Key Points:

• In today’s Recommendation for Industry, we provide current updates and recommendations on COVID and Monkeypox transmission. Read more below.
• COVID vaccines prevented poor outcomes in people of all sizes. COVID-19 vaccination protected people of all body sizes from hospitalization and death—although vaccinated people with a low or high body mass index (BMI) were at greater risk. University of Oxford researchers led the study, which involved 9,171,524 adult primary care patients in England with available body mass index (BMI) data from Dec 8, 2020 (when the COVID-19 vaccine first became available in the United Kingdom), to Nov 17, 2021. While vaccinated underweight participants were at about half the risk of hospitalization or death than unvaccinated people with the same BMI, those with healthy or high BMIs were about 70% less likely to be hospitalized than their unvaccinated peers. Participants with healthy or high BMIs were roughly two-thirds less likely to die after a second vaccine dose. A BMI of 17 was tied to a 50% higher risk of hospitalization than a healthy BMI of 23, while a very high BMI of 44 was associated with three times the risk of hospitalization than a healthy BMI.
• New York launches mobile test-and-treat, World Bank OKs pandemic fund. New York City officials, flanked by the White House COVID-19 coordinator, unveiled the nation’s first test-to-treat mobile units, which are designed to speed treatment to vulnerable groups. The mobile units will provide testing and include a clinician to provide instant access to prescriptions for no-cost antiviral medications for eligible people who test positive for COVID-19, NYC Health said in a statement. In global developments, World Bank officials yesterday approved a new pandemic preparedness fund, designed to shore up disease surveillance, lab networks, and other key health activities in low- and middle-income countries.
• Updated COVID Shots Are Coming. Will They Be Too Late? In a bid to match the latest forms of the virus, the FDA asked vaccine manufacturers to tailor their new shots to the BA.4 and BA.5 subvariants, rather than to the original version of Omicron from last winter. Pfizer and Moderna said that they could deliver subvariant vaccine doses no earlier than October. Some FDA advisers warned in a public meeting last week that the timeline could be slowed even further by any number of routine delays. Moving too slowly [creating updated boosters] would risk leaving older and other vulnerable people exposed to a pathogen that looks different than what the original vaccines had prepared them for.
• CDC COVID-19 Community Level Map:

Influenza:

• From the CDC, the most up to date influenza data is as follows. As seen through the reported data, cases of influenza have decreased significantly in comparison to winter and spring months.

Public Health & Food Safety:

• New York, Illinois get doses of monkeypox vaccine. New York has secured 8,195 doses of Jynneos and plans to distribute them to health centers serving LGBTQ+ communities, as men who have sex with men have made up the vast majority of US cases. New York City has at least 78 monkeypox cases. The Illinois Department of Health will be getting 1,291 doses of the Jynneos vaccine, and the Chicago Department of Public Health will get a separate allocation of 3,200 doses, according to the state health department and the Chicago Tribune. There are 46 probable cases of monkeypox in Illinois. In Eurosurveillance, researchers reported that environmental sampling from the hospital rooms of two recovered monkeypox patients in Germany showed isolated virus on surfaces, particularly those touched by patients’ hands. The highest levels were found in bathrooms, and high loads were also seen on chair seats and on the touch screen of one patient’s phone.
• CDC says ice cream is implicated in deadly outbreak of Listeria infections. This outbreak has affected people in 10 states so far because of Listeria monocytogenes. As of June 30^th, there were 23 confirmed patients, one of whom died. Big Olaf Creamery located in Sarasota, Florida, recalled their products and recommended consumers who have these ice cream products at home should throw them away.
• FDA Alert on Homemade Infant Formula from Plug Heist Trap House EST. 2017. The FDA advises parents and caregivers of infants to stop using homemade infant formula from Plug Heist Trap House. The manufacturer was marketing this product as an infant formula with no product labeling and did not submit the required pre-market notification to the FDA. Homemade infant formulas have not been evaluated by the FDA for safety and may lack nutrients vital to an infant’s growth. Parents and caregivers of infants who have purchased this product should discontinue use and throw it away. Parents and caregivers of infants who have used this product and are concerned about the health of their child should contact their health care provider.
• Vidalia onions recalled from Wegmans, Publix and Sam’s Club locations in five states after testing finds Listeria. A&M Farms of Lyons, Georgia, is recalling Vidalia onions because of potential Listeria monocytogenes contamination. The recalled Little Bear onions were available for sale to consumers on June 23 and 24 at Wegmans stores in the Rochester-area, Massachusetts, and at the Erie West and Erie Peach Street Wegmans stores in Pennsylvania. The onions were also available for sale June 22 – 24, 2022 at Publix stores in the state of Florida and in Publix stores in Georgia in Barrow, Clarke, DeKalb, Forsyth, Fulton, Gwinnett, Hall, Jackson, Oconee and Walton counties. Consumers can identify the recalled Vidalia Onions by the purchase location, PLU 4159 and Little Bear brand on the PLU sticker as provided in the table at the end of the notice.
• Salmonella stops operations at Barry Callebaut chocolate plant. Barry Callebaut has halted production at one of its factories in Belgium after detecting Salmonella. The company found the positive production lot on June 27 and blocked all chocolate products made at the Wieze site since testing on June 25. All chocolate production lines have been stopped at what some say is the largest chocolate factory in the world. Lecithin has been identified as the source of the contamination. This ingredient is used in chocolate production to reduce thickness.

Recommendations for Industry

TAG Recommendations for COVID and Monkeypox

With cases of COVID-19 and Monkepox continuing to be detected, TAG provides the following recommendations:

• COVID-19. As shown in CDC’s latest COVID community level map (in TAG’s Key Points above), we are seeing a grea deal of red (high) and yellow (medium) levels across the country, particularly in the west and in Florida – which is showing high community levels across the majority of the state. TAG advises businesses to ensure you are maintaining wellness checks on workers, watching for any signs of illness, and ensuring those who are ill stay home to limit spread.

• Monkeypox. With European researchers now finding isolated monkeypox virus on surfaces touched by infected persons, TAG also encourages businesses, particularly those with known cases of monkeypox, ensure they are thoroughly cleaning and sanitizing areas that may have been touched. Although the research was based in hospitals, its finding that the highest levels occurred in bathrooms. It also is advised that restrooms, particularly those open to the public, be kept clean and sanitized as well.

In case you missed it:

• In last Thursday’s Recommendation for Industry, we took a look at the latest statistics on COVID and expectations for the next few months. Read more here.
• FDA advisory committee is recommending Omicron variant to be within COVID boosters. The proportion of BA.4 and BA.5 increased in the week ending June 25^th, mainly due to BA.5. The CDC said on June 28th that BA.4 and BA.5 now make up 52.3% of subtyped samples, up from 35% the previous week. A rising proportion of BA.5 made up most of the jump, with BA.5 now making up 36.6% of samples and BA.4 making 15.7% of samples. Though mRNA vaccine manufacturers said they can start distributing bivalent vaccine doses this summer, they noted it would take a few months longer to produce versions that target BA.4 and BA.5.
• Data collected this week from New York Times shows the following statistics: Daily average cases of 108,963, test positive rate of 15%, and 377 daily deaths. To compare, at the height of Omicron in January there was a reported daily average of about 800,000 cases.
• Maternal deaths climbed 33% during COVID-19. Maternal deaths in the first months of the COVID-19 pandemic increased 33%—and even higher in Black and Hispanic women, according to a study in Jama Network Open. Pre-pandemic data from 2018-2020 was used to compare with pandemic death rates. Pre-pandemic death rate was 18.8 per 100,000 births while the pandemic period was found to be 25.1 per 100,000 births. Late maternal mortality (42 days to 1 year after birth) increased 41%. For underlying cause-of-death codes, the authors determined that the largest relative increase was among indirect causes (56.9%), specifically other viral diseases (2,374.7%), diseases of the respiratory system (117.7%), and diseases of the circulatory system (72.1%). Relative increases in direct causes (27.7%) were mostly associated with diabetes in pregnancy (95.9%), high blood pressure (39.0%), and other pregnancy-related conditions (48.0%).
• BioNTech, Pfizer to start testing universal vaccine for coronaviruses. The two companies would start tests on humans of next-generation shots that protect against a wide variety of coronaviruses in the second half of the year. Their experimental work on shots that go beyond the current approach include T-cell-enhancing shots, designed to primarily protect against severe disease if the virus becomes more dangerous, and pan-coronavirus shots that protect against the broader family of viruses and its mutations.

Public Health & Food Safety:

• Abbott Nutrition remains closed for flood cleanup; no word on how long it will take. Operations were shut down the third week of June after floodwaters from a local storm drain system were overcome by torrential rain. The plant has only put word out that they need to clean and sanitize the plant before production begins again. There was no timeline mentioned for when production will pick up.
• Monkeypox
  • CDC opens monkeypox center as Europe begins vaccinations. On June 28, the CDC activated its Emergency Operations Center (EOC) to better address the monkeypox outbreak. Spain became the first European Union country to receive delivery of monkeypox vaccines ordered by the European Commission’s Health Emergency Preparedness and Response Authority (HERA) in response to a growing outbreak mainly affecting men who have sex with men. Doses will be distributed based on population, with Portugal, Germany, and Belgium the next countries receiving doses. The European Medicines Agency also is reviewing the use of smallpox vaccine Imvanex to treat people exposed to monkeypox. Previous studies have shown smallpox vaccines are roughly 85% protective against monkeypox, and Imvanex is already licensed as a smallpox vaccine in the EU.
  • US rolls out monkeypox vaccine plan. Under a new plan, 296,000 doses of the Jynneos vaccine will be made available in the U.S. throughout July with a combined 1.6 million additional doses becoming available in the coming months. Vaccines are primarily intended for those who had close physical contact with someone diagnosed with monkeypox, those who know their sexual partner was diagnosed with monkeypox, and men who have sex with multiple men where monkeypox is known to be or is spreading. While the WHO Director-General said that high-risk groups (e.g., children, immunocompromised individuals, and pregnant women) may be at a higher risk, there have been no reported cases in children in the U.S., and of the 305 US cases, all but 5 have been in men.
• Swimmer’s itch cases beginning, follow CDC recommendations. Swimmer’s itch, also called cercarial dermatitis, appears as a skin rash caused by an allergic reaction to certain microscopic parasites that infect some birds and mammals. These parasites are released from infected snails into fresh and salt water (such as lakes, ponds, and oceans).
  • To prevent from getting swimmer’s itch do not swim in areas where swimmer’s itch is a known problem or where signs have been warning of unsafe water; do not swim near or wade in marshy areas where snails are commonly found; towel dry or shower immediately after leaving the water; do not attract birds (e.g., by feeding them) to areas where people are swimming; encourage health officials to post signs on shorelines where swimmer’s itch is a current issue.
  • If contracted, you may find relief from using corticosteroid cream, applying cool compresses to the affected areas, bathing in Epsom salts or baking soda, soaking in colloidal oatmeal baths, applying baking soda paste to the rash, or by using an anti-itch lotion.