Healthcare & Laboratory News

The Wall Street Journal (4/2, Essley Whyte, Subscription Publication) reports the FDA missed the April 1 deadline to approve Novavax’s COVID-19 vaccine. The agency has permitted emergency use of the vaccine since 2022. Senior agency leaders say more data is needed, signaling that it was unlikely to be approved soon. It would have been the FDA’s first major vaccine approval since Dr. Peter Marks announced his resignation as director of Center for Biologics Evaluation and Research. Reuters (4/2, Satija, Sunny, Erman) reports Marks played a “key role in developing COVID-19 vaccines during U.S. President Donald Trump’s first term.” His departure from CBER “led to a selloff in drugmakers’ stocks on Monday and some analysts said it could put pressure on companies that currently have therapies under regulatory review.” Novavax was disappointed by the news, noting that it had responded to all of the FDA’s information requests as of April 1 and it believes its application is “ready for approval.”

MedPage Today (4/2, Monaco) reports a study suggests “there was no overall increased risk of new-onset type 2 diabetes after SARS-CoV-2 infection in a highly vaccinated and boosted Asian cohort when milder COVID-19 variants were predominant.” Compared to people who were not infected, “new-onset type 2 diabetes risk wasn’t significantly higher during either Delta or Omicron predominance from September 2021 to December 2022.” Researchers also found “that during the Delta wave, Indian individuals had a 29% higher risk for new-onset diabetes after infection; this risk wasn’t reported in Chinese or Malay individuals. During Omicron, no ethnic subgroup stood out as having a higher diabetes risk.” The study was published in JAMA Network Open.

Healio (4/2, Kellner) reports an analysis found that six common pathogens – Campylobacter species, Clostridium perfringens, Listeria monocytogenes, norovirus, nontyphoidal Salmonella, and shiga toxin-producing Escherichia coli (STEC) – “were responsible for nearly 10 million foodborne illnesses in 2019.” The six pathogens were “responsible for an estimated 37.6 million illnesses in 2019, of which 9.9 million were domestically acquired foodborne illnesses, the authors wrote. Additionally, 53,300 people were hospitalized for foodborne illnesses caused by all seven pathogens, and 931 people died.” Researchers noted “norovirus was the most prolific, causing an estimated 5.5 million foodborne illnesses and 22,400 hospitalizations per year.” Meanwhile, nontyphoidal Salmonella “was the deadliest of the pathogens – roughly 238 people died per year from the bacteria.” The analysis was published in Emerging Infectious Diseases.

The New York Times (4/2, Belluck) reports a study published in Nature “found that people who received the shingles vaccine were 20 percent less likely to develop dementia in the seven years afterward than those who were not vaccinated.” Compared to prior studies suggesting that shingles vaccinations might reduce dementia risk, this study was able to rule out “other dementia-protective characteristics, like healthier lifestyles, better diets or more years of education.” Overall, the results “provide some of the strongest evidence yet that some viral infections can have effects on brain function years later and that preventing them can help stave off cognitive decline.” The AP (4/2, Neergaard) reports the study “tracked people in Wales who were around 80 when receiving the world’s first-generation shingles vaccine over a decade ago.” NBC News (4/2, Carroll) reports that the “most important take-home message” from the study “is that getting vaccinated might lower the risk for dementia.” It is also possible “that the Food and Drug Administration could review research linking shingles vaccines to a lower risk of dementia and allow the drug company to add that indication to the label,” experts said.

ABC News (4/1, Kekatos) reports the measles outbreak in western Texas has reached 422 cases as of Tuesday, with 22 new cases confirmed over the last five days. According to the Texas Department of State Health Services, “almost all of the cases are in unvaccinated individuals or in individuals whose vaccination status is unknown.” Children and teens between ages 5 to 17 “make up the majority of cases at 169, followed by children ages 4 and under at 141.” Meanwhile, Reuters (4/1) adds that New Mexico “reported four additional measles cases from March 28, taking the total to 48 in the state, its health department said.” Oklahoma reported an additional case since its last report on Friday, raising the state’s total to 10 cases. The CDC recently “said there were a total of 483 confirmed measles cases in the country as of March 27, more than last year’s nationwide count of 285.”

Healio (3/31, Stulpin) reported a study found that “clostridioides difficile isolates with reduced fidaxomicin susceptibility may emerge during treatment and could spread to other patients.” Researchers found that “of 108 patients treated with fidaxomicin, six had isolates with reduced fidaxomicin susceptibility three achieved clinical cure with fidaxomicin, two had clinical failure and one refractory CDI.” In addition, they “noted that none of the isolates with reduced susceptibility had mutations associated with rifamycin resistance and that all were susceptible to vancomycin, rifampin, moxifloxacin and erythromycin.” Researchers concluded, “Clinicians should be aware that reduced susceptibility should be considered as a potential contributor to fidaxomicin treatment failure.” The study was published in Clinical Infectious Diseases.

Healio (4/1, Southall) reports data show that “sick workers contaminating food with foodborne germs led to the majority of viral outbreaks across the U.S. between 2014 and 2022.” Researchers identified “food temperatures that led to germ growth and survival...as the most common food worker practice associated with bacterial outbreaks.” The results “showed an increase in the proportion of bacterial outbreaks from 41.9% from 2014 to 2016 to 48.4% from 2020 to 2022, but a decrease in the proportion of viral outbreaks from 33.3% to 23.2% during these times.” In conclusion, the researchers encouraged restaurant managers to “play an important role in reducing these practices that contribute to outbreaks,” such as establishing clear policies “on managing sick workers” and training employees “about proper temperature control of food.” The data were published in the CDC’s Morbidity and Mortality Weekly Report.

MedPage Today (4/1, George) reports, “A novel plasma-based assay was more strongly associated with tau tangle pathology in Alzheimer’s disease than other established blood biomarkers, researchers said.” This “assay measured a new plasma tau species known as endogenously cleaved, microtubule-binding region containing residue 243 (MTBR-tau243), which specifically reflected tau tangle pathology.” The investigators found that “plasma MTBR-tau243 was associated with tau PET binding...and cognitive performance...outperforming other markers like phosphorylated tau 217 (p-tau217) and p-tau205.” MedPage Today adds, “The assay was tested in three cohorts. It distinguished between early- versus later-stage Alzheimer’s disease and separated Alzheimer’s disease from non-Alzheimer’s tauopathies.” The findings were published in Nature Medicine.

Infectious Disease Advisor (3/31, McSwiggin) reports a study suggests that “patients with Prader-Willi syndrome (PWS) may be at increased risk for severe outcomes when infected with COVID-19, highlighting the need to prioritize infection prevention and vaccination efforts in this population.” Researchers found that “patients in the PWS group were hospitalized longer than those in the non-PWS group (median, 6 vs 5 days) and exhibited higher rates of ventilator use (18.6% vs 11.8%) and obesity (47.5% vs 28.4%).” Additionally, they noted “in-hospital mortality was less common among patients with vs without PWS (8.5% vs 12.8%), but the median age at death was lower for those with PWS (30 vs 72 years). Patients in the PWS group also had higher total hospital charges (median, $64,804 vs $47,846).” Results from the study were published in the American Journal of Medical Genetics Part A.

Reuters (3/31, Godoy) reports the Federal Trade Commission has expressed concern “about the potential sale or transfer of Americans’ personal information by 23andMe ancestry testing company which recently filed for bankruptcy.” FTC Chairman Andrew Ferguson said in a letter to the US trustee “that any purchaser of 23andMe assets should agree to be bound by the company’s existing privacy policy.” Officials including California Attorney General Rob Bonta “had questioned what would happen to the genetic data collected by 23andMe” since filing for bankruptcy protection on March 23 “amid weak demand for its ancestry testing kits. It has said the bankruptcy process will not affect how it stores, manages or protects customer data.”