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IAC Express 2010 |
| Issue number 858: March 29, 2010 |
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Contents
of this Issue
Select a title to jump to the article. |
- CDC and
FDA publish Q&As for providers and parents about temporary suspension of
Rotarix (GSK)
- Global
organizations release statements on the use of Rotarix vaccine
- MMWR
reports on H1N1 influenza in pregnant women who require intensive care
- 2010 U.S.
immunization schedules available in a variety of formats
- IAC
updates two resources for parents, one on hepatitis B vaccine for babies
and one on rotavirus vaccine
- Keep
vaccinating against influenza this spring and be sure to also give
pneumococcal vaccine when indicated
- IAC's
Video of the Week teaches young adults about the value of immunization
- PPSV and
multi-vaccine VISs now available in Thai
- IAC posts
updated Turkish translations of three popular parent pieces
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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 858: March 29, 2010 |
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1. |
CDC and FDA publish Q&As for providers and parents about temporary suspension
of Rotarix (GSK)
On March 26, CDC posted two sets of Q&As online
about FDA's
recommendation to temporarily suspend use of Rotarix
vaccine.
To access "Q&A on Rotarix Vaccine for Healthcare Providers
and Public Health Professionals," go to:
http://www.cdc.gov/vaccines/vpd-vac/rotavirus/rotarix-providers.htm
To access "Parents & Caregivers: Q&A about the Rotarix
Vaccine and Rotavirus," go to:
http://www.cdc.gov/vaccines/vpd-vac/rotavirus/rotarix-parents.htm
On the same date, FDA updated its Q&As for providers and
parents.
To access "Additional Information for Healthcare Providers
and Public Health Professionals," go to:
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm205548.htm
To access "Information for Parents and Caregivers," go to:
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm205547.htm
To access the FDA index web page titled "Update on Rotarix
Vaccine," go to:
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm205539.htm
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2. |
Global organizations release statements on the use of Rotarix vaccine
The World Health Organization (WHO) and the
Global Advisory
Committee on Vaccine Safety (GACVS) released statements last
week on the use of Rotarix vaccine. Neither organization
recommends suspension of Rotarix use. The statements from
WHO and GACVS are reprinted below.
ROTAVIRUS VACCINATION--WORLD HEALTH ORGANIZATION DOES NOT
RECOMMEND ANY CHANGE TO USE OF ROTARIX VACCINE
Following announcements today by the United States Food and
Drug Administration (FDA) and the European Medicines Agency
(EMA) regarding use of the rotavirus vaccine, Rotarix, the
World Health Organization (WHO) encourages all countries
using the vaccine to carefully consider the significant
benefits of continued use of the vaccine in any decisions
about further use.
The FDA and EMA statements follow the recent report to the
vaccine manufacturer that DNA sequences originating from
porcine circovirus 1 (PCV1) had been detected in two batches
of the vaccine during a study undertaken in the United
States of America.
WHO concurs with the views of the FDA and EMA that the
findings do not present a threat to public health. Moreover,
rotaviruses are the most common cause of severe diarrhoeal
disease in young children throughout the world, with an
estimated 527,000 deaths among children under five years
old, most of whom live in low-income countries. Therefore,
WHO does not recommend any change to use of the vaccine. The
vaccine is prequalified by WHO, and the prequalification
status remains unchanged.
WHO will continue to work closely with the FDA, EMA, and
other regulatory agencies to evaluate further information
that the manufacturer will be providing as a matter of
urgency.
STATEMENT OF THE GLOBAL ADVISORY COMMITTEE ON VACCINE SAFETY
ON ROTARIX
On 25 March 2010, WHO's Global Advisory Committee on Vaccine
Safety (GACVS) met by teleconference to review new data on
Rotarix, an oral vaccine for prevention of rotavirus
gastroenteritis. Academic investigators recently reported to
the vaccine manufacturer, GlaxoSmithKline, that the vaccine
contains DNA from porcine circovirus type 1 (PCV1). PCV1 is
not known to cause disease in animals or humans. Further
analysis of the master cell bank and master viral seed used
for vaccine production have demonstrated the presence of
PCV1 DNA, which in retrospect has been in the vaccine
throughout its clinical development, including the
prelicensure clinical trials. There are studies underway
both by the manufacturer and others that will provide
additional information to help more fully assess this new
finding.
The safety of Rotarix is supported by both large clinical
trials prelicensure and an extensive (>60 million doses)
postlicensure safety experience. GACVS reviewed the safety
data from both clinical trials and spontaneous reports, both
of which supported the continued safety of Rotarix.
Rotavirus gastroenteritis is the most common cause of severe
diarrheal disease in young children throughout the world,
with an estimated 527,000 deaths annually among children
under five years old. Given the extensive clinical data
supporting the safety of Rotarix and the benefits of
rotavirus vaccination for children, GACVS considers that the
benefits of vaccination far outweigh any currently known
risk associated with use of Rotarix. GACVS will continue to
review data as it becomes available and will update this
statement as we learn more.
To read the WHO statement online, click
here.
To access the GACVS statement online, click
here.
To access the WHO position paper on rotavirus vaccines, go
to:
http://www.who.int/wer/2009/wer8451_52.pdf
To access the European Medicine Agency's statement about
Rotarix, go to:
http://www.ema.europa.eu/humandocs/PDFs/EPAR/rotarix/18935010en.pdf
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3. |
MMWR reports on H1N1 influenza in pregnant women who require intensive care
CDC published "2009 Pandemic Influenza A (H1N1)
in Pregnant
Women Requiring Intensive Care--New York City, 2009" in the
March 26 issue of MMWR. The first paragraph of the article
and the first two paragraphs of the editorial note are
reprinted below.
Pregnant women are at increased risk for severe illness and
complications from infection with seasonal influenza and
2009 pandemic influenza A (H1N1). To characterize the
severity of 2009 H1N1 infection in pregnant women, the New
York City Department of Health and Mental Hygiene (DOHMH)
conducted active and passive surveillance for cases of 2009
H1N1 infection in pregnant women requiring intensive care.
This report summarizes the results of that surveillance,
which found that, during 2009, 16 pregnant women and one who
was postpartum were admitted to New York City intensive-care
units (ICUs). Two women died. Of the 17 women, 12 had no
recognized risk factors for severe influenza complications
other than pregnancy. All 17 women received antiviral
treatment with oseltamivir; however, treatment was initiated
<=2 days after symptom onset in only one woman and was begun
>=5 days after symptom onset in four women. Because
initiation of antiviral treatment <=2 days after onset is
associated with better outcomes, pregnant women should be
encouraged to seek medical care immediately if they develop
influenza-like symptoms, and healthcare providers should
initiate empiric antiviral therapy for these women as soon
as possible, even if >2 days after symptom onset. Health
departments and healthcare providers should educate pregnant
and postpartum women regarding the risks posed by influenza
and highlight the effectiveness and safety of influenza
vaccination. Obstetricians and other healthcare providers
should offer influenza vaccination to their pregnant
patients. . . .
An analysis of New York City 2009 H1N1 hospitalizations
during May-June 2009 showed that pregnant women were 7.2
times more likely to be hospitalized and 4.3 times more
likely to be admitted to an ICU than nonpregnant women.
Immunologic changes, increased ventilatory demand, and
decreased functional residual capacity and oncotic pressure
all are postulated to predispose pregnant and postpartum
women to severe respiratory complications from influenza
virus infection.
The case series in this report highlights some delays in
pregnant women seeking care and obtaining appropriate
diagnosis and treatment of 2009 H1N1 virus infection in New
York City, despite extensive outreach to the public and
healthcare providers by public health officials. The
illustrative cases highlight some factors contributing to
the delays, including false-negative rapid diagnostic test
results and not taking oseltamivir as prescribed. In
addition, only one of the 17 women was reported to have
received 2009 H1N1 vaccine. Although no vaccine is 100%
effective, vaccination remains the most important and
effective means of preventing influenza among pregnant
women. . . .
To access the full article in web-text (HTML) format, go to:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5911a1.htm
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4. |
2010 U.S. immunization schedules available in a variety of formats
CDC recently released pocket-size versions of the
official
2010 childhood and adult immunization schedules. To access
the pocket-size schedules, go to:
http://www.cdc.gov/vaccines/recs/schedules/pocketsize.htm
To access the general CDC immunization schedule page, go to:
http://www.cdc.gov/vaccines/recs/schedules
In addition, IAC's popular laminated versions of the full-size 2010 child/teen and adult immunization schedules are
now available for ordering. These laminated versions are
covered with a tough, washable coating, are printed in color
for easy reading, come complete with essential tables and
footnotes, and include contraindications and precautions.
Visit the following web pages for specific information, to
view images, or to order online or download an order form:
Child and Adolescent Laminated U.S. Immunization Schedules
(0-18 years)
http://www.immunize.org/shop/schedule_child.asp
Adult Laminated U.S. Immunization Schedules
http://www.immunize.org/shop/schedule_adult.asp
For quotes on customizing or placing orders in excess of 999
schedules, call (651) 647-9009 or email
admininfo@immunize.org
To learn about other essential immunization resources
available for purchase from IAC, go to:
http://www.immunize.org/shop
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5. |
IAC updates two resources for parents, one on hepatitis B vaccine for babies
and one on rotavirus vaccine
IAC recently revised the following two resources.
The parent brochure "Hepatitis B shots are recommended for
all new babies" received minor edits.
To access this revised ready-to-print (PDF) piece, go to:
http://www.immunize.org/catg.d/p4110.pdf
The print piece for parents titled "Rotavirus: Questions and
Answers" was updated with new safety information.
To access this revised ready-to-print (PDF) piece, go to:
http://www.immunize.org/catg.d/p4217.pdf
IAC's Print Materials web section offers healthcare
professionals and the public approximately 250 FREE English-language materials (many also available in translation),
which we encourage website users to print out, copy, and
distribute widely. To access all of IAC's free print
materials, go to: http://www.immunize.org/printmaterials
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6. |
Keep vaccinating against influenza this spring and be sure to also give
pneumococcal vaccine when indicated
Please continue to vaccinate patients against
H1N1 and
seasonal influenza (as vaccine supplies permit). Remember:
2009 H1N1 influenza vaccine will not protect people against
seasonal influenza, and seasonal influenza vaccine will not
protect against H1N1 influenza.
Providers who don't have H1N1 vaccine or seasonal influenza
vaccine can direct patients to the Google Flu Shot Finder at
http://www.google.com/flushot
Also remember that CDC advises healthcare professionals that
during seasonal and H1N1 influenza outbreaks, all people who
have existing indications for pneumococcal polysaccharide
vaccine (PPSV) should be vaccinated according to current
ACIP recommendations. This is important because people with
existing indications are not only at increased risk for
pneumococcal disease, but are also at increased risk for
serious complications from influenza.
CDC has issued related guidance titled "Prevention of
Pneumococcal Infections Secondary to Seasonal and 2009 H1N1
Influenza Viruses Infection." To access it, go to:
http://www.cdc.gov/h1n1flu/vaccination/provider/provider_pneumococcal.htm
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7. |
IAC's Video of the Week teaches young adults about the value of immunization
IAC encourages IAC Express readers to watch a
6-minute video
that introduces young adults to the value of immunization.
In the video, which was developed by Canada's BC Centre for
Disease Control, two teens investigate why some of their
familial ancestors did not survive childhood. To access the
video, please read the directions below.
The video will be available on the home page of IAC's
website through April 4. To access it, go to:
http://www.immunize.org and click on the image under the
words Video of the Week. This will take you to the
Immunization & Vaccines section of the BC Centre for Disease
Control. Scroll down to the section titled "Disease Scene
Investigation (DSI) Videos for Kids," and click on the video
titled "How Immunization Works." It may take a few moments
for the video to begin playing; please be patient!
Remember to bookmark IAC's home page to view a new video
every Monday. To view an IAC Video of the Week from the
past, go to the video archive at http://www.immunize.org/votw
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8. |
PPSV
and multi-vaccine VISs now available in Thai
The pneumococcal polysaccharide vaccine (PPSV)
VIS and the
multi-vaccine VIS are now available in Thai. IAC gratefully
acknowledges the Asian Pacific Health Care Venture, Inc.,
for the translations.
To access the PPSV VIS in Thai, go to:
http://www.immunize.org/vis/th_pne97.pdf
To access the multi-vaccine VIS in Thai, go to:
http://www.immunize.org/vis/th_multi.pdf
For information about the use of VISs, and for VISs in more
than 35 languages, visit IAC's VIS web section at
http://www.immunize.org/vis
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9. |
IAC
posts updated Turkish translations of three popular parent pieces
Mustafa Kozanoglu, MD, kindly updated three
popular parent
pieces that IAC had recently revised.
To access "Immunizations for Babies: A Guide for Parents--These are the vaccinations your baby needs!" in Turkish, go
to: http://www.immunize.org/catg.d/p4010-21.pdf
To access the same piece in English, go to:
http://www.immunize.org/catg.d/p4010.pdf
To access "When Do Children and Teens Need Vaccinations?" in
Turkish, go to:
http://www.immunize.org/catg.d/p4050-21.pdf
To access the same piece in English, go to:
http://www.immunize.org/catg.d/p4050.pdf
To access "Are you 11-19? Then you need to be vaccinated
against these serious diseases!" in Turkish, go to:
http://www.immunize.org/catg.d/p4020-21.pdf
To access the same piece in English, go to:
http://www.immunize.org/catg.d/p4020.pdf
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