Key Points:

• In today’s Recommendation for Industry, we provide updates on COVID-19 and Monkeypox. Read more below.
• Pfizer’s Omicron-Targeting COVID-19 Vaccines Generate Stronger Immune Response. A modified booster shot targeting Omicron specifically increased neutralizing antibody levels 13.5 to 19.6 times higher than the current shot. A booster targeting both Omicron and the original virus increased neutralizing antibody levels 9.1 to 10.9 times, depending on the dose. Federal health authorities are trying to decide whether to stick with the current shots for a fall vaccination campaign or use a tweaked version. The study didn’t measure whether and how well the shots reduced the risk of COVID-19. Early lab testing showed the modified vaccines were also effective against the Omicron subvariants BA.4 and BA.5, but lost some of their power, generating about three times lower antibody levels against those subvariants than against the original Omicron subvariant. Moderna Inc. also found its Omicron-targeting booster produced a stronger immune response, suggesting possible benefit to modifying the shots to improve protection against an evolving virus.
• Britain is being hit by a new wave of COVID. This is Britain’s third COVID wave this year. Within the last week 1.7 million people in the UK were infected with COVID (week ending in June 18), 23% more than the previous week. BA.4 and BA.5 are the cause for this increase. In addition to Britain having an increase in cases, Portugal and South Africa all are experiencing jumps in numbers. The vaccine to be given in the fall hasn’t been determined yet by scientists; they aren’t sure if they should stick with the protection of the original strain or the most prevalent Omicron variant.
• Beijing to reopen schools, Shanghai declares victory over COVID. Shanghai has reported zero new local cases for the first time in two months. In-person classes for schools will resume soon. Both Beijing and Shanghai came out of their two-month long lockdowns on June 1, this was all due to the Omicron variants that hit. Shanghai is requiring that residents show a negative COVID-19 test within the last 24 hours to enter public venues.
• COVID-19 vaccines saved an estimated 20 million lives in 1 year. The scientists estimated that 18.1 million deaths would have occurred during the study period without vaccination. Of those, the model estimated that vaccination prevented 14.4 million deaths, or 79%. When they accounted for under-reporting, however, they found that COVID vaccination prevented an estimated 19.8 million deaths out of a total of 31.4 million potential deaths that would have occurred without vaccination—a reduction of 63%. The authors found that high- and upper-middle-income countries accounted for the greatest number of prevented deaths (12.2 million). Scientists claim that more deaths could have been prevented if the target of vaccinating 40% of the population in each country had been met by the end of 2021.

Influenza:

• HealthMap.org reported that Asia has warned of early occurrences of “summer flu” – in China, Macau, Japan, specifically. There’s also a report in Oklahoma of a “continuation” of the flu season.
• The US CDC flu tracker indicates lowering in case rates, but the “low” isn’t as low as what we’ve seen in the past indicating that there’s still a small undercurrent of flu out there. There is currently a 2.5% test positive rate.

Public Health & Food Safety:

• Acute hepatitis outbreak swells to nearly 900 cases; global data shows ‘mixed picture’. There are cases across 33 countries with more than half from European regions, mainly the United Kingdom. The United Kingdom makes up about 30% of all cases while the United States sits at about 35%. Most cases have been identified in children less than five years old. Forty-four children have required liver transplantation, and there have been 18 reported deaths. In terms of current COVID infection, in both Europe and the U.S. rates of detection are approximately 10%. There was a hypothesis that the COVID-19 vaccination caused a rare variant of multisystem inflammatory syndrome in children causing organ damage. Researchers ruled out the vaccination as a contributing factor because the majority of children were unvaccinated.
• Scientists Zero in on Origins of the Monkeypox Outbreak. Genetic analysis suggests that although the monkeypox virus is rapidly spreading in the open, it has been silently circulating in people since about 2018. Health officials have already identified two versions of monkeypox among American patients, suggesting at least two separate chains of transmission. Researchers in several countries have found cases with no known source of infection, indicating undetected community spread. And one research team argued last month that monkeypox had already crossed a threshold into sustainable person-to-person transmission. If the virus has adapted to include people as hosts, monkeypox outbreaks could become more frequent and more difficult to contain. That carries the risk that monkeypox could spill over from infected people into animals, sporadically triggering new infections in people. The longer it takes to contain the virus, the higher the odds that it will find a permanent new home in people or animals. As of Wednesday, the United States had identified 244 cases in 26 states and the District of Columbia. The global toll has surpassed 3,400 confirmed cases, and another 3,500 cases are being evaluated, tripling the numbers from two weeks ago.
• WHO: Monkeypox not a global public health emergency. This event will continue to be closely monitored for several more weeks to see if the situation warrants a reconsideration of their advice. Currently the advice still stands for using caution around individuals who may be infected and to avoid close contact with individuals when possible. WHO currently reports 4,265 confirmed cases worldwide. Additional states within the US such as Minnesota and Kentucky are reporting their first monkeypox cases. In wastewater within San Francisco there have been traces of monkeypox identified. San Francisco currently has 10 confirmed cases.
• Study documents rise of antibiotic-resistant typhoid. Antibiotic-resistant strains of typhoid fever are now spreading from South Asia to other parts of the world. Caused by the bacterium Salmonella enterica serovar Typhi, it is frequently transmitted by contaminated water and food and person-to-person contact, and it tends to spread in areas with poor sanitation. Scientists report that countries where typhoid fever isn’t endemic should introduce typhoid conjugate vaccine (TCV) as the disease could become an issue in the future.
• Solicitor General of United States finds Prop 12 violates Interstate Commerce Clause. Prop 12 claims animals kept in “less than” spaces are “confined cruelly” and bars their sale in California. Essentially, California would be able to dictate how other state’s farms are raising their animals. This applies to egg-laying hens, mother pigs, and calves raised for veal. It also prohibits in-state sale of products from caged animals out-of-state. Solicitor General filed an amicus brief finding Proposition 12 violating the constitution and will create unnecessary burdens for interstate commerce. State attorney generals are supporting the pork producers on behalf of Alabama, Arizona, Arkansas, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Montana, Nebraska, New Hampshire, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, and Wyoming. Now, the Solicitor General of the United States (“10^th justice”) has joined the 26 states.

Recommendations for Industry

COVID-19 & Monkeypox Updates

We are continuing to see some increases in different parts of the world of both COVID-19 and monkeypox. We don’t see either as a significant cause for concern, but do feel businesses should be aware of these and continue to monitor the health of workers.

1. COVID-19 – The UK has been hit with a bit of a surge being attributed to the Omicron BA.4 and BA.5 variants. It is just a fraction of what we saw in January, but it is real and is indicative of what the U.S. is facing, i.e., nothing extensive, but cases are occurring. Overall the U.S. is continuing the maintain the same trajectory it has and we’re seeing there to be about a four-month window from start to finish.
2. Monkeypox – The virus is appearing to continue to mutate with current strains in nonendemic countries appearing to have diverged from the monkeypox virus that caused a 2018-19 outbreak. Scientific predictions are also beginning to show that if public health measures to curb ongoing outbreaks are not taken, the spread could increase significantly. However, the WHO is not yet considering it to be a global public health emergency. As of Wednesday, the United States had identified 244 cases in 26 states and the District of Columbia. The global toll has surpassed 3,400 confirmed cases, and another 3,500 cases are being evaluated, tripling the numbers from two weeks ago.

To assist businesses in detecting and preventing spread of monkeypox in the workplace, TAG has developed a Monkeypox Fact Sheet, available for download in the Infectious Disease Fact Sheet section of TAG’s Public Health webpage. Please contact TAG if you should need further information or assistance with this or other public health issues or infectious disease.

In case you missed it:

• In last Thursday’s Recommendation for Industry, we discussed the encouraging trajectory of COVID based on TAG’s matrix and CDC’s mapping. Read more here.
• Women more likely to have long COVID, different symptom profile. For the shorter-term COVID, females were more likely than males to experience issues related to mood; ear, nose, and throat; musculoskeletal; and respiratory problems. Males were significantly more likely to experience renal problems. For long COVID, females were more likely to experience the condition, with an odds ratio of 1.22 (95% confidence interval, 0.75 to 0.93). Females presented with a variety of symptoms that can include ear, nose, and throat problems and mood disorders, as well as neurological, skin, gastrointestinal and rheumatologic, and fatigue symptoms. In contrast, male patients were significantly more likely to experience endocrinological disorders such as diabetes and kidney disease. Immune function is what could drive sex differences in long COVID.
• Moderna 2-strain booster shows strong subvariant antibody response against Omicron BA.4 and BA.5 subvariants. Moderna said this bivalent booster neutralizes antibodies 5.4-fold against both BA.4 and BA.5 above the baseline. Additionally, it has a 6.3-fold increase in seronegative individuals (evidence of previous infection). Moderna is planning on supplying another bivalent booster in August prior to a projected rise of cases coming in the fall.
• Study finds Paxlovid reduces risk for severe COVID-19, death by 46%. Paxlovid lowered the risk for severe COVID-19 or death by 46% in a study of patients in Israel and was especially effective among older or immunosuppressed patients, or patients with underlying neurological or cardiovascular diseases. Among the 180,351 eligible patients included in the study, 4,737 were treated with Paxlovid and 135,482 had an adequate COVID-19 vaccination status. The study demonstrated that both Paxlovid and adequate COVID-19 vaccination status were associated with a significant decrease in the rate of severe COVID-19 or mortality. They also found that the effect of Paxlovid was seemingly more significant among older patients, immunosuppressed patients and patients with underlying neurological or cardiovascular disease.

Public Health & Food Safety:

• Rutgers Scientist Develops Antimicrobial, Plant-Based Food Wrap Designed to Replace Plastic. This is a sprayable coating that will protect foods from pathogenic and spoilage microorganisms and transportation damage. This is essentially a “shrink-wrap” that is sturdy enough to prevent bruising of food. The technology utilizes polysaccharide/biopolymer-based fibers. The fibers are laced with thyme oil, citric acid and nisin. The coating can be rinsed off with water and it will degrade in soil within 3 days.
• FDA provides update on efforts to increase supply and availability of safe and nutritious infant formula. The FDA is working around the clock to ensure manufacturers have increased their production efforts. FDA flexibilities have resulted in approximately 365 million bottles worth of infant formula.The products are primarily coming from six different countries. The FDA will be annually inspecting infant formula manufacturers because the product is so crucial for babies’ nutrition. Metabolic infant formula will be released case-by-case from the Abbot facility.
• Important 30-day notice for FSVP importers re: “UNK.” Beginning July 24, 2022, the Entity Number field by U.S. Customs and Border Protection (CBP) will no longer accept the entity identification code “UNK.” Consistent with 21 CFR 1.509(a), FSVP importers will be required to ensure that their valid, 9-digit DUNS number is provided in the Entity Number field. The entity identification code “UNK” was accepted temporarily to allow Foreign Supplier Verification Programs for Food Importers time to obtain a Data Universal Numbering System (DUNS) number. Request a new DUNS number from Dun & Bradstreet (D&B) through the D&B’s Import Safety Lookup Portal https://www.importregistration.dnb.com. For questions about the FSVP requirement to provide a DUNS number, contact FDA’s Division of Import Operations via email at [email protected].
• Daily Harvest recalls French Lentil + Leek Crumbles after complaints of illnesses and hospitalizations. There has been a plethora of social media postings of individuals who have been affected by this product. Daily Harvest has now taken wind of the situation and has taken steps to inform people to dispose of this product and to not eat it. Social media training and awareness is crucial in today’s world due to how quickly individuals can post about an experience that went wrong.