- In today’s Recommendation for Industry, we discuss the westward movement of COVID and increase of BA.4 and BA. 5 in the U.S. Read more below.
- Reporting Home COVID Test Results Can Be Confusing. Here’s How to Do It. The Centers for Disease Control and Prevention “strongly encourages” everyone who self-tests to report their positive results to a health care provider, who may order a P.C.R. test or otherwise report the data to state authorities. But only a few state health departments, including those in Colorado and Washington, collect data from home tests. Others, like in Massachusetts and New York, allow individual county health departments to decide whether they want to collect home test results. The result is that official case counts are becoming an increasingly unreliable measure of the virus’s true toll.
- Moderna’s Omicron-targeted booster shot shows promise. Moderna announced on Wednesday that data from its study on Omicron-containing bivalent booster, revealed that it offers superior antibody response against Omicron – one month after injection – compared to the company’s current vaccine. Moderna plans to propose this new booster to the FDA soon. The geometric mean titer (GMT), a measure of antibody response, was 2,372 for the bivalent vaccine against Omicron, compared with 1,473 for the original Moderna vaccine.
- FDA advisers recommend authorizing Novavax coronavirus vaccine. A panel of independent vaccine experts recommended Tuesday that the Food and Drug Administration authorize a coronavirus vaccine developed by the Maryland biotechnology company Novavax, paving the way for the fourth shot in the United States. There is not yet a date that this vaccine will become available because the FDA must review data in regard to manufacturing. The Novavax shot is a protein-based vaccine from traditional technology used against influenza and shingles. Many scientists believe that the creation of this vaccine will potentially help convince individuals to take this vaccine because it is closely related to traditional vaccines.
Public Health & Food Safety:
- CDC raises travel alert level for monkeypox. The CDC raised the monkeypox travel alert to level 2 which warns Americans to practice enhanced precautions when traveling to both endemic and non-endemic countries that are experiencing outbreaks. The agency said 29 countries have reported 1,019 infections of the poxvirus as of yesterday. The United States has 31 cases of the virus so far in 13 states, according to CDC data. New York has 7 monkeypox cases, and California has 6.
- FDA Launches Campaign Aimed at Preventing E-Cigarette Use Among American Indian/Alaska Native Youth. “Next Legends” Youth E-cigarette Prevention Campaign as part of the agency’s ongoing efforts to protect youth from the dangers of tobacco use. The campaign will educate American Indian/Alaska Native (AI/AN) youth, ages 12-17, about the harms of vaping. 47.3% of AI/AN high school students reported past 30-day use of “electronic vapor products” including e-cigarettes compared to 32.7% of high school students overall.
- No, you’re not imagining it — package sizes are shrinking. From toilet paper to yogurt and coffee to corn chips, manufacturers are quietly shrinking package sizes without lowering prices. It’s dubbed “shrinkflation,” and it’s accelerating worldwide. In the U.S., a small box of Kleenex now has 60 tissues; a few months ago, it had 65. Chobani Flips yogurts have shrunk from 5.3 ounces to 4.5 ounces. Global consumer price inflation was up an estimated 7% in May, a pace that will likely continue through September, according to S&P Global.
- Researchers hope to develop rapid pathogen testing for poultry. Researchers at Michigan State University are working on a rapid testing cell phone method to detect bacteria on poultry that causes human illnesses such as infections from Salmonella and Campylobacter. Currently it can take days for culture testing to identify bacteria on poultry, according to researchers, and some modern rapid tests are extremely expensive and require training. The goal is to create rapid tests that are inexpensive and accessible, and easy enough to use that people from many different industries can implement them.
- Nine baby deaths reported to FDA during Abbott Nutrition investigation. Between December 1, 2021, and March 3, 2022, the US Food and Drug Administration (FDA) received nine (9) reports of infant deaths among babies who were fed powdered infant formula manufactured by Abbott Nutrition in Sturgis, Michigan. The infections some of the babies had were: Cronobacter sakazakii and Proteus mirabilis, COVID-19, CDIFF (Clostridioides difficile), Salmonella, Shigella, astrovirus, and “shigelloides.”
Recommendations for Industry
COVID U.S.: Surge Moving Westward; BA.4 and BA.5 Increasing
Both TAG’s weekly matrix and the latest CDC Community Map (below) are showing some increase in COVID-19 levels, particularly in the Central and Western U.S. As we’ve been stating, there is a definite swing in cases with the surge continuing to shift westward. While it is causing an impact in states it hits, it is not setting alarming rates or causing excessive community risk as earlier surges did.
One thing we are seeing is that the Omicron variants BA.4 and BA.5 are increasing in the US (as also shown below). This is relevant because those infected with BA.1 are susceptible to reinfection with BA.4 and BA.5. This means that those infected in January and February are likely at risk of reinfection this summer and beyond, meaning those who have enjoyed some level of immunity for the past four or five months should be aware of their risk of reinfection and consider taking appropriate precautions in higher risk settings (crowded or poorly ventilated indoor spaces).
Compared to last week which had 22 states with a TPR≥10%,CR≥25 cases/100K, this week only 20 states have a TPR≥10%,CR≥25 cases/100K. However, as we’ve observed with time and as the wave seems to be moving across the U.S., we are seeing higher trends in states like Nevada and Utah (TPR: 26%, CR: 38 cases & 26 cases/100K, respectively.) as well as Arizona at 22% (CR: 26 cases/100K) which had not been as high in the previous weeks. Additionally, states like Hawaii, North Carolina, and Florida, while trending high in both case rates and test positives rates, are slightly lower.
In case you missed it:
- In Tuesday’s Recommendation for Industry, we discussed defending against infectious disease. Read more here.
- COVID-19 vaccine during pregnancy may protect infants. The COVID-19 vaccination has shown through a study performed by JAMA Internal Medicine that it can protect babies for their first 4 months of life. Protection for infants was 33% during the Omicron surge.
- US and other nations track shifts in COVID-19 activity, reported by CIDRAP. The overall pace of COVID-19 activity in the United States has showed some signs of leveling off, with the disease burden indicating a shift from east to west. On Tuesday, the FDA is meeting to discuss emergency use of the Novavax COVID vaccine. Uganda’s and France’s cases are rising while China’s seem to be on a downward trend.
- The U.S. has wasted over 82 million COVID vaccine doses. This number has increased from 65 million doses in February that was reported by the CDC. Two retail pharmacy chains, CVS and Walmart, were responsible for over a quarter of the doses thrown away in the United States in that time period. The millions of wasted vaccine doses included some that expired on pharmacy shelves before they could be used, others that were spoiled by the thousands when power went out or freezers broke, and still others that were tossed at the end of the day when no one wanted the last few doses in an opened vial.
- Why boosted Americans seem to be getting more COVID-19 infections. For the week of April 23, the rate of COVID-19 infections among boosted Americans was 119 cases per 100,000 people. That was more than double the rate of infections in those who were vaccinated but unboosted, but a fraction of the levels among unvaccinated Americans. That could be because there is a “higher prevalence of previous infection” right now among those who are unvaccinated and unboosted, the CDC said. More boosted Americans may now have abandoned “prevention behaviors” like wearing masks, leading to an uptick. Some boosted Americans might be more likely to seek out a lab test for COVID-19, as opposed to relying on over-the-counter rapid tests that go largely unreported to health authorities.
- Pfizer Portage, MI facility to produce oral COVID-19 treatment, create hundreds of jobs. Pfizer will make history as the first U.S based manufacturing facility to support the production of the oral COVID-19 treatment, Paxlovid. Paxlovid is used to treat mild-to-moderate COVID-19 in adults and kids 12 years old and older, who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid has not been approved by the U.S Food and Drug Administration, however it was authorized for emergency use.
- Reported by HealthMap.org: The flu season is getting off to an early start in Australia and New Zealand, with numbers of cases being reported that are higher than what’s been seen in recent years. Calls to encourage vaccination are going out.
- The CDC reports this week that 1 jurisdiction experienced moderate activity and 4 jurisdictions experienced high or very high activity. Seasonal influenza viruses continue to circulate, and activity is increasing in parts of the country. The percentage of outpatient visits due to respiratory illness decreased slightly over the past two weeks. Influenza is contributing to levels of respiratory illness, but other respiratory viruses are also circulating.
Public Health & Food Safety:
- Hepatitis update provided by HealthMap.org: In the ongoing hepatitis outbreak of unknown origin, as of May 27, 33 countries and regions around the world have reported 650 suspected cases of acute hepatitis in children of unknown etiology to WHO, of which at least 38 require liver transplantation. There have been nine deaths.
- Experts highlight sexual aspect of monkeypox spread. Researchers on Tuesday at a World Health Organization (WHO) meeting spelled out the sexual transmission component of a monkeypox outbreak that has affected hundreds of people—mostly men who have sex with men—in at least 27 countries outside of Africa. The Centers for Disease Control and Prevention (CDC) confirmed another case in the United States, bringing the total to 19, but news reports in both Atlanta and Los Angeles suggest officials in those cities have suspected the virus in residents. Globally, the monkeypox outbreak in nonendemic countries continues to grow, with more than 780 cases reported in the last 3 weeks. So far, 27 countries have reported cases.
- Abbott resumes production of infant formula under strict eye of FDA. Abbott Nutrition has resumed operations at its baby formula plant which was shut down by the FDA in mid-February because of dirty conditions and a link to a cronobacter outbreak that saw two babies die. Product won’t be available for 6 weeks. The plant in Sturgis, MI, had to meet “hundreds” of requirements before reopening according to Food and Drug Administration Commissioner Robert Califf who testified before a congressional panel in late mid-May.
- Project looks at how to modernize meat inspection. Meat inspection in the United Kingdom can be changing in the future. A project assessed the feasibility of using sensor technologies and advanced data analytics for poultry inspection. It focused on post-mortem inspection and included technologies such as visual, near-infrared, infrared and hyperspectral, X-ray and ultrasonic as well as IT-enabled benefits. Despite technology, a meat inspector would be needed to identify other conditions or to remove birds from the line and place them in the correct category bin.
- Study assesses link between inspection results and outbreaks. Institutional catering services that had significantly poorer inspection results detected outbreaks more likely. Restaurants didn’t tend to have a correlation between inspection results and outbreaks.