FDA approves formula for fall COVID vaccines

News brief

COVID vaccine being prepared — Alejandro Martinez Gonzalez / iStock

The US Food and Drug Administration (FDA) yesterday issued new instructions to COVID vaccine manufacturers regarding the next round of updated COVID shots.

In a document posted on the FDA website, the agency said COVID-19 vaccines used in the United States starting in fall 2025 should be based on JN.1 lineage strains, preferably the LP.8.1 strain, which, according to the Centers for Disease Control and Prevention, currently accounts for 70% of US COVID cases.

"Based on the totality of the evidence, FDA has advised the manufacturers of the approved COVID-19 vaccines that to more closely match currently circulating SARS-CoV-2 viruses, the COVID-19 vaccines for use in the United States beginning in fall 2025 should be monovalent JN.1-lineage-based COVID-19 vaccines (2025-2026 Formula), preferentially using the LP.8.1 strain," the FDA said.

The document was posted following a meeting of the FDA's Vaccines and Related Biologic Products Advisory Committee (VRBPAC). At that meeting, advisers unanimously recommended sticking with a JN.1 lineage for the 2025-26 formula but did not take a position on a specific strain. The current US COVID vaccines use the KP.2 strain, which is within the JN.1 family of variants.

The VRBPAC recommendation is similar to the position of the World Health Organization's COVID-19 vaccine composition committee, which said on May 15 that JN.1 and KP.2 vaccines are still appropriate, but LP.8.1 is a suitable alternative.

New COVID vaccine framework

One question that remains is how updated COVID vaccines will be affected by the new COVID vaccine framework laid out this week by FDA Commissioner Marty Makary, MD, MPH, and Vinay Prasad, MD, MPH, director of the FDA's Center for Biologics Evaluation and Research. Going forward, Makary and Prasad said COVID-19 vaccines will be approved only for those aged 65 and older and people age 6 months and older with one or more underlying medical conditions that put them at high risk of severe illness. Approval of COVID shots for other groups will require randomized controlled trial data, they said.

FDA officials said yesterday that implementation of the new framework may be a topic for a future VRBPAC meeting.

New 'Make America Healthy Again' report takes aim at vaccines

News brief

Jim Wappes

The "Make Our Children Healthy Again" report issued yesterday by the Make America Healthy Again (MAHA) Commission—spearheaded by Health and Human Services (HHS) Secretary Robert F. Kennedy Jr.—focuses on addressing chronic disease in kids in four areas, one of which includes the "growth of the childhood vaccine schedule."

The approach indicates that officials will probe whether vaccines contribute to autism in kids, among other chronic health issues. The move comes after years of Kennedy casting doubt on the effectiveness of childhood vaccines and making false claims about them and seems to ignore the fact that the vaccine schedule has grown because it now addresses more potentially deadly diseases. The report also doesn't appear to acknowledge the large number of published vaccine safety studies—including those finding no link to autism.

The report addresses ultra-processed foods, environment chemicals, the threat of technology to mental and physical health, and "the overmedicalization of our kids," which includes vaccines. Areas of vaccine concern, according to the report, include clinical trial rigor, side effect reporting, and conflicts of interest.

Benefits far outweigh risks

Kennedy said in an HHS news release, "We will follow the truth wherever it leads, uphold rigorous science, and drive bold policies that put the health, development, and future of every child first."

But a number of scientists question the federal approach and are pushing back against a narrative that questions the safety of vaccines.

In a statement, Tina Tan, MD, president of the Infectious Diseases Society of America, said, "It's important to investigate those causes [of chronic conditions], but decades of rigorous and scientifically sound research has proven that vaccines are not among them. In fact, the benefits of vaccines far outweigh the risks and provide significant protection.

Vaccines have saved millions of lives of people of all ages.

"Vaccines have saved millions of lives of people of all ages… The recent measles outbreak in the U.S.—occurring mostly among unvaccinated kids—is a painful reminder of how dangerous inaccurate information can be."

The Pharmaceutical Research and Manufacturers of America (PhRMA) said, "Other than clean water, arguably nothing has done more to improve public health than vaccines."

Study details economic impact of RSV infections in young children

News brief

Chris Dall, MA

A study published yesterday in Eurosurveillance highlights the substantial costs associated with respiratory syncytial virus (RSV) infections in children ages 5 and under.

The study, conducted at multiple primary care sites in five European countries (Belgium, Italy, the Netherlands, Spain, and the United Kingdom) from 2021 through 2023, recruited 3,414 children 5 years and younger with acute respiratory infection and tested them for RSV. Parents of the 1,124 children (33%) who tested positive for RSV were invited to complete follow-up questionnaires 14 days and 30 days after the initial visit. The questionnaires asked about symptoms, illness duration, healthcare use, medications, and parental work absences.

Costs were assessed from an outpatient healthcare sector and societal perspective, with the results stratified by country and the age-group of children diagnosed as having RSV.

Primary care, work absences drive cost

Outpatient costs ranged from €79 (US $90) in the Netherlands to €300 (US $341) in Spain and were higher in infants than children aged 1 to 5 years. The costs were primarily driven by repeated visits to primary care physicians (46% to 83% of total outpatient costs), followed by emergency department visits (9% to 45%), and medication (2% to 17%).

Societal costs ranged from €454 (US $516) in the United Kingdom to €994 (US $1,130) in Belgium and were primarily driven by parental work absences among parents of children ages 1 through 5. Parental work absences varied considerably, ranging from 13% of parents reporting absences and a mean of 1.3 missed working days in Spain to 71% of parents missing work days with a mean of 4.1 days off in Belgium.

In infants, the main societal cost driver varied by country, but overall outpatient healthcare costs represented a higher proportion of societal costs compared with older children.

The study authors say the findings are timely given the recent introduction of RSV immunization strategies for infants and the development of RSV vaccines for toddlers and older children.

"This study highlights differences in economic costs per RSV-episode across countries, emphasising the importance of considering country-specific cost estimates when evaluating the implementation of RSV immunisation strategies," they wrote.