Key Points:

• In today’s Recommendation for Industry, we discuss the continued westward movement of COVID in the U.S. Read more below.
• BA.4/5 COVID-19 variants now dominant in all US regions. Combined, the two subvariants make up more than 70% of recently sequenced samples, up sharply from 52.3% the previous week. Of the variants CDC is tracking, BA.5 now makes up 53.6%, and BA.4 makes up 16.5%. In global developments, virologists are closely watching another Omicron variant called BA.2.75 that appears to be competing with BA.5 in India. So far, BA.2.75 hasn’t been designated as a variant of interest or a variant of concern.
• Coronavirus (COVID-19) Update: FDA Authorizes Pharmacists to Prescribe Paxlovid with Certain Limitations. July 6, 2022, the FDA revised the Emergency Use Authorization (EUA) for Paxlovid, to authorize state-licensed pharmacists to prescribe Paxlovid to eligible patients (COVID positive individuals 12 years of age and older weighing at least 40 kilograms or about 88 pounds), with certain limitations to ensure appropriate patient assessment and prescribing of Paxlovid. Patrizia Cavazzoni, M.D., director for the FDA’s Center for Drug Evaluation and Research stated, “since Paxlovid must be taken within five days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients who are eligible to receive this drug for the treatment of COVID-19.” There are some limitations for receiving Paxlovid that can be found here. To receive Paxlovid, a positive COVID individual should bring the following to a state-licensed pharmacist:
  • Electronic or printed health records less than 12 months old, including the most recent reports of laboratory blood work for the state-licensed pharmacist to review for kidney or liver problems. State-licensed pharmacists could also receive this information through a consult with the patient’s health care provider.
  • A list of all medications they are taking, including over-the-counter medications so the state-licensed pharmacist can screen for drugs with potentially serious interactions with Paxlovid.

• COVID-19 third leading cause of death in 2020, 2021– In the first 20 months of the COVID-19 pandemic, the disease accounted for one in eight deaths and was the third leading cause of death in the United States, according to a study published in JAMA Internal Medicine. From March 2020 to October 2021, COVID-19 was one of the top five causes of death in every age group 15 years and older. Overall, the leading causes of death during this time frame was heart disease (20.1%), followed by cancer (17.5%), COVID-19 (12.2%), accidents (6.2%) and stroke (4.7%). In 2020, COVID-19 was the fourth leading cause of death for those aged 45 to 54 years and the fifth leading cause for those aged 35 to 44 years, but it jumped to the first and second leading causes of death in these age groups in 2021. Among adults aged 85 years and older, COVID-19 was the second leading cause of death in 2020 (12.8%) and the third leading cause in 2021 (8.9%).
• COVID-19 Vaccine Doses, Once in High Demand, Now Thrown Away. Governments, drugmakers and vaccination sites are discarding tens of millions of unused COVID-19 vaccine doses amid sagging demand, a sharp reversal from the early days of the mass-vaccination campaign, when doses were scarce. Moderna recently discarded about 30 million doses while there were no takers for it. Germany’s health officials have disposed of about 3.9 million COVID-19 vaccine doses that were sitting in a federal central warehouse and expired at the end of June. Canada has disposed of 1.2 million expired doses of Moderna’s vaccine, and is set to throw out about 13.6 million expired doses of AstraZeneca PLC’s COVID-19 vaccine, according to the government health department. Demand for vaccines may pick up in the fall as those shots will be targeted to prevent against the Omicron variant. On July 6, the U.S. government agreed to purchase 105 million doses of a modified vaccine from Pfizer and BioNTech for a fall booster campaign.

Public Health & Food Safety:

• Study on monkeypox outbreak shows differing symptoms. A new study published in The Lancet Infectious Diseases found that the clinical profile in recent monkeypox cases is different than in past events, with fatigue and fever less common and genital skin lesions more likely. Men who have sex with men (MSM) has played an important role in the  reporting of such symptoms. In the study, 47 of 52 men who answered questions on recent sexual history said they had at least one new sexual partner in the 3 weeks prior to symptoms, and 29 of 52 (55.8%) had more than 5 new partners in the 12 weeks prior to diagnosis. Almost all (49/52) patients presented with lesions and rashes on their genitals or anal regions. Only five patients required hospitalization, and no one died. One-quarter of the patients also were diagnosed with another sexually transmitted infection at the same time as monkeypox. US cases of monkeypox are continuing to grow, with Iowa, Wisconsin, and Connecticut reporting their first cases of the virus. According to the Centers for Disease Control and Prevention, the country has 460 cases in 32 states. California currently reports the most cases in the country with 95.
• Global monkeypox cases top 6,000, WHO says. The World Health Organization (WHO) confirmed the global outbreak of monkeypox consists of 7,075 confirmed cases, with 80% in European countries. The European Centre for Disease Prevention and Control (ECDC) and the WHO released a new toolkit aimed at event organizers who wish to minimize the spread of monkeypox at large gatherings. Labcorp will be able to test for monkeypox virus, doubling the nationwide capacity for testing, according to the US Centers for Disease Control and Prevention (CDC).
• FDA Developing New Framework for Continued, Expanded Access to Infant Formula Options for U.S. Parents and Caregivers. The FDA has prioritized review of requests from firms that can: 1) produce documentation to demonstrate the safety and nutritional adequacy of the product; 2) make the largest volume of product available; and/or 3) get product onto U.S. shelves quickly. The FDA intends to consider enforcement discretion requests until the temporary shortage is addressed. To date the FDA’s flexibilities have resulted in a total estimated quantity of more than 400 million, 8-ounce bottles worth of formula from nine countries for children in the U.S. The enforcement discretion described in the May guidance is set to remain in effect until Nov. 14, 2022. Additionally, the FDA intends to:
  • Provide a single technical assistance contact at the FDA for any company aiming to enter the U.S. infant formula market, making it easier for potential new entrants to navigate the FDA’s regulatory review process.
  • Host meetings this summer with companies that import, sell, and/or distribute formula under the FDA’s temporary enforcement discretion policy to determine what additional steps would be needed to provide a pathway to long-term, uninterrupted marketing for safe and nutritious formula.
  • Provide a pathway for companies that import, sell, and/or distribute formula under the FDA’s temporary enforcement discretion policy to continue to supply infant formula to the U.S. past November.
• FDA completes Food for Animals Guidance as required by FSMA. The U.S. Food and Drug Administration on Wednesday finalized Guidance for Industry (GFI) #245: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals to help animal food facilities subject to the FDA Food Safety Modernization Act (FSMA) Hazard Analysis and Risk-Based Preventive Controls for animal food requirements develop a food safety plan to prevent or significantly minimize hazards that could cause illness or injury to people or animals.

Recommendations for Industry

Current Status & Trajectory of COVID

For the last few months, TAG’s COVID matrix assessments have discussed the steady U.S. movement of COVID cases from East to West. That migration is now also clearly depicted in the four-week comparison of CDC Community Level maps (shown above). It also is important to note, however, that while the maps show growing areas of yellow (medium) and red (high) levels due to the newer Omicron strains, the numbers of daily new cases in the U.S. are still significantly lower than they were earlier in the year, and at other high points of the pandemic, as shown in the worldometer graph below, but this does not mean the pandemic is over or that precautions should be stopped.

In case you missed it:

• In Tuesday’s Recommendation for Industry, we provided current updates and recommendations on COVID and Monkeypox transmission. Read more here.
• 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.
• The 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.