by Playfuls Staff |
29th July 2006
Merck & Co. announced that
GARDASIL (quadrivalent human papillomavirus types 6, 11, 16, 18, recombinant
vaccine), has received a positive opinion from the Committee for Medicinal
Products for Human Use (CHMP) in
Europe. The
CHMP opinion recommends that GARDASIL be approved for the [more] immunization
of children and adolescents aged 9 to 15 years and of adult females aged 16 to
26 years for the prevention of cervical cancer, high-grade cervical dysplasia
(CIN 2/3), high-grade vulvar dysplastic lesions (VIN 2/3) and external genital
warts caused by human papillomavirus types 6, 11, 16 and 18. Following the CHMP
review, the opinion for GARDASIL is transmitted to the European Commission
(EC). If the EC approves the opinion, the EC then deliberates on the decision
for approval. This decision will be applicable to the 25 countries that are
members of the European Union (EU), of which the five largest are the
United Kingdom,
Germany,
France,
Italy and
Spain.
GARDASIL will be marketed by
Sanofi Pasteur MSD (SPMSD), a joint venture between Sanofi Pasteur and Merck
& Co., Inc., Whitehouse Station,
New Jersey, USA,
in EU countries covered by the joint venture and several other European
countries. In the remaining European countries, located in central and eastern
Europe, GARDASIL will be marketed by Merck Sharp & Dohme as either GARDASIL
or SILGARD(R).
On June 8, the FDA approved
GARDASIL to prevent cervical cancer and vaginal and vulvar pre-cancers caused
by human papillomavirus (HPV) types 16 and 18 and to prevent low-grade and
pre-cancerous lesions and genital warts caused by HPV types 6, 11, 16 and 18.
GARDASIL is approved in the United
States for 9- to 26-year-old girls and
women. GARDASIL is approved for use in the U.S.,
Mexico, Australia, Canada
and New Zealand.
Additional applications for GARDASIL are currently under review with regulatory
agencies in more than 50 countries around the world. Additionally, Merck is
actively working to accelerate the availability of GARDASIL in the developing
world: in December, Merck announced a partnership with India's Council
of Medical Research to study GARDASIL. Merck is also working with PATH and the
Gates Foundation to develop HPV vaccination programs that will facilitate the
introduction of GARDASIL to the most impoverished nations. Merck will make our
new vaccines, including GARDASIL, available at dramatically lower prices to
developing world countries.
GARDASIL is contraindicated in
individuals who are hypersensitive to the active substances or to any of the
excipients of the vaccine. As with any vaccine, vaccination with GARDASIL may
not result in protection in all vaccine recipients. GARDASIL is not intended to
be used for treatment of active genital warts; cervical cancer; CIN, VIN, or
VaIN. GARDASIL has not been shown to protect against disease due to non-vaccine
HPV types. The health-care provider should inform the patient, parent, or
guardian that vaccination does not substitute for routine cervical cancer
screening. Women who receive GARDASIL should continue to undergo cervical
cancer screening per standard of care.
Vaccine-related adverse
experiences that were observed in clinical trials at a frequency of at least
1.0 percent among recipients of GARDASIL and also greater than those observed
among recipients of placebo, respectively, were pain (83.9 percent vs. 75.4
percent), swelling (25.4 percent vs. 15.8 percent), erythema (24.6 percent vs.
18.4 percent), fever (10.3 percent vs. 8.6 percent), and pruritis (3.1 percent
vs. 2.8 percent).
