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Immunization Action Coalition
IAC Express 2008
Issue number 722: April 7, 2008
 
Contents of this Issue
Select a title to jump to the article.
  1. CDC updates recommendation for use of PCV7 in children ages 24-59 months who are not completely vaccinated
  2. FDA approves new rotavirus vaccine for use in U.S.
  3. CDC issues Health Advisory in response to widespread measles outbreaks in U.S.
  4. New: Popular child/teen vaccination resources now in Spanish, Arabic, Chinese, French, Korean, Russian, and Vietnamese
  5. Important: Be sure to give influenza vaccine throughout the influenza season--from now through spring
  6. Revised VISs for DTaP, HPV, and meningococcal vaccines now available in Thai
  7. National Immunization Survey data tables for July 2006-June 2007 now posted on CDC website
  8. CDC reports on transplantation-transmitted tuberculosis in Oklahoma and Texas in 2007
  9. For coalitions: California Immunization Coalition Summit planned for April 28-29 in Sacramento
  10. Phacilitate Vaccine Forum 2008 scheduled for May 14-16 in Geneva, Switzerland
 
Abbreviations
AAFP, American Academy of Family Physicians; AAP, American Academy of Pediatrics; ACIP, Advisory Committee on Immunization Practices; AMA, American Medical Association; CDC, Centers for Disease Control and Prevention; FDA, Food and Drug Administration; IAC, Immunization Action Coalition; MMWR, Morbidity and Mortality Weekly Report; NCIRD, National Center for Immunization and Respiratory Diseases; NIVS, National Influenza Vaccine Summit; VIS, Vaccine Information Statement; VPD, vaccine-preventable disease; WHO, World Health Organization.
  
Issue 722: April 7, 2008
1.  CDC updates recommendation for use of PCV7 in children ages 24-59 months who are not completely vaccinated

CDC published "Updated Recommendation from the Advisory Committee on Immunization Practices (ACIP) for Use of 7-Valent Pneumococcal Conjugate Vaccine (PCV7) in Children Aged 24-59 Months Who Are Not Completely Vaccinated" in the April 4 issue of MMWR. The article is reprinted below in its entirety, excluding references.


This notice updates the recommendation for use of 7-valent pneumococcal conjugate vaccine (PCV7) among children aged 24-59 months who are either unvaccinated or who have a lapse in PCV7 administration. In February 2000, PCV7, marketed as Prevnar and manufactured by Wyeth Vaccines (Collegeville, Pennsylvania), was approved by the Food and Drug Administration for use in infants and young children. At that time, the Advisory Committee on Immunization Practices (ACIP) recommended that children aged 24-59 months who have certain underlying medical conditions or are immunocompromised receive PCV7. In addition, ACIP recommended that PCV7 be considered for all other children aged 24-59 months, with priority given to those who are American Indian/Alaska Native or of African-American descent, and to children who attend group day care centers. The recommendation also provided schedules for administering PCV7 to children aged 24-59 months who were either unvaccinated or who had a lapse in PCV7 administration; these schedules included (1) 1 dose of PCV7 for healthy children, and (2) 2 doses of PCV7 >=2 months apart for children with certain chronic diseases or immunosuppressive conditions.

ACIP's rationale for limiting the recommendation for routine vaccination to children aged 24-59 months who have certain underlying medical conditions or are immunocompromised was concern about limited vaccine supply and cost. Since September 2004, PCV7 has not been in short supply. Additionally, certain healthcare providers have found the permissive recommendation for healthy children aged 24-59 months to be confusing. The ACIP Pneumococcal Vaccines Work Group reviewed data on safety and immunogenicity of PCV7 in children aged 24-59 months, current rates of PCV7-type invasive disease, vaccination coverage rates, and post-licensure vaccine effectiveness. In October 2007, on the basis of that review, ACIP approved the following revised recommendation for use of PCV7 in children aged 24-59 months:
  • For all healthy children aged 24-59 months who have not completed any recommended schedule for PCV7, administer 1 dose of PCV7.
     
  • For all children with underlying medical conditions aged 24-59 months who have received 3 doses, administer 1 dose of PCV7.
     
  • For all children with underlying medical conditions aged 24-59 months who have received <3 doses, administer 2 doses of PCV7 at least 8 weeks apart.

No changes were made to previously published recommendations regarding (1) the use of PCV7 in children aged 2-23 months, (2) the list of underlying medical or immunocompromising conditions, or (3) the use of 23-valent pneumococcal polysaccharide vaccine in children aged >=2 years who have previously received PCV7.


To access a web-text (HTML) version of the complete article, go to: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5713a4.htm

To access a ready-to-print (PDF) version of this issue of MMWR, go to: http://www.cdc.gov/mmwr/PDF/wk/mm5713.pdf

To receive a FREE electronic subscription to MMWR (which includes new ACIP statements), go to:
http://www.cdc.gov/mmwr/mmwrsubscribe.html

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2 FDA approves new rotavirus vaccine for use in U.S.

On April 3, FDA issued a press release announcing it had approved a new rotavirus vaccine for use in the U.S. It is reprinted below in its entirety. Also on April 3, FDA posted the package insert for the new vaccine and the approval letter FDA sent to the vaccine manufacturer. Links to both are given at the end of this IAC Express article.


FDA APPROVES NEW VACCINE TO PREVENT GASTROENTERITIS CAUSED BY ROTAVIRUS

The U.S. Food and Drug Administration today announced the approval of Rotarix, the second oral U.S. licensed vaccine for the prevention of rotavirus, an infection that causes gastroenteritis (vomiting and diarrhea) in infants and children. Rotarix is a liquid and given in a two-dose series to infants from 6 to 24 weeks of age.

Although the disease is usually self-limiting, rotavirus causes about 2.7 million cases of gastroenteritis in U.S. children each year--about 55,000 to 70,000 of those require hospitalization; and between 20 and 60 deaths are attributed to it. Without vaccination, nearly every child in the United States would likely be infected at least once with rotavirus by age 5.

There are many different strains of rotavirus. The vaccine protects against rotavirus gastroenteritis caused by the G1, G3, G4, and G9 strains.

"This vaccine provides another option to combat and reduce a potentially severe illness that affects so many children," said Jesse L. Goodman, MD, MPH, director of FDA's Center for Biologics Evaluation and Research.

During studies involving more than 24,000 infants, Rotarix was effective in preventing both severe and mild cases of rotavirus-caused gastroenteritis during the first two years of life. The most common adverse reactions reported during clinical trials were fussiness, irritability, cough, runny nose, fever, loss of appetite, and vomiting.

In 1999, a different rotavirus vaccine from another manufacturer was voluntarily withdrawn from the U.S. market because of an association with an increased risk of intussusception, or intestinal folding, which can lead to potentially life-threatening intestinal blockage. Intussusception can occur in children spontaneously in the absence of vaccination, but to help ensure that Rotarix does not increase the risk of intussusception, its manufacturer conducted a study of more than 63,000 infants.

In that study, there was no increase in the risk of intussusception in those who received Rotarix (31,673 infants) compared to those who received placebo (31,552 infants). Increased rates of convulsion and pneumonia-related deaths were observed in the Rotarix recipients in the intussusception study, however these events were not observed in other studies conducted by the manufacturer. Although the FDA has concluded that the available data do not establish that these events are related to the vaccine, the agency has requested the manufacturer to conduct post-marketing safety studies involving more than 40,000 infants to provide additional safety information.

Rotarix is manufactured by GlaxoSmithKline Biologicals, Rixensart, Belgium.


To access the press release, go to:
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01814.html

To access the package insert, go to:
http://www.fda.gov/cber/label/rotarixLB.pdf

To access the approval letter, go to:
http://www.fda.gov/cber/approvltr/rotarix040308L.htm

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3 CDC issues Health Advisory in response to widespread measles outbreaks in U.S.

On April 2, CDC issued an Official Health Advisory, "Measles outbreaks in the United States: Public health preparedness, control, and response in healthcare settings and the community." A large portion of it is reprinted below.


A measles outbreak linked to an importation from Switzerland currently is ongoing in Arizona. The first case, with rash onset on February 12, 2008, occurred in an adult visitor from Switzerland who was hospitalized with measles and pneumonia. This hospital admission prompted verification of the measles immune status of approximately 1,800 healthcare personnel and vaccination of those without evidence of immunity. Through March 31, 2008, nine confirmed cases have been reported to the Arizona Department of Health Services, and there are two suspected cases (one in a Colorado resident) and hundreds of contacts under investigation. The nine case-patients range in age from 10 months to 50 years. All but one were infected in healthcare settings, one of the five adult case-patients is a healthcare worker, and all cases were unvaccinated at the time of exposure.

In January and February 2008, San Diego experienced an outbreak of 11 measles cases, with an additional case-patient who was exposed in San Diego but became ill in Hawaii. The index case was an unvaccinated child who had recently traveled to Switzerland, where a measles outbreak is ongoing (see
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5708a3.htm). Transmission in this outbreak occurred in a doctor's office as well as in community settings. Measles genotype D5 was identified from more than one case in the San Diego and Arizona outbreaks; this genotype is currently circulating in Switzerland (see
http://www.eurosurveillance.org/edition/v13n08/080221_1.asp). Confirmed measles cases also have been reported from New York City (involving genotype D4, which is identical to the genotype responsible for a large ongoing measles outbreak in Israel; see http://www.eurosurveillance.org/edition/v13n08/080221_3.asp) and from Virginia (importation from India). In addition, two measles cases recently confirmed in unvaccinated siblings from Michigan may have resulted from exposure during a long stop-over in the Atlanta airport.

Although measles is no longer an endemic disease in the United States, it remains endemic in most countries of the world, including some countries in Europe. Large outbreaks currently are occurring in Switzerland and Israel. In the United States from January 1 through March 28, 2008, 24 confirmed cases of measles resulting from importations from endemic countries have been reported to the Centers for Disease Control and Prevention (CDC). These cases highlight the ongoing risk of measles importations, the risk of spread in susceptible populations, and the need for a prompt and appropriate public health response to measles cases. Because of the severity of the disease, people with measles commonly present in physician's offices or emergency rooms and pose a risk of transmission to other patients and healthcare personnel in these and in inpatient hospital settings. Healthcare providers should remain aware that measles cases may occur in their facility and that transmission risks can be minimized by ensuring that all healthcare personnel have evidence of measles immunity and that appropriate infection control practices are followed.

Transmission and case definition
Measles is a highly contagious disease that is transmitted by respiratory droplets and airborne spread. The disease can result in severe complications, including pneumonia and encephalitis. The incubation period for measles ranges from 7 to 18 days. The diagnosis of measles should be considered in any person with a generalized maculopapular rash lasting >=3 days, a temperature >=101 degrees F (38.3 degrees C), and cough, coryza, or conjunctivitis. Immunocompromised patients may not exhibit rash or may exhibit an atypical rash.

Recommendations
Rapid and aggressive public health action is needed in response to measles cases. Case investigation and vaccination of household or other close contacts without evidence of immunity should not be delayed pending the return of laboratory results. Preparation for other control activities may need to be initiated before laboratory results are known. Control activities include isolation of known and suspected case-patients and administration of vaccine (at any interval following exposure) or immune globulin (within 6 days of exposure, particularly contacts <=6 months of age, pregnant women, and immunocompromised people, for whom the risk of complications is highest) to susceptible contacts. For contacts who remain unvaccinated, control activities include exclusion from day care, school, or work and voluntary home quarantine from 7 to 21 days following exposure. Persons who are known contacts of measles patients and who develop fever and/or rash should be considered suspected measles case-patients and be appropriately evaluated by a healthcare provider. If healthcare providers are aware of the need to assess a suspected measles case, they should schedule the patient at the end of the day after other patients have left the office and inform clinics or emergency rooms if they are referring a suspected measles patient for evaluation so that airborne infection control precautions can be implemented prior to their arrival.

Healthcare providers should maintain vigilance for measles
importations and have a high index of suspicion for measles in persons with a clinically compatible illness who have traveled abroad or who have been in contact with travelers. They should assess measles immunity in U.S. residents who travel abroad and vaccinate if necessary. Measles outbreaks are ongoing in Switzerland and Israel, and measles outbreaks are common throughout Europe. Measles is endemic in many countries, including popular travel destinations, such as Japan and India. Suspected measles cases should be reported immediately to the local health department, and serologic and virologic specimens (serum and throat or nasopharyngeal swabs) should be obtained for measles virus detection and genotyping. Laboratory testing should be conducted in the most expeditious manner possible.

Preventing transmission in healthcare settings
To prevent transmission of measles in healthcare settings, airborne infection control precautions (available at http://www.cdc.gov/ncidod/dhqp/gl_isolation.html) should be followed stringently. Suspected measles patients (i.e., persons with febrile rash illness) should be removed from emergency department and clinic waiting areas as soon as they are identified, placed in a private room with the door closed, and asked to wear a surgical mask, if tolerated. In hospital settings, patients with suspected measles should be placed immediately in an airborne infection (negative-pressure) isolation room if one is available and, if possible, should not be sent to other parts of the hospital for examination or testing purposes.

All healthcare personnel should have documented evidence of measles immunity on file at their work location. Having high levels of measles immunity among healthcare personnel and such documentation on file minimizes the work needed in response to measles exposures, which cannot be anticipated. Recent measles exposures in hospital settings in three states necessitated verifying records of measles immunity for hundreds or thousands of hospital staff, drawing blood samples for serologic evidence of immunity when documentation was not on file at the work site, and vaccinating personnel without evidence of immunity.

Recommendations for vaccination
Measles is preventable by vaccination. MMR vaccine is routinely recommended for all children at 12–15 months of age, with a second dose recommended at age 4–6 years. Two doses of MMR vaccine are recommended for all school students and for the following groups of persons without evidence of measles immunity: students in post–high school educational facilities, healthcare personnel, and international travelers who are >=12 months of age. Other adults without evidence of measles immunity should routinely receive one dose of MMR vaccine. To prevent acquiring measles during travel, U.S. residents aged >=6 months traveling abroad should be vaccinated or have documentation of measles immunity before travel. Infants 6–11 months of age should receive one dose of monovalent measles vaccine (or MMR vaccine if monovalent vaccine is not available) prior to travel.

During a measles outbreak, additional vaccine recommendations should be considered: (1) children >=12 months of age should receive their first dose of MMR vaccine as soon after their first birthday as possible and their second dose 4 weeks later, (2) healthcare facilities should strongly consider recommending one dose of MMR vaccine to unvaccinated healthcare personnel born before 1957 who do not have serologic evidence of immunity or physician documentation of measles disease, and (3) one dose of measles or MMR vaccine should be considered for infants >=6 months of age.

Further information on measles and measles vaccine is available at state health departments' websites and at http://www.cdc.gov/vaccines/vpd-vac/measles/default.htm

Additional Sources of Information
The Centers for Disease Control and Prevention maintains a website with many informative articles and references on measles and the MMR vaccine. Several links are listed below. [IAC Express editor's note: The Health Advisory listed 18 resources; we have culled the list, reducing it to the eight we think IAC Express readers will find most useful.]

CDC. Measles, Mumps, and Rubella--Vaccine use and strategies for elimination of measles, rubella, and congenital rubella syndrome and control of mumps: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1998:4(No RR-8);1–57 http://www.cdc.gov/MMWR/preview/MMWRhtml/00053391.htm

Immunization of Health-Care Workers, Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Hospital Infection Control Practices Advisory Committee (HICPAC). MMWR 1997:46 (RR-18):1–42 http://www.cdc.gov/mmwr/preview/mmwrhtml/00050577.htm

MMR Vaccine Information Statement
http://www.cdc.gov/vaccines/pubs/vis/downloads/vis-mmr.pdf

MMR Vaccine Questions and Answers for Clinicians
http://www.cdc.gov/vaccines/vpd-vac/combo-vaccines/mmr/faqs-mmr-hcp.htm

Vaccines and Preventable Diseases: Measles Disease In-Short, provides general information about measles, including a description of the disease, information about symptoms, complications, transmission, and the vaccine and who needs it http://www.cdc.gov/vaccines/vpd-vac/measles/in-short-adult.htm

Vaccines and Preventable Diseases: Measles Vaccination, provides general information about the disease, vaccination information, beliefs and concerns, vaccine safety, and who should not be vaccinated. It also contains more specific information for clinicians, including technical information, recommendations, references and resources, provider education, and materials for patients http://www.cdc.gov/vaccines/vpd-vac/measles

Travelers' Health, including information for specific groups and settings http://wwwn.cdc.gov/travel

Travelers' Health: Yellow Book, CDC health information for international travel 2008
http://wwwn.cdc.gov/travel/contentYellowBook.aspx

To access the complete Health Advisory, go to:
http://www2a.cdc.gov/HAN/ArchiveSys/ViewMsgV.asp?AlertNum=00273

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4 New: Popular child/teen vaccination resources now in Spanish, Arabic, Chinese, French, Korean, Russian, and Vietnamese

IAC now offers two of its popular child/teen vaccination resources in languages in addition to English. The resources are "Immunizations for Babies: A guide for parents" and "When Do Children and Teens Need Vaccinations?" Both are now available in Spanish, Arabic, Chinese, French, Korean, Russian, and Vietnamese. Links to all follow.

"IMMUNIZATIONS FOR BABIES: A GUIDE FOR PARENTS"
For Spanish version of "Immunizations for Babies: A guide for parents," go to: http://www.immunize.org/catg.d/p4010-01.pdf

For Arabic version of "Immunizations for Babies: A guide for parents," go to: http://www.immunize.org/catg.d/p4010-20.pdf

For Chinese version of "Immunizations for Babies: A guide for parents," go to: http://www.immunize.org/catg.d/p4010-08.pdf

For French version of "Immunizations for Babies: A guide for parents," go to: http://www.immunize.org/catg.d/p4010-10.pdf

For Korean version of "Immunizations for Babies: A guide for parents," go to: http://www.immunize.org/catg.d/p4010-09.pdf

For Russian version of "Immunizations for Babies: A guide for parents," go to: http://www.immunize.org/catg.d/p4010-07.pdf

For Vietnamese version of "Immunizations for Babies: A guide for parents," go to: http://www.immunize.org/catg.d/p4010-05.pdf

For English version of "Immunizations for Babies: A guide for parents," go to: http://www.immunize.org/catg.d/p4010.pdf


"WHEN DO CHILDREN AND TEENS NEED VACCINATIONS?
For Spanish version of "When Do Children and Teens Need Vaccinations?" go to:
http://www.immunize.org/catg.d/p4050-01.pdf

For Arabic version of "When Do Children and Teens Need Vaccinations?" go to:
http://www.immunize.org/catg.d/p4050-20.pdf

For Chinese version of "When Do Children and Teens Need Vaccinations?" go to:
http://www.immunize.org/catg.d/p4050-08.pdf

For French version of "When Do Children and Teens Need Vaccinations?" go to:
http://www.immunize.org/catg.d/p4050-10.pdf

For Korean version of "When Do Children and Teens Need Vaccinations?" go to:
http://www.immunize.org/catg.d/p4050-09.pdf

For Russian version of "When Do Children and Teens Need Vaccinations?" go to:
http://www.immunize.org/catg.d/p4050-07.pdf

For Vietnamese version of "When Do Children and Teens Need Vaccinations?" go to:
http://www.immunize.org/catg.d/p4050-05.pdf

For English version of "When Do Children and Teens Need Vaccinations?" go to:
http://www.immunize.org/catg.d/p4050.pdf

For a continually updated listing (in date order) of IAC's new and revised website materials, go to: http://www.immunize.org/new Click on "html" or "pdf" to view the pertinent resource.

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5 Important: Be sure to give influenza vaccine throughout the influenza season--from now through spring

Influenza is currently circulating, and vaccination should continue from now until May. Visit the following websites often to find the information you need to keep vaccinating. Both are continually updated with the latest resources.

The National Influenza Vaccine Summit website at http://www.preventinfluenza.org

CDC's Seasonal Flu web section at http://www.cdc.gov/flu

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6 Revised VISs for DTaP, HPV, and meningococcal vaccines now available in Thai

The current versions of the VISs for diphtheria-tetanus-acellular pertussis (DTaP) vaccine, human papillomavirus (HPV) vaccine, and meningococcal vaccine are now available on the IAC website in Thai. IAC gratefully acknowledges Asian Pacific Health Care Venture of Los Angeles for the translations.

DTaP VACCINE VIS(dated 5/17/07)
For Thai version of the VIS for DTaP vaccine, go to:
http://www.immunize.org/vis/thdtap01.pdf

For English version of the VIS for DTaP vaccine, go to:
http://www.immunize.org/vis/dtap01.pdf

HPV VACCINE VIS (dated 2/2/07)
For Thai version of the VIS for HPV vaccine, go to:
http://www.immunize.org/vis/th_hpv.pdf

For English version of the VIS for HPV vaccine, go to:
http://www.immunize.org/vis/vis-hpv-gardasil.pdf

MENINGOCOCCAL VACCINE VIS (interim; dated 1/28/08)
For Thai version of the interim VIS for meningococcal vaccine, go to: http://www.immunize.org/vis/th_men05.pdf

For English version of the interim VIS for meningococcal vaccine, go to: http://www.immunize.org/vis/menin06.pdf

For information about the use of VISs, and for VISs in more than 30 languages, visit IAC's VIS web section at http://www.immunize.org/vis

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7 National Immunization Survey data tables for July 2006-June 2007 now posted on CDC website

The CDC website recently posted the full set of National Immunization Survey (NIS) data tables for July 2006-June 2007. NIS is a large, on-going survey of immunization coverage among U.S. pre-school children (19-35 months old).

To access the data tables for July 2006-June 2007, go to:
http://www.cdc.gov/vaccines/stats-surv/nis/data/tables_0607.htm

For additional information about NIS, go to:
http://www.cdc.gov/vaccines/stats-surv/imz-coverage.htm

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8 CDC reports on transplantation-transmitted tuberculosis in Oklahoma and Texas in 2007

CDC published "Transplantation-Transmitted Tuberculosis--Oklahoma and Texas, 2007" in the April 4 issue of MMWR. A portion of press summary of the article is reprinted below.


This report summarizes the results of the investigation to evaluate possible tuberculosis transmission through organ transplantation. Disseminated tuberculosis occurred in two of three transplant recipients from a common donor, and one recipient died. To reduce the low but serious risk of tuberculosis transmission by organ transplantation, organ recovery personnel should consider risk factors for tuberculosis in potential donors and conduct further testing of those at risk. Clinicians should recognize that transplant recipients with tuberculosis might present with unusual signs or symptoms. When transmission is suspected, investigation of potential donor-transmitted infection requires rapid communication among physicians, transplant centers, organ procurement organizations, and public health authorities.


To access a web-text (HTML) version of the complete article, go to: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5713a1.htm

To access a ready-to-print (PDF) version of this issue of MMWR, go to: http://www.cdc.gov/mmwr/PDF/wk/mm5713.pdf

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9 For coalitions: California Immunization Coalition Summit planned for April 28-29 in Sacramento

The California Immunization Coalition's 2008 Summit, "Emerging Issues and New Directions," is planned for April 28-29 in Sacramento.

For extensive information about the event, including details about the agenda, conference brochure, lodging, and online and mail-in registration, go to:
http://immunizeca.org/index.pacq?id=59&tier=2

For more information, contact Catherine Martin by phone at (916) 447-7063, extension 333, or by email at
cmartin@communitycouncil.org or Sabrina Torres by email at storres@communitycouncil.org

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10.  Phacilitate Vaccine Forum 2008 scheduled for May 14-16 in Geneva, Switzerland

The Phacilitate Vaccine Forum 2008 is scheduled for May 14-16 in Geneva, Switzerland. For complete details about the event, go to: http://www.phacilitate.co.uk/gv

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Immunization Action Coalition  •  Saint Paul, MN
tel 651-647-9009  •  fax 651-647-9131
 
This website is supported in part by a cooperative agreement from the National Center for Immunization and Respiratory Diseases (Grant No. 5U38IP000290) at the Centers for Disease Control and Prevention (CDC) in Atlanta, GA. The website content is the sole responsibility of IAC and does not necessarily represent the official views of CDC.