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Monday, January 31, 2022

Diabetes deaths exceed 100,000 in US for second straight year

 

  • Diabetes deaths have exceeded 100,000 in the United States for the second consecutive year.
  • Approximately 37 million Americans have diabetes, while 96 million U.S. adults are prediabetic.
  • Those who struggle to control their diabetes are twice as likely to die of COVID-19.

Diabetes deaths have exceeded 100,000 in the United States for the second consecutive year, according to a report by Reuters.   

Reuters analyzed exclusive data from the Centers for Disease Control and Prevention (CDC) to compare the number of diabetics and diabetes-related deaths in the U.S. over recent years.   

Diabetes was the seventh-leading cause of death in the U.S. in 2019 and was responsible for more than 87,000 deaths. In 2020, deaths due to diabetes increased by 17 percent from 2019, to more than 100,000 deaths. In 2021, diabetes-related deaths also surpassed 100,000, increasing 15 percent from 2019. This data excludes deaths of diabetics that were ruled to have been caused by COVID-19.   

"The large number of diabetes deaths for a second year in a row is certainly a cause for alarm," Paul Hsu, an epidemiologist at UCLA's Fielding School of Public Health, told Reuters. 

The exponential costs diabetes patients face to acquire doctor's visits and medications has forced many to ration their insulin — a hormone that regulates blood glucose levels, used as a drug to manage diabetes — or forgo the necessary treatments altogether. Insulin costs on average 800 percent more in the U.S. than in similar developed countries.   

President Biden’s Build Back Better Act includes provisions to cap the cost of insulin at $35. However, the plan is facing criticism from patients and advocates, as it only applies to patients using Medicare or those who have private group or individual health insurance plans.  

Approximately 37 million Americans, or 11 percent of the U.S. population, have diabetes, while 96 million U.S. adults are prediabetic, and the numbers continue to rise.    

The increasing number of Americans who have diabetes, coupled with the struggles to purchase insulin and access medical treatment has left diabetics at a greater disadvantage amid the coronavirus pandemic. According to the report, those who struggle to control their diabetes are twice as likely to die of COVID-19.   

Meanwhile, further job losses due to the coronavirus pandemic has only further complicated diabetes patients’ efforts to afford their medications and medical needs.   

"People with diabetes and other chronic illnesses were already facing challenges well before the pandemic hit, and COVID has only made these problems worse," Sen. Patty Murray (D-Wash.), chairwoman of the Senate Health Committee, told Reuters in a statement. "It is absolutely crucial to research and find solutions to better support diabetes patients and get them the care they need."

https://thehill.com/changing-america/well-being/prevention-cures/592114-diabetes-deaths-exceed-100000-in-us-for-second

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Novavax Requests Emergency Use Authorization for COVID-19 Vaccine

  Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that it has submitted a request to the U.S Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) for NVX-CoV2373, its protein-based COVID-19 vaccine candidate for immunization of individuals 18 year of age and older against SARS-CoV-2.

The request for EUA is based on the totality of pre-clinical, clinical and manufacturing-related (CMC) data provided to the agency, including results of two large pivotal clinical trials that demonstrated an overall efficacy of approximately 90 percent and a reassuring safety profile.

https://finance.yahoo.com/news/novavax-submits-request-u-fda-184200011.html

Humacyte: Clinical Case Series Shows Potential of Human Acellular Vessel

  Outcomes of first eight compassionate use cases presented at 46th Annual Winter Meeting of the Vascular and Endovascular Surgery Society –

– HAV observed to maintain patency and resist infection in the treatment of critical limb ischemia, infection and vascular trauma –

– All patients lacked suitable alternative conduit options –

https://finance.yahoo.com/news/humacyte-announces-clinical-case-series-123000043.html

Daiichi makes play for share of Japan’s COVID booster market

 Daiichi Sankyo has stepped up its efforts to bring a Japanese COVID-19 vaccine to patients, starting a new clinical trial of its mRNA-based candidate DS-5670 that focuses on its use as a booster dose.

The Japanese group says it hopes to complete clinical development of the vaccine and bring it to market in Japan before the end of the year.

Daiichi Sankyo started human testing of the shot in March 2021, with preliminary results in studies involving 142 healthy adults showing no safety concerns after two doses, as well as increases in SARS-CoV-2 neutralising antibodies.

The vaccine has previously been shown to be effective against the Delta variant of SARS-CoV-2, and new lab studies suggest it has activity against Omicron “to a certain extent” when used as an initial vaccination regimen, with a third dose boosting neutralising antibodies against the new strain.

Now, Daiichi Sankyo is moving ahead with a fast-track phase 1/2/3 study that will involve Japanese adults, including elderly subjects, who will receive DS-5670 as a booster at least six months after primary immunisation using COVID-19 vaccines approved in Japan.

The country’s vaccination programme has been carried out using AstraZeneca’s Vaxzevria, Pfizer/BioNTech’s Comirnaty and Moderna’s SpikeVax, which is produced for the Japanese market by Takeda, with an estimated 81% of the population fully vaccinated.

“The current rapid spread of the Omicron variant of SARS-CoV-2 has imposed an urgent need to develop a booster vaccination programme in countries around the world,” said Daiichi Sankyo.

“As a Japanese pharmaceutical company with specialty in developing vaccines, Daiichi Sankyo is giving special priority to tackling this task and striving to help restore safety and security in society through control of the COVID-19 pandemic,” it added.

Subsidiary Daiichi Sankyo Biotech has previously said it plans to have capacity for producing the vaccine at scale by March of this year.

Japan has recorded around 2.68 million cases of COVID-19 since the start of the pandemic, with just under 19,000 deaths, which is a relatively low rate for its 126 million population.

Like most countries it is currently experiencing a spike in cases caused by Omicron, with hospital bed occupancy in the capital Tokyo approaching the 50% occupancy that would trigger a state of emergency for the city, according to a Japan Times report. There were nearly 88,000 new infections nationally on Friday.

The big question for Daiichi Sankyo is whether there will be a place for DS-6570 in Japan’s future vaccination plans, even if its accelerated booster dose trials are successful.

The country is already several weeks into a mix-and-match booster campaign using the already-authorised mRNA vaccines from Pfizer/BioNTech and Moderna for people age 18 and over who are at least six months removed from their initial doses.

However, in mid-January it was reported that fewer than 1% of Japanese citizens were boosted, well behind the rate seen in other industrialised nations like the UK and US, which has provided boosters to more than half and a quarter of their populations at that timepoint, respectively.

If take-up continues to be slow, Daiichi Sankyo’s home-grown shot could have a chance of claiming a slice of the market in future, particularly if it is decided that regular boosters are needed to control the virus.

https://pharmaphorum.com/news/daiichi-makes-play-for-share-of-japans-covid-booster-market/

New diagnostic finds hidden lung damage in long COVID

 People with long-lasting symptoms of breathlessness after COVID-19 infection may have damage to their lungs that does not show up using routine diagnostic scans, according to a small UK study.

The researchers from Oxford, Sheffield, Cardiff and Manchester universities used a new form of diagnostic that involves patients breathing in the inert gas xenon whilst undergoing an MRI scan, which allows them to gauge how well gases like oxygen are being transferred from the lungs to blood vessels.

Out of 11 patients who had reported symptoms of long COVID for at least six months from their initial infection, the technique identified seven who showed significant reductions in gas transfer compared to uninfected control subjects.

The group included non-hospitalised people with breathlessness but no evidence of lung damage seen by chest X-ray or CT imaging.

The authors of the study suggest that the finding may point to microstructural abnormalities in long COVID patients that would not show up using standard tests, such as micro-clots or thickening of the membranes of cells lining the airways, although they stress this is entirely hypothetical at the moment.

Another group of 12 post-hospitalised patients who did not have long COVID was also enrolled into the study, and testing revealed they also had lower gas transfer but were not as severely affected as the long COVID group, despite having had pneumonia.

The findings are in a preprint paper and haven’t been peer-reviewed, but nevertheless could provide important new insights into long COVID, which according to the ongoing Office of National Statistics (ONS) survey study is self-reported by around 1.3 million people in the UK.

The figures suggest that around a third of people reporting long COVID symptoms have breathlessness, with around half saying they had fatigue and 28% reporting a difficulty in concentrating known as ‘brain fog’.

“This current research highlights what many patients have experienced, that conventional diagnostic assays…do not identify damage in most long COVID patients,” commented Dr Jeremy Rossman, a virologist at the University of Kent.

“This can result in incorrectly framing long Covid as a psychological disease, with patients then struggling to obtain the care they need,” he added.

The investigators are now planning to expand their study to enrol a larger cohort of long COVID patients, including those without breathlessness. They will also follow-up patients for up to 12 months to see if the gas transfer abnormalities resolve over time.

https://pharmaphorum.com/news/new-diagnostic-finds-hidden-lung-damage-in-long-covid/

States were sharing COVID test kits. Then omicron hit

 In a few short months, states have gone from donating surplus rapid COVID-19 tests to states with shortages to hoarding them as demand driven by the spike in cases strains supplies.

Last January, North Dakota had amassed 2.7 million Abbott Laboratories BinaxNOW rapid COVID tests from the federal government—roughly 3.5 tests for each person in the state of 775,000 people.

The state had so many COVID tests that it donated a total of 1 million of them to Montana and Pennsylvania as part of a sharing program among states that formed when the delta variant was the dominant strain and COVID outbreaks rippled across the nation in waves. But now that omicron has turned the entire nation into a coronavirus hot spot and driven up demand for tests everywhere, that system has been upended.

Some states are holding on to expired tests for use as a last resort. In early January, North Dakota was one of them, with a stockpile of 600,000 expired rapid tests.

“I want to make sure that our state is covered,” said Nicole Brunelle, North Dakota’s chief nursing officer. “The entire nation is fighting for these tests.”

Jasmine Reed, a spokesperson for the Centers for Disease Control and Prevention, said the state exchange program has stopped operating, and while federal health officials are working to get it going again, the timing is unclear. “Once COVID-19 and its variants began to ramp up and more testing was needed, states no longer had a surplus to provide extra tests,” Reed said.

By early January, some states, including Montana and Indiana (PDF), had depleted their inventory of rapid COVID tests for distribution. Along with North Dakota, Florida and Maryland have held on to expired tests in hopes the federal government would extend the tests’ shelf life.

The inevitable result: States have gone from cooperation to competition.

“Emergency management and federal assistance across the country is built on the idea that we won’t have a need everywhere at once,” said Ken Sturrock, a Colorado-based regional emergency coordinator for the U.S. Department of Health and Human Services.

The state test exchange program was created amid concerns that tests would expire unused. Federal health agencies built an online platform that states could use to relay what they had or needed.

Some states have gone outside the program to exchange tests. For example, Mississippi donated more than 79,000 tests to Pennsylvania in November, said Jim Craig, senior deputy for the Mississippi State Department of Health.

For the states that participated, the exchange program was effective in identifying and shipping tests to places in need across the country through much of 2021. Colorado, for instance, received tests from five states from May through August of last year, bringing in about 340,000 kits that were close to expiring.

Some donations went farther. When nationwide demand for testing diminished early last year, the Arkansas Department of Health couldn’t find a state to take 300,000 tests close to expiring. Danyelle McNeill, a department spokesperson, said Arkansas donated the tests to India, where the delta variant was first identified, in late winter 2021.

Brunelle, North Dakota’s chief nursing officer, said the state expanded access to its supply of tests to schools, businesses, health providers, and others, offering free kits and training to those who would use them. Even then, Brunelle said, the state had more tests than it could distribute before they expired.

In January 2021, North Dakota sent 250,000 tests to Montana. Demand in Montana was low at the time, but Jon Ebelt, a spokesperson for the state Department of Public Health and Human Services, said the state “did not want to turn down free tests” after supplies had been tight earlier in the pandemic.

That summer, Montana sent 51,000 of those tests to Colorado.

But by January 2022, Montana’s supplies had been depleted. Health officials notified school districts that the pool of BinaxNOW test kits had run dry. The state worked through suppliers to order 650,000 tests and planned to start distributing them on Jan. 30. Montana Gov. Greg Gianforte, a Republican, blamed the Biden administration, saying it had repeatedly failed to increase testing supplies.

The Biden administration has created a website where households can sign up to receive four free tests, and officials have said tests are expected to ship within seven to 12 days of orders being placed. But that initial rollout raised access issues for some of the most vulnerable.

In fall 2021, North Dakota sent 750,000 rapid tests to the Children’s Hospital of Philadelphia. David Rubin, M.D., the hospital’s director of population health innovation, said the hospital distributed those supplies to a school-based testing program in southeastern Pennsylvania.

Rubin said that without the federal platform, the hospital is trying to get more tests for the program through federal agencies but that the line for them is long.

“We’re starting to imagine a world with less testing right now because it’s the reality,” Rubin said.

In some cases, the FDA has extended the shelf life for certain tests, most recently this month when it put a 15-month life span on Abbott’s at-home tests.

Amid the shortage, states have also sought permission to use outdated stock still on their shelves. Andy Owen, a spokesperson for the Maryland Department of Health, said that on Jan. 18, the FDA gave the state an additional three months to use 97,000 expired rapid tests that must be administered by a provider. That’s after Florida got another three-month extension to use roughly 1 million test kits that had expired at the end of December.

The Centers for Medicare & Medicaid Services released guidelines in 2020 that allowed states to use expired tests “until non-expired supplies become available.”

New Mexico Department of Health spokesperson Katy Diffendorfer said the state told a school that it could use older tests after the school’s supply dwindled to outdated kits. “They desperately needed to be able to test,” Diffendorfer said, adding that the state would send non-expired tests as soon as possible.

In North Dakota, which once had an abundance of tests, Brunelle said the state was starting to see access issues this winter, especially in rural places. The state has been careful about sending tests out, even within the state. North Dakota stalled its program to distribute tests to businesses, which Brunelle hopes is temporary.

“Right now, we need to keep our priority with our health care system, our first responders, our vulnerable populations,” she said.

https://www.fiercebiotech.com/medtech/states-were-sharing-covid-test-kits-then-omicron-hit