In a joint announcement, the leaders of the NIH, HHS, and FDA, made comments about this CDC immunization removal.
Today, in a social media post, the Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. confirmed the previous recommendations that both healthy children and pregnant women get vaccinated for COVID-19 has been rescinded.
"I couldn't be more pleased to announce that, as of today, the COVID-19 vaccine for healthy children and healthy pregnant women has been removed from the CDC recommended immunization schedule," Kennedy said.
The social post included FDA Commissioner Marty Makary, MD, MPH, and National Institutes of Health (NIH) Director Jay Bhattacharya, MD, PhD.
Kennedy said the previous Biden administration continued to provide the guidance that children should get another COVID-19 vaccine.
"That ends today,” Bhattacharya said in the announcement. “It’s common sense and it’s good science.”
“There’s no evidence healthy kids need it today,” Makary said. “Most countries have stopped recommending it for children.”
As these changes are immediate and contradictory to past vaccine policy, reaction has been less than enthusiastic. "The craziness never ends and the recent change to the CDC immunization schedule regarding the COVID-19 vaccine and use in pregnant women and healthy children is complete madness,” Tina Tan, MD, FIDSA, FPIDS, FAAP, president, Infectious Diseases Society of America (IDSA), said of the announcement in an interview with Contemporary Pediatrics. “Also not vaccinating healthy children is completely inappropriate given that some healthy children can have severe COVID infections with long lasting consequences; children can get Long COVID. This will make it much more difficult for practitioners as they will have to determine which of their patients are eligible for the COVID vaccine to determine how much vaccine to order and to determine if insurance will cover vaccine cost."
With regards to pregnant women and the vaccine, Tan offered some potential serious health issues associated with COVID-19.
“COVID-19 infection can have extremely serious consequences in pregnant women resulting in hospitalization, pre-term labor, pre-eclampsia, heart injury, blood clots, hypertension, kidney damage, so not vaccinating them is sheer madness and will contribute to a significant increase in possible morbidity and mortality,” she said.
This is an ongoing series on the newly proposed changes to these vaccines and the immunization schedule going forward.
Check out other articles in the series:
FDA Shifts COVID-19 Vaccine Policy, Requires Further Testing
How Will the New FDA COVID-19 Vaccine Policy Affect the Pediatric Population?
FDA VRBPAC Makes Recommendations For 2025-2026 Formula for COVID-19 Vaccines
This announcement comes on the heels of an article published last week 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), wrote in the piece the new recommendations for COVID-19 vaccines, and how they will be approved going forward.2
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.2
“On the basis of immunogenicity — proof that a vaccine can generate antibody titers in people — the FDA anticipates that it will be able to make favorable benefit–risk findings for adults over the age of 65 years and for all persons above the age of 6 months with one or more risk factors that put them at high risk for severe COVID-19 outcomes, as described by the CDC,” they wrote.2
In terms of consideration for approving COVID-19 vaccines, FDA is requiring placebo-controlled trials going forward.
“For all healthy persons — those with no risk factors for severe COVID-19 — between the ages of 6 months and 64 years, the FDA anticipates the need for randomized, controlled trial data evaluating clinical outcomes before Biologics License Applications can be granted. Insofar as possible, when approving a COVID-19 vaccine for high-risk groups, the FDA will encourage manufacturers to conduct randomized, controlled trials in the population of healthy adults as part of their postmarketing commitment,” they wrote.2
During last week’s FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting, the committee members voted unanimously 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).
Subsequently, the FDA advised the manufacturers of the approved COVID-19 vaccines to match the 2025-2026 vaccine formula with the circulating SARS-CoV-2 viruses for use in the US beginning in fall 2025. The federal agency said the immunizations should be monovalent JN1-lineage-based COVID-19 vaccines, preferentially using the LP81 strain.
