Key Points:

• In today’s Recommendation for Industry, we discuss the encouraging trajectory of COVID based on TAG’s matrix and CDC’s mapping. Read more below.
• 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.
• 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.

Recommendations for Industry

COVID: Progressive Trajectories Very Encouraging

TAG’s weekly COVID matrix, as well as the CDC community level map continue to show the trends following TAG’s predicted trajectory. The east coast is staying relatively flat with some northeastern states now showing decreases, while the westward movement is continuing, but at consistent or reduced levels. We aren’t seeing anything that is increasing at any rates of concern. While there is some slight increase in some parts of Europe due to BA.5, even these are showing to be a fraction of rates we saw earlier in the year.

With TAG seeing U.S. transmission rates as strong predictors of emergence, we see the U.S. as heading in the right direction, as only six states are in our danger zone of 1.2 or higher, with many below 1.0. Additionally, there are no more states in the red high-risk rates of hospitalization, with both Delaware and Washington DC now in the yellow. TAG sees these steady, progressive trajectories as being very encouraging.

Risk Matrix:

In case you missed it:

• In Tuesday’s Recommendation for Industry, we discussed the low risk of monkeypox in the US, and what businesses can do to keep it low. Read more here.
• Omicron is as much as 50% less likely to lead to long COVID, study finds. The numbers of individuals that were infected with Omicron were more significant than other variants, such as Delta. Omicron is an easily transmissible variant of COVID. Long COVID was defined as having new or ongoing symptoms 4 weeks or more after COVID-19 onset. Symptoms include fatigue, shortness of breath, loss of concentration, and joint pain. These symptoms can limit daily activities and in some cases be severely limiting. The odds of long COVID for Omicron patients were 24% to 50% less than for Delta patients.
• CDC Recommends COVID-19 Vaccines for Young Children. On June 18, the CDC began recommending that all children 6 months through 5 years of age receive a COVID-19 vaccine. This age group can receive both Pfizer and Moderna vaccines to help protect themselves from COVID-19. Parents can reach out to their doctor, nurse, local pharmacy, or health department, or visit vaccines.gov to see where vaccines for children are available.    
• US & Global Status
  • For two years, a few weeks after infections climbed so did deaths, but that pattern appears to have changed. At nearly three months since new Omicron variants launched a springtime resurgence of cases, fewer people are dying from COVID – closest to the lowest rate of the pandemic and at only one-tenth of the deaths of January 2021. (NYT)
  • However, WHO’s epidemiological update for COVID shows while there has been a global decline of cases for the past 5 weeks, the weekly deaths have risen. There are over 8,700 fatalities reported, with an increase of 4% compared to the previous week. As of 12 June 2022, over 533 million confirmed cases and over 6.3 million deaths have been reported globally.
• Canada drops COVID-19 vaccine travel restrictions Monday. Starting on June 20, vaccinations will no longer be required to board a plane or train in Canada. Masks will remain mandatory except for when individuals are eating or drinking for everyone over 2. Unvaccinated foreign visitors remain banned from entering Canada. They must be fully vaccinated against COVID or submit to a mandatory 14 day quarantine and multiple PCR tests.

Influenza:

• Reported through data collected by the CDC there has been a 3.4% positive clinical test positive for influenza last week. Influenza cases are decreasing as this week there are 3 jurisdictions that experienced high activity and 0 jurisdictions experienced very high activity. There is a current report of 29 influenza- related pediatric deaths. This flu season there is estimated to be at least 8 million flu illnesses, 82,000 hospitalizations, and 5,000 deaths.
• WHO reports in the temperate zones of the southern hemisphere, overall influenza activity increased slightly in recent weeks.

Public Health & Food Safety:

• Reported by HealthMap.org: In yet another possible health impact of the pandemic, TB cases in the US showed a substantial decline in 2020, likely due to a shifting of surveillance resources to COVID-19.  Health officials encourage continued vigilance, so TB cases are not missed.
• Hepatitis source infection is still under debate – There is insufficient evidence to support the view that the recent unexplained acute hepatitis in children is contagious, and the disease’s link to COVID-19 or adenovirus remains unclear, the National Health Commission in the UK suggests.  However, a small study in Israel suggests that there may be a link between the recent unexplained cases of hepatitis in children and prior coronavirus infections, but the sample size is very small. Although recent cases of hepatitis of unknown origin are concerning, a US CDC study showed no increase in pediatric hepatitis or adenovirus types 40/41 above pre–COVID-19 pandemic baseline levels.
• As more states report monkeypox, officials urge caution. In new research, yet to be peer reviewed, there is found to be a 4–17 day incubation period for monkeypox. Nineteen states and Washington DC have all reported cases. The overall count of cases in the U.S. is at 84.
• After 40 million dead birds, hot weather may be killing off the bird flu virus. 40 million birds have been reported dead from the avian flu since February. Avian flu was confirmed in 372 commercial and backyard flocks in 36 states. The avian flu does not survive hot weather so an end might be in sight.
• APHIS turns attention to swine fever after months of battling avian flu. USDA’s Animal and Plant Health Inspection Service is putting forth efforts to help prevent the spread of African swine fever which is found in pork. Although this disease does not affect humans, we can spread it from pig to pig through clothing, farming equipment, and uncooked pork. The U.S. has never had a confirmed case but nearby countries have, such as Haiti and the Dominican Republic. There isn’t a current treatment for this disease and there isn’t an effective vaccine. If this hits the U.S., it is estimated to cost about $50 billion dollars over the next 10 years. Protect our Pigs campaign information can be found here.
• Floodwaters force infant formula plant to close again ‘for a few weeks’. Abbott Nutrition has closed now due to floodwaters that have swept through Sturgis, MI. They are currently assessing damage that was caused and cleaning and re-sanitizing the plant. This situation will push back production and distribution for a few weeks.