Advisory committee on immunization practices




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2004,23:985-989) reported interviews of parents of infants with pertussis to determine the source of pertussis, defined as persons with acute cough illness in contact with the infant 7 to 20 days before the infant’s cough onset. If more than one source was identified, the one spending the “most time” with the infant was considered to be the source. Of 494 infants aged less than 4 months with pertussis (1999 to 2002), the source relationship was unknown for 57 percent, but was a mother, father, or grandparent for 24 percent. The age of source case was unknown in 64 percent cases; 20 percent of the infants were reported infected by an adult aged ≥20 years.


Economics and Cost Effectiveness of Adult Pertussis Vaccination

Presenter: Dr. Grace Lee, Harvard Medical School/Harvard Pilgrim Health Care


Overview: Analysis to explore the cost effectiveness (or cost saving) of adult prevention strategies at varying incidence rates and severity of disease.


Background. Prior economic analyses of adult vaccination strategies disagreed as to the cost effectiveness (C.E.) of this intervention. In 2004, Purdy et al analyzed the approach of one-dose vaccination against pertussis of all adults aged ≥20 years and found it to be cost saving, while Dr. Lee and her team’s 2005 analysis of adult vaccination with decennial boosters found it not to be cost-effective. Aside from study design, a major reason for different conclusions could be the use of different incidence figures (Purdy’s of 159 to 548 per 100,000, Lee’s of 11 per 100,000). In addition, neither study adjusted for disease severity with increased incidence, which may favor more cost effectiveness or savings.


The Lee study analyzed the C.E. of one dose of vaccine for adults aged 20 to 64 years, and the impact of incidence and disease severity on C.E. The decision tree moves from vaccination or not vaccinated, to no pertussis or pertussis; and if the latter, severity of disease and adverse events (or not) from local reactions to anaphylaxis.


Lee study assumptions estimated:

  • Disease severity for a range of incidence rates, 10 per 100,000 to 500 per 100,000. For the former, 67 percent cases were assumed to have severe cough, 30 percent cases moderate cough, none with mild cough, and 3 percent with pneumonia. For the high (500) incidence, 38 percent cases were assumed to have mild cough, 21 percent moderate cough, 40 percent severe cough, and 1 percent with pneumonia.

  • Vaccine coverage: 57 percent to 66 percent (using N.H.I.S. data) with a V.E. of 87 percent.

  • Incremental vaccine events (Tdap versus Td):

    • 1) 2 percent local reactions, 1 percent systemic reactions, 0.0001 percent anaphylaxis, and no adverse events due to vaccination, and

    • 2) waning immunity over time, dropping V.E. from 87 percent to approximately 20 percent at ten years and zero at 15 years.

  • Medical costs averaged approximately 338 dollars per case and non-medical costs for severe cough illness of approximately 460 dollars (most from work lost).

  • Incremental vaccine cost (Tdap and Td cost difference) of approximately 20 dollars.

  • No vaccination costs (Tdap simply replacing Td).


The Q.A.L.Y. analysis estimated the benefit from prevented morbidity as well as mortality. The same metric was used to measure both disease and vaccine outcomes as well as vaccine and non-vaccine interventions (for example, vaccination benefits versus risk of adverse events). Also considered was the impact of a pertussis vaccination program on other interventions in a setting of limited resources.


To assign values for different pertussis-associated health states (varied widely between studies), a time trade-off method was used (that is, willingness to sacrifice time from life’s end to avoid an 8-week severe cough). The results were charted on a scale ranging from 0 (equal to death) to 1 (equal to perfect health). Infant respiratory and neurological outcomes were the least acceptable, with a value of 0.5. Local or systemic reactions due to vaccination were the most acceptable (approximately 0.9), and moderate or severe cough illness was in between at approximately 0.8. Vaccine adverse events were preferred to adult pertussis, and adult pertussis was preferred to infant pertussis. Quality-adjusted life-years saved (Q.A.L.Y.s) were calculated by multiplying these health state values times the duration of the health state.


The outcome measures were: prevented pertussis cases, Q.A.L.Y.s saved, and total programmatic costs. The C.E. measures were the dollar per case prevented and cost per Q.A.L.Y. saved, and 50,000 dollars to 100,000 dollars per Q.A.L.Y. was the C.E. benchmark. Results were:

  • Very low incidence of 10 per 100,000, approximately 164,000 cases over a ten-year period, 72,000 cases preventable with a vaccination program: Not C.E. (in fact, negative Q.A.L.Y.s), because minor vaccine events are not necessarily offset by the gain in quality of life achieved by preventing pertussis when disease incidences is very low.

  • Disease incidence of 500 per 100,000, 8 million cases of pertussis, 3.5 million cases (104,000 Q.A.L.Y.s saved) preventable with adult vaccination: C.E. The quality of life gained from prevented pertussis outweigh potential vaccine adverse events.

  • Disease incidence, with fixed vaccination program costs of 2.1 billion dollars, at 10 per 100,000 incidence (100 million dollars saved): Net cost remains 2 billion dollars; at 500 per 100,000 incidence (1.6 billion dollars saved), net cost is approximately 500 million dollars.

  • Disease incidence levels and C.E. ratios. Costs vary according to disease incidence, ranging from 25,000 dollars per case prevented with low-incidence (10 per 100,000) to 100 dollars per case at 500 per 100,000 incidence. The cost per Q.A.L.Y. saved ranged from dominated (at low incidence) to 4,000 dollars (at 500 per 100,000). The C.E. threshold for an adult vaccination program begins at incidence rates of approximately 100 per 100,000. As incidence rises, the cost per Q.A.L.Y. drops.

  • Severity of illness at high-incidence. When no change in the distribution of disease severity was assumed, the overall C.E. of adult pertussis vaccination changed little.

  • Impact of herd immunity on vaccine C.E. was analyzed in three scenarios: no herd immunity; herd immunity from one vaccination to 57 percent to 66 percent of adults preventing an additional 5 percent of infant cases and 15 percent of adult cases; and herd immunity from one vaccination preventing an additional 10 percent of cases in infants and 30 percent in adults. Not surprisingly, the inclusion of herd immunity improved the C.E. of a vaccination program. The program is very C.E. at high-incidence rates, but C.E. could be improved further by herd immunity in low-incidence settings.


Study limitations were the assumption that incidence rates average out over time (pertussis is an endemic disease with epidemic cycles every few years) and the unknown degree of herd immunity provided by an adult pertussis vaccination program, which depend on vaccine uptake and contact patterns in the population.


Physician Perspectives on Tdap Administration to Adults

Presenter: Dr. Katrina Kretsinger, N.I.P.


Overview: Results of a survey of family practitioners, internists and obstetricians about adult Tdap vaccination


Data were collected on the current vaccination practices reported by primary-care adult physicians and by obstetricians, as well as factors affecting their likelihood to recommend and administer Tdap if A.C.I.P. recommends Tdap for the general adult population and for adults in close contact with infants less than 6 months of age. A national cross-sectional sample of internists, family physicians and obstetricians (400 each) was requested from the A.M.A. master data file. Two questionnaires, one for internists and family physicians and one for obstetricians, and accompanying fact sheets on pertussis and Tdap were sent in a single mailing. The response rate was 46 percent by internists, 52 percent by family physicians and 54 percent by obstetricians. Results were:

  • Among family practitioners and internists who reported seeing adults for primary care:

    • Td booster practices: 63 percent routinely assess Td at health-maintenance visits, 68 percent administer Td for routine health maintenance, and 93 percent administer Td for wound management as indicated.

    • Major barriers to routine Td vaccination: knowing who needs a Td booster (51 percent), too busy (42 percent), patient reluctance (42 percent). Reimbursement and vaccine supply issues were also raised.

    • Disease severity justification: 50 percent of primary-care physicians agreed that adult pertussis was serious enough to warrant vaccinating adults, 13 percent disagreed; 73 percent agreed that infant pertussis was serious enough to warrant vaccination of adult contacts of infants less than 6 months of age.

    • Anticipated response to A.C.I.P. recommendation of one Tdap dose to replace Td. 71 percent would stock Tdap; 81 percent would recommend it to their patients.

    • Vaccine cost: greater than 80 percent reported 20 dollars increased incremental cost of Tdap over Td would constitute a slight or strong barrier to stocking Tdap; approximately 75 percent found the increase in cost a slight or strong barrier to recommending it to their patients.

    • Responsibility for promoting and administering Tdap to adults rests with primary-care providers: approximately 89 percent would promote it and 95 percent would administer it; the responsibility should be shared among pediatricians, obstetricians and other public-health providers.

  • Among obstetricians who reported providing obstetrical care:

    • 61 percent reported routinely administering influenza vaccine during pregnancy and 87 percent reported routinely administering MMR to a rubella non-immune woman immediately after delivery during the postpartum hospital stay.

    • If recommended by A.C.I.P./ACOG, 78 percent would recommend Tdap for women immediately after delivery during the postpartum hospital stay; 69 percent would recommend Tdap for pregnant women.

    • Likely barriers to Tdap vaccination included not knowing the date of the last booster vaccination (74 percent) and patient reluctance (4 percent); 14 percent cited cost or reimbursement concerns.

    • OBs believed that adult primary-care providers should be responsible for promoting (72 percent) and administering (62 percent) Tdap to adults likely to come into contact with infants less than 6 months of age; the role of promoting vaccination should be shared.


Discussion included

  • Only a few of the cough studies looked for pathogens other than pertussis (for example, mycoplasma), due to the difficulty of diagnosing the etiology of cough illness.

  • Dr. Treanor recalled the A.P.E.R.T. studies’ determination of influenza as a significant cause of prolonged cough illness. That suggests the wisdom of recommending routine influenza vaccination as well.

  • The administration of tetanus toxoid during pregnancy is a standard of care. The high percentage of respondents willing to administer Tdap during pregnancy and post-partum was a surprise to N.I.P., which expected a more cautious response.

  • Dr. James Cherry reported that their study of college students found few cases of Mycoplasma pneumoniae, and only a few other co-infections or cross-reacting antibody. A study of military personnel in Korea showed some mycoplasma and Chlamydia pneumoniae but no adenovirus. Most studies of prolonged paroxysmal cough find pertussis as the primary cause.

  • Dr. Martin Myers asked about data on co-administration of Tdap with MMR in children, and with influenza and pneumococcal polysaccharide vaccines in adults. Dr. Broder reported that the one concomitant administration trial done with trivalent influenza vaccine compared immune responses of the simultaneous group to those of the sequential group (influenza first, followed later by Tdap). Immunogenicity and safety responses were non-inferior except for pertactin (lower in simultaneous group), as they also were when hepatitis was simultaneously administered to adolescents.


Working Group Recommendations on A.C.I.P. Decision for Tdap Use Among Adults

Presenter: Dr. Kretsinger


Overview: Information on and rationale for the proposed recommendations on Tdap use among adults, for A.C.I.P. decision.


The F.D.A. licensed Tdap vaccine for use among persons 11 to 64 years of age, and A.C.I.P. recommended its use among adolescents 11 to 18 years of age. There is no A.C.I.P. guidance on Tdap use among the other age groups for which it is licensed. The Pertussis Working Group’s discussions involved several general principles and assumptions: 1) maintaining the A.C.I.P. standard of care for tetanus and diphtheria (decennial boosters or five years after the last Td shot in the event of a tetanus-prone wound); 2) future expected licensure of Tdap boosters (this first proposed recommendation assumed a 10-year duration of immunity); and 3) recommendations for adults aged 19 to 64 years, not previously addressed. Issues to be addressed later relate to Tdap use during pregnancy and among healthcare workers.


The proposed recommendations were based on two objectives: 1) protection of the vaccinated adult from pertussis morbidity, and 2) decreased transmission of pertussis to infants aged less than 6 months. The recommendations were weighed by the science or evidence, the existing standard of care and programmatic considerations. They were formatted in three sections:


Routine Tdap vaccination. To protect the vaccinated adult from pertussis, tetanus and diphtheria, the Working Group proposes that a single dose of Tdap should replace one dose of Td for adults aged 19 to 64 years, if ≥10 years have elapsed since the last Td and Tdap was not previously administered. This proposed recommendation is justified by safety and efficacy data of the vaccine, and substantial morbidity of pertussis among adults. The standard of care for tetanus and diphtheria protection of adults will be maintained with this recommendation, and it parallels the June A.C.I.P. recommended substitution of one Tdap for one Td dose among adolescents. Programmatically, Tdap can be given within the existing immunization infrastructure, replacing one Td vaccination in the routine schedule, is easy to understand and implement, applies to the general adult population and therefore to all risk groups, and physician acceptance is likely with an A.C.I.P. recommendation.


Intervals. The Working Group proposed that Tdap be given at intervals shorter than 5 to 10 years to protect against pertussis, when adults are not otherwise due for tetanus and diphtheria boosting. A minimum interval should not be specified. The safety of a two-year interval is described in Special Situations and the text allows for shorter intervals. The option of an “accelerated” schedule allows flexibility for catch-up vaccination with Tdap, which may be particularly helpful when the Td vaccination history is unreliable.

Vaccination of adults in close contact with infants aged less than 6 months is proposed by the Working Group to reduce transmission of pertussis from adults to infants. This group includes women in the preconception and postpartum periods who have not received Tdap, with an encouragement for all women of childbearing age to receive Tdap. Adults are known to be a source of infant pertussis, and mothers in particular are a common source of the infant’s pertussis, when a source is identified. Infants less than 6 months of age with pertussis have severe pertussis and are at high risk for death; infants complete the routine 3 dose series of D.T.a.P. at 6 months of age. Because infants aged less than 2 months are at the highest risk of death and complications from pertussis, their close contacts should receive Tdap before or as soon as possible after the birth of the infant.


Four complementary programmatic strategies are outlined, targeting: 1) any adult contact, 2) women in preconception, planning a pregnancy, 3) postpartum women, and 4) women of childbearing age in general. Existing program models exist, such as those for MMR and influenza. Targeting women of childbearing age would protect against pertussis in unintended pregnancies (estimated at 50 percent of pregnancies) and would protect against peri-partum transmission at delivery. A postpartum strategy is likely to be accepted by providers, as was MMR administration in that period.


Core recommendation. The core elements of the routine recommendation include:

  1. Tdap vaccination instead of Td for the next regularly scheduled booster - recommended

  2. Tdap may be administered after Td at a shorter interval to provide pertussis protection; the safety of intervals shorter than 2 years has been demonstrated and may be used – this would be a permissive recommendation;

  3. Tdap is recommended for adults in close contact with infants less than 6 months of age, and for women at preconception and post-partum, if not already vaccinated with Tdap; Tdap is encouraged for women of childbearing age at an implied shorter interval.


Contraindications and precautions. The Working Group retained the wording of the previous A.C.I.P. adolescent Tdap recommendation as follows:

Contraindications are unchanged and include a history of serious allergic reactions (anaphylaxis) and a history of encephalopathy within 7 days of receipt of a pertussis vaccine


Precautions and Reasons to Defer Tdap: The following are unchanged: Guillain-Barré Syndrome, moderate or severe acute illness or history of an Arthus hypersensitivity reaction following a prior dose of tetanus toxoid and/or diphtheria toxoid-containing vaccine. Changes were made to drop the term "progressive neurological conditions" in the adult patient population, since that could be applied to patients with dementia, Parkinson's disease, and other progressive conditions that are not precautions to Tdap, and replace with “unstable neurological condition (for example, cerebrovascular event, acute encephalopathic condition, etc.)”


Conditions Not Contraindications or Precautions to Tdap Use: No change was made to these conditions from the adolescent statement. The reader is referred to the adolescent statement for changes from the pediatric contraindications. The standard wound management algorithm was retained, substituting Tdap for Td. Recommendations for non-simultaneous administration of Tdap was unchanged from the provisional adolescent recommendations.


  • Special situations. The Working Group proposed the following: recommend Tdap during pertussis outbreaks or other settings of increased exposure, given the safety data. Health departments and physicians are allowed discretion on use of Tdap in such settings. Although not specifically indicated, health care settings could be inferred.

  • Prior pertussis. In situations in which the patient had pertussis, Tdap should be administered if otherwise indicated for incomplete or unclear primary vaccination history. Tdap should be one of the three-dose primary series.

  • Sequencing. A preference for simultaneous vaccination was proposed, with vaccines administered in any sequence when simultaneous vaccination is not feasible.

  • Adults ≥ 65 years of age. There are no pre-licensure safety or immunogenicity data available; Tdap showed tetanus and diphtheria protection that was non-inferior compared with Td. The working group proposed that older adults not be included in the general recommendations; it be stated that there is no known risk to administration of Tdap in older adults.


Discussion:

  • It can be clarified that the data support a vaccination interval of two years and, in certain circumstances, shorter than that. The U.S. Td post-licensure data suggest no excess serious local reactions among adults vaccinated at “short” intervals. While not impossible, it is highly unlikely that many people would be hyper-immunized from annual boosters, as was seen in the 1950s and 1960s.

  • Based on data indicating that infants have a higher rate of hospitalization to nine months, Dr. Neal Halsey suggested omitting the less than 6 month text and simply saying “infants.”

  • Dr. Middleman suggested dropping the text referencing the “next regularly scheduled booster,” since use of a 2- or 5-year interval could lower incidence rates more quickly, and wondered whether the Working Group had considered a catch-up campaign.

  • The Working Group considered giving pediatricians the option of immunizing mothers when they come in with their children, to use that infrastructure for pertussis as well as influenza. .

  • Dr. Neuzil asked if the wording on infant contacts should include older adults, greater than 64 years of age, who are not included in the routine recommendation (that is, to include all ages). Dr. Kretsinger said that this situation was not specifically addressed, but the recommendation may be interpreted as permissive for Tdap among persons greater than 64 years.

  • Dr. Michael Decker reported sanofi pasteur’s intent to submit data to F.D.A. on Tdap among adults ≥65 years of age to extend the license indication. Mr. Phil Hosbach assured that the vaccine supply should be sufficient. Although vaccine uptake is unpredictable, sanofi pasteur anticipated a recommendation for healthcare workers and key contacts.

  • Dr. Nichol suggested consideration of alternative immunization settings for Tdap, as done for those offering pneumococcal vaccine.

  • Dr. Sandra Hammer, of the state of California, commented that Tdap might take as long for the public to convert as it took to go from TT to Td. She urged the A.C.I.P. to do all in its power to encourage use of Tdap, particularly for wound management.


Public Comment

Ms. Pamela Durkin of Hatboro, Pennsylvania, spoke of her fourth son, Colin. He became ill with pertussis at age 5 weeks, and died four days after entering the hospital. She had followed the routine schedule for all her children, but did not know how contagious and dangerous pertussis could be. She recommended vaccination for all ages to control ‘this real threat that affects real lives, with devastating consequences.”


Proposed Recommendation


“The following sections present recommendations for the use of Tdap (ADACELTM, sanofi pasteur, Toronto, Ontario, Canada) for booster immunization against tetanus, diphtheria and pertussis among adults aged 19 to 64 years who have not received Tdap before. Tdap is licensed for use as a single dose.

“Adults should receive decennial Td boosters, beginning 10 years after Tdap, until guidance on subsequent Tdap doses is available (A.C.I.P. M.M.W.R. 1991,40(RR-10):1-28). Recommendations for Tdap use among adolescents are described elsewhere (C.D.C., A.C.I.P. adolescent Tdap statement, 2006).


Routine recommendations for adults: Adults who received their last dose of Td greater than 10 years earlier should receive a single dose of Tdap to replace a single dose of Td, for booster immunization against tetanus, diphtheria and pertussis.”


The A.C.I.P. accepted this text as presented.


Shorter interval between Td and Tdap: Intervals shorter than 10 years since the last Td may be used to protect against pertussis. Particularly in settings that carry an increased risk of pertussis or its complications, the benefits of using a single dose of Tdap at shorter intervals to protect against pertussis generally outweigh the risk of local and systemic reactions after vaccination. The safety of intervals of approximately 2 years between Td and Tdap is supported by a Canadian study; shorter intervals may be used.”


Discussion included:

  • Dr. Middleman reiterated that recommending shorter intervals would be a stronger statement and more quickly affect the disease burden. Dr. Abramson rejoined that the statement gives the flexibility to do that, while clearly not advocating catch-up campaigns.

  • Dr. Marcuse asked that wound management be specifically mentioned. Dr. Kretsinger pointed out that wound care is addressed in Section 3, Special Situations, but acknowledged the wish to move it up in the recommendation.


The recommendation continues:

“Prevention of pertussis exposure in infants aged less than 6 months. Adults who have or who anticipate having close contact with an infant aged less than 6 months (for example, parents, caregivers) should receive a single dose of Tdap to protect against pertussis if they have not received Tdap. Ideally, these adults should receive Tdap at least one month before beginning close contact with the infant.  


“A 2-year interval between Td and Tdap is suggested to reduce the risk of local and systemic reactions after vaccination; shorter intervals may be used (See Shorter Interval, see Pregnancy Considerations).”


Discussion included:

  • “Caregivers” is open to interpretation. If this term includes daycare providers, that should be explicitly stated.

  • Dr. Baker supported post-pregnancy Tdap administration to take advantage of the existing infrastructure. And, with outbreaks already occurring in children’s hospitals, she stressed the importance of exposure control. The A.A.P. would not ask for a blanket recommendation on healthcare workers, but wished for specific attention for others such as daycare providers, as a large proportion of U.S. infants are in daycare full- or part-time. Dr. Murphy stated that healthcare workers will be addressed at a future date. Currently, the N.I.P. is consulting with health care worker stakeholder organizations.

  • Text changes suggested were: “… for example, daycare or in-home care givers, etc.,” “up to one year of age,” and “adults of any age” (the latter to include grandparents), and “if or when licensed” referring to the vaccine.

  • Dr. Pickering cautioned the committee about making a recommendation for adults older than 64 years of age when Tdap is unlicensed with few data in this age group. Dr. Baylor disagreed, citing F.D.A.’s encouragement that a recommendation be made by A.C.I.P.


The recommendation continues:

“Women should receive a dose of Tdap as soon as feasible in the immediate post-partum period if they have not previously received Tdap.


“When possible, women should receive Tdap prior to conception. Since it is estimated that approximately half of all pregnancies in the United States are unplanned, any woman of childbearing age who might become pregnant is encouraged to receive a single dose of Tdap.”

Discussion included advice that the text refer to “infants” in general (that is, those aged less than 12 months), but with particular emphasis on those younger, such as the 0 to 2 month-olds with the highest mortality.


Contraindications. Recommended contraindications include:

  • History of serious allergic reaction (that is, anaphylaxis) to any component of the vaccine (Tdap)

  • History of encephalopathy (for example, coma, prolonged seizures) within 7 days of administration of a pertussis vaccine, that is not attributable to another identifiable cause. These individuals should receive Td instead of Tdap.


The A.C.I.P. accepted this text as presented.


Precautions. Proposed recommendations on precautions were as follow:

  • Guillain-Barré Syndrome ≤6 weeks after a previous dose of a tetanus toxoid-containing vaccine.

  • Moderate or severe acute illness with or without fever.

  • Unstable neurological condition (for example, cerebrovascular events, acute encephalopathic conditions).

  • History of an Arthus hypersensitivity reaction following a prior dose of a tetanus toxoid and/or diphtheria toxoid-containing vaccine. A footnote advises consideration of “deferring Tdap or Td vaccination until 10 years after the last tetanus or diphtheria toxoid-containing vaccine.”


The A.C.I.P. agreed to this text as presented.


Other Conditions that are Not Contraindications or Precautions for Tdap.

The proposed recommendations included:

  • Stable neurological disorder including well-controlled seizures, a history of seizure disorder that has resolved, and cerebral palsy.

  • Brachial neuritis.

  • Immunosuppression.

  • Pregnancy (See Special Situations, Pregnancy).

  • Breastfeeding.

  • Intercurrent minor illness.

  • Antibiotic use.

  • History of extensive limb swelling (E.L.S.) reactions following pediatric D.T.a.P./D.T.P. or Td that was not an Arthus reaction.

  • “Certain systemic reactions following administration of pediatric D.T.P./D.T.a.P. are precautions for pediatric D.T.a.P. but not for Tdap (C.D.C. A.C.I.P. adolescent Tdap statement, 2006).”


Discussion included Dr. Marcuse’s suggestion that the last conditions be listed in the adult Tdap recommendations, rather than referencing the adolescent Tdap statement, for adult providers’ quick referral.


Special Situations proposed recommendations included:

  • Outbreaks/increased exposure: Tdap at intervals shorter than 10 years may be considered; safety of intervals as short as approximately 2 years is supported. Further guidance on healthcare workers will be considered by A.C.I.P. in the future.


The A.C.I.P. accepted this text as presented.


The recommendation continues:

  • Tetanus prophylaxis in wound management: Tdap is preferred over Td if there was no prior Tdap administered and Tdap is available.

  • History of pertussis: Tdap as otherwise indicated.

  • Adults with incomplete or unknown D.T.P./D.T.a.P. vaccination history: Use a 3-dose primary series, and Tdap should replace one Td dose (Tdap is preferred for the first dose).


Proposed Special Situations, Non-simultaneous Vaccination with Tdap and Other Vaccines, including M.C.V.4. The proposed recommendation was as follows:

“A.C.I.P. states that inactivated vaccines may be administered at any time before or after a different inactivated or live vaccine, unless a contraindication exists (C.D.C., A.C.I.P. General recommendations 2002). Simultaneous administration of Tdap and M.C.V.4 (which all contain diphtheria toxoid) during the same visit is preferred when both Tdap and M.C.V.4 vaccines are indicated (C.D.C. 54, RR-7:2005, C.D.C. M.M.W.R. 54.1-3. 2005). If simultaneous vaccination is not feasible (for example, a vaccine is not available), M.C.V.4 and Tdap can be administered in any sequence.”


The A.C.I.P. accepted this text as presented which was identical to that of the adolescent recommendations:


Older Adults Aged greater than 65 years. The proposed recommendation was as follows:

“Tdap is not licensed for use among persons aged greater than 65 years. There are no pre-licensure data on safety and immunogenicity in this population. There are no known risks to replacing Td with a single dose of Tdap among adults aged greater than 65 years to provide protection against pertussis.”


The A.C.I.P. accepted this text as presented.


Dr. Marcuse suggested, to general agreement, that the text on wound management, citing that the patient “can” receive, be changed to “should” receive to encourage rather than be permissive on the vaccine’s use. Wound management would also be referenced at the beginning of the recommendation.


Dr. Finger moved to accept the Tdap recommendations as amended. Dr. Allos seconded the motion.

Vote

In favor: Allos, Beck, Campbell, Finger, Gilsdorf, Hull, Lieu, Marcuse, Morita, Treanor, Womeodu, Abramson
1   2   3   4   5   6   7   8   9   10

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