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IAC Express 2010 |
| Issue number 868: May 17, 2010 |
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as well as other FREE IAC periodicals. |
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Contents
of this Issue
Select a title to jump to the article. |
- FDA
revises its recommendations for rotavirus vaccine: clinicians can resume
use of Rotarix and continue use of RotaTeq
- New: CDC
revises interim VIS for rotavirus vaccine
- IAC's
"Hepatitis B shots are recommended for all new babies" now available in
Spanish and five other languages
- IAC's
Video of the Week examines the growing bias against science, including
opposition to vaccination
- CDC
provides information on the supply of shingles and MMRV vaccines
- Want to
know more about using the new PCV 13 vaccine? A CDC Commentary video on
Medscape can help you
- PKIDs'
June 10 webinar will focus on using social marketing to target parents who
are hesitant about vaccines
- Please
take three minutes out of your day to give PATH feedback about its Vaccine
Resource Library
- MMWR
publishes report on worldwide progress made toward interrupting wild
poliovirus transmission during 2009
- CDC
reports on Regional Vaccination Weeks, held April 24 to May 1, 2010
- MMWR
corrects errors in its April 30 interim report on seasonal influenza
coverage during August 2009-January 2010
- MMWR
corrects an error in its April 2 interim report on H1N1 influenza coverage
during October 2009-January 2010
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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 868: May 17, 2010 |
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1. |
FDA revises its recommendations for rotavirus vaccine: clinicians can resume
use of Rotarix and continue use of RotaTeq
On May 14, CDC issued "Update on Recommendations
for the Use
of Rotavirus Vaccines." It is reprinted below in its
entirety.
Also on May 14, FDA posted information for parents and
caregivers, information for healthcare providers and the
public, and extensive background information. Links to these
resources are given at the end of this IAC Express article.
UPDATE ON RECOMMENDATIONS FOR THE USE OF ROTAVIRUS VACCINES
Summary:
FDA is updating its recommendations on both Rotarix and
RotaTeq vaccines for the prevention of rotavirus disease in
infants. Based on careful evaluation of a variety of
scientific information, FDA has determined it is appropriate
for clinicians and health care professionals to resume the
use of Rotarix and to continue the use of RotaTeq.
Background:
On March 22, 2010, FDA provided an early communication
regarding Rotarix, manufactured by GlaxoSmithKline
Biologicals (GSK). At that time, FDA recommended that
clinicians and public health professionals in the United
States temporarily suspend the use of Rotarix while the
agency and manufacturer investigated the finding of DNA from
porcine circovirus type 1 (PCV1) in the vaccine. Since that
time, both FDA and GSK have confirmed the presence of PCV1
in the vaccine.
On May 6, 2010, FDA provided information about RotaTeq,
manufactured by Merck & Co, Inc. FDA indicated that
preliminary studies conducted by Merck identified fragments
of DNA from PCV1 and from a related porcine circovirus type
2 (PCV2) in RotaTeq. FDA noted that it would seek input from
its Vaccines and Related Biological Products Advisory
Committee (VRBPAC) and provide updates in the near future.
Updated Recommendations:
FDA has evaluated laboratory results from the manufacturers
and its own laboratories. In addition, FDA's Vaccines and
Related Biological Products Advisory Committee (VRBPAC)
convened on May 7, 2010, to discuss the findings of PCV and
PCV DNA in rotavirus vaccines. Based on a careful evaluation
of this information, a thorough review of the scientific
literature, and input from scientific and public health
experts, the agency is revising its recommendation to
temporarily suspend use of the Rotarix vaccine. FDA has
determined it is appropriate for clinicians and healthcare
professionals to resume the use of Rotarix and to continue
the use of RotaTeq.
FDA considered the following information in its decision:
- Both vaccines have strong safety records, including
clinical trials involving tens of thousands of patients as
well as clinical experience with millions of recipients.
FDA has no evidence that either PCV1 or PCV2 poses a safety
risk in humans, and notes that neither is known to cause
infection or illness in humans.
- The benefits of the vaccines are substantial, and include
prevention of hospitalization for severe rotavirus disease
in the U.S. and of death in other parts of the world. The
benefits of the vaccines, which are known, outweigh the
risk, which is theoretical.
Next Steps:
FDA is working with each of the manufacturers (GSK and
Merck) to update the labeling for both Rotarix and RotaTeq
vaccines to include information about the presence of PCV1
(Rotarix) and DNA from PCV1 and PCV2 (RotaTeq) in the
vaccines.
FDA is working with each of the manufacturers to plan the
appropriate follow-up studies, taking into account the input
received from members of the VRBPAC on May 7, 2010.
FDA and the manufacturers will continue to investigate the
findings of PCV in rotavirus vaccines, and will evaluate
information from ongoing testing by FDA and the
manufacturers. As noted by the firm during the May 7, 2010,
VRBPAC meeting, GSK plans to re-derive its vaccine, in
consultation with FDA. Merck is in the early stages of its
investigation, and has not yet determined next steps in this
regard.
Updated Information for Clinicians and Public Health
Professionals:
FDA has determined it is appropriate for clinicians and
healthcare professionals to resume the use of Rotarix and to
continue the use of RotaTeq. FDA also recommends that
clinicians and public health professionals inform parents of
the findings of PCV DNA or PCV in rotavirus vaccines, and
that there is no evidence that these findings pose a safety
risk in humans. Both the prescribing information and patient
labeling will be revised to include this information.
The benefits of vaccination against rotavirus disease are
substantial, both in the United States and the developing
world and far outweigh any theoretical risk posed by PCV
types 1 and 2. The safety record of both rotavirus vaccines
is excellent.
FDA will keep the public and clinical community updated
through http://www.fda.gov and other communications.
To access "Update on Recommendations for the Use of
Rotavirus Vaccines," go to:
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm212140.htm
LINKS TO RESOURCES:
To access "Information for Parents and Caregivers," go to:
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm205547.htm
To access "Additional Information for Healthcare Providers
and Public Health Professionals," go to:
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm205548.htm
To access extensive background information, go to:
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm205539.htm
To access a letter addressed to healthcare professionals
from GlaxoSmithKline, go to:
http://www.gsksource.com/gskprm/en/US/images/gsk_content/ROTARIX/RTX343R0-Final.pdf
Note: Merck did not issue a similar letter because FDA has
never recommended temporary suspension of RotaTeq, Merck's
rotavirus vaccine.
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2. |
New: CDC revises interim VIS for rotavirus vaccine
On May 14, CDC issued a revised interim VIS for
the use of
rotavirus vaccine. It replaces the interim VIS dated
8/28/08.
Page 1 of the 5/14/10 interim VIS includes a box with this
information: "A virus (or parts of the virus) called porcine
circovirus is in both rotavirus vaccines. This virus is not
known to infect people and there is no known safety risk.
For more information, see http://www.fda.gov"
Note: Providers may use up existing stocks of the 8/28/08
version of the interim VIS. Providers who want ensure that
parents are informed about the issue of porcine circovirus
may want to use the 5/14/10 version of the interim VIS or to
supplement the 8/28/08 version with pertinent materials from
FDA such as "Information for Parents and Caregivers"
(http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm205547.htm).
To access the 5/14/10 interim VIS for rotavirus vaccine from
the IAC website, go to:
http://www.immunize.org/vis/vis_rotavirus.asp
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 general information about VISs from CDC's website go to:
http://www.cdc.gov/vaccines/pubs/vis
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3. |
IAC's "Hepatitis B shots are recommended for all new babies" now available in
Spanish and five other languages
Updated in March 2010, IAC's parent-education
piece
"Hepatitis B shots are recommended for all new babies" is
now available in Arabic, Chinese, French, Korean, Spanish,
and Vietnamese.
To access the Spanish version of "Hepatitis B shots are
recommended for all new babies," go to:
http://www.immunize.org/catg.d/p4110-01.pdf
For Arabic: http://www.immunize.org/catg.d/p4110-20.pdf
For Chinese: http://www.immunize.org/catg.d/p4110-08.pdf
For French: http://www.immunize.org/catg.d/p4110-10.pdf
For Korean: http://www.immunize.org/catg.d/p4110-09.pdf
For Vietnamese: http://www.immunize.org/catg.d/p4110-05.pdf
For English: http://www.immunize.org/catg.d/p4110.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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4. |
IAC's Video of the Week examines the growing bias against science, including
opposition to vaccination
IAC encourages IAC Express readers to watch a
16-minute
video of writer Michael Specter discussing ideas from his
book "Denialism: How Irrational Thinking Hinders Scientific
Progress, Harms the Planet and Threatens Our Lives."
The video will be available on the home page of IAC's
website through May 24. To access it, go to:
http://www.immunize.org and click on the image under the
words Video of the Week.
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. |
CDC provides information on the supply of shingles and MMRV vaccines
On May 5, CDC updated its Current Vaccine
Shortages and
Delays web page with the following information about the
supply of shingles vaccine and measles-mumps-rubella-varicella (MMRV) vaccine.
"Zostavax [the shingles vaccine manufactured by Merck] is
available for order at this time; however, providers will
experience backorders, or periods where they are unable to
place orders for Zostavax, throughout 2010 and possibly into
2011."
"Merck will begin taking orders for MMRV (ProQuad) beginning
May 10, 2010. A limited number of doses will be available
for distribution (approximately 1.4 million doses), and how
long this supply lasts will depend upon market demand for
the vaccine. Merck has adequate supply of both their MMR and
varicella vaccines to meet current demand."
NOTE: On May 7, CDC released " Use of Combination Measles,
Mumps, Rubella, and Varicella Vaccine: Recommendations of
the Advisory Committee on Immunization Practices." To access
it, go to: http://www.cdc.gov/mmwr/pdf/rr/rr5903.pdf
For continuing vaccine supply information, go to CDC's
Current Vaccine Shortages and Delays web page at
http://www.cdc.gov/vaccines/vac-gen/shortages
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6. |
Want to know more about using the new PCV 13 vaccine? A CDC Commentary video
on Medscape can help you
On May 10, Medscape posted a 5-minute video
titled "CDC
Commentary: Pneumococcal Disease in Children--New
Immunization Recommendations." Featuring CDC's Matthew
Moore, MD, MPH, the video gives a brief overview of the CDC
recommendations for the use of the new 13-valent
pneumococcal conjugate vaccine, PCV13.
To view the video, go to:
http://www.medscape.com/viewarticle/721154
Note: to access the video, you must register with Medscape.
There is no charge for this service.
The video is a collaboration between CDC and Medscape; it is
one of a series of commentaries designed to deliver CDC's
authoritative guidance directly to healthcare professionals.
To view the available commentary choices, go to:
http://www.medscape.com/partners/cdc/public/cdc-commentary
Medscape is a free resource for clinicians and other
healthcare professionals that provides timely and relevant
clinical information.
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7. |
PKIDs' June 10 webinar will focus on using social marketing to target parents
who are hesitant about vaccines
PKIDs (Parents of Kids with Infectious Diseases)
has
scheduled a one-hour webinar titled "Spotlight on
Immunization Hesitancy: Washington State." Planned for June
10, the webinar will present information on how a diverse
group of public and private partners in Washington state
have developed a social marketing plan intended to increase
timely immunizations among children from birth to age 24
months, targeting parents who are hesitant about vaccines.
The webinar is part of Communications Made Easy, a PKIDS'
program intended to help immunization educators learn the
ropes of social marketing and traditional and social media.
"Spotlight on Immunization Hesitancy: Washington State" is
scheduled for June 10 at 9AM Pacific Time. Space is limited
and pre-registration is recommended. To register, go to:
https://cc.readytalk.com/cc/schedule/display.do?udc=c2up8vtc89z0
For more information on the Communications Made Easy
program, go to: http://www.pkids.org/cme
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8. |
Please take three minutes out of your day to give PATH feedback about its
Vaccine Resource Library
PATH, an international nonprofit organization
that enables
communities worldwide to break longstanding cycles of poor
health, is conducting an online survey about its Vaccine
Resource Library (VRL). The goal of the survey is to help
PATH determine who is using the website and what type of
information is most useful. The VRL offers a collection of
high-quality, scientifically accurate documents and links on
specific diseases and topics in immunization.
Whether you are a regular user of the VRL or new to the
website, take time now to visit the VRL at
http://www.path.org/vaccineresources
And then take three minutes to complete the online survey at
http://www.surveymonkey.com/s/HTWZRF6
PATH thanks you--your valuable feedback will help improve
the VRL website.
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9. |
MMWR
publishes report on worldwide progress made toward interrupting wild poliovirus
transmission during 2009
CDC published "Progress Toward Interruption of
Wild
Poliovirus Transmission--Worldwide, 2009" in the May 14
issue of MMWR. The first paragraph is reprinted below.
In 1988, an estimated 350,000 cases of poliomyelitis were
occurring annually worldwide. By 2005, because of global
vaccination efforts, indigenous transmission of wild
poliovirus (WPV) types 1 and 3 (WPV1 and WPV3) had been
eliminated from all but four countries (Afghanistan, India,
Nigeria, and Pakistan). No cases of WPV type 2 have been
reported since 1999. This report describes progress toward
global WPV eradication during 2009 and updates previous
reports. During 2009 a total of 1,606 cases of WPV infection
were reported, compared with 1,651 in 2008. WPV3 incidence
increased 67%, to 1,124 cases, compared with 675 in 2008.
However, WPV1 incidence decreased 51%, to 482 cases in 2009,
compared with 976 cases in 2008. In India, nearly all polio
cases in 2009 were reported in high-risk districts in
western Uttar Pradesh and central Bihar. In Afghanistan and
Pakistan, WPV circulation in high-risk districts continued
because of difficulties vaccinating children in conflict-affected areas and operational limitations in parts of
Pakistan. In Nigeria, cases decreased by 51%, to 388 cases
in 2009, compared with 798 in 2008. During 2009, outbreaks
from importation of WPV affected 19 previously polio-free
African countries. Two key steps are needed to make further
progress in polio eradication: (1) addressing local barriers
to interrupting transmission, and (2) using bivalent oral
poliovirus vaccine (bOPV) broadly for WPV 1 and 3 in
supplemental immunization activities (SIAs).
To access the full article in web-text (HTML) format, go to:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5918a1.htm
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10. |
CDC reports on Regional Vaccination Weeks, held April 24 to May 1, 2010
CDC provided the text below on the Vaccination
Weeks
sponsored by three World Health Organization regions.
Promoting the life-saving importance of vaccines, strengthening country immunization programs, and increasing
access to vaccines were the goals of the Global Vaccination
Week that was held April 24 to May 1, 2010. These events
were sponsored by three World Health Organization (WHO)
regional offices and their member states to promote
immunization, increase vaccine access, and strengthen
existing programs in the Eastern Mediterranean, Europe, and
the Americas regions of the globe. The activities of the
regional WHO offices and their member states are part of a
growing endeavor to develop an international vaccination
week that yearly promotes the life saving potential of
immunization reaching out to people across the globe.
"Vaccination is the Obvious Choice" was the theme for the
first Vaccination Week in Eastern Mediterranean area. To
read about the immunization achievements and challenges of
the Eastern Mediterranean area, go to:
http://www.emro.who.int/vpi/vwem
The fifth European Immunization Week (EIW) promoted
vaccination by emphasizing the importance of vaccinating
every child to prevent disease and protect life. For
details, go to: http://www.euro.who.int/eiw
Vaccination Week in the Americas (VWA) is an annual
hemispheric event that works to strengthen the Expanded
Program on Immunization (EPI). For details, go to:
http://www.paho.org/vwa
In collaboration with VWA, the United States sponsored
National Infant Immunization Week
(http://www.cdc.gov/vaccines/events/niiw), and Canada
sponsored National Immunization Awareness Week (http://www.immunize.cpha.ca/en/events/niaw.aspx) to promote
vaccination during this week.
The convergence of all of these activities during a specific
week is building a platform for future vaccination weeks
that will annually focus world attention on the importance
of vaccination and proclaim the life saving benefits of
immunization. As Dr. Margaret Chan, the Director-General of
the World Health Organization, has stated, "In the future, I
hope we will see even greater numbers of countries
participating in these immunization weeks." Next year,
Africa is considering launching its regional vaccination
week, having participated in the launch in the Americas. It
is anticipated that a worldwide Global Vaccination Week will
become a reality, and this international effort will become
an international event that prevents disease through
vaccination.
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11. |
MMWR corrects errors in its April 30 interim report on seasonal influenza
coverage during August 2009-January 2010
CDC published "Errata: Vol. 59, No. 16" in the
May 14 issue
of MMWR. The errors concerned details in coverage and range.
To access the errata in web-text (HTML) format, go to:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5918a6.htm
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12. |
MMWR corrects an error in its April 2 interim report on H1N1 influenza
coverage during October 2009-January 2010
CDC published " Errata: Vol. 59, No. 12" in the
May 14 issue
of MMWR. The error concerned a detail in the coverage
information.
To access the errata in web-text (HTML) format, go to:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5918a7.htm
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