Mu Variant Not a New Strain in U.S.

• In today’s Recommendations for Industry, we look at the Mu variant and the Flu Vaccine. Read more below.
• S. COVID-19 cases have reached 40 million with 4 million of those cases arising from the last 4 weeks. The number is set to be much higher as the 4 million were those identified with a COVID-19 test and doesn’t count those that haven’t been tested!
  • Through this, the FDA has published vaccine information (videos and pamphlets) in multiple languages, including Spanish, Korean, Navajo, Chinese, Tagalog, and Vietnamese.
  • As of yesterday, Monday, two primary COVID-19 safety nets have ended, affecting millions including: (a) the loss of all unemployment benefits; and (b) the expiration of the federal eviction moratorium.
  • The Mu COVID-19 variant has been identified in 49 states; it hasn’t been identified in Nebraska! However, there is evidence to show that cases of the Mu variant hit a peak in mid-July and has since decreased.
• While some health officials are advising the White House to scale back on its COVID-19 vaccine booster plan (NYT), the FDA is set to meet on September 17 (CIDRAP) to discuss COVID-19 vaccine third doses by Pfizer. The meeting will be livestreamed on YouTube. At the same time, European officials as part of the European Centre for Disease Prevention and Control are saying that boosters are not urgent (CIDRAP); instead, “the priority now should be to vaccinate all those eligible individuals who have not yet completed their recommended vaccination course.” In fact, Reuters reports that EU watchdogs are currently studying data on Pfizer’s vaccine booster dose!
• A recent study finds that “the odds of long COVID-19 fall by more than half after two doses of vaccine, the risk of hospitalization drops by more than two-thirds, and breakthrough infections are nearly twice as likely to be asymptomatic.” Some risk factors that could lead to a breakthrough COVID-19 vaccine after the 1^st vaccine dose was linked to frailty in >60 years or those living areas of high deprivation.
• The WHO is currently paying attention to a new COVID-19 variant first identified in South Africa in May 2021. There is fear that the mutations and number of mutations are higher than other variants. Al Jazeera discusses this further.
• Last Friday, Tyson Foods announced that it would provide “up to two weeks of paid administrative leave if they tested positive for Covid-19 over the next six months” for fully vaccinated employees.

Food Safety & Public Health:

• The FDA has provided further guidance for the food industry, “Microbiological Considerations for Antimicrobial Agents Used in Food applications” to “assist submitters of food additive petitions (FAPs), food contact notifications (FCNs), generally recognized as safe (GRAS) notices (GRNs), and threshold of regulation (TOR) exemption requests in providing data to demonstrate that an antimicrobial agent (defined in Section II.A) achieves its intended technical effect in or on food or food contact articles”
• On October 19 – 21, 2021, the FDA is set to host New Era of Smarter Food Safety Summit on E-Commerce to discuss the various types of B2C e-commerce models (including produce and meal kit subscription services, ghost kitchens, dark stores) and the safety risks associated with B2C e-commerce. For more information and to register, check this out!
• According to the CDC, healthcare associated infections rose in 2020 with a significant rise in MRSA.

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Mu Variant Not a New Strain in U.S.

With media headlines touting the “emergence” of the B.1.621 (Mu) variant of COVID, TAG has been receiving a number of questions on Mu. While there is currently little epidemiological data on this variant, the World Health Organization (WHO) provided a focused update on August 31, with some information on Mu including the statement, “Preliminary data presented to the Virus Evolution Working Group show a reduction in neutralization capacity of convalescent and vaccinee sera similar to that seen for the Beta variant, but this needs to be confirmed by further studies.”

In layman’s terms, this is stating that there is some indication that natural immunity or the current vaccines may provide less or little protection against Mu. However, WHO states that further research is needed, and TAG has seen no definitive clinical or epidemiological data showing breakthrough or reinfections by Mu. Additionally, there is data suggesting that Mu has been present in the US since early 2021, so while it could become a dominant strain, it is not as new as is being indicated in some recent coverage.

For businesses, this means that you should continue to enforce COVID worker protections, but not overreact. TAG is continuing to track Mu, as well as all the variants, and will continue to keep you informed through this newsletter.

Tracking the Flu

Each Tuesday, TAG will be providing an update on the presence and transmission of the influenza virus across the U.S. as published by the CDC. With the flu having many overlapping symptoms with COVID, it is essential to stay on top of both viruses, understand the symptoms, and rates of transmission, as depicted in the following graphs.

• In Thursday’s Recommendations for Industry, we looked at the Risk Matrix. Read more here.
• In Flu Season News: According to the WHO global flu update (for the first half of August), flu levels are seeming to remain low in both hemispheres. While there has been an increase in India and Nepal, flu elsewhere is sporadic. There is evidence that this year’s influenza season is tilted towards influenza A as most samples subtyped thus far fall into this category.
• The total number of countries now reporting the Delta variant is 170 countries. Following with EU standards, Italy has added restrictions to unvaccinated travelers coming in from the U.S., they will now be required to quarantine for 5 days.
• While vaccinations have risen in August, with 52.6% of Americans being fully vaccinated and 61.9% having received at least one vaccine dose, COVID-19 cases continue to reach new daily highs across the United States with daily average hospitalization rates topping 100,000 (with three times as many people dying of COVID-19 in August – about 27,000 Americans – than in July). As Labor Day Weekend also approaches, the CDC has warned that unvaccinated Americans refrain from traveling over the holiday weekend.
• 70% of adults in the European Union are now fully vaccinated. If accounting for children and teenagers also vaccinated, “more than 55 percent of the overall E.U. population has been fully vaccinated, compared with 52 percent in the United States, 61 percent in Israel, and 64 percent in Britain.”
• In the last 3 weeks, more than 500,000 children have tested positive for COVID-19; experts recommend the necessitation of mask mandates to allow for the safe return to in-person learning.
• The WHO is currently monitoring a new coronavirus variant of concern named “Mu” (B.1.621) which was first identified in Colombia in January 2021. There is concern that the variant contains “mutations that indicate a risk of resistance to vaccines” and can have “mutations connected to immune escape, similar to what was seen with the Beta variant.” This variant has now been seen in a total of 39 countries including other South American countries and also in Europe; although its prevalence globally is <0.1%, it accounts for 39% of all cases in Colombia.
• High-risk allergy patients have low reactions rates to the Pfizer vaccine, come findings from a new JAMA Network Open study of 429 patients who were “considered to be high-risk for allergic reactions against the Pfizer” vaccine.
• Recent research published in the Journal of the American Society for Nephrology from Washington University School of Medicine in St. Louis that explored federal data is finding that there is “a significant decline in kidney function among those dubbed COVID-19 long-haulers — and even among those who had mild infections of the virus […] Known as the silent killer, kidney dysfunction and disease tend to be free of pain and other symptoms — so much so that the National Kidney Foundation estimates that 90% of people with ailing kidneys don’t know it. Kidney disease affects 37 million people in the U.S. and is one of the nation’s leading causes of death.” The study further found that people who were infected with COVID-19 and were not hospitalized had a “15% higher risk of suffering from a major adverse kidney event such as chronic kidney disease, a 30% higher risk of developing acute kidney injury, and a 215% (more than twofold) higher risk of acquiring end-stage kidney disease.”
• In the latest MMWR, “at least 180 coronavirus infections in three states have been traced to an Illinois church camp for teenagers and an affiliated men’s conference that did not require attendees to be vaccinated or tested for the virus” in June, reports the New York Times. While there are thus far no deaths, 5 people have been hospitalized. However, from this event, at least 1,000 people in four states were exposed!
• A new report has found that the COVID-19 recession has pushed social security insolvency up a year from 2035 to 2034. By 2034 “the new projections in the annual Social Security and Medicare trustees reports indicate that Social Security’s massive trust fund will be unable to pay full benefit[s].”
• Finally, a massive study of 340,000 adults across 600 villages in rural Bangladesh further highlights the importance of utilizing surgical masks to limit the spread of coronavirus.

Food Safety & Public Health:

• The FDA will hold its 2021 Retail Food Protection Seminar on September 13 – 16, 2021. Registration for the virtual event is free and open to all interested in retail food safety, including state, local, territorial, and tribal regulators, industry, and academia. Retail modernization is a priority in the New Era of Smarter Food Safety blueprint. FDA is exploring the best ways to further modernize and help ensure the safety of foods sold at restaurants and other retail establishments. Register now for free!
• The EU is evaluating food irradiation rules due to the process being less used as “driven by industry and consumer fears […] The evaluation found the directives had been inefficient at ensuring a level playing field between EU and non-EU countries and, because of a labeling requirement, had affected businesses’ ability to use irradiation.” As in the U.S., right now irradiation is mostly used for “dried aromatic herbs, spices and vegetable seasonings.” However, as we know, irradiation is a safe and effective process to eliminate pathogens!
• There are at least 6 foodborne outbreaks that the FDA is currently investigating. See the Table below.
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  • (Source: Food Safety News – https://link.achesongroup.com/85h).