FDA advisers back maternal RSV shot
A panel advising the U.S. Food and Drug Administration (FDA) last week recommended that it approve a vaccine given to pregnant people to protect infants from respiratory syncytial virus (RSV), which can cause severe lung infections. The vote was unanimous based on the efficacy of the vaccine, called RSVpreF and branded Abrysvo. Ten members of the panel also endorsed the safety of the vaccine, which is designed to cause mothers to produce protective antibodies that their babies acquire during pregnancy. But four panel members weren’t persuaded. A large, phase 3 trial by Pfizer, maker of the shot, found an elevated rate of premature births—5.7% in the vaccinated group versus 4.7% in the placebo group—but the difference did not reach statistical significance and neonatal deaths did not increase. Lower respiratory tract infections from RSV kill an estimated 46,000 babies younger than 7 months every year, hundreds of them in the United States, where RSV is the leading cause of infant hospitalization. The Pfizer vaccine was 69.4% efficacious in protecting this age group from severe disease. FDA is expected to rule in August whether to license the vaccine.
ARPA-H takes on osteoarthritis
The U.S. Advanced Research Projects Agency for Health (ARPA-H), a new federal funder charged with taking bold, innovative approaches to health research, last week announced its first program targeting a specific disease will focus on osteoarthritis. Thirty-two million people in the United States suffer from the degenerative condition, in which cartilage in the joints breaks down, causing pain and impairing mobility. Patients are typically treated with physical therapy and anti-inflammatory drugs and, when necessary, are offered metal joint replacements. ARPA-H’s new program, Novel Innovations for Tissue Regeneration in Osteoarthritis, seeks to use a patient’s own cells to regenerate lost bone and cartilage. ARPA-H was launched last year, modeled on the applications-focused, outside-the-box science sponsored by the Defense Advanced Research Projects Agency.
Cancer trials move goal posts
Large clinical trials testing cancer therapies frequently alter their primary endpoint—the key health outcomes being measured—midstream, a study reports. A research team at the University of Texas MD Anderson Cancer Center and other institutions looked for design changes while the studies were underway by examining publicly available data from ClinicalTrials.gov, where trial sponsors post details about them, as well as in available protocol documents and publications reporting the studies. Of 755 phase 3 clinical trials, 145, or 19%, had such endpoint changes, including swapping the primary outcome measured for secondary ones, the researchers found; of those, 70% did not disclose the shifting endpoints in manuscripts, the team reported on 17 May in JAMA Network Open. The practice has raised concerns that researchers rework the endpoints to cast the trial results in a more positive light.
If it’s safe enough to drink, they should use it as drinking water.
- South Korean opposition leader Lee Jae-myung
- in the South China Morning Post, about Japan’s plan to release treated radioactive water from the ruined Fukushima power plant into the ocean. Many countries neighboring Japan oppose the plan.
Mpox vaccine shows protection
A year after many countries started to immunize those at highest risk of mpox during a global outbreak, a study has shown the shots are effective against the monkeypox virus. The vaccine, called Jynneos and manufactured by Bavarian Nordic, was originally developed as a smallpox vaccine and licensed for mpox based largely on animal data. Now, researchers have used U.S. electronic health records to compare 2193 patients diagnosed with mpox with 8319 matched controls who were considered at high risk because they were living with HIV or taking pre-exposure prophylaxis to prevent HIV infection. (Mpox has primarily spread among men who have sex with men and their sexual networks.) Those in the control group were much more likely to have received the vaccine, the researchers report in The New England Journal of Medicine. They estimate it was 66% effective for those who received a full course of two doses and 35.8% for those who received only a single dose.
Proteins get $210 million gift
Immunologist Timothy Springer, a founder of vaccinemaker Moderna, this week announced he will give $210 million to a nonprofit research center he created to develop the use of proteins for medical research. The gift to the Institute for Protein Innovation in Boston is among the largest ever to a medical research center. It follows Springer’s previous donations totaling $40 million to launch the institute in 2017 and expand it. The institute intends to provide scientists with synthetic antibodies and other protein tools to help illuminate fundamental biological processes and therapeutic leads. Springer, who still has a lab at Harvard Medical School, became a billionaire from his investments in research ventures including Moderna, which turned its expertise in messenger RNA into one of the most widely administered vaccines against SARS-CoV-2.
Brain-spine link helps paralyzed man walk, navigate obstacles
A 40-year-old man whose lower body is partially paralyzed has been able to walk and navigate obstacles thanks to a digital bridge between his brain and spinal cord, researchers report this week in Nature. The international team had previously fitted Gert-Jan Oskam of the Netherlands with a stimulator that delivered electric pulses to his spinal cord, enabling him to walk over flat ground using crutches. But his movement was robotic, and he had difficulty navigating obstacles. In a first in a human, the team implanted electrodes above his motor cortex and connected them wirelessly via a headset to the stimulator. This allowed Oskam to walk more naturally and with more control. The team says it is working to test the technology in more patients and to make it less bulky.
China vows ethics oversight
The Chinese Academy of Sciences (CAS) this month warned it will crack down on researchers over ethics violations, highlighting a case involving human embryonic development. A CAS ethics official told the academy’s China Science Daily newspaper that investigators concluded researchers falsified an ethics review report for a study that produced cells resembling human embryonic stem cells in vitro and implanted chimeric embryos containing both human and mouse cells into female mice. CAS reduced the unidentified team leader’s funding and suspended him from supervising postgraduates for a year, according to the news report. In an email to Science, Miguel Esteban, a stem cell biologist at CAS’s Guangzhou Institutes of Biomedicine and Health, acknowledges he led the research in question, which he and colleagues published in Nature in March 2022. He denies falsifying documents and says the team followed international regulations and had ethical clearance for work on interspecies chimeras. In March, China’s government announced revised rules for ethically problematic research involving human genetics, including requirements for ethics reviews. The mandate came 5 years after a Chinese scientist sparked worldwide outrage by announcing he had helped create genetically edited babies.
