A new study of Merck MRK +0.21% & Co.'s Gardasil cervical-cancer vaccine showed it was associated with fainting on the day of inoculation and skin infections two weeks afterward, but no link with more serious health problems was found.
vaccine protects against four strains of the human papillomavirus, or
HPV, two of which account for about 70% of cervical-cancer cases in
women. HPV is also linked to vaginal cancer in women and mouth and
throat cancer in both men and women. The Centers for Disease Control and
Prevention estimates about 15,000 women and 7,000 men are diagnosed
with an HPV-related cancer each year in the U.S.
Fainting and skin problems such as
redness and swelling at the injection site are known side effects of the
vaccine. Doctors are instructed to have patients sit or lie down for 15
minutes after getting the shot.
The Gardasil study—led by the Kaiser Permanente Vaccine Study Center
in Oakland, Calif.—was required by the U.S. Food and Drug Administration
and the European Medicines Agency to provide an additional look at the
vaccine's safety in a large group of people. It was funded by Merck.
Gardasil was first approved in 2006 for girls and women ages 9 to 26
years old before later being approved for use in males. GlaxoSmithKline
PLC also sells an HPV vaccine, Cervarix, in the U.S. which was approved
for use in females in 2009. Federal guidelines recommend that girls and
boys ages 11 to 12 receive the HPV vaccine in a three-dose series before
they are sexually active, and it coincides with recommendations on
other vaccines given to that age group.
However, immunization rates lag that of other vaccines such as ones
that protect against meningitis, partly because of concerns about the
vaccine's safety, doctors say. The most recent CDC figures showed that
53% of girls ages 13 to 17 had received at least one dose of the HPV
vaccine in 2011 but only 35% had completed the three-dose series, which
are supposed to be given over six months.
The research published Monday in the Archives of Pediatrics &
Adolescent Medicine involved about 190,000 females who were part of
Kaiser Permanente's health system. They received at least one dose of
the HPV vaccine between August 2006 and March 2008. About 44,000 women
received all three doses of the vaccine.
Researchers, led by Nicola Klein, the co-director of Kaiser's
vaccine-study center, looked for emergency-room visits and
hospitalizations for 60 days following each dose of the vaccine and then
reviewed the records to see if there might be a link to it. More than
200 categories of illnesses such as asthma, diabetes, nervous-system
disorders and medical conditions such as attention deficit disorder,
back pain and other injuries were reviewed. In most cases the condition
existed before the vaccine was given.
There were 14 deaths recorded among girls and women in the study but
the causes, including car accidents, congenital heart problems, suicide,
lupus and pneumonia, weren't linked to the vaccine.
Dr. Klein said that an independent group of doctors also reviewed any
medical records in the study involving deaths and certain other
conditions such as autoimmune diseases. Data from the same group of
women published earlier this year found no increased risk of lupus,
rheumatoid arthritis, multiple sclerosis or Type 1 diabetes, which are
all considered autoimmune diseases.
"This is very reassuring," said Mary Anne Jackson, section chief,
infectious disease at Children's Mercy Hospitals and Clinics in Kansas
City, Mo. The "bottom line is it's a very safe vaccine," added Dr.
Jackson, who wasn't involved in the current study, but is involved in a
separate, continuing, federally funded study of Gardasil looking at the
vaccine's effectiveness in girls who receive the second or third dose
much later than recommended.
Write to Jennifer Corbett Dooren at firstname.lastname@example.org