This article is more than 5 years old. Information may no longer be current.
ACIP recommends Tdap vaccine for health care workers
The ACIP decided against permissive off-label use of the vaccine among older adults.
Click Here to Manage Email Alerts
ATLANTA — The Advisory Committee on Immunization Practices (ACIP) recommends that health care workers receive the tetanus toxoid and reduced diphtheria toxoid and acellular pertussis, adsorbed vaccine (Tdap; Adacel, Sanofi Pasteur), two years after their last tetanus and diphtheria toxoid (Td) shot.
The ACIP already recommended that adults aged 19 to 64 years receive Tdap as a replacement for the decennial Td vaccine, but wanted a stronger recommendation for health care workers.
The committee also recommended that hospitals and ambulatory facilities should provide the vaccine for health care workers and take steps to maximize vaccination rates.
“Preventing pertussis among health care workers will decrease the exposures and secondary cases in both pediatric and adult care settings,” Trudy Murphy, MD, of the National Immunization Program (NIP) at the CDC, said.
At the same meeting, the ACIP considered recommending Tdap off-label in adults older than 65, but decided against it.
Although there are two Tdap vaccines, GlaxoSmithKline’s vaccine, Boostrix, is indicated for adolescents aged 10 to 18 years. Sanofi Pasteur’s product is licensed for use in people aged 11 to 64.
Health care workers
Pertussis affects 600,000 adults aged 20 to 64 years every year. It can result in weeks of coughing, cracked ribs from severe spells of coughing, pneumonia and other complications, according to the CDC.
The goal of the recommendation is to protect health care workers from contracting pertussis infection and to thwart transmission of infection from health care workers to patients, other health care staff, household members or people in the community.
Physicians, nurses, medical and nursing students and primary care providers are among the estimated 8 to 10 million health care workers recommended for the vaccine. The ACIP recommended that health care workers who do not work in hospitals or ambulatory care settings, or do not have direct patient contact, receive Tdap according to the adult vaccine recommendations.
“This looks like a slam dunk to me,” ACIP member Tracy Lieu, MD, MPH, of the department of ambulatory care and prevention at Harvard Pilgrim Health Care and Harvard Medical School, said.
The ACIP also recommended priority vaccination for health care workers with direct contact with infants younger than 12 months.
Although a vaccination program in a hospital or ambulatory care setting will mean an increase in spending, Ismael Ortega-Sanchez, PhD, of the CDC, said the benefits, or savings, of vaccination could be sizable for hospitals, even after covering program costs with a possible benefit-cost ratio of greater than one, meaning that benefits may be greater than cost.
“The Tdap vaccination program [of] health care workers could have substantial impact in reducing hospital-acquired pertussis morbidity,” he said.
Until the head of the CDC and secretary of the Department of Health and Human Services approve the recommendations and they are published in the Morbidity and Mortality Weekly Report, the recommendations are not official.
Older adults
In a vote of 9-4, the ACIP rejected permissive, off-label recommendations for the use of Tdap people 65 and older.
Katrina Kretsinger, MD, of the Bacterial Vaccine-Preventable Diseases Branch of the NIP at the CDC, said that despite a lack of pre-licensure data on the safety and efficacy of giving Tdap in the older population, pertussis is likely underreported and underrecognized among people 65 and older.
“In the United States, while the burden of pertussis among older adults is not clearly defined, it is likely substantial,” Kretsinger said as she pitched the recommendations. Those in the 65 and older set might fall into one of the vaccine-recommended groups anyway, she added, as health care workers or adults with contact with an infant younger than 12 months.
Off-label recommendations are on the books for other vaccines; for example, the FDA indicated yellow fever vaccine for infants at least 9 months old. The vaccine, however, is recommended for infants at least 6 months old.
The first part of the proposed recommendation acknowledged that Tdap is not licensed in the 65 and older age group and the safety and immunogenicity of the vaccine in that population is unstudied. The proposed recommendation included a sentence that read, “recommendations for use of Tdap in adults >65 years will be updated as new data become available.”
Debate ensued over one sentence in particular: “Clinicians can choose to administer Tdap for adults >65 years of age for protection against pertussis in addition to protection against tetanus and diphtheria.”
The vote was to take that sentence out of the recommendations, in effect removing the meat of the proposal.
Lieu was one of the members who voted to remove the sentence.
“I feel very hesitant about going so far beyond the FDA indications for this vaccine,” Lieu said. “This would be for universal immunization of an entire age group, and I think that it just seems to me that it’s actually not within ACIP precedent and that there are good reasons not to.”
Gregory A. Poland, MD, professor of medicine, infectious diseases, molecular pharmacology and experimental therapeutics and pediatrics at the Mayo Medical School and Mayo Clinic and Foundation in Rochester, Minn., voted to leave the sentence.
“I would be supportive of this,” he said. “If we add a statement that data will be forthcoming in the next few years … maybe that would be reassuring.”
Representatives from both Sanofi Pasteur and GlaxoSmithKline said they are studying their vaccines for expanded age indications.
The ACIP recommended Tdap for adults with close contact to infants younger than 12 months of age, ideally about one month before close contact with the child. In situations when it is important to protect against pertussis, intervals shorter than 10 years since the last Td vaccination may be applied.
The committee suggested a two-year interval between Td and Tdap to reduce the risk of reactions following vaccination.
In June 2005, the ACIP recommended that adolescents aged 11 and 12 years receive Tdap – either product – in place of the Td booster. The committee also recommended that adolescents aged 13 to 18 who missed the 11- to 12-year dose of Td receive Tdap. – by Judith Rusk
For more information:
- Calugar A, Ortega-Sánchez IR, Tiwari T, et al. Nosocomial pertussis: costs of an outbreak and benefits of vaccinating health care workers. Clin Infect Dis. 2006;42:981-988.