Changing virus poses challenges to updating Covid-19 vaccines

FDA photo

Efforts to update Covid-19 vaccines are struggling to keep up with mutations in the novel coronavirus, raising the question of whether updated vaccines will be outdated by the time they become available this fall, Caitlin Owens reports for Axios. This challenge comes as clinical trials are studying new versions of the Pfizer and Moderna vaccines and the crunch for the U.S. Food and Drug Administration to decide whether to allow them to be recommended later this year, Owens notes.

Moderna announced June 8 that preliminary data shows that its new booster vaccine has demonstrated superior antibody response against the Omicron variant, making it their lead candidate for a booster in the fall. The FDA has set a meeting in late June to evaluate data from clinical trials, PBS NewsHour reports.

Vaccine makers face many challenges in keeping up with recent mutations that appear to be more immune-resistant than the original Omicron variant, Owens writes, citing a study that found the latest Omicron subvariants are more likely to evade the immunity gained from being infected by Omicron.

Another challenge, Owens reports, is that the virus keeps changing in the time it takes to collect data on a new vaccine's effectiveness and mass-produce it.

Right now, "Three doses of the existing vaccines are still very good at preventing severe disease and death, despite the drop in effectiveness against infection," Owens reports. However, "If a more dangerous variant that requires new vaccines emerges, the current situation suggests that very tough choices will have to be made."

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6 children in 5 Ky. counties have hepatitis from unknown cause(s)

Photo from healthline.com

By Melissa Patrick
Kentucky Health News

Six cases of hepatitis from an unknown cause have been reported in Kentucky, in children between 8 months and 4 years old.

The cases, which are under investigation, have been reported in these counties: Jefferson, with two possible cases; Todd, Lyon, Bourbon and Meade, Sarah Ladd reports for the Louisville Courier Journal. 

Hepatitis is an inflammatory condition of the liver that is usually caused by a viral infection. The Centers for Disease Control and Prevention says it is not unusual for the cause of hepatitis in children to remain unknown, but a growing number of cases has prompted an investigation. 

Nationally, health officials are looking into 274 potential cases of hepatitis with unknown origin in children in 39 states, according to the latest CDC data. 

Health Commissioner Steven Stack said Thursday that while the cause is unknown, the cases are not related to the common causes of hepatitis or Covid-19 and could possibly be linked to the Type 41 adenovirus, which he described as a common virus that causes cold and flu-like symptoms.  He said two of Kentucky's six cases have been linked to the adenovirus.

And while there is no cause for alarm at this time, Stack said. families with children who have yellow skin and eyes, vomiting and diarrhea and abnormal blood tests should seek medical care from a pediatric specialist in a timely fashion. 

"This is not something for you to panic about, or to get excessively alarmed about but it is something for you to be careful about," he said.

He added that while it's important to get a diagnosis, there is no specific treatment for adenovirus and that severe cases could require hospitalization or ongoing evaluation from a pediatrician. 

Stack said parents need to be aware that these are illnesses that can spread through the respiratory system or through body fluids and to take precautions. 

"So for parents right now, the important thing is to constantly educate and train children to wash your hands, cover your cough, and make sure they're vaccinated for all preventable diseases through the pediatricians office or the health department. And just to pay careful attention their child," he said. 

There have been 650 probable cases of hepatitis with unknown cause in children in 33 nations between April 5 and May 26 and at least 38 of them needed liver transplants and nine of them died, according to the World Health Organization. 

Stack said none of the six children in Kentucky with this condition have needed liver transplants.

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Beshear signs executive order to activate price-gouging laws for baby formula, which remains in short supply

Beshear signs executive order (Photo via Facebook)

By Melissa Patrick
Kentucky Health News

Gov. Andy Beshear signed an executive order Thursday declaring a state of emergency in order to apply state price-gouging laws for baby formula. 

“By implementing our price-gouging laws, we can make sure that families are not being charged more than they should to obtain a critical supply of formula to feed their baby,” Beshear said at his weekly news conference.

Beshear said Attorney General Daniel Cameron has not reported any claims of price gouging, or requested that the price gouging laws be activated, but other states have reported such claims and have taken steps to address them. 

Beshear encouraged any families who have experienced price gouging to contact Cameron's office. That can be done by calling 502-695-5485 or by filling out a price-gouging complaint form. 

Cameron encouraged those who use the form to report as many details as possible about the suspected gouging, including the name and address of the seller or retailer, the item purchased, the price of the item after the emergency declaration and the price of the item before the emergency declaration, if known. And if consumers are seeking a refund, he said they should keep receipts to show proof of purchase. 

“As parents, Makenze and I recognize the incredible stress and fear that the shortage is causing Kentucky families, and our office will use the full force of the law to ensure that the price charged for essential products like baby formula is no more than the law allows," Cameron said in a news release. 

Beshear acted a week after Kentucky lawmakers met to discuss the baby formula shortage, and Rep. Kim Moser, R-Taylor Mill, called in an opinion article for him to address price-gouging issues. 

State Health Commissioner Steven Stack encouraged families who are struggling to find baby formula to seek support from a number of agencies.  

“The infant formula shortage has caused worry and frustration for Kentucky’s families as they have sought to provide nutrition to our most precious citizens,” Stack said in a news release.  “We encourage families to reach out to all available resources in their community, including local health departments, pediatricians, food pantries, community action councils and other supporting agencies to meet the nutritional needs of their infants and to ensure they thrive. We also encourage all eligible families to enroll in WIC or SNAP to help during this shortage.”

Women, Infants and Children nutrition benefits are available to Kentucky residents who are pregnant, breastfeeding or have a child 5 or younger and have household income of no more than 185% of the federal poverty level, with rules governing what counts as income. Anyone who receives Medicaid or is part of the Supplemental Nutrition Assistance Program (SNAP, formerly food stamps) automatically meets income requirements for WIC. Click here for a WIC pre-screening Tool to see if you are eligible.

Cameron warned families to guard against baby formula scams and encouraged Kentuckians to only purchase baby formula from known, reputable sources; to use a credit card to make the purchase if possible; to avoid paying for formula up front if purchasing from an unknown source; and to be suspicious of sources advertising formula at prices that are too good to be true. Any suspected scams can be reported to ag.ky.gov/scams.

The shortage is largely the result of of violations at Abbott Nutrition's Michigan factory that caused the U.S. Food and Drug Administration to shut it down in February. The investigation was prompted by four bacterial infections in infants who had consumed formula from the plant. Abbot has up to 40% of the formula market in the U.S.

Abbott announced June 4 that it had resumed production at the factory after meeting initial requirements agreed to with the FDA in a consent decree May 16.

But that doesn't mean an immediate end to the shortage. Abbott says its priority is production of EleCare, a special formula for children with multiple allergies, before it ramps up production of its other products. The initial EleCare product is expected to be released "on or about June 20," Abbott's release said.

Some relief is also expected from oversea shipments of non-specialty baby formula. On June 6, President Biden announced that his administration had sourced a flight through the Operation Fly Formula initiative. His administration says the delivery will include Nestlé NAN SupremePro Stage 1 infant formula and that additional deliveries will be announced soon.

FDA Administrator Robert Califf told lawmakers on May 26 that the baby formula shortage in the U.S. will likely not be resolved until late July.

The latest dataset from Datasembly, a retail data firm, for the week ending May 29th shows a 73% out-of-stock rate for baby formula nationally and a 76% out-of-stock rate for Kentucky. 

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UK gets $3.7 million grant to find out why Appalachian Kentucky is so sleep-deprived, part of 'public-health epidemic' cited by CDC

By Elizabeth Chapin
University of Kentucky

The University of Kentucky has received a $3.7 million grant from the National Institutes of Health to find out why people in the Appalachian region of Kentucky have such consistently poor sleep outcomes.

Poor sleep is linked to a wide range of medical issues, including hypertension, diabetes, depression, obesity and cancer. With more than a third of U.S. adults reporting insufficient sleep, the Centers for Disease Control and Prevention calls a "public-health epidemic."

Kentuckians are some of the nation’s most sleep-deprived, particularly in the state's Appalachian counties, where 25% to 58% of adults report insufficient sleep, defined as less than six hours a day.

Over five years, the team will track the sleep of 400 adults from Appalachian Kentucky, along with health information such as heart rate, physical activity, blood sugar levels, and immune function. Participants will also report their daily experiences including stress and substance use.

Participants will come from 12 Appalachian counties: six coalfield counties that have been identified as insufficient sleep hotspots (Pike, Knott, Perry, Letcher, Bell and Whitley), and six non-coal counties that are not considered hotspots (Jackson, Lincoln, Russell, Adair, Rockcastle and Estill) even though they have comparable economic distress, rurality, and demographics.

Researchers will look for what drives sleep deficiencies and health outcomes over time, how factors linked to sleep deficiencies differ between hotspot and non-hotspot counties, and the degree to which daytime distress affects sleep.

Ph.D.s Christal Badour and Mariead Moloney

The study, titled "Researching Equitable Sleep Time in Kentucky Communities (REST-KY)," is led by Associate Professors Mairead Moloney and Christal Badour.

It aims to provide answers to longstanding questions about the causes and consequences of sleep deficiencies in rural populations, not just Appalachia. But the new knowledge will inform interventions to reduce sleep disparities among people in Appalachia, who also experience severe health inequities including higher mortality rates for many conditions including diabetes, heart disease and cancer.

“Sleep is the critical pivot point for understanding ways in which people in this region experience health disparities,” said Badour. “If we can understand why people are getting poor sleep, we can then identify interventions that can help them sleep better, which would have cascading benefits for many aspects of their health.”

The REST-KY team includes experts across four UK colleges: Badour, Moloney, Suzanne Segerstrom and Lauren Whitehurst from the College of Arts and Sciences, Daniela Moga from the College of Pharmacy, Nancy Schoenberg from the College of Medicine, and Emily Slade from the College of Public Health.

“This collaboration of experts across so many disciplines will enable us to get a holistic look at the biological, behavioral, emotional, and social contributions to sleep health,” Moloney said.

The REST-KY grant is one of NIH’s prestigious “R01” awards. It builds on the team’s previous interdisciplinary research, including a 2018 intervention study to address insomnia among women in Appalachian Kentucky.

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All of Kentucky's Covid-19 metrics rose last week; state has attributed the deaths of more than 16,000 Kentuckians to the virus

Kentucky Health News graph, from state Department for Public Health data

By Melissa Patrick
Kentucky Health News

All of the metrics to measure the coronavirus in Kentucky crept up in the last week, and the state passed the mark of 16,000 Kentuckians dying from the virus since the pandemic came to Kentucky in March 2020. Nationwide, that number is more than 1 million.

The state's weekly report shows the share of Kentuckians testing positive for the virus in the last Monday-to-Sunday reporting period has gone up for nine straight weeks, from a low of 1.97%. This week's rate rose to 12.42% from 11.21%. The figures do not include results from home tests. 

The report showed 9,761 new cases of the virus, an average of 1,394 per day. That's 37% more than the week before, when the rate was 1,020 cases per day. Of the new cases, 12% of them were in people 18 and younger. 

The statewide incidence rate is 23.97 cases per 100,000 residents, up from 21.68 the week before. Elliott County, with 57 cases per 100,000, and Crittenden County, with 48.7, are the only counties with rates more than double the statewide rate; the next 10 are Clark, 46.1; Lewis, 43; Woodford, 42.2; Boyd, 41.6; Greenup, 39.5; Carter, 38.9; Ballard, 36.2; Fayette, 36.1; Jefferson, 35.9; and McCracken, 35.6.

The New York Times ranks Kentucky's infection 31st among the states and Washington, D.C., with a 15% drop in cases in the last 14 days. 

The state reported 59 more Covid-19 deaths last week, an average of 8.4 per day. The previous week had 37 and 5.29 per day, The state's pandemic death toll is now 16,004. 

Kentucky's Covid-19 hospitalization numbers remain low, although they are a bit higher than last Monday's report. Kentucky hospitals reported 299 patients with Covoid-19 Monday, up from 234 a week ago, with 34 in intensive care (up five) and 17 on mechanical ventilation (up eight). 

Statewide, 74% of intensive-care beds are in use. The Northern Kentucky hospital region is using 100% of its beds, but only 4.4% are being used by Covid-19 patients.

This week's Centers for Disease Control and Prevention national Covid-19 risk map places seven Kentucky counties in the red, indicating a high level of coronavirus transmission, and 21 of them in the yellow, indicating a medium level of transmission. The map is updated every Thursday evening.

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Madison County OD deaths up 27%, twice the state gain; coroner says he has told one mother about deaths of three of her children

A preliminary federal report shows drug overdose deaths in Kentucky rose 13.55% in 2021, to an estimated 2,391 deaths. It also shows that again, opioids and synthetic opioids, such as fentanyl, were the two main contributors.

Coroner Jimmy Cornelison
(Madison County website photo)

County figures will be released in the annual state report in a few weeks, but county coroners keep a running count, and they can tell the story of how such deaths impact a community. Madison County Coroner Jimmy Cornelison told Lexington's WKYT-TV a bit of that story.

Cornelison told reporter Jeremy Tombs that he knocks on the doors of families to tell them they’ve lost loved ones.

“I’ve done a family where I did three children in that same family,” he said. “Three times I hugged that mother; three times.” 

Madison County saw 75 people die from a drug overdose in 2021, up 27 percent from the 59 OD deaths recorded in 2020, WKYT reports. Cornelison added that these numbers don't show the full scale of the problem.

He told Tombs that one problem is that Madison County, is along Interstate 75, “so you can hop on, hop off. Stop in Richmond and sell your goods, meet somebody in a parking lot and be gone in 10 minutes.”

Cornelison said that while he didn't see a way out of this worsening situation, it's important to not give up on people who have a drug problem. “We have to invest in these folks. Number one invest in keeping them clean,” he said. “Find them something to do, get them a job.”

First responders help curb overdose deaths by carrying Narcan, a drug that blocks the effect of opioids. Cornelison told WKYT that his county's overdose death numbers would likely be one-third higher if it weren’t for the pre-hospital care some people receive.

People who are struggling with drug abuse or who are concerned about a family member's substance use can search for treatment providers at www.findhelpnowky.org.

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Commission named to award grants from state's half of $483 million opioid settlement; local governments will get the other half

By Al Cross

Kentucky Health News

Attorney General Daniel Cameron has named the people who will oversee the state's half of the $483 million settlement it reached with opioid manufacturers and distributors. The Opioid Abatement Advisory Commission will meet twice a year to approve awards from the settlement fund and will have an executive director, W. Bryan Hubbard, appointed by Cameron from his staff.

Bryan Hubbard

Hubbard, a lawyer, has overseen Cameron's Medicaid fraud unit. In the Matt Bevin administration, he ran the state agency that handles Social Security disability and child-support enforcement.

“Bryan has dedicated his career to the welfare of Kentucky families and children, and he intimately understands the ripple effects of the opioid crisis in the commonwealth,” Cameron said. “I know that he will guide the work of the commission with a steady hand and ensure that the settlement funds are distributed to meaningful opioid abatement initiatives.”

Hubbard will be a member of the commission "representing victims of the opioid crisis," as described in the 2021 law creating the commission. The commission members mandated by the law are Cameron, who will serve as chair; state Treasurer Allison Ball, and Cabinet for Health and Family Services Secretary Eric Friedlander, who works for Gov. Andy Beshear, a fellow Democrat. The others are Republicans (Cameron is running to unseat Beshear in 2023) and so is Rep. Danny Bentley of Russell, appointed as a non-voting member by House Speaker David Osborne. The other non-voting member, appointed by Senate President Robert Stivers, is Karen Kelly, district director for U.S. Rep. Harold "Hal" Rogers, R-Somerset, and former director of his Operation UNITE anti-drug initiative.

The other members, filling seats specified by the law, are state Office of Drug Control Policy Director Van Ingram, representing the drug treatment and prevention community; Vic Brown, representing law enforcement; Karen Butcher, representing citizens at large; Von Purdy, representing citizens at large; Dr. Jason Roop, representing victims of the opioid crisis; and Dr. Sharon Walsh, representing the HEALing Communities Study at the University of Kentucky, which appointed her. The press release from Cameron's office didn't further identify the other members, and the office did not respond to a request for the information.

The release said the commission will hold its first meeting "in the coming days" and establish a framework for distributing funds. The other half of the settlement will go to local governments and be distributed "in accordance with an agreement reached among them," the law says. "If no such agreement is reached, the money shall be paid to a trustee appointed jointly by the Kentucky Association of Counties and the Kentucky League of Cities for distribution of the funds."

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