Key Points:

• In today’s Recommendation for Industry, we discuss the continued westward wave of COVID. Read more below.
• 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.

Recommendations for Industry

Westward Wave of COVID Continues – as Projected

As shown in both the CDC community levels maps (above and at CDC) and TAG’s matrix (below), we are continuing to see COVID transmission moving in westward waves across the U.S. – as TAG has continually projected. Compared with last week, much of the Northeast and upper Midwest has dropped to low (green) levels, while areas of the west have increased to medium (yellow) or high (red) levels.

With BA.5 continuing to be the predominant variant, the weekly TAG matrix is showing 33 states plus the District of Columbia with a TPR>10% and case rates >25 cases/100K. Nationally, cases are rising in 40 states and hospitalizations are also rising in the U.S. and 37,000 people are currently hospitalized with the coronavirus on an average day, an increase of 17 percent since the start of the month. While the vast majority of BA.5 infections are mild (either due to vaccine or previous infection-induced immunity), the nation is still averaging over 400 COVID-related deaths per day. The U.S. is in the midst of a summer-surge, driven by BA.5, and we encourage people to be attentive to symptoms and get tested if COVID-like symptoms develop. Previous infection is far less protective against BA.5, and the risk of reinfection is greater now than at any time since the end of the huge BA.1 surge this winter.

As we also have shown in previous newsletters, the Novavax vaccine, which has been approved by FDA for emergency use (see Key Point 1, above), may provide another means of reducing transmission. Its protein-based vaccine uses a more traditional technology that has been widely used for decades, so the hope is that it will appeal to Americans who declined to be vaccinated with the MNRA or J&J vaccines.

Risk Matrix:

In case you missed it:

• In Tuesday’s Recommendation for Industry, we discussed the possibility of COVID transmission from packaging. Read more here.
• Nitric oxide boosts oxygen in pregnant women with COVID-19 pneumonia. Inhaled high-dose nitric oxide (INO²⁰⁰) safely shortened time on supplemental oxygen and hospital stays among pregnant women diagnosed as having severe bilateral COVID-19 pneumonia, suggests a new study led by Massachusetts General Hospital (MGH) researchers. INO²⁰⁰ recipients didn’t require oxygen for as many days as their standard-care counterparts (median days, 22 vs 24). And in multivariable-adjusted analyses, INO²⁰⁰ was tied to 63.2% (95% confidence interval [CI], 36.2% to 95.4%) more oxygen-supplementation-free days, a 59.7% (95% CI, 45.0% to 63.2%) shorter stay in an intensive care unit, and a 63.6% (95% CI, 55.1% to 70.8%) shorter hospitalization.
• The U.S. government will buy 3.2 million doses of Novavax’s COVID vaccine. Although the vaccine has not yet been authorized, it is expected to be soon. This would be the fourth vaccine available in the US. The company hopes that its protein-based shot, a vaccine technology that has been widely used for decades, will appeal to Americans who declined to be vaccinated with shots using messenger RNA technology. Novavax is still meeting the needs of FDA standards and is expected to finish its quality testing within the next few weeks.
• Most Americans say life is starting to return to normal, a poll shows. While 12 percent of adults think their life is the same as it was before the pandemic, 54 percent think their lives are somewhat the same, according to the poll and 34 percent think that their lives are not the same. According to the survey, a slim majority of 51 percent of Americans think that getting a COVID-19 vaccine is essential for them, while 39 percent think that nearly all people need to receive the vaccine before things can go back to the way they were. Only 22 percent think that wearing masks in public indoor places is essential to going back to pre-pandemic life, while 20 percent think regular testing is essential.

Influenza:

• The most recent data provided from CDC with the week ending in July 2 shows there were 0 jurisdictions with very high activity level, 1 with high, 2 with moderate, 2 with low, and 47 with minimal. Based on NCHS mortality surveillance data available on July 7, 2022, 8.8% of the deaths that occurred during the week ending July 2, 2022 (week 26), were due to pneumonia, influenza, and/or COVID-19 (PIC).

Public Health & Food Safety:

• An update from HealthMap.org shows that there was a 95% drop in whooping cough cases in the UK when comparing 2021 to 2020 which is likely due to the imposition of COVID-19 precautions.
• Officials note multiple sex partners as monkeypox risk: The European Centre for Disease Prevention and Control (ECDC) published its first update to its rapid risk assessment of monkeypox, saying that the likelihood of disease spread in people with multiple sexual partners in Europe is high, but the risk to the broader population is very low. Cases globally have reached 8,127, with the vast majority reported in nonendemic European countries, including Spain, Germany, and the United Kingdom. Beginning July 11^th, Jynneos vaccine will be made available for US states. From May 17 to Jun 30, Laboratory Response Network (LRN) within the US tested 2,009 specimens for suspected monkeypox, with 730 (36%) specimens from 395 patients showing positives.
• China links seven COVID-19 outbreaks to food packaging: Seven outbreaks and 689 cases were linked to imported cold-chain foods from June 2020 to mid-July 2021, according to the study in China CDC Weekly. Positive swabs came from seafood, poultry meat, and other foods. Outer packaging contamination by SARS-CoV-2 nucleic acid was much more common than inner packaging or the food itself. They added handlers and processors of imported frozen foods should be effectively protected, monitored daily for symptoms of COVID-19, and tested for SARS-CoV-2 nucleic acid at regular intervals. Another survey, published in the same journal, analyzed 56 million samples, 1,455 were positive for SARS-CoV-2 nucleic acid. Out of 1,398 SARS-CoV-2-positive food and packaging materials, all but seven were imported.
• Additive in Barry Callebaut chocolate Salmonella case came from Hungary. The contaminated raw materials that forced Barry Callebaut to halt chocolate production in Belgium came from Hungary. On July 1, Barry Callebaut confirmed that, based on its internal investigation, no affected products had entered the retail food chain and no implicated chocolate has been exported by the company outside Europe. Affected countries include Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Romania, Serbia, Spain, Sweden and the United Kingdom, according to a RASFF alert.
• Public health alert issued over rendered pork fat without federal inspection. FSIS was notified by the New York State Department of Agriculture and Markets that the rendered pork fat products were produced and shipped into commerce without the benefit of FSIS inspection.  These products are misbranded due to the unauthorized use of the marks of federal inspection. A recall was not requested because the products are no longer available for purchase. However, FSIS is concerned that some product may be in consumers’ refrigerators or pantries. Product subject to the public health alert: 1.8-lb. plastic containers of “MANTECA RENDERED PORK FAT DON PANCHITO;” the products bear establishment number “EST. 19900” inside the USDA mark of inspection.
• Bird flu eases in commercial poultry, but APHIS fears it could return in fall. A world snapshot for the period from May 19 through June 8 by the World Animal Health Information System of the World Organization for Animal Health also shows commercial poultry flocks in the United States have mostly escaped highly pathogenic avian influenza during the past month (HPAI) tapering off. A total of 384 flocks in 36 states have been struck in 2022 by the bird flu. A total of 186 commercial poultry flocks and 198 backyard flocks were infected. While the Animal and Plant Health Inspection Service remains concerned about the virus remaining in wild bird flyways during the summer with the risk of migrating birds bringing it back into the country this fall, it does see a break in the hectic action.