Study affirms safety of HPV4 vaccine for adolescents and young women in routine clinical care

October 1, 2012

A study of almost 200,000 young females who received the quadrivalent human papilloma virus (HPV4) vaccine found that immunization was associated only with same-day syncope (fainting) and skin infections in the two weeks after vaccination. These findings support the general safety of routine vaccination with HPV4 in a clinical care setting to prevent cervical and other genital and reproductive cancers.

The association between HPV4 and syncope was not unexpected, the researchers noted, because injections in general are known to have a to fainting, particularly in the study's age group. The review of skin-infection diagnoses suggested that some may have been local injection-site reactions, although there was insufficient detail to exclude .

The study appears in the current online issue of Archives of Pediatrics & Adolescent Medicine.

"Taking into account all the analyses, subanalyses and relevant medical record reviews, an independent safety committee noted that there may be an association between HPV4 vaccination and same-day syncope, as well as during the two weeks after immunization," said lead author Nicola Klein, MD, PhD, co-director and research scientist at the Kaiser Permanente Vaccine Study Center in Oakland, Calif.

Dr. Klein outlined the study's strengths—a large, ethnically diverse population who received a total of nearly 350,000 HPV4 doses; an integrated health care delivery system that assured complete or near-complete medical information; and a pre-specified, validated, clinically meaningful system to categorize all outcomes. However, she noted that ongoing monitoring of spontaneous reports and other sources such as the Vaccine Safety Datalink will further contribute to HPV4's safety profile.

Human papillomavirus (HPV) is a family of small DNA viruses that are associated with the most commonly detected sexually transmitted infection in women. While most HPV infections cause no symptoms and are self-limited, persistent genital HPV infection can lead to cervical cancer. HPV is estimated to cause over half a million new cancers every year, most of which affect women in developing countries.

The Food and Drug Administration approved the quadrivalent HPV vaccine in 2006 for between the ages of 9 to 26 for prevention of a range of diseases attributed to HPV. More recently, HPV4 was approved for the same age group for the prevention of vaginal and vulvar cancer, for males between the ages of 9 to 26 years for the prevention of genital warts, and in both males and females for the prevention of anal intraepithelial neoplasia and cancer.

The study was conducted within the integrated health care delivery systems of Northern and Southern California Kaiser Permanente, which each have more than 3 million members representative of the regions' populations, and included 189,629 females who received one or more doses of HPV4 between August 2006 and March 2008.

The design of the study compared the risk of emergency department visits and hospitalizations during post-vaccination intervals of 1-60 days, 1-14 days and day 0 (day of vaccination) with control intervals ranging from 60 days for those who received one dose of HPV4 to 180 days for those who received three doses.

"That this study detected two potentially expected outcomes provides reasonable reassurance that it was a valid approach to uncovering HPV4-associated safety signals," Dr. Klein said. "The findings substantiate the overall safety of the HPV4 vaccine in women and girls following routine administration."

Explore further: Gardasil does not trigger autoimmune conditions after vaccination

More information: Arch Pediatr Adolesc Med. Published online October 1, 2012. doi:10.1001/archpediatrics.2012.1451

Related Stories

Gardasil does not trigger autoimmune conditions after vaccination

January 25, 2012
Gardasil, the human papillomavirus vaccine that is now recommended for male and female adolescents and young adults, does not trigger autoimmune conditions such as lupus, rheumatoid arthritis, type 1 diabetes or multiple ...

Young girls more likely to report side effects after HPV vaccine

April 3, 2012
Younger girls are more likely than adult women to report side effects after receiving Gardasil, the human papillomavirus vaccine. The side effects are non-serious and similar to those associated with other vaccines, according ...

US recommends routine HPV vaccination for boys

February 3, 2012
US health authorities on Friday urged all boys age 11-12 to get a routine vaccination against the most common sexually transmitted disease, human papillomavirus, or HPV.

Recommended for you

Is rushing your child to the ER the right response?

October 16, 2017
If a child gets a small burn from a hot pan, starts choking or swallows medication, parents may struggle to decide whether to provide first aid at home or rush them to the hospital, suggests a new national poll.

Happier mealtimes, healthier eating for kids

October 13, 2017
(HealthDay)—Parents who struggle to get their children to follow a healthy diet may want to make dinnertime a pleasant experience, new research suggests.

Children born prematurely have greater risk of cognitive difficulties later in life

October 11, 2017
Babies born preterm have a greater risk of developing cognitive, motor and behavioural difficulties and these problems persist throughout school years, finds a new study led by Queen Mary University of London (QMUL).

Helping preemies avoid unnecessary antibiotics

October 5, 2017
(HealthDay)—Researchers say they have identified three criteria that suggest an extremely premature infant has a low risk of developing sepsis, which might allow doctors to spare these babies early exposure to antibiotics.

Got a picky eater? How 'nature and nurture' may be influencing eating behavior in young children

October 3, 2017
For most preschool-age children, picky eating is just a normal part of growing up. But for others, behaviors such as insisting on only eating their favorite food item—think chicken nuggets at every meal—or refusing to ...

Anxious moms may give clues about how anxiety develops

September 27, 2017
Moms may be notorious worriers, but babies of anxious mothers may also spend more time focusing on threats in their environment, according to a team of researchers.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.