Letter from the director
National and
international media coverage is spreading the word about remarkable
progress in recent months that moves us closer to bringing lifesaving
rotavirus vaccines to children in the world's poorest countries.
Advances continue to be made with each step, from the publication of
successful clinical trial results for new vaccine candidates and
important regulatory approvals to the growing recognition that new
technologies can improve upon historical trends in significantly
decreasing diarrheal disease mortality.
New estimates of diarrheal disease and rotavirus burden worldwide are
providing greater insight into the related challenges and potential of
introducing rotavirus vaccines. FDA approval and a unanimous vote from
the CDC's Advisory Committee On Immunization Practices to include a
rotavirus vaccine in routine US childhood immunization programs are
further examples of the exciting progress we have seen in just the past
couple of weeks.
As noted in much of the media coverage, and in PATH's responses to
these milestones, clinical studies are still needed to determine the
safety and efficacy of rotavirus vaccines in the developing world.
PATH's rotavirus vaccine program, with support from GAVI and in
partnership with the US Centers for Disease Control and Prevention
(CDC) and the World Health Organization, is working with the vaccine
manufacturers to design and conduct these studies.
Tremendous momentum toward eventual vaccine introduction in the poorest
countries is building. We have seen heightened awareness about the
potential of new vaccines and great strides forward, but many hurdles
remain to make rotavirus vaccines available in the developing world.
Together with our partners, we must harness this momentum to strengthen
our shared commitment and continue to move forward toward our goal of
ensuring that the world's children, no matter where they live, have
access to the promise of vaccines.
Sincerely,
John R. Wecker, PhD
FDA approves licensure of rotavirus vaccine;
committee votes for inclusion in routine US immunization programs
Merck's rotavirus
vaccine, RotaTeq™, was approved by the US Food and Drug Administration
(FDA) on February 3, 2003, making RotaTeq™ the only rotavirus vaccine
approved for use in the United States. Read the official FDA
announcement.
Following the FDA approval, the CDC's Advisory Committee on
Immunization Practices (ACIP) met to determine whether the vaccine
should be added to routine immunization schedules in the US.
Recommendations of the ACIP become recommendations of CDC once they are
accepted by the director of CDC and the Secretary of Health and Human
Services. The committee voted unanimously to recommend the addition of
RotaTeq™ to the list of vaccines provided to American children. Further
details are available in a press
release from the CDC, and official recommendations will be posted
on the ACIP website in
mid-March.
CDC review of DD incidence reveals higher
rates of rotavirus
The January 12
issue of Emerging
Infectious Diseases featured new estimates from the CDC that
indicate an increase in the global burden of rotavirus. While the
updated figures mark a decrease in diarrheal disease incidence
worldwide, due in part to improved sanitation, they note an increase in
diarrheal disease hospitalizations attributable to rotavirus. These new
data emphasize the need for rotavirus vaccines as part of a broad
approach to diarrheal disease intervention, offering evidence that
improved access to clean water and better hygiene practices can reduce
the prevalence of some diarrheal diseases but have little impact on
rotavirus infection.
Studies in Europe and the Americas find
rotavirus vaccines safe and effective
Last month, the New
England Journal of Medicine published the results of two
groundbreaking clinical trials of rotavirus vaccines. The studies
demonstrated that Rotarix™, manufactured by GlaxoSmithKline (GSK), and
RotaTeq™, produced by Merck, were highly efficacious and safe among the
infant populations in Europe, North America, and South America, where
the trials were conducted. The studies also evaluated the risk of
intusussception associated with administration of the vaccine and found
no evidence of a link between the vaccine and the rare bowel condition.
While these study results are encouraging, the vaccines have not yet
been tested among children in poor populations of Asia and Africa,
where the burden of rotavirus is greatest. In collaboration with GSK
and Merck, PATH is planning and conducting clinical trials to answer
these important questions and evaluate the vaccines' performance in
these settings.
Full text of the studies, along with an accompanying editorial by Drs.
Roger Glass and Umesh Parashar, may be viewed on the journal's website
by clicking the following links:
"The
Promise of New Rotavirus Vaccines" (editorial)
"Safety and
Efficacy of an Attenuated Vaccine against Severe Rotavirus
Gastroenteritis"
"Safety
and Efficacy of a Pentavalent Human–Bovine (WC3) Reassortant Rotavirus
Vaccine"
PAHO workshop develops and distributes
regional surveillance guidelines
PAHO welcomed
representatives from 18 countries, including high-level officials from
the host country of Brazil, to a regional surveillance workshop last
December. The event aimed to build upon efforts to expand the network
of countries conducting surveillance for rotavirus diarrhea among
hospitalized children. Participants focused on streamlining
surveillance in the region and worked to standardize concepts and
definitions, identify indicators for evaluation, plan future
surveillance and vaccine introduction activities, and educate each
other on basic clinical, epidemiologic, and laboratory aspects of
rotavirus infection. Representatives from countries already conducting
surveillance offered insight and preliminary data, while participants
interested in initiating surveillance in their home countries received
guidelines and protocol developed by WHO and PAHO.
WHO group recommends integrated approach to
diarrheal disease control
Following its
November 2005 meeting, WHO's Strategic Advisory Group of Experts (SAGE)
issued official conclusions and recommendations, including
acknowledgement of the promise of rotavirus vaccines and the need for
trials testing their safety and efficacy in developing countries. The
group also noted the importance of an integrated approach to address
diarrheal disease that combines vaccines and treatment interventions,
such as oral rehydration solution. Other recommendations were
summarized in the January 6 issue of WHO's Weekly
Epidemiological Record.
PATH appoints Dr. John Boslego to lead vaccine
development program
John Boslego, MD,
recently joined PATH to direct a new strategic program for vaccine
development. In this role, he will lead PATH's efforts to identify and
conduct clinical trials of promising protein vaccines to prevent
pneumococcal disease. Formerly executive director and department head
for Biologics, Clinical Research at Merck & Co, Inc., Dr. Boslego
has extensive experience working with new vaccines, including
leadership on development of Merck's rotavirus vaccine, RotaTeq™. Click
here
for more details.
©
2004-2006, PATH.
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