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Gardasil HPV4 vaccine determined safe despite parental concerns
Gardasil quadrivalent HPV vaccine was determined to be well-tolerated and safe for routine use in girls and boys as well as young men and women despite increased parental safety concerns, according to recent study data.
“The data presented here, reflecting experiences with the HPV4 vaccine in hundreds of thousands of recipients, and the reviews by global health experts and organizations, reinforce the favorable safety profile of the vaccine,” Michelle Vichnin, MD, executive director of oncology at Merck, and colleagues wrote in The Pediatric Infectious Disease Journal. “The HPV4 vaccine has also been shown to be highly effective at the population level, with marked reductions in the prevalence of HPV vaccine-type related infection and disease.”
The researchers analyzed data from numerous passive and active surveillance studies conducted after the FDA licensed Gardasil quadrivalent HPV vaccine (Merck) for routine use in 2006. Serious adverse events commonly associated with vaccine risk — such as autoimmune conditions, multiple sclerosis, stroke, anaphylaxis, adverse pregnancy outcomes and venous thromboembolism — were analyzed. The researchers reported no increased incidence for such events compared with background rates.
Two nonserious adverse events were associated with quadrivalent HPV vaccine, syncope and skin infections. Researchers suggested, however, that cases of syncope reported after vaccination were most likely due to vagal nerve stimulation resulting in bradycardia and transient hypotension. They said this is common in adolescents immediately after injections, prompting the Advisory Committee on Immunization Practices in 2006 to recommend a 15-minute post-vaccination observation period.
Despite these findings, researchers cited a 2013 study that found parental concern regarding the safety of HPV vaccines has increased significantly. In 2008, 39.8% of parents surveyed said they did not intend for their child to be vaccinated against HPV, compared with 43.9% of parents in 2010 (OR for trend = 1.08; 95% CI, 1.04–1.13). The researchers said false allegations of harm based on incomplete information may lead to parental concern and underutilization of vaccines.
“The extensive information presented here can be used by health care providers to help address questions regarding the safety of the HPV4 vaccine and improve vaccination rates so that patients may benefit from the protection afforded by the vaccine,” Vichnin and colleagues wrote. – by David Costill
Disclosure: Vichnin reports being an employee and holding stock/stock options with Merck. Please see the full study for a list of all other authors’ relevant financial disclosures.
