With the pertussis outbreak in California nearing a 60-year high in the number of cases reported, the CDC's Advisory Committee on Immunization Practices, or ACIP, has voted to recommend the off-label use of tetanus, diphtheria and acellular pertussis, or Tdap, vaccine in two specific patient groups.
The ACIP recommended during its Oct. 27-28 meeting in Atlanta that children ages 7 through 10 years who did not complete the recommended childhood series(5 page PDF) of diphtheria and tetanus toxoids and acellular pertussis, or DTaP, vaccine receive a catch-up dose(4 page PDF) of Tdap.
The ACIP also recommended that adults ages 65 and older who have close contact with infants receive a dose of Tdap. A dose also may be given to people in this age group who have not previously received Tdap.
"Pertussis is not particularly dangerous to either of these two groups," said Doug Campos-Outcalt, M.D., M.P.A., the AAFP's liaison to the ACIP. "It can make them sick, but the purpose of this recommendation is to protect those in whom pertussis is dangerous -- infants."
A booster dose of Tdap already is recommended for adolescents beginning as early as age 10 for the GlaxoSmithKline product Boostrix or at age 11 with Sanofi Pasteur's Adacel.
As of Oct. 26, 10 infant deaths from pertussis had been reported in California this year. The California Department of Public Health reported(www.cdph.ca.gov) that as of Oct. 19, the state had received reports of 6,257 confirmed, probable and suspected cases of pertussis. That number approaches the highest yearly total of cases in the state's recorded history, which was 6,613 cases in 1950.
California issued expanded pertussis immunization recommendations(www.cdph.ca.gov) in August to include the following groups:
- anyone age 7 years or older who is not fully immunized, including those who are older than 64;
- women of childbearing age before, during or immediately after pregnancy; and
- others who have contact with pregnant women or infants.
Several other states also have experienced increased pertussis activity this year, said Campos-Outcalt, who is associate head of the department of family and community medicine at the University of Arizona College of Medicine, Phoenix.
Meanwhile, the ACIP also recommended changes for meningococcal vaccination.
Children in certain high-risk groups -- including those with persistent complement component deficiency, anatomic or functional asplenia, HIV infection, or sickle cell disease -- already had been recommended to receive quadrivalent meningococcal conjugate vaccine, or MCV4, as early as age 2, with a booster dose to follow in either three or five years, depending on the age at which they received their first dose.
During last month's meeting, the ACIP voted to recommend a second MCV4 dose be added to the primary series for high-risk children. The recommendation for a booster dose either three or five years after that second dose remains in place.
In addition, all adolescents already were recommended to receive one dose of MCV4 at age 11 or 12 years (or at 13-18 years if not previously vaccinated). The committee now has voted to recommend a booster dose at age 16 for adolescents who received their first dose at the preteen (age 11 or 12) visit. Those who received their initial dose at ages 13-15 should get a booster dose five years after that first dose.
This latter change, according to Campos-Outcalt, reflects that fact that although the incidence of meningococcal disease is "low and getting lower," serological studies have shown that antibody levels conferred by the vaccine wane in time. People ages 16-21, particularly college freshmen living in dormitories, now are considered to be at increased risk for meningococcal disease.
Finally, the committee voted unanimously to adopt an evidence-based vaccination recommendation process.
Campos-Outcalt said the change, which will be implemented during the next few years, will give the committee's recommendations added credibility.
"They're credible now, but there have been questions in some circles about the amount and quality of evidence behind some recommendations," he said. "The committee hadn't adjusted with the times and had continued to do things the way it had always done them. Guideline development has progressed, and the methodology has progressed.
"AAFP members, when they see new recommendations and guidelines, have become used to seeing the amount of evidence and how good it is. Most guidelines now describe that when they come out, and this will bring the ACIP in line with state-of-the-art, evidence-based methodology and reporting of it."
ACIP member Jonathan Temte, M.D., Ph.D., who served as chair of the committee's workgroup on evidence-based recommendations, said an evidence-based framework for vaccination recommendation has been in development for years.
Temte, a professor in the department of family medicine at the University of Wisconsin School of Medicine and Public Health, Madison, also said the new process will be more transparent for stakeholders, including family physicians.
"The American Academy of Family Physicians has always partnered very well with the U.S. Preventive Services Task Force, and we're used to using their recommendations as part of our preventive care systems," he said. "I think by adopting a system that is similar, in which we have clear recommendations and clear statements of the evidence base behind those recommendations, it allows the practicing clinician to more confidently use the recommendations coming from an organization outside of AAFP."
The ACIP is scheduled to meet again Feb. 23-24 in Atlanta.