Healthcare & Laboratory News

HHS’ Placebo Testing Requirement May Delay Approval Of Updated COVID-19 Vaccines

CNN (4/30, Tirrell) reported that HHS “said it will require that all new vaccines be tested in placebo-controlled trials before they’re licensed for use, raising urgent questions about the system used to clear updated Covid-19 boosters each respiratory virus season.” The FDA usually selects strains for updated COVID-19 vaccines in June so they can be ready by the fall. Experts fear that “requiring placebo-controlled trials before clearing new versions – which could involve enrolling participants, giving some the vaccine and some a placebo shot, and waiting some period of time to assess safety and efficacy – would delay availability of updated Covid shots by months, putting vulnerable people at risk.” NBC News (5/1, Lovelace Jr.) reports the FDA’s vaccine advisory committee is “expected to meet in May or June to make a recommendation on which strains should be included in the next round of shots.” If the agency “deems Pfizer’s and Moderna’s updated vaccines ‘new’ products, requiring fresh trials, it’s extremely unlikely the doses would be ready for the fall, experts said.” The Hill (5/1, O'Connell-Domenech) reports HHS indicated “in its release that none of the vaccines on the Centers for Disease Control and Prevention’s childhood recommended schedule were tested against an inert placebo, but health experts say this is false.”

US Whooping Cough Cases Continue To Rise

CNN (5/1, Hetter) says there have been about 6,600 cases of whooping cough reported in the US this year, “nearly four times the number at the same point last year.” There were 35,000 cases of whooping cough reported in 2024, resulting in 10 deaths “including six babies less than 1 year old.” The disease “is especially dangerous in infants. Globally, it is a significant cause of disease and death in infancy, according to the World Health Organization.”

Measles Cases Continue To Surge Across North America

The AP (5/1, Shastri, Janetsky) reports measles outbreaks in the US, Mexico, and Canada “continue to balloon, with more than 2,500 known cases; three people have died in the U.S. and one in Mexico.” The outbreak has reached 663 cases in West Texas, while Mexico’s Chihuahua state “is up to 786 cases since mid-February.” Meanwhile, six out of Canada’s 10 provinces have reported measles cases, with Ontario’s case count reaching 1,020 as of Wednesday. The outbreaks are located “in areas with a notable population of certain Mennonite Christian communities who trace their migration over generations from Canada to Mexico to Seminole, Texas.” Mexican and US officials also warn that “the genetic strains of measles spreading in Canada match the other large outbreaks.”

HHS To Develop Universal Flu Vaccines Targeting Multiple Virus Strains

CNN (5/1, Tirrell, Goodman) reports HHS “said Thursday that it aims to accomplish within four years a scientific feat that hasn’t been achieved for the past 45: the development of a universal flu vaccine that could protect against multiple virus strains with pandemic potential, including H5N1 avian influenza.” HHS explained the in-house project is targeting FDA “approval of universal influenza vaccines in 2029, with human clinical trials scheduled to start next year.” Reuters (5/1, Mishra) says the government’s $500 million investment “is to come from the Biomedical Advanced Research and Development Authority, or BARDA, a center within the HHS that funds measures to protect the public from threats such as pandemics.”

Unnecessary Antibiotic Therapy Remains Common Among Inpatients With COVID-19 Or Other Viral ARTIs, Study Finds

Infectious Disease Advisor (4/30, Nye) reports a study found that “antibiotic stewardship interventions are still needed to address unnecessary antibiotic prescribing among patients hospitalized with COVID-19 or other viral acute respiratory tract infections (ARTIs).” Researchers observed that “between March 2020 and December 2023, the percentage of patients with COVID-19 who were prescribed antibiotics declined from 82.7% to 33.8%, with the lowest rate (33.8%) observed in May 2022. Data captured from patients with other viral ARTIs showed antibiotics were prescribed to 55.8% in January 2019, 64.7% in July 2019, and 40.0% in December 2020.” In an adjusted analysis, “patients with COVID-19 were significantly less likely to be prescribed at least 1 dose of antibiotic therapy during the study period than those with other viral ARTIs.” The study was published in Open Forum Infectious Diseases.

Eight Clusters Of Related Biomarkers Associated With RA-ILD, Study Finds

Healio (4/30, Cooper) reports a study found that “biomarkers in blood and plasma can be used to predict rheumatoid arthritis-associated interstitial lung disease more accurately than clinical risk factors alone, suggesting potential new opportunities in screening and treatment.” Researchers said their “process yielded a total of 15 principal components, or clusters of related biomarkers. After adjusting for clinical factors, eight were significantly associated with RA-ILD.” The study was published in Arthritis & Rheumatology.