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IAC Express 2008 |
| Issue number 722: April 7, 2008 |
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Contents
of this Issue
Select a title to jump to the article. |
- CDC
updates recommendation for use of PCV7 in children ages 24-59 months who
are not completely vaccinated
- FDA
approves new rotavirus vaccine for use in U.S.
- CDC
issues Health Advisory in response to widespread measles outbreaks in U.S.
- New:
Popular child/teen vaccination resources now in Spanish, Arabic, Chinese,
French, Korean, Russian, and Vietnamese
-
Important: Be sure to give influenza vaccine throughout the influenza
season--from now through spring
- Revised
VISs for DTaP, HPV, and meningococcal vaccines now available in Thai
- National
Immunization Survey data tables for July 2006-June 2007 now posted on CDC
website
- CDC
reports on transplantation-transmitted tuberculosis in Oklahoma and Texas
in 2007
- For
coalitions: California Immunization Coalition Summit planned for April
28-29 in Sacramento
-
Phacilitate Vaccine Forum 2008 scheduled for May 14-16 in Geneva,
Switzerland
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| Abbreviations |
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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. |
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Issue 722: April 7, 2008 |
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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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