It has been a busy week for FDA-related news. On Tuesday, in an article published in the New England Journal of Medicine, FDA Commissioner Marty Makary, MD, MPH, and Vinay Prasad, MD, MPH, director of the FDA’s Center for Biologics Evaluation and Research (CBER), laid out their plan that will change the bar for how COVID-19 vaccines will be approved going forward as well as who will be eligible to receive the seasonal vaccines.
With this major COVID-19 vaccine FDA policy changes as a backdrop, the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) met yesterday to decide what COVID-19 strains should be included in the vaccines for this coming seasonal respiratory season.
The committee unanimously voted to recommend a monovalent JN1-lineage vaccine composition. Following the vote, the committee discussed considerations for the selection of JN1 and/or a specific JN1-lineage strain for COVID-19 vaccines (2025-2026 Formula).1
During this meeting, the advisory committee was informed of the manufacturing timelines, they reviewed the available data on the circulation of SARS-CoV-2 virus variants, current vaccine effectiveness, human immunogenicity data of current vaccines against recently circulating virus variants, the antigenic characterization of circulating virus variants, animal immunogenicity data on new candidate vaccines expressing or containing updated spike components, and human immunogenicity data on the COVID-19 vaccines (2024-2025 Formula).1
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 JN1-lineage-based COVID-19 vaccines (2025-2026 Formula), preferentially using the LP81 strain.1
Clinician Feedback on New Vaccine Policy
Although it appears the formulation for the 2025-2026 vaccines will not need to go through clinical trials, the policy going forward is to require placebo-controlled trials for COVID-19 vaccines in order for them to seek FDA approval. This could take months and therefore the potential of being unprepared going into a respiratory virus season is very real.
“A new vaccine will not roll out in a timely fashion for it to be useful in that season,” Sharon Nachman, MD, chief of pediatric infectious diseases at Stony Brook Children’s Hospital, said. “Just playing by the numbers, you will need several 100 people to be enrolled on a vaccine study and wait to see if they have any side effects or if there’s any problems with the vaccine or placebo, which means it has to go through a season.”
In terms of who is eligible for COVID-19 vaccines, that policy had changed drastically. Whereas, previously everyone who was 6 months and older were recommended to get vaccines, now the FDA is no longer recommending annual COVID vaccinations for healthy people younger than 65. For those who are 65 and older they are still recommended to get their annual vaccinations as well as those 6 months and older who have underlying health conditions such as diabetes, cancer, asthma, etc.
For those who are not in those patient populations, it leaves clinicians, families, and individuals with questions about access and eligibility.
“Unfortunately, that basically does eliminate access of vaccination to the majority of the pediatric population,” Tina Tan, MD, FIDSA, FPIDS, FAAP, Infectious Diseases Society of America (IDSA) president, said in an interview with Contemporary Pediatrics. And COVID 19 is a disease that occurs in children. Even though there is all this misinformation out there that COVID 19 doesn’t cause infection in children, but it does…some kids can actually get quite sick with it, and they can develop Long COVID symptoms.”
Nachman also sees the potential complication of Long COVID. “When we look at the data on who got Long COVID, not only just among children, but adults, there is fascinating information now from multiple studies that people that got vaccinated had a much lower risk of Long COVID,” Nachman said.
This new policy may lead to delays in vaccine rollouts in the future.
“That’s going to be a major factor in delaying whether or not individuals are going to be able to receive the vaccine, and that is not how this should be done, because we know these vaccines work,” Tan said. “The vaccines are being reformulated every year to take into account the circulating sub stereotypes. And you know, there’s no need for a clinical trial to prove that these vaccines work; we know the vaccines work. We know the vaccines are safe…you’re really going to delay availability.”
Clinicians point out that limiting access will be a major issue for some who wish to get vaccinated but will likely now how to pay for it.
“Limiting broad access to updated vaccines while COVID-19 continues to circulate is a dangerous gamble. We must not weaken our defenses against a virus that still poses a serious public health threat,” NFID Medical Director Robert H. Hopkins Jr, MD, said in a statement to Contagion.
Reference
1. COVID-19 Vaccines (2025-2026 Formula) for Use in the United States Beginning in Fall 2025. FDA. May 22, 2025. Accessed May 23, 2025.
https://www.fda.gov/vaccines-blood-biologics/industry-biologics/covid-19-vaccines-2025-2026-formula-use-united-states-beginning-fall-2025
