Key Points:

• In today’s Recommendation for Industry, we discuss BA.5’s continued transmission and low severity. Read more below.
• FDA green-lights Novavax vaccine as COVID-19 levels rise: While the FDA has approved emergency use authorization for Novavax vaccine, the CDC must recommend it before it can be administered. The CDC Advisory Committee on Immunization Practices (ACIP) will be meeting on July 19 to discuss the Novavax vaccine. The vaccine is composed of the SARS-CoV-2 spike protein produced in insect calls and contains the Matrix-M adjuvant as an immune booster. Other parts of the world such as the European Union, United Kingdom, South Korea, and Australia already use Novavax.
• COVID-19 boosters offer good protection against early Omicron subvariants. A study of adults in 10 US states was published that determined the first and second COVID-19 vaccine booster doses conferred substantial protection against emergency department/urgent care visits and hospitalizations cause by Omicron subvariants BA.1, BA.2, and BA.2.12.1. During BA.1, 41.6% of all patients hospitalized for COVID-like illness were unvaccinated, 28.5% had received two vaccine doses, and 29.9% had received three. Amid BA.2/BA.2.12.1, 28.6% of patients were unvaccinated, 23.4% had received two doses, 42.9% had received three doses, and 5.1% had received four.
• As U.S. Covid hospitalizations climb, a chronic nursing shortage is worsening. Hospitalizations have risen steadily in recent weeks due to BA.5 infections. Some states are struggling to retain nursing staff such as New York, Massachusetts, and North Carolina, along with many others. The shortage has even caused a temporary shutdown at a hospital in North Carolina. New York’s Mount Sinai’s hospital network alone had 771 unfilled registered nurse and nurse practitioner positions. Demand for nurses is projected to keep growing significantly in the United States. The McKinsey consulting firm projected in a report in May that the nation could face a shortage of up to 450,000 nurses by 2025.

Influenza:

• Reported by WHO, global influenza activity has remained stable, following a decrease from the peak in March 2022. Most commonly in countries throughout the world, influenza A (H3N2) has been the dominant virus subtype.

Public Health & Food Safety:

• Monkeypox viral DNA detected in saliva, semen. From a study of monkeypox infected patients, DNA of the poxvirus was found in semen, saliva, urine, and feces. In the study, indications of high viral loads were detected in all 12 saliva samples and in skin lesions of all 12 patients. Detectable DNA was collected from 11 of 12 rectal swabs, 10 of 12 from nasopharyngeal swabs, 7 of 9 from semen, 9 of 12 from urine, and 8 of 12 from feces. All samples were collected at the time of diagnosis. No deaths from monkeypox have been reported from the European region, but three people have required intensive care unit admission. Globally, 11,208 cases have been confirmed, mainly in non-endemic countries.
• CDC director: Expect more monkeypox cases in coming weeks. As more tests are becoming available, there is expected to be a rise in case numbers across the country. Among the US, the government has distributed approximately 160,000 vaccine doses. An additional 131,000 doses are being made available starting this week. The United States currently has 1,470 cases from 44 jurisdictions, an increase of 417 from last Thursday.
• Adenovirus common in kids with unexplained acute hepatitis, studies show. In two new studies, researchers isolated human adenovirus from the vast majority of children diagnosed as having acute hepatitis but couldn’t determine whether the ubiquitous virus typically associated with transient respiratory, gastrointestinal, and conjunctival illnesses was the cause. Eight of the nine children (89%) with unexplained hepatitis tested positive for human adenovirus. In the other study, twenty-seven of the 30 patients (90%) who underwent molecular testing were positive for human adenovirus. Six patients (14%) developed liver failure and received a liver transplant. From Oct 1, 2021, to Jul 13, 2022, 338 children with unexplained acute hepatitis were reported to the US Centers for Disease Control and Prevention (CDC) from 42 US states and territories, according to an update yesterday. The data reflect 6 new cases.
• FDA proposes another delay for pre-harvest agricultural water requirements. The 2021 agricultural water proposed rule, if finalized, will require farms to conduct annual systems-based agricultural water assessments to determine and guide appropriate measures to minimize potential risks associated with pre-harvest agricultural water. The supplemental rulemaking proposes to establish the following compliance dates for the pre-harvest agricultural water requirements for covered produce other than sprouts: 2 years and 9 months after the effective date of a final rule for very small businesses; 1 year and 9 months after the effective date of a final rule for small businesses; and 9 months after the effective date of a final rule for all other businesses. There will be continued enforcement discretion for the harvest and post-harvest agricultural water requirements of the Produce Safety Rule until the following dates: Jan. 26, 2025, for very small businesses; Jan. 26, 2024, for small businesses; and Jan. 26, 2023, for all others. Companies impacted by this should ensure that development of their agricultural water assessments is underway.
• Blueberries recalled nationwide over high levels of lead. BrandStorm Inc. is recalling certain Natierra Organic Freeze-Dried Blueberry pouches because of the presence or potential presence of lead above the FDA’s recommended limits. After further investigation, it was found that the products’ country of origin is Lithuania and aggressive monitoring of heavy metals may be deemed necessary. The recall is limited to two batches of Natierra Freeze-Dried Blueberries with the following codes Best By Date 12/2024 & 01/2025.
  1. Lot 2021363-1, Best By Date: 12/2024
  2. 1 serving, 1.2oz (34g), UPC 812907011160
  3. Lot 2022026-1, Best By Date: 01/2025
  4. 1 serving, 1.2oz (34g), UPC 812907011160

• FDA Issues RFI on Fluorinated Polyethylene Food Contact Containers– The FDA is seeking scientific data and information on the current food contact uses of fluorinated polyethylene, consumer dietary exposure that may result from those uses, and safety information on substances that may migrate from fluorinated polyethylene food containers. Fluorination of polyethylene may result in the formation of per- and polyfluoroalkyl substances (PFAS) and this request is part of our continued work to ensure that authorized food contact uses are safe.

Recommendations for Industry

BA.5 Continues Transmission, but Severity is Low

With just over 100,000 COVID cases being reported per day, the U.S. is continuing to maintain a fairly consistent transmission level, following the east-to-west migration, as TAG has been reporting for about the last two month. Even with this transmission rate, however, hospitalization rates remain relatively low compared to the Delta wave in Fall of 2021 and the original Omicron wave earlier this year. Increasing population immunity (either naturally or vaccine acquired) against the Omicron variants such as BA.5 are a key factor in the proportionally lower levels of severe illness.

So COVID is definitely continuing to show its presence, with no signs of dropping off in the U.S. and even spiking in Europe. But overall, there has been no dramatic change from what we’ve been seeing for the last two months.

As shown in the key points, monkeypox is continuing as well, with cases throughout the world, with just over 11,000 cases confirmed, mainly in non-endemic countries.

In case you missed it:

• In last Thursday’s Recommendation for Industry, we discussed the continued westward wave of COVID. Read more here.
• Coronavirus (COVID-19) Update: FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine, Adjuvante. On July 13, the USDA issued an emergency use authorization for Novavax COVID-19, Adjuvante vaccine for individuals 18 years of age and older. The FDA has determined that the Novavax COVID-19 Vaccine, Adjuvanted has met the statutory criteria for issuance of an EUA. The data support that the known and potential benefits of the vaccine outweigh its known and potential risks in people 18 years of age and older, and that this vaccine may be effective in preventing COVID-19. This vaccine is administered as a two-dose series, three weeks apart. Studies were conducted before the authorization. Approximately 17,200 received the vaccine and approximately 8,300 received saline placebo during this study. Overall, the vaccine was 90.4% effective in preventing mild, moderate or severe COVID-19, with 17 cases of COVID-19 occurring in the vaccine group and 79 cases in the placebo group. No cases of moderate or severe COVID-19 were reported in participants who received the vaccine, compared with 9 cases of moderate COVID-19 and 4 cases of severe COVID-19 reported in placebo recipients. In the subset of participants 65 years of age and older, the vaccine was 78.6% effective. The clinical trial was conducted prior to the emergence of the Delta and Omicron variants.
• White House officials encourage boosters as BA.5 becomes more dominant. BA.4 and BA.5 make up about 81% of circulating COVID cases, up from about 70% last week. Hospitalizations are slightly up, and 32% of the US population lives in a high community transmission area, a metric that triggers a CDC recommendation for indoor masking. The White House released a five-part strategy for managing BA.5, which includes ensuring easy access to vaccines and treatments, making high-quality masks and tests free and widely available, prioritizing immunocompromised people, urging building owners to improve ventilation, and providing clear recommendations about masking.
• The pandemic kept many children less active around the world, researchers find. The pandemic led to children’s daily physical activity declining by 20 percent, according to the review, which analyzed the results of 22 studies. The studies revealed an average decrease of 17 minutes a day in children’s “moderate-to-vigorous physical activity” during the pandemic. These results were tied to COVID restrictions such as social distancing, disrupted school schedules, remote learning, and increases in screen time.

Public Health & Food Safety:

• Monkeypox cases continue to spike in UK. Since May 6, the United Kingdom has recorded 1,735 cases of monkeypox, 1,660 of them in England alone. The median age of confirmed cases is 36 years of age. UK cases are doubling every 15 days. The CDC reports there are 1,053 confirmed cases within 41 states. The states that currently do not have confirmed cases are Montana, North Dakota, Wyoming, Kansas, Mississippi, Alabama, Maine, Vermont, and Alaska. Globally, cases are reported at 10,000 in non-endemic countries with Spain, the United Kingdom, Germany, and the United States having the most.
• Warnings about honey with ingredients that are not disclosed, including ED drugs. The U.S. Food and Drug Administration on Tuesday issued warning letters to four companies for illegally selling honey-based products that may pose a significant health risk to consumers. After FDA testing was performed on samples of product, there were found to be active drug ingredients that were not listed within the product labels. Those ingredients found were Cialis (tadalafil) and Viagra (sildenafil), which are prescribed medications used to treat men with erectile dysfunction (ED). These undeclared ingredients may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Warning letters were issued to Thirstyrun LLC (US Royal Honey LLC), MKS Enterprise LLC, Shopaaz.com, and 1am USA Incorporated dba Pleasure Products USA.
• FDA says Big Olaf ice cream still on sale despite recall and deadly outbreak. The FDA, along with the U.S. Centers for Disease Control and Prevention, is assisting the Florida Department of Health (FL DOH) and Florida Department of Agriculture & Consumer Services (FDACS) in investigating the outbreak of Listeria monocytogenes infections linked to ice cream supplied by Big Olaf Creamery of Sarasota, FL. There are still some unnamed locations selling the recalled ice cream. Media in Florida are reporting that state officials there have been investigating the company for a year, with the most recent health inspection having been completed July 6. As of June 30, the CDC reported 23 illnesses in 10 states with one person having died. Five pregnant women were reported ill, with one having miscarried.