This article is more than 5 years old. Information may no longer be current.
Experts find discrepancies between FDA, CDC vaccine recommendations
Click Here to Manage Email Alerts
Although both the CDC and the FDA strive for optimal safety and efficacy when recommending how vaccines are to be used in the Unites States, the two agencies may consider different criteria to form their recommendations, according to research published in Pediatrics.
H. Cody Meissner, MD, professor of pediatrics at Tufts University School of Medicine, director of pediatric infectious diseases at Tufts Medical Center and an Infectious Diseases in Children Editorial Board member, said that because the agencies consider different factors during licensing or making recommendations — including disease epidemiology, public acceptance, vaccine supply and cost — their conclusions may differ.
“Pediatricians are encouraged to follow recommendations from the AAP as noted in statements from the Committee on Infectious Diseases (COID) and in the current Red Book,” Meissner said. “In almost all occasions, AAP recommendations are harmonious with those from the CDC. Special effort is made by both the AAP and the CDC to ensure consistency.”
Meissner and colleagues wrote that the development and licensure of new immunizations intended for use in the U.S. is regulated by the Center for Biologics Evaluation and Research (CBER) at the FDA. This group reviews clinical studies to ensure that the manufacturer is complying with ethical and scientific quality standards. They also examine clinical study sites, analyze primary data from clinical studies and assesses assay validation information. Additionally, the CBER reviews comprehensive manufacturing information and inspects facilities in which the vaccines are manufactured.
According to the researchers, scientific data collected by CBER influence prescribing information, including usage, dosing and administration. This information is updated when new information is available.
The recommendations for prescribing information are made for both doctors and manufacturers for marketing purposes, but it does not include recommendations on use during specific disease outbreaks, shortages and in those with pre-existing medical conditions — criteria considered by the Advisory Committee on Immunization Practices (ACIP).
ACIP, an external federal advisory committee, makes recommendations to the CDC on how licensed vaccines should be used within the civilian population. This organization is also responsible for choosing which vaccines should be used, the number of doses, the schedule that should be used and contraindications for the Vaccines for Children program.
To make these decisions, members of ACIP analyze safety and efficacy data and other available scientific information collected from prescribing information and pharmaceutical company presentations. This group considers additional criteria that the FDA does not consider when licensing a vaccine, including disease epidemiology, burden of disease, cost and concerns with using a specific vaccine in the U.S. population.
Meissner and colleagues cited two examples in which the CDC and FDA have made different recommendations: immunizing pregnant women with Tdap, and the use of FluMist Quadrivalent (live-attenuated influenza vaccine [LAIV], AstraZeneca) during the 2016-2017 and 2017-2018 influenza seasons.
According to the researchers, no FDA-approved Tdap vaccine is contraindicated for use in pregnant women, but the vaccine is not approved for use in pregnant women to prevent pertussis in their children — a practice recommended by the CDC. They also wrote that although the CDC recommended against using LAIV for the prevention of influenza because it demonstrated low efficacy compared with inactivated vaccine, the FDA said the benefits outweighed the potential risks associated with vaccination.
Pediatricians who have concerns about the differences between FDA and CDC recommendations regarding vaccine use in their patients should contact the AAP COID, according to Meissner.
“Members of the COID are always interested in hearing concerns from pediatricians,” he said. “Concerns [related to differences in recommendations] should be relayed to the Academy, and every effort will be made to address the issue.” – by Katherine Bortz
Disclosures: The authors report no relevant financial disclosures.
Click Here to Manage Email Alerts