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FDA approves Gardasil 9 for prevention of certain cancers caused by five additional types of HPV

December 15, 2014 Comments off

FDA approves Gardasil 9 for prevention of certain cancers caused by five additional types of HPV
Source: U.S. Food and Drug Administration

The U.S. Food and Drug Administration today approved Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) for the prevention of certain diseases caused by nine types of Human Papillomavirus (HPV). Covering nine HPV types, five more HPV types than Gardasil (previously approved by the FDA), Gardasil 9 has the potential to prevent approximately 90 percent of cervical, vulvar, vaginal and anal cancers.

Gardasil 9 is a vaccine approved for use in females ages 9 through 26 and males ages 9 through 15. It is approved for the prevention of cervical, vulvar, vaginal and anal cancers caused by HPV types 16, 18, 31, 33, 45, 52 and 58, and for the prevention of genital warts caused by HPV types 6 or 11. Gardasil 9 adds protection against five additional HPV types—31, 33, 45, 52 and 58— which cause approximately 20 percent of cervical cancers and are not covered by previously FDA-approved HPV vaccines.

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New From the GAO

November 21, 2014 Comments off

New GAO Reports
Source: Government Accountability Office
1. Defense Logistics: Greater Awareness of Recommendations and Improvements in Data Quality Needed to Resolve Container-Management Challenges. GAO-15-114, November 21.
http://www.gao.gov/products/GAO-15-114
Highlights – http://www.gao.gov/assets/670/667147.pdf

2. Vaccine Injury Compensation: Most Claims Took Multiple Years and Many Were Settled through Negotiation. GAO-15-142, November 21.
http://www.gao.gov/products/GAO-15-142
Highlights – http://www.gao.gov/assets/670/667135.pdf

Vaccination Coverage Among Children in Kindergarten — United States, 2013–14 School Year

October 22, 2014 Comments off

Vaccination Coverage Among Children in Kindergarten — United States, 2013–14 School Year
Source: Morbidity and Mortality Weekly Report (CDC)

State and local vaccination requirements for school entry are implemented to maintain high vaccination coverage and protect schoolchildren from vaccine-preventable diseases (1). Each year, to assess state and national vaccination coverage and exemption levels among kindergartners, CDC analyzes school vaccination data collected by federally funded state, local, and territorial immunization programs. This report describes vaccination coverage in 49 states and the District of Columbia (DC) and vaccination exemption rates in 46 states and DC for children enrolled in kindergarten during the 2013–14 school year. Median vaccination coverage was 94.7% for 2 doses of measles, mumps, and rubella (MMR) vaccine; 95.0% for varying local requirements for diphtheria, tetanus toxoid, and acellular pertussis (DTaP) vaccine; and 93.3% for 2 doses of varicella vaccine among those states with a 2-dose requirement. The median total exemption rate was 1.8%. High exemption levels and suboptimal vaccination coverage leave children vulnerable to vaccine-preventable diseases. Although vaccination coverage among kindergartners for the majority of reporting states was at or near the 95% national Healthy People 2020 targets for 4 doses of DTaP, 2 doses of MMR, and 2 doses of varicella vaccine (2), low vaccination coverage and high exemption levels can cluster within communities.* Immunization programs might have access to school vaccination coverage and exemption rates at a local level for counties, school districts, or schools that can identify areas where children are more vulnerable to vaccine-preventable diseases. Health promotion efforts in these local areas can be used to help parents understand the risks for vaccine-preventable diseases and the protection that vaccinations provide to their children.

Announcement: Now Available Online: Final 2013–14 Influenza Vaccination Coverage Estimates for Selected Local Areas, States, and the United States

October 14, 2014 Comments off

Announcement: Now Available Online: Final 2013–14 Influenza Vaccination Coverage Estimates for Selected Local Areas, States, and the United States
Source: Morbidity and Mortality Weekly Report (CDC)

Final 2013–14 influenza season vaccination coverage estimates are now available online at FluVaxView (http://www.cdc.gov/flu/fluvaxview). The online information includes estimates of the cumulative percentage of persons vaccinated by the end of each month, from July 2013 through May 2014, for select local areas, each state, each U.S. Department of Health and Human Services region, and the United States overall.
Analyses were conducted using National Immunization Survey influenza vaccination data for children aged 6 months–17 years and Behavioral Risk Factor Surveillance System data for adults aged ≥18 years. Estimates are provided by age group and race/ethnicity. These estimates are presented in an interactive report (http://www.cdc.gov/flu/fluvaxview/interactive.htm) and complemented by an online summary report (http://www.cdc.gov/flu/fluvaxview/coverage-1314estimates.htm).

Human Papillomavirus Vaccination: Recommendations of the Advisory Committee on Immunization Practices (ACIP)

October 9, 2014 Comments off

Human Papillomavirus Vaccination: Recommendations of the Advisory Committee on Immunization Practices (ACIP)
Source: Morbidity and Mortality Weekly Report (CDC)

This report summarizes the epidemiology of human papillomavirus (HPV) and associated diseases, describes the licensed HPV vaccines, provides updated data from clinical trials and postlicensure safety studies, and compiles recommendations from CDC’s Advisory Committee on Immunization Practices (ACIP) for use of HPV vaccines.

Persistent infection with oncogenic HPV types can cause cervical cancer in women as well as other anogenital and oropharyngeal cancers in women and men. HPV also causes genital warts. Two HPV vaccines are licensed in the United States. Both are composed of type-specific HPV L1 protein, the major capsid protein of HPV. Expression of the L1 protein using recombinant DNA technology produces noninfectious virus-like particles (VLPs). Quadrivalent HPV vaccine (HPV4) contains four HPV type-specific VLPs prepared from the L1 proteins of HPV 6, 11, 16, and 18. Bivalent HPV vaccine (HPV2) contains two HPV type-specific VLPs prepared from the L1 proteins of HPV 16 and 18. Both vaccines are administered in a 3-dose series.

ACIP recommends routine vaccination with HPV4 or HPV2 for females aged 11 or 12 years and with HPV4 for males aged 11 or 12 years. Vaccination also is recommended for females aged 13 through 26 years and for males aged 13 through 21 years who were not vaccinated previously. Males aged 22 through 26 years may be vaccinated. ACIP recommends vaccination of men who have sex with men and immunocompromised persons (including those with HIV infection) through age 26 years if not previously vaccinated.

As a compendium of all current recommendations for use of HPV vaccines, information in this report is intended for use by clinicians, vaccination providers, public health officials, and immunization program personnel as a resource. ACIP recommendations are reviewed periodically and are revised as indicated when new information and data become available.

Use of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine Among Adults Aged ≥65 Years: Recommendations of the Advisory Committee on Immunization Practices (ACIP)

September 23, 2014 Comments off

Use of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine Among Adults Aged ≥65 Years: Recommendations of the Advisory Committee on Immunization Practices (ACIP)
Source: Morbidity and Mortality Weekly Report (CDC)

A single dose of PPSV23 is recommended for routine use in the United States among adults aged ≥65 years. Effectiveness of PPSV23 in preventing IPD in adults has been demonstrated, but the data on the effectiveness of this vaccine in preventing noninvasive pneumococcal pneumonia among adults aged ≥65 years have been inconsistent. PPSV23 contains 12 serotypes in common with PCV13 and 11 additional serotypes. In 2013, 38% of IPD among adults aged ≥65 years was caused by serotypes unique to PPSV23. Given the high proportion of IPD caused by serotypes unique to PPSV23, broader protection is expected to be provided through use of both PCV13 and PPSV23 in series. ACIP considered multiple factors when determining the optimal interval between a dose of PCV13 and PPSV23, including immune response, safety, the risk window for protection against disease caused by serotypes unique to PPSV23, as well as timing for the next visit to the vaccination provider.

National, State, and Selected Local Area Vaccination Coverage Among Children Aged 19–35 Months — United States, 2013

September 16, 2014 Comments off

National, State, and Selected Local Area Vaccination Coverage Among Children Aged 19–35 Months — United States, 2013
Source: Morbidity and Mortality Weekly Report (CDC)

In the United States, among children born during 1994–2013, vaccination will prevent an estimated 322 million illnesses, 21 million hospitalizations, and 732,000 deaths during their lifetimes (1). Since 1994, the National Immunization Survey (NIS) has monitored vaccination coverage among children aged 19–35 months in the United States. This report describes national, regional, state, and selected local area vaccination coverage estimates for children born January 2010–May 2012, based on results from the 2013 NIS. In 2013, vaccination coverage achieved the 90% national Healthy People 2020 target* for ≥1 dose of measles, mumps, and rubella vaccine (MMR) (91.9%); ≥3 doses of hepatitis B vaccine (HepB) (90.8%); ≥3 doses of poliovirus vaccine (92.7%); and ≥1 dose of varicella vaccine (91.2%). Coverage was below the Healthy People 2020 targets for ≥4 doses of diphtheria, tetanus, and pertussis vaccine (DTaP) (83.1%; target 90%); ≥4 doses of pneumococcal conjugate vaccine (PCV) (82.0%; target 90%); the full series of Haemophilus influenzae type b vaccine (Hib) (82.0%; target 90%); ≥2 doses of hepatitis A vaccine (HepA) (54.7%; target 85%); rotavirus vaccine (72.6%; target 80%); and the HepB birth dose (74.2%; target 85%).† Coverage remained stable relative to 2012 for all of the vaccinations with Healthy People 2020 objectives except for increases in the HepB birth dose (by 2.6 percentage points) and rotavirus vaccination (by 4.0 percentage points). The percentage of children who received no vaccinations remained below 1.0% (0.7%). Children living below the federal poverty level had lower vaccination coverage compared with children living at or above the poverty level for many vaccines, with the largest disparities for ≥4 doses of DTaP (by 8.2 percentage points), full series of Hib (by 9.5 percentage points), ≥4 doses of PCV (by 11.6 percentage points), and rotavirus (by 12.6 percentage points). MMR coverage was below 90% for 17 states. Reaching and maintaining high coverage across states and socioeconomic groups is needed to prevent resurgence of vaccine-preventable diseases.

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