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IAC Express 2010 |
| Issue number 857: March 22, 2010 |
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Contents
of this Issue
Select a title to jump to the article. |
- CDC
Health Advisory notifies providers about FDA's recommendation to
temporarily suspend use of GSK's Rotarix vaccine
- MMWR
publishes CDC's recommendations for the use of a reduced (4-dose) vaccine
schedule for postexposure prophylaxis to prevent human rabies
- MMR
vaccine VIS now available in Yiddish
- Video
presents a mother's powerful narrative of her son's decade-long struggle
with complications from chickenpox
- Keep
vaccinating against H1N1 and seasonal influenza!
- Nearly 8
million Afghan children to benefit in latest United Nations polio
vaccination drive
- Free CME
webinar: American College of Preventive Medicine's "H1N1--Lessons Learned"
webinar is scheduled for March 24
-
California Immunization Coalition's 2010 Summit is planned for May 3-4 in
Sacramento
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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 857: March 22, 2010 |
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1. |
CDC Health Advisory notifies providers about FDA's recommendation to
temporarily suspend use of GSK's Rotarix vaccine
On March 22, CDC issued a Health Advisory titled
"Recommendation to Temporarily Suspend Usage of
GlaxoSmithKline Rotarix (Rotavirus) Vaccine." The complete
text of the advisory is reprinted below.
RECOMMENDATION TO TEMPORARILY SUSPEND USAGE OF
GLAXOSMITHKLINE ROTARIX (ROTAVIRUS) VACCINE
Summary: The U.S. Food and Drug Administration (FDA) has
learned that DNA from porcine circovirus type 1 (PCV1), a
virus not known to cause disease in humans, is present in
the Rotarix vaccine. All available evidence indicates that
there has been no increased risk to patients who have
received this vaccine. PCV1 is not known to cause any
disease in animals or humans; therefore, it has not been
routinely tested for in vaccine development. Rotarix has
been extensively studied, before and after approval, and
found to have an excellent safety record (i.e., no unusual
adverse events). However, FDA is recommending that
healthcare practitioners temporarily suspend usage of the
Rotarix vaccine for rotavirus immunization in the United
States while the agency learns more about the detection of
components of the virus found in the vaccine.
BACKGROUND
FDA has learned that DNA from porcine circovirus type 1
(PCV1) is present in the Rotarix vaccine. This finding was
reported to FDA by GlaxoSmithKline on March 15th, 2010,
based on work originally performed by an academic research
team using a novel technique to look for viruses.
GlaxoSmithKline then conducted additional studies and
confirmed that PCV1 DNA is present in the finished Rotarix
vaccine, as well as in the cell bank and seed from which the
vaccine is derived. This finding suggests that the PCV1 DNA
has likely been present since the early stages of the
vaccine's development.
Rotavirus vaccines are given by mouth to young infants to
prevent rotavirus disease, which can cause severe diarrhea
and dehydration. Each year, rotavirus disease causes more
than 500,000 deaths in infants globally, and more than
50,000 hospitalizations and several dozen deaths in the
United States. There are two licensed rotavirus vaccines in
the United States: RotaTeq (Merck) and Rotarix
(GlaxoSmithKline).
RECOMMENDATIONS
While FDA is learning more about the situation, the agency
is recommending that clinicians temporarily suspend the use
of Rotarix. This recommendation applies to all lots of the
Rotarix vaccine. RotaTeq vaccine is available for rotavirus
immunization during this period. For children who have
received one dose of Rotarix, CDC advises that clinicians
complete the series with RotaTeq for the next two doses.
Since RotaTeq was licensed in 2006 and Rotarix in 2008, most
children vaccinated in the United States received RotaTeq.
The RotaTeq vaccine is made using a different process from
the Rotarix vaccine. Preliminary studies by FDA on the
RotaTeq vaccine have not shown the presence of PCV1 DNA. FDA
is working with Merck to confirm these results.
FDA is obtaining additional information about the presence
of PCV1 DNA in Rotarix, including whether intact virus (as
opposed to DNA components) is present. FDA is also
investigating how the PCV1 DNA came to be present in the
vaccine.
Within the next four to six weeks, FDA will convene an
advisory committee to review the available data and make
recommendations on the licensed rotavirus vaccines. FDA will
also seek input on the use of new techniques for identifying
viruses in vaccines. The agency anticipates that following
the advisory committee meeting, based on expert input and
additional review, FDA will make further recommendations on
the use of the two licensed rotavirus vaccines in the United
States.
The recommendations detailed above are for the United
States, where there is less rotavirus disease and an
alternative vaccine is available. Other countries may decide
to continue vaccinating with Rotarix while more information
becomes known. Available evidence suggests that the benefits
of continued use of Rotarix in countries where rotavirus
disease is common and severe far outweigh any potential risk
from the vaccine.
Clinicians are requested to report any suspected adverse
events following Rotarix vaccination to the Vaccine Adverse
Event Reporting System (VAERS) via phone (800) 822-7967 or
online: http://vaers.hhs.gov
FOR MORE INFORMATION
FDA intends to provide frequent updates to patients,
providers, and the general public as its understanding
evolves. Additional information is available at http://www.fda.gov
To access the CDC Health Advisory online, go to:
http://www2a.cdc.gov/HAN/ArchiveSys/ViewMsgV.asp?AlertNum=00311
To read the related FDA press release, go to:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm205625.htm
To access a web section of FDA resources related to the
suspension of Rotarix use, including Q&As for parents and healthcare
providers, click
here.
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2. |
MMWR publishes CDC's recommendations for the use of a reduced (4-dose)
vaccine schedule for postexposure prophylaxis to prevent human rabies
On March 19, CDC published "Use of a Reduced
(4-Dose)
Vaccine Schedule for Postexposure Prophylaxis to Prevent
Human Rabies: Recommendations of the Advisory Committee on
Immunization Practices (ACIP)" in MMWR Recommendations and
Reports. The Summary section is reprinted below.
This report summarizes new recommendation and updates
previous recommendations of the Advisory Committee on
Immunization Practices (ACIP) for postexposure prophylaxis
(PEP) to prevent human rabies (CDC. Human rabies prevention--United States, 2008: recommendations of the Advisory
Committee on Immunization Practices. MMWR 2008;57[No. RR-3]). Previously, ACIP recommended a 5-dose rabies
vaccination regimen with human diploid cell vaccine (HDCV)
or purified chick embryo cell vaccine (PCECV). These new
recommendations reduce the number of vaccine doses to four.
The reduction in doses recommended for PEP was based in part
on evidence from rabies virus pathogenesis data,
experimental animal work, clinical studies, and
epidemiologic surveillance. These studies indicated that 4
vaccine doses in combination with rabies immune globulin
(RIG) elicited adequate immune responses and that a fifth
dose of vaccine did not contribute to more favorable
outcomes. For persons previously unvaccinated with rabies
vaccine, the reduced regimen of 4 1-mL doses of HDCV or
PCECV should be administered intramuscularly. The first dose
of the 4-dose course should be administered as soon as
possible after exposure (day 0). Additional doses then
should be administered on days 3, 7, and 14 after the first
vaccination. ACIP recommendations for the use of RIG remain
unchanged. For persons who previously received a complete
vaccination series (pre- or postexposure prophylaxis) with a
cell-culture vaccine or who previously had a documented
adequate rabies virus-neutralizing antibody titer following
vaccination with noncell-culture vaccine, the recommendation
for a 2-dose PEP vaccination series has not changed.
Similarly, the number of doses recommended for persons with
altered immunocompetence has not changed; for such persons,
PEP should continue to comprise a 5-dose vaccination regimen
with 1 dose of RIG. Recommendations for pre-exposure
prophylaxis also remain unchanged, with 3 doses of vaccine
administered on days 0, 7, and 21 or 28. Prompt rabies PEP
combining wound care, infiltration of RIG into and around
the wound, and multiple doses of rabies cell-culture vaccine
continue to be highly effective in preventing human rabies.
To access the complete recommendations in PDF format, go to:
http://www.cdc.gov/mmwr/pdf/rr/rr5902.pdf
For the document in web-text (HTML) format, go to:
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5902a1.htm
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3. |
MMR vaccine VIS now available in Yiddish
Dated 3/13/08, the current VIS for
measles-mumps-rubella
(MMR) vaccine is now available in Yiddish. IAC gratefully
acknowledges the New York City Department of Education and
New York City Department of Health and Mental Hygiene for
the translation.
To access the Yiddish version of the 3/13/08 VIS for MMR
vaccine, go to: http://www.immunize.org/vis/yi_mmr.pdf
To access the English version of the 3/13/08 VIS for MMR
vaccine, go to: http://www.immunize.org/vis/mmr03.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
For more information about the ongoing multi-state mumps
outbreak, see the Health Advisory released by CDC on March
11 titled "Notice to Providers Concerning Potential Cases of
Mumps During a Multi-State Outbreak" at:
http://www2a.cdc.gov/HAN/ArchiveSys/ViewMsgV.asp?AlertNum=00310
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4. |
Video presents a mother's powerful narrative of her son's decade-long
struggle with complications from chickenpox
IAC encourages IAC Express readers to watch a
3-minute video
that recounts how one family's life was forever changed by
their son's experience with chickenpox. The video was
produced by PKIDS (Parents of Kids with Infectious
Diseases).
The video will be available on the home page of IAC's
website through March 28. To access it, go to:
http://www.immunize.org and click on the image under the
words Video of the Week. It may take a few moments for the
video to begin playing; please be patient!
To view more excellent videos about other vaccine-preventable diseases from PKIDS, go to
http://www.pkids.org/im_videos.php
To find out more about PKIDS, go to: http://www.pkids.org
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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5. |
Keep vaccinating against H1N1 and seasonal influenza!
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
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6. |
Nearly 8 million Afghan children to benefit in latest United Nations polio
vaccination drive
On March 14, United Nations agencies and the
Afghan health
ministry started conducting a 3-day campaign aimed at
vaccinating an estimated 7.7 million children under age 5
years against polio. Afghanistan is one of four countries
where polio is still endemic.
To read the entire press release, go to:
http://www.un.org/apps/news/story.asp?NewsID=34080&Cr=afghan&Cr1=
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7. |
Free CME webinar: American College of Preventive Medicine's "H1N1--Lessons
Learned" webinar is scheduled for March 24
The American College of Preventive Medicine has
scheduled a
live, interactive webinar, "H1N1--Lessons Learned," for
March 24 at 7PM ET. Participants can earn free CME credit by
viewing the presentation, completing a self-assessment and
evaluation form, and submitting it.
For information on the faculty, course objectives, and system requirements,
click
here.
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8. |
California Immunization Coalition's 2010 Summit is planned for May 3-4 in
Sacramento
"Preparing For Tomorrow, Taking Action Today" is
the theme
of the California Immunization Coalition's 2010 Summit. It
will be held in Sacramento on May 3-4. The two day Summit
will feature speakers, expert panels, workshops, and
important opportunities for discussion with some of the top
leaders in immunization and healthcare advocacy in
California and beyond.
This year's Summit speakers include Litjen (LJ) Tan, PhD,
Director of Medicine and Public Health at the American
Medical Association; Tom T. Shimabukuro, MD, Deputy Director
H1N1 Vaccine Task Force at CDC; and Lisa Randall, Associate
Executive Director, Immunization Action Coalition.
Individuals from outside California are welcome to attend.
For comprehensive information, go to:
http://immunizeca.org/summit.cfm
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