Moderna receives expanded approval for RSV vaccine

News brief

Older man getting vaccine — Drazen Zigic / iStock

Vaccine maker Moderna said yesterday that it has received expanded approval from the Food and Drug Administration (FDA) for its respiratory syncytial virus (RSV) vaccine.

In a news release, Moderna said the FDA has approved mResvia (mRNA-1345) for the prevention of RSV in people ages 18 to 59 years old who are at increased risk for disease. The vaccine was initially approved by the FDA in May 2024 for adults ages 60 and older.

The company said studies have shown that over one-third of adults ages 18 to 59 have at least one underlying condition that puts them at risk of severe RSV, with hospitalization rates being comparable or even exceeding those in older adults.

"RSV poses a serious health risk to adults with certain chronic conditions, and today's approval marks an important step forward in our ability to protect additional populations from severe illness from RSV," Moderna CEO Stéphane Bancel said in a press release.

ACIP recommendation in question

The expanded approval was based on data from a phase 3 clinical trial, which showed the shot generated comparable levels of neutralizing antibodies against RSV in the 18 to 59 age group as were observed in older adults. Moderna presented the data at the April meeting of the Advisory Committee on Immunization Practices (ACIP), which voted unanimously to recommend that people aged 50 to 59 who are at increased risk of severe disease receive a single dose of either of the two RSV vaccines that were FDA-approved for that age group at the time (GSK's Arexvy and Pfizer's Abrysvo).

According to information posted by the Centers for Disease Control and Prevention (CDC) in the Federal Register on the upcoming ACIP meeting at the end of June, members will be voting again on recommendations for RSV vaccines in younger adults. But the outcome may be different after Department of Health and Human Services Secretary Robert F. Kennedy Jr. removed the 17 sitting members of ACIP this week and replaced them with 8 new members, some of whom are critics of mRNA vaccines.

The CDC typically adopts ACIP advice, and insurance coverage for vaccines is often based on ACIP recommendations.

CDC estimates show jump in NB.1.8.1 COVID variant proportions

News brief

Lisa Schnirring

In its latest update on variant proportion estimates, the US Centers for Disease Control and Prevention (CDC) said the level of NB.1.8.1 viruses, recently added as a variant under monitoring (VUM) by the World Health Organization (WHO), has grown from 15% to 37% since late May, bringing it nearly even with LP.8.1, which has been dominant over the last few months.

NB.1.8.1 has been fueling rises in cases and hospitalizations in some countries in Asia. When the WHO advisory group added it as a VUM in late May, they said though proportions are growing rapidly, the virus seems to be only minimally more immune-evasive than the dominant LP.8.1 subvariant.

The CDC also reported a rise in XFG variant proportions, which rose from 6% to 8% over the same period. Both viruses are descendants of the JN.1 Omicron SARS-CoV-2 variant.

ECDC notes slow rise in COVID activity

The European Centre for Disease Prevention and Control (ECDC) today said it is monitoring slowly increasing COVID activity, which is up from low baselines. Doctors’ visits for the illness are still at or below levels seen for this period in past seasons. The group hasn’t noted any rise in severe disease indicators, such as hospitalizations or intensive care unit admissions.

Eduardo Colzani, MD, MPH, PhD, ECDC’s head of respiratory viruses, said in a statement that NB.1.8.1 doesn’t appear to pose a greater threat than other Omicron descendants, and officials don’t expect an impact on vaccine effectiveness or severe disease. However, he noted that since SARS-CoV-2 activity was low over the winter, population immunity may have waned, especially in older adults and those who have underlying health conditions.

In the United States, COVID activity remains low based on the latest CDC data, which show wastewater SARS-CoV-2 detections still at the low level, with higher levels in the west compared to other regions.

Quick takes: New polio cases in 3 countries, chikungunya in France, cholera vaccine campaign in Sudan

News brief

Chris Dall, MA

Three African countries reported new vaccine-derived polio cases this week, according to the latest update from the Global Polio Eradication Initiative. Angola reported a circulating vaccine-derived poliovirus type 2 (cVDPV2) case from Benguela, with paralysis onset on April 16, bringing its total number of cVDPV2 cases for 2025 to three. Benin reported its first cVDPV2 case of 2025, while Niger reported its third.
France has reported its first mainland chikungunya case of the year, according to French media reports. The case was detected in La Crau in Var, which is in southeastern France. The French overseas territory Reunion, located in the Indian Ocean, has reported a large outbreak this year, and earlier mainland cases involved people who had recently travelled abroad. A chikungunya case not linked to travel suggests mosquitoes that carry the virus are in the country. Health authorities in the area are conducting a door-to-door survey to see if other individuals are showing symptoms of the virus.
The World Health Organization said this week that it's helping the government of Sudan launch a 10-day cholera vaccination program in Khartoum State to protect 2.6 people million from infection, interrupt transmission, and help contain an outbreak that began in May. Sudan has been in a civil war since 2023, and Khartoum State is one of the hot spots. The WHO said the outbreak of the acute diarrheal infection, which has resulted in 16,000 cumulative cases and 239 deaths since May, has been fueled by a shortage of safe water following attacks on power plants and water sources, and compounded by mass displacement and the breakdown of the health system.