ACIP Meeting

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices unanimously voted in favor of adding various recently licensed influenza vaccines to the list of acceptable vaccines for the prevention of influenza at the most recent meeting of the committee on Feb. 21.

The four influenza vaccines licensed by the Food and Drug Administration over the past year are two quadrivalent vaccines that include two influenza B strains and two influenza A strains; a cell-culture-based vaccine; and an egg-free, recombinant hemagglutinin vaccine manufactured without the use of influenza viruses.

These vaccines are expected to be available during the 2013-2014 influenza season, along with previously available vaccines, Dr. Lisa Grohskopf of the influenza division in the CDC’s National Center for Immunization and Respiratory Diseases said at the meeting.

She also provided an overview of new influenza vaccine abbreviations, reflecting the availability of the new vaccines. With the introduction of the quadrivalent vaccines, "we’ve had to replace our time-honored TIV abbreviation," replacing the abbreviation for trivalent inactivated vaccine (TIV) with IIV (inactivated influenza vaccine), she said.

The IIV class includes trivalent (IIV3) vaccines (those that are egg based and those that are cell-culture based) and quadrivalent (IIV4) inactivated vaccines. Cell-culture-based IIV is referred to as ccIIV or ccIIV3m. RIV3 refers to the trivalent recombinant hemagglutinin influenza vaccine, and LAIV and LAIV4 refer to live attenuated influenza vaccine.

The new vaccines "are acceptable alternatives to the other licensed vaccine products within specified indications," she said. But there are no formal recommendations proposed for using one vaccine over another when a provider has more than one vaccine that is available and appropriate for a given recipient, she added. Moreover, during her presentation Dr. Grohskopf emphasized repeatedly that providers should not delay vaccinating a patient in order to wait for a specific product.

The four new influenza vaccines are:

Flumist Quadrivalent (MedImmune). This quadrivalent live-attenuated influenza vaccine (LAIV4) was licensed in February 2012 for the same indication as the trivalent LAIV for healthy, nonpregnant people aged 2-49 years. Based on evidence from studies comparing the trivalent LAIV with IIV3 that indicate LAIV is more effective in children, providers "may consider use of LAIV4 rather than IIV for children in situations in which both vaccines are available and are otherwise appropriate," Dr. Grohskopf said. But vaccination should not be delayed if the LAIV4 is not available, she added.

• Fluarix Quadrivalent (GSK). This quadrivalent inactivated influenza vaccine (IIV4) was licensed in December 2012 for people aged 3 years and older. This vaccine is "an acceptable alternative" to other licensed products, used within indications. Both the trivalent version (IIV3) and IIV4 will be available in 2103-2014, but IIV3 will make up most of the supply. Either is acceptable, and since IIV4 "may provide broader coverage of circulating influenza viruses, providers who have access to both IIV4 and IIV3 may wish to consider IIV4 for individuals with conditions that confer high risk for influenza complications, when either vaccine is otherwise appropriate," Dr. Grohskopf said.

• Flucelvax (Novartis). This cell-culture-based inactivated influenza vaccine (ccIIV3) was licensed in November 2012 for people aged 18 years and older. It is also an acceptable alternative to other licensed products "used within indications," Dr. Grohskopf said. Although the vaccine viruses are not propagated in eggs, this vaccine cannot be considered completely egg free, but it is expected to contain "considerably less egg protein than other IIVs." Providers "may consider use" of ccIIV3 for egg-allergic patients aged 18 years and older, but "vaccination of mildly egg-allergic individuals should not be delayed if ccIIV3 is not available," when any licensed IIV should be administered, she noted.

• Flublok (Protein Sciences). This recombinant hemagglutinin vaccine (RIV3) – the first purified, recombinant hemagglutinin (HA) protein influenza vaccine, manufactured without the use of influenza virus – was licensed for adults aged 18-49 years in January 2013. The vaccine contains 45 mcg of each HA component, more than other vaccines, and contains no egg protein, preservative, or latex, Dr. Lisa M. Dunkle, chief medical officer at Protein Sciences, said at the meeting. She said that 3-5 million doses of Flublok, which is contained in single-use vials, are expected to be available for the 2013-2014 season. The company is working on a quadrivalent version of Flublok.

RIV3 is truly egg free, and in a situation where both IIV and RIV3 are available and "otherwise appropriate," a provider could consider using RIV3 for people aged 18-49 years who have a mild egg allergy, Dr. Grohskopf said. But vaccination should not be delayed if RIV3 is not available. RIV3 is not contraindicated in people with anaphylaxis to egg.

In 2011, the Advisory Committee on Immunization Practices (ACIP) recommended that people with a mild egg allergy receive IIV. Noting that egg allergy is most prevalent in younger children, she pointed out that Flucelvax or Flublok are not approved in children, and that there is no recommendation for off-label use of these vaccines in egg-allergic children.

Dr. Dunkle said that Protein Sciences is conducting additional studies in younger and older people, and the company expects that licensure of the vaccine will be expanded to include adults aged 50 years and older for the 2013-2014 season. At the FDA’s request, the company is planning a Flublok pregnancy registry. Reproductive toxicology tests of the vaccine in rats were negative, and during clinical trials, 20 women who received Flublok became pregnant, and with 75% follow-up, there have been no birth defects among the live births or vaccine-related adverse events, she said.

The panel also reaffirmed the recommendation for annual influenza vaccination for people aged 6 months and older, with the caveat that younger children through age 8 years receive two doses at least 20 days apart.

There are 15 experts in immunization-related fields on ACIP, which develops written recommendations for the routine administration of vaccines to children and adults in the civilian population.

Information on approved influenza vaccines is available here.

[email protected]

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices unanimously voted in favor of adding various recently licensed influenza vaccines to the list of acceptable vaccines for the prevention of influenza at the most recent meeting of the committee on Feb. 21.

The four influenza vaccines licensed by the Food and Drug Administration over the past year are two quadrivalent vaccines that include two influenza B strains and two influenza A strains; a cell-culture-based vaccine; and an egg-free, recombinant hemagglutinin vaccine manufactured without the use of influenza viruses.

These vaccines are expected to be available during the 2013-2014 influenza season, along with previously available vaccines, Dr. Lisa Grohskopf of the influenza division in the CDC’s National Center for Immunization and Respiratory Diseases said at the meeting.

She also provided an overview of new influenza vaccine abbreviations, reflecting the availability of the new vaccines. With the introduction of the quadrivalent vaccines, "we’ve had to replace our time-honored TIV abbreviation," replacing the abbreviation for trivalent inactivated vaccine (TIV) with IIV (inactivated influenza vaccine), she said.

The IIV class includes trivalent (IIV3) vaccines (those that are egg based and those that are cell-culture based) and quadrivalent (IIV4) inactivated vaccines. Cell-culture-based IIV is referred to as ccIIV or ccIIV3m. RIV3 refers to the trivalent recombinant hemagglutinin influenza vaccine, and LAIV and LAIV4 refer to live attenuated influenza vaccine.

The new vaccines "are acceptable alternatives to the other licensed vaccine products within specified indications," she said. But there are no formal recommendations proposed for using one vaccine over another when a provider has more than one vaccine that is available and appropriate for a given recipient, she added. Moreover, during her presentation Dr. Grohskopf emphasized repeatedly that providers should not delay vaccinating a patient in order to wait for a specific product.

The four new influenza vaccines are:

Flumist Quadrivalent (MedImmune). This quadrivalent live-attenuated influenza vaccine (LAIV4) was licensed in February 2012 for the same indication as the trivalent LAIV for healthy, nonpregnant people aged 2-49 years. Based on evidence from studies comparing the trivalent LAIV with IIV3 that indicate LAIV is more effective in children, providers "may consider use of LAIV4 rather than IIV for children in situations in which both vaccines are available and are otherwise appropriate," Dr. Grohskopf said. But vaccination should not be delayed if the LAIV4 is not available, she added.

• Fluarix Quadrivalent (GSK). This quadrivalent inactivated influenza vaccine (IIV4) was licensed in December 2012 for people aged 3 years and older. This vaccine is "an acceptable alternative" to other licensed products, used within indications. Both the trivalent version (IIV3) and IIV4 will be available in 2103-2014, but IIV3 will make up most of the supply. Either is acceptable, and since IIV4 "may provide broader coverage of circulating influenza viruses, providers who have access to both IIV4 and IIV3 may wish to consider IIV4 for individuals with conditions that confer high risk for influenza complications, when either vaccine is otherwise appropriate," Dr. Grohskopf said.

• Flucelvax (Novartis). This cell-culture-based inactivated influenza vaccine (ccIIV3) was licensed in November 2012 for people aged 18 years and older. It is also an acceptable alternative to other licensed products "used within indications," Dr. Grohskopf said. Although the vaccine viruses are not propagated in eggs, this vaccine cannot be considered completely egg free, but it is expected to contain "considerably less egg protein than other IIVs." Providers "may consider use" of ccIIV3 for egg-allergic patients aged 18 years and older, but "vaccination of mildly egg-allergic individuals should not be delayed if ccIIV3 is not available," when any licensed IIV should be administered, she noted.

• Flublok (Protein Sciences). This recombinant hemagglutinin vaccine (RIV3) – the first purified, recombinant hemagglutinin (HA) protein influenza vaccine, manufactured without the use of influenza virus – was licensed for adults aged 18-49 years in January 2013. The vaccine contains 45 mcg of each HA component, more than other vaccines, and contains no egg protein, preservative, or latex, Dr. Lisa M. Dunkle, chief medical officer at Protein Sciences, said at the meeting. She said that 3-5 million doses of Flublok, which is contained in single-use vials, are expected to be available for the 2013-2014 season. The company is working on a quadrivalent version of Flublok.

RIV3 is truly egg free, and in a situation where both IIV and RIV3 are available and "otherwise appropriate," a provider could consider using RIV3 for people aged 18-49 years who have a mild egg allergy, Dr. Grohskopf said. But vaccination should not be delayed if RIV3 is not available. RIV3 is not contraindicated in people with anaphylaxis to egg.

In 2011, the Advisory Committee on Immunization Practices (ACIP) recommended that people with a mild egg allergy receive IIV. Noting that egg allergy is most prevalent in younger children, she pointed out that Flucelvax or Flublok are not approved in children, and that there is no recommendation for off-label use of these vaccines in egg-allergic children.

Dr. Dunkle said that Protein Sciences is conducting additional studies in younger and older people, and the company expects that licensure of the vaccine will be expanded to include adults aged 50 years and older for the 2013-2014 season. At the FDA’s request, the company is planning a Flublok pregnancy registry. Reproductive toxicology tests of the vaccine in rats were negative, and during clinical trials, 20 women who received Flublok became pregnant, and with 75% follow-up, there have been no birth defects among the live births or vaccine-related adverse events, she said.

The panel also reaffirmed the recommendation for annual influenza vaccination for people aged 6 months and older, with the caveat that younger children through age 8 years receive two doses at least 20 days apart.

There are 15 experts in immunization-related fields on ACIP, which develops written recommendations for the routine administration of vaccines to children and adults in the civilian population.

Information on approved influenza vaccines is available here.

[email protected]

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices unanimously voted in favor of adding various recently licensed influenza vaccines to the list of acceptable vaccines for the prevention of influenza at the most recent meeting of the committee on Feb. 21.

The four influenza vaccines licensed by the Food and Drug Administration over the past year are two quadrivalent vaccines that include two influenza B strains and two influenza A strains; a cell-culture-based vaccine; and an egg-free, recombinant hemagglutinin vaccine manufactured without the use of influenza viruses.

These vaccines are expected to be available during the 2013-2014 influenza season, along with previously available vaccines, Dr. Lisa Grohskopf of the influenza division in the CDC’s National Center for Immunization and Respiratory Diseases said at the meeting.

She also provided an overview of new influenza vaccine abbreviations, reflecting the availability of the new vaccines. With the introduction of the quadrivalent vaccines, "we’ve had to replace our time-honored TIV abbreviation," replacing the abbreviation for trivalent inactivated vaccine (TIV) with IIV (inactivated influenza vaccine), she said.

The IIV class includes trivalent (IIV3) vaccines (those that are egg based and those that are cell-culture based) and quadrivalent (IIV4) inactivated vaccines. Cell-culture-based IIV is referred to as ccIIV or ccIIV3m. RIV3 refers to the trivalent recombinant hemagglutinin influenza vaccine, and LAIV and LAIV4 refer to live attenuated influenza vaccine.

The new vaccines "are acceptable alternatives to the other licensed vaccine products within specified indications," she said. But there are no formal recommendations proposed for using one vaccine over another when a provider has more than one vaccine that is available and appropriate for a given recipient, she added. Moreover, during her presentation Dr. Grohskopf emphasized repeatedly that providers should not delay vaccinating a patient in order to wait for a specific product.

The four new influenza vaccines are:

Flumist Quadrivalent (MedImmune). This quadrivalent live-attenuated influenza vaccine (LAIV4) was licensed in February 2012 for the same indication as the trivalent LAIV for healthy, nonpregnant people aged 2-49 years. Based on evidence from studies comparing the trivalent LAIV with IIV3 that indicate LAIV is more effective in children, providers "may consider use of LAIV4 rather than IIV for children in situations in which both vaccines are available and are otherwise appropriate," Dr. Grohskopf said. But vaccination should not be delayed if the LAIV4 is not available, she added.

• Fluarix Quadrivalent (GSK). This quadrivalent inactivated influenza vaccine (IIV4) was licensed in December 2012 for people aged 3 years and older. This vaccine is "an acceptable alternative" to other licensed products, used within indications. Both the trivalent version (IIV3) and IIV4 will be available in 2103-2014, but IIV3 will make up most of the supply. Either is acceptable, and since IIV4 "may provide broader coverage of circulating influenza viruses, providers who have access to both IIV4 and IIV3 may wish to consider IIV4 for individuals with conditions that confer high risk for influenza complications, when either vaccine is otherwise appropriate," Dr. Grohskopf said.

• Flucelvax (Novartis). This cell-culture-based inactivated influenza vaccine (ccIIV3) was licensed in November 2012 for people aged 18 years and older. It is also an acceptable alternative to other licensed products "used within indications," Dr. Grohskopf said. Although the vaccine viruses are not propagated in eggs, this vaccine cannot be considered completely egg free, but it is expected to contain "considerably less egg protein than other IIVs." Providers "may consider use" of ccIIV3 for egg-allergic patients aged 18 years and older, but "vaccination of mildly egg-allergic individuals should not be delayed if ccIIV3 is not available," when any licensed IIV should be administered, she noted.

• Flublok (Protein Sciences). This recombinant hemagglutinin vaccine (RIV3) – the first purified, recombinant hemagglutinin (HA) protein influenza vaccine, manufactured without the use of influenza virus – was licensed for adults aged 18-49 years in January 2013. The vaccine contains 45 mcg of each HA component, more than other vaccines, and contains no egg protein, preservative, or latex, Dr. Lisa M. Dunkle, chief medical officer at Protein Sciences, said at the meeting. She said that 3-5 million doses of Flublok, which is contained in single-use vials, are expected to be available for the 2013-2014 season. The company is working on a quadrivalent version of Flublok.

RIV3 is truly egg free, and in a situation where both IIV and RIV3 are available and "otherwise appropriate," a provider could consider using RIV3 for people aged 18-49 years who have a mild egg allergy, Dr. Grohskopf said. But vaccination should not be delayed if RIV3 is not available. RIV3 is not contraindicated in people with anaphylaxis to egg.

In 2011, the Advisory Committee on Immunization Practices (ACIP) recommended that people with a mild egg allergy receive IIV. Noting that egg allergy is most prevalent in younger children, she pointed out that Flucelvax or Flublok are not approved in children, and that there is no recommendation for off-label use of these vaccines in egg-allergic children.

Dr. Dunkle said that Protein Sciences is conducting additional studies in younger and older people, and the company expects that licensure of the vaccine will be expanded to include adults aged 50 years and older for the 2013-2014 season. At the FDA’s request, the company is planning a Flublok pregnancy registry. Reproductive toxicology tests of the vaccine in rats were negative, and during clinical trials, 20 women who received Flublok became pregnant, and with 75% follow-up, there have been no birth defects among the live births or vaccine-related adverse events, she said.

The panel also reaffirmed the recommendation for annual influenza vaccination for people aged 6 months and older, with the caveat that younger children through age 8 years receive two doses at least 20 days apart.

There are 15 experts in immunization-related fields on ACIP, which develops written recommendations for the routine administration of vaccines to children and adults in the civilian population.

Information on approved influenza vaccines is available here.

[email protected]

The first update in almost 20 years to the Centers for Disease Control and Prevention’s statement on Haemophilus influenzae type b will reflect changes in the epidemiology of the disease and the vaccines available to prevent it.

The CDC’s Advisory Committee on Immunization Practices unanimously approved a draft of the updated statement on Haemophilus influenzae type b (Hib) at the committee’s meeting Feb. 20.

Dr. Elizabeth C. Briere* summarized the draft statement, which lists the currently available and licensed vaccines, with no changes to previously published recommendations on routine use. But the statement includes guidance for special populations not included in the 1993 statement, consistent with the 2013 IDSA Clinical Practice Guideline for Vaccination of the Immunocompromised, which has not yet been published; as well as 2012 Red Book recommendations, 2011 ACIP General Recommendations on Immunizations, and 2009 ACIP Guidelines for the Prevention and Treatment of Opportunistic Infections for HIV-Infected Adults and Adolescents.In the years since the first Hib vaccine –a polysaccharide vaccine – was licensed in 1985, and the first conjugate Hib vaccine was licensed in 1989, the incidence of invasive Hib infection among children aged under 5 years has dropped dramatically, and has remained low through the 2000s, Dr. Briere of the CDC’s National Center for Immunization and Respiratory Diseases, pointed out at the meeting.

The special populations listed are Alaskan natives and American Indians, children aged under 24 months with invasive Hib, preterm infants, and high-risk groups (those with functional or anatomic asplenia, HIV, IgG deficiency, early component complement deficiency, and recipients of hematopoietic stem cell transplant and chemotherapy).

The guidance for high risk groups includes the recommendation to provide one dose of Hib vaccine to asplenic children aged 60 months and older and asplenic adults who are unimmunized**; and for HIV-infected children aged 60 months and older, who are unimmunized, she said. The Hib vaccination is not recommended for HIV-infected adults.

For patients undergoing an elective splenectomy, who are aged 15 months and older and are unimmunized, one dose of vaccine prior to the procedure is recommended. For children undergoing chemotherapy or radiation therapy who are aged younger than 59 months, revaccination is not required if routine Hib doses were administered 14 or more days before starting treatment. But if the dose is given within 14 days of starting treatment – or during therapy – the recommendation in the guidance is to repeat doses starting at least 3 months following the completion of treatment, Dr. Briere said.

In the updated statement, the guidance for chemoprophylaxis – which was limited in the old statement – is consistent with the guidance in the 2012 Red Book, and includes recommendations for the use of rifampin as chemoprophylaxis, she added.

The draft of the statement was updated after a review of Hib vaccine recommendations, including a draft of IDSA clinical practice guidelines for vaccination of the immunocompromised host, peer-reviewed literature, and surveillance data; and was reviewed by ACIP’s meningococcal and Haemophilus influenzae type b vaccine work group and ACIP voting members, providing comments, prior to the ACIP meeting.

There are 15 experts in immunization-related fields on the ACIP committee, which develops written recommendations for the routine administration of vaccines to children and adults in the civilian population.

*Updated: 2/26/13

**CORRECTION: A previous version of this story incorrectly described the asplenic patients who should receive the Hib vaccine.

[email protected]

The first update in almost 20 years to the Centers for Disease Control and Prevention’s statement on Haemophilus influenzae type b will reflect changes in the epidemiology of the disease and the vaccines available to prevent it.

The CDC’s Advisory Committee on Immunization Practices unanimously approved a draft of the updated statement on Haemophilus influenzae type b (Hib) at the committee’s meeting Feb. 20.

Dr. Elizabeth C. Briere* summarized the draft statement, which lists the currently available and licensed vaccines, with no changes to previously published recommendations on routine use. But the statement includes guidance for special populations not included in the 1993 statement, consistent with the 2013 IDSA Clinical Practice Guideline for Vaccination of the Immunocompromised, which has not yet been published; as well as 2012 Red Book recommendations, 2011 ACIP General Recommendations on Immunizations, and 2009 ACIP Guidelines for the Prevention and Treatment of Opportunistic Infections for HIV-Infected Adults and Adolescents.In the years since the first Hib vaccine –a polysaccharide vaccine – was licensed in 1985, and the first conjugate Hib vaccine was licensed in 1989, the incidence of invasive Hib infection among children aged under 5 years has dropped dramatically, and has remained low through the 2000s, Dr. Briere of the CDC’s National Center for Immunization and Respiratory Diseases, pointed out at the meeting.

The special populations listed are Alaskan natives and American Indians, children aged under 24 months with invasive Hib, preterm infants, and high-risk groups (those with functional or anatomic asplenia, HIV, IgG deficiency, early component complement deficiency, and recipients of hematopoietic stem cell transplant and chemotherapy).

The guidance for high risk groups includes the recommendation to provide one dose of Hib vaccine to asplenic children aged 60 months and older and asplenic adults who are unimmunized**; and for HIV-infected children aged 60 months and older, who are unimmunized, she said. The Hib vaccination is not recommended for HIV-infected adults.

For patients undergoing an elective splenectomy, who are aged 15 months and older and are unimmunized, one dose of vaccine prior to the procedure is recommended. For children undergoing chemotherapy or radiation therapy who are aged younger than 59 months, revaccination is not required if routine Hib doses were administered 14 or more days before starting treatment. But if the dose is given within 14 days of starting treatment – or during therapy – the recommendation in the guidance is to repeat doses starting at least 3 months following the completion of treatment, Dr. Briere said.

In the updated statement, the guidance for chemoprophylaxis – which was limited in the old statement – is consistent with the guidance in the 2012 Red Book, and includes recommendations for the use of rifampin as chemoprophylaxis, she added.

The draft of the statement was updated after a review of Hib vaccine recommendations, including a draft of IDSA clinical practice guidelines for vaccination of the immunocompromised host, peer-reviewed literature, and surveillance data; and was reviewed by ACIP’s meningococcal and Haemophilus influenzae type b vaccine work group and ACIP voting members, providing comments, prior to the ACIP meeting.

There are 15 experts in immunization-related fields on the ACIP committee, which develops written recommendations for the routine administration of vaccines to children and adults in the civilian population.

*Updated: 2/26/13

**CORRECTION: A previous version of this story incorrectly described the asplenic patients who should receive the Hib vaccine.

[email protected]

The first update in almost 20 years to the Centers for Disease Control and Prevention’s statement on Haemophilus influenzae type b will reflect changes in the epidemiology of the disease and the vaccines available to prevent it.

The CDC’s Advisory Committee on Immunization Practices unanimously approved a draft of the updated statement on Haemophilus influenzae type b (Hib) at the committee’s meeting Feb. 20.

Dr. Elizabeth C. Briere* summarized the draft statement, which lists the currently available and licensed vaccines, with no changes to previously published recommendations on routine use. But the statement includes guidance for special populations not included in the 1993 statement, consistent with the 2013 IDSA Clinical Practice Guideline for Vaccination of the Immunocompromised, which has not yet been published; as well as 2012 Red Book recommendations, 2011 ACIP General Recommendations on Immunizations, and 2009 ACIP Guidelines for the Prevention and Treatment of Opportunistic Infections for HIV-Infected Adults and Adolescents.In the years since the first Hib vaccine –a polysaccharide vaccine – was licensed in 1985, and the first conjugate Hib vaccine was licensed in 1989, the incidence of invasive Hib infection among children aged under 5 years has dropped dramatically, and has remained low through the 2000s, Dr. Briere of the CDC’s National Center for Immunization and Respiratory Diseases, pointed out at the meeting.

The special populations listed are Alaskan natives and American Indians, children aged under 24 months with invasive Hib, preterm infants, and high-risk groups (those with functional or anatomic asplenia, HIV, IgG deficiency, early component complement deficiency, and recipients of hematopoietic stem cell transplant and chemotherapy).

The guidance for high risk groups includes the recommendation to provide one dose of Hib vaccine to asplenic children aged 60 months and older and asplenic adults who are unimmunized**; and for HIV-infected children aged 60 months and older, who are unimmunized, she said. The Hib vaccination is not recommended for HIV-infected adults.

For patients undergoing an elective splenectomy, who are aged 15 months and older and are unimmunized, one dose of vaccine prior to the procedure is recommended. For children undergoing chemotherapy or radiation therapy who are aged younger than 59 months, revaccination is not required if routine Hib doses were administered 14 or more days before starting treatment. But if the dose is given within 14 days of starting treatment – or during therapy – the recommendation in the guidance is to repeat doses starting at least 3 months following the completion of treatment, Dr. Briere said.

In the updated statement, the guidance for chemoprophylaxis – which was limited in the old statement – is consistent with the guidance in the 2012 Red Book, and includes recommendations for the use of rifampin as chemoprophylaxis, she added.

The draft of the statement was updated after a review of Hib vaccine recommendations, including a draft of IDSA clinical practice guidelines for vaccination of the immunocompromised host, peer-reviewed literature, and surveillance data; and was reviewed by ACIP’s meningococcal and Haemophilus influenzae type b vaccine work group and ACIP voting members, providing comments, prior to the ACIP meeting.

There are 15 experts in immunization-related fields on the ACIP committee, which develops written recommendations for the routine administration of vaccines to children and adults in the civilian population.

*Updated: 2/26/13

**CORRECTION: A previous version of this story incorrectly described the asplenic patients who should receive the Hib vaccine.

[email protected]

Vaccination with the 13-valent pneumococcal conjugate vaccine should be routine for certain high-risk children aged 6-18 years, panel members unanimously agreed at a meeting of the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices.

Specifically, the panel recommended expanding the indication for this vaccine to include a group of older children – those between 6 and 18 years of age – who are at high risk for invasive pneumococcal disease (IPD) because of immunocompromising conditions, functional or anatomic asplenia, cerebrospinal fluid leaks, or cochlear implants, regardless or whether they have previously received the PCV7 or pneumococcal polysaccaride vaccine (PPSV23) vaccines. The 13-valent pneumococcal conjugate vaccine (PCV13) is already recommended by ACIP for high risk children 24-71 months of age who have these underlying conditions.*

The ACIP panel voted 15-0 in favor of this recommendation proposed by ACIP’s pneumococcal vaccines work group at its Feb. 20 meeting.

The inclusion of the older pediatric age group will harmonize the PCV13 pediatric recommendation and may improve vaccine uptake in these groups, Tamara Pilishvili, M.P.H., a member of the CDC’s pneumococcal vaccines work group, said at the meeting. Previously, the recommendation for this group was that a dose of PCV13 "may be administered" to children and adolescents 6 through 18 years of age who have certain medical conditions.

Initially approved in 2010, PCV13 (marketed by Pfizer as Prevnar 13) was approved in January 2013 for children aged 6 through 17 years for preventing invasive disease caused by the Streptococcus pneumoniae serotypes contained in the vaccine (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). PCV13 contains the seven strains contained in PCV7 (4, 6B, 9V, 14, 18C, 19F, and 23F), plus six more (1, 3, 5, 6A, 7F, and 19A).

PCV13 was added to the most recent updated adult schedule, released in January, for PCV13-naive adults 19 years and older who have immunocompromising conditions such as chronic renal failure, functional or anatomic asplenia, cerebrospinal fluid leaks, or cochlear implants and are immunocompromised (such as HIV infection).

After a review of the available evidence, the working group concluded that the burden of disease is "extremely high" among immunocompromised children aged 6-18 years and that the vaccine would probably be effective and the benefits would likely outweigh the risks in this group, Ms. Pilishvili of the respiratory diseases branch in the CDC’s National Center for Immunization and Respiratory Diseases, said at the meeting.

When compared with children without underlying conditions, the relative risk of IPD is over 1,000 times higher among children with a hematologic malignancy, almost 44-fold higher among children with sickle cell disease, and 158-fold higher among those with HIV/AIDS, she said, citing unpublished CDC data.

In addition, the use of both PCV13 and PPSV23 would provide broader serotype coverage for high-risk children in this age group, she said. In 2011, 38% of the IPD cases among high-risk children aged 6-18 years were caused by serotypes included in the PCV13 vaccine, 33% were the result of non-PCV13 serotypes in the PPSV23 vaccine, and 29% were caused by serotypes not included in either vaccine, she said.

Studies reviewed by the working group indicated that vaccination with other PCV vaccines reduced IPD, which included vaccine efficacy studies of PCV7 and PCV9, which, when combined, were estimated to be 69% effective in reducing IPD from serotypes included in the vaccines, Other evidence reviewed by the working group included immunogenicity data of PCV13 in people with sickle cell disease who had previously been vaccinated with PPSV23, in an open-label, single-arm study of children aged 6-7 years, as well as HIV-infected children.

Experts in immunization-related fields are members of the ACIP committee, which develops written recommendations for the routine administration of vaccines to children and adults in the civilian population.

*Updated 2/22/13

[email protected]

Vaccination with the 13-valent pneumococcal conjugate vaccine should be routine for certain high-risk children aged 6-18 years, panel members unanimously agreed at a meeting of the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices.

Specifically, the panel recommended expanding the indication for this vaccine to include a group of older children – those between 6 and 18 years of age – who are at high risk for invasive pneumococcal disease (IPD) because of immunocompromising conditions, functional or anatomic asplenia, cerebrospinal fluid leaks, or cochlear implants, regardless or whether they have previously received the PCV7 or pneumococcal polysaccaride vaccine (PPSV23) vaccines. The 13-valent pneumococcal conjugate vaccine (PCV13) is already recommended by ACIP for high risk children 24-71 months of age who have these underlying conditions.*

The ACIP panel voted 15-0 in favor of this recommendation proposed by ACIP’s pneumococcal vaccines work group at its Feb. 20 meeting.

The inclusion of the older pediatric age group will harmonize the PCV13 pediatric recommendation and may improve vaccine uptake in these groups, Tamara Pilishvili, M.P.H., a member of the CDC’s pneumococcal vaccines work group, said at the meeting. Previously, the recommendation for this group was that a dose of PCV13 "may be administered" to children and adolescents 6 through 18 years of age who have certain medical conditions.

Initially approved in 2010, PCV13 (marketed by Pfizer as Prevnar 13) was approved in January 2013 for children aged 6 through 17 years for preventing invasive disease caused by the Streptococcus pneumoniae serotypes contained in the vaccine (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). PCV13 contains the seven strains contained in PCV7 (4, 6B, 9V, 14, 18C, 19F, and 23F), plus six more (1, 3, 5, 6A, 7F, and 19A).

PCV13 was added to the most recent updated adult schedule, released in January, for PCV13-naive adults 19 years and older who have immunocompromising conditions such as chronic renal failure, functional or anatomic asplenia, cerebrospinal fluid leaks, or cochlear implants and are immunocompromised (such as HIV infection).

After a review of the available evidence, the working group concluded that the burden of disease is "extremely high" among immunocompromised children aged 6-18 years and that the vaccine would probably be effective and the benefits would likely outweigh the risks in this group, Ms. Pilishvili of the respiratory diseases branch in the CDC’s National Center for Immunization and Respiratory Diseases, said at the meeting.

When compared with children without underlying conditions, the relative risk of IPD is over 1,000 times higher among children with a hematologic malignancy, almost 44-fold higher among children with sickle cell disease, and 158-fold higher among those with HIV/AIDS, she said, citing unpublished CDC data.

In addition, the use of both PCV13 and PPSV23 would provide broader serotype coverage for high-risk children in this age group, she said. In 2011, 38% of the IPD cases among high-risk children aged 6-18 years were caused by serotypes included in the PCV13 vaccine, 33% were the result of non-PCV13 serotypes in the PPSV23 vaccine, and 29% were caused by serotypes not included in either vaccine, she said.

Studies reviewed by the working group indicated that vaccination with other PCV vaccines reduced IPD, which included vaccine efficacy studies of PCV7 and PCV9, which, when combined, were estimated to be 69% effective in reducing IPD from serotypes included in the vaccines, Other evidence reviewed by the working group included immunogenicity data of PCV13 in people with sickle cell disease who had previously been vaccinated with PPSV23, in an open-label, single-arm study of children aged 6-7 years, as well as HIV-infected children.

Experts in immunization-related fields are members of the ACIP committee, which develops written recommendations for the routine administration of vaccines to children and adults in the civilian population.

*Updated 2/22/13

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Vaccination with the 13-valent pneumococcal conjugate vaccine should be routine for certain high-risk children aged 6-18 years, panel members unanimously agreed at a meeting of the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices.

Specifically, the panel recommended expanding the indication for this vaccine to include a group of older children – those between 6 and 18 years of age – who are at high risk for invasive pneumococcal disease (IPD) because of immunocompromising conditions, functional or anatomic asplenia, cerebrospinal fluid leaks, or cochlear implants, regardless or whether they have previously received the PCV7 or pneumococcal polysaccaride vaccine (PPSV23) vaccines. The 13-valent pneumococcal conjugate vaccine (PCV13) is already recommended by ACIP for high risk children 24-71 months of age who have these underlying conditions.*

The ACIP panel voted 15-0 in favor of this recommendation proposed by ACIP’s pneumococcal vaccines work group at its Feb. 20 meeting.

The inclusion of the older pediatric age group will harmonize the PCV13 pediatric recommendation and may improve vaccine uptake in these groups, Tamara Pilishvili, M.P.H., a member of the CDC’s pneumococcal vaccines work group, said at the meeting. Previously, the recommendation for this group was that a dose of PCV13 "may be administered" to children and adolescents 6 through 18 years of age who have certain medical conditions.

Initially approved in 2010, PCV13 (marketed by Pfizer as Prevnar 13) was approved in January 2013 for children aged 6 through 17 years for preventing invasive disease caused by the Streptococcus pneumoniae serotypes contained in the vaccine (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). PCV13 contains the seven strains contained in PCV7 (4, 6B, 9V, 14, 18C, 19F, and 23F), plus six more (1, 3, 5, 6A, 7F, and 19A).

PCV13 was added to the most recent updated adult schedule, released in January, for PCV13-naive adults 19 years and older who have immunocompromising conditions such as chronic renal failure, functional or anatomic asplenia, cerebrospinal fluid leaks, or cochlear implants and are immunocompromised (such as HIV infection).

After a review of the available evidence, the working group concluded that the burden of disease is "extremely high" among immunocompromised children aged 6-18 years and that the vaccine would probably be effective and the benefits would likely outweigh the risks in this group, Ms. Pilishvili of the respiratory diseases branch in the CDC’s National Center for Immunization and Respiratory Diseases, said at the meeting.

When compared with children without underlying conditions, the relative risk of IPD is over 1,000 times higher among children with a hematologic malignancy, almost 44-fold higher among children with sickle cell disease, and 158-fold higher among those with HIV/AIDS, she said, citing unpublished CDC data.

In addition, the use of both PCV13 and PPSV23 would provide broader serotype coverage for high-risk children in this age group, she said. In 2011, 38% of the IPD cases among high-risk children aged 6-18 years were caused by serotypes included in the PCV13 vaccine, 33% were the result of non-PCV13 serotypes in the PPSV23 vaccine, and 29% were caused by serotypes not included in either vaccine, she said.

Studies reviewed by the working group indicated that vaccination with other PCV vaccines reduced IPD, which included vaccine efficacy studies of PCV7 and PCV9, which, when combined, were estimated to be 69% effective in reducing IPD from serotypes included in the vaccines, Other evidence reviewed by the working group included immunogenicity data of PCV13 in people with sickle cell disease who had previously been vaccinated with PPSV23, in an open-label, single-arm study of children aged 6-7 years, as well as HIV-infected children.

Experts in immunization-related fields are members of the ACIP committee, which develops written recommendations for the routine administration of vaccines to children and adults in the civilian population.

*Updated 2/22/13

[email protected]