Welcome to the
fourth issue of Rotavirus Update, a quarterly newsletter from
PATH's Rotavirus Vaccine Program (RVP). This issue highlights the
launch of a rotavirus vaccine, proceedings from the Mexico City
rotavirus symposium, a major outbreak in Latin America, new clinical
trial results, and new GAVI funding from the Gates Foundation and
the governments of the United Kingdom, Norway, and Canada.
GSK Launches Rotarix™ in
Mexico
In a unique step
that may pave the way for future vaccines, GSK announced the launch
of its rotavirus vaccine, Rotarix™, in Mexico on January 7. This is
the first time a major pharmaceutical company has launched a vaccine
directly into the developing world, where the vaccine is needed
most, before entering the US and European markets. Mexico's Ministry
of Health approved the vaccine for sale in July 2004.
The
rotavirus vaccine community recognizes the importance of this
innovative approach as one way to reduce the years of delay that
developing countries have historically experienced when introducing
new vaccines. Dr. John Wecker, Director of RVP, said, "The early
experience in Mexico will help inform decision-makers in Latin
America and around the world about the potential benefits of
rotavirus vaccines."
In Mexico, GSK is first introducing
Rotarix™ into the private sector and the Mexican government is
making plans to introduce the vaccine into the public sector.
According to the company's press release about the launch, GSK plans
to introduce the vaccine into other Latin American countries this
year, as well as in some Asian countries.
See more news on
GSK's Rotarix™ launch:
Proceedings of the Sixth
International Rotavirus Symposium Now
Available
The Sixth
International Rotavirus Symposium held in Mexico City in July 2004
brought together rotavirus experts from around the world. Convened
by the Pan American Health Organization, the Albert B. Sabin Vaccine
Institute, the Centers for Disease Control and Prevention, and the
US National Institutes of Health, the symposium was a watershed in
the efforts to advance rotavirus vaccines and resulted in 16 Latin
American countries signing a declaration to prioritize and support
rotavirus prevention. The proceedings are now available in English
and Spanish and provide a synthesis of information presented and
consensus reached at the symposium.
View/Download
English PDF
View/Download
Spanish PDF
Merck Clinical Trial Results
Presented to ACIP
The Advisory
Committee on Immunization Practices (ACIP) met in Atlanta on
February 10-11 to discuss a rotavirus vaccine for the first time
since Rotashield™ rotavirus vaccine was removed from the market. The
group reviewed a recently completed clinical trial by Merck Research
Laboratories of their investigational rotavirus vaccine and updated
estimates of the health burden of rotavirus disease in US children.
The ACIP, a group of experts selected by the Secretary of the US
Department of Health and Human Services, provides advice and
guidance to US health authorities on the most effective means to
prevent vaccine-preventable diseases.
Penny Heaton, Director
of Biologics, Clinical Research at Merck, presented data from the
Rotavirus Efficacy and Safety Trial (REST), a trial to evaluate
Merck's oral human bovine reassortant rotavirus vaccine (RotaTeq™)
in more than 70,000 infants in 11 countries. Results of this trial,
in which 3 doses of RotaTeq™ were given at 1-2 month intervals
beginning at 6-12 weeks of age, showed that the vaccine is 74%
efficacious in preventing any rotavirus disease, and 98% efficacious
in preventing severe rotavirus disease. This efficacy data is
against serotypes G1, G2, G3, and G4 through the first full
rotavirus season post-vaccination. The vaccine is also well
tolerated with respect to intussusception. Merck is planning to
apply for licensure of RotaTeq™ in the United States, Europe, and
Latin America this year.
Umesh Parashar from the US Centers
for Disease Control and Prevention presented data showing that each
year in the United States rotavirus gastroenteritis is associated
with 20-70 deaths; 55,000-70,000 hospitalizations; 200,000-270,000
emergency department visits; 400,000 outpatient visits; and 2.7
million episodes of illness.
The ACIP will address key policy
issues and recommendations relating to the implementation of
rotavirus vaccines in US children at future meetings.
Rotavirus Outbreaks in Latin
America
Since January
several countries in Central America have been suffering from a
significant outbreak of rotavirus. Already dozens of children in the
region have died and tens of thousands of children have been
sickened. In Nicaragua, 27,000 children have fallen ill. If the
number reaches 30,000 a national state of emergency will be issued.
In El Salvador over 57,500 children were ill with rotavirus, and
emergencies have been declared in several districts. See a story on
the El Salvador outbreak under "'Rota bits."
Gates Foundation Awards $750
Million to GAVI; UK, Canada, and Norway Also Make Large
Donations
Making major
headlines around the world in late January, the Bill & Melinda
Gates Foundation announced that it will contribute $75 million a
year over the next 10 years for global vaccination work to the
Global Alliance for Vaccines and Immunization (GAVI), bringing the
foundation's total pledge to $1.5 billion.
GAVI is an
historic alliance between private- and public-sector stakeholders,
including WHO, UNICEF, the vaccine industry, the World Bank, the
Gates Foundation, governments, NGOs, and other institutions. The
group reports that $8-$12 billion will be needed for vaccination
efforts through 2015. The Gates Foundation has said it hopes other
donors will follow suit and make financial commitments to support
this important effort in global health.
GAVI also received a
US$290 million pledge from the Government of Norway the same day as
the Gates announcement.
More recently, the United Kingdom
pledged US$1.8 billion over the next 15 years and the government of
Canada announced a donation of US$130 million to scale up the work
of GAVI. The Canadian donation represents the largest one-year
commitment ever made by a government to GAVI.
GAVI, through
the Vaccine Fund, supports the Rotavirus Vaccine Program. Read more
on GAVI's
website.
© 2004-2005, Rotavirus Vaccine Program.
The Rotavirus Vaccine Program is a limited liability company
of PATH.
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