increase but remains well below levels observed in previous seasons.