Although no changes were seen in trends in serious adverse event reporting for the human papillomavirus (HPV) vaccine, more parents are raising safety concerns when they choose not to vaccinate their children, a cross-sectional study found.
From 2015 to 2018, the proportion of parents citing safety concerns as the main reason not to start the HPV vaccination increased from 13% to 23% (P.
A total of 30 states saw this type of increase in parental reluctance to use the HPV vaccine, the results in JAMA network open.
Over this time, however, the adverse events reported to the Vaccine Adverse Event Reporting System (VAERS) decreased from 44 to 29 per 100,000 doses distributed (P.
“These results suggest that there is an urgent need to address the growing sense of safety concerns among caregivers in order to increase confidence in the HPV vaccine,” wrote Sonawane and colleagues.
HPV vaccination can prevent six types of cancer (vulvar, vaginal, cervical, penile, oropharyngeal, anal cancer), the researchers found, and the study is the first to present nationwide trends in evaluating adverse event reporting .
In an accompanying editorial, Nosayaba Osazuwa-Peters, BDS, PhD, MPH, of Duke University School of Medicine in Durham, North Carolina, and colleagues said the study was “a reminder that there may be more innuendo, half-truths, and exaggerations gives case studies and propaganda raising concerns about the safety of HPV vaccines as actual scientific facts. “
“To be clear, social media is not responsible for all vaccine safety concerns,” they added. “There has always been resistance to vaccines, dating back to the polio vaccination and even before it.”
For their study, Sonawane and colleagues conducted an analysis of VAERS and the National Immunization Survey (NIS), including data from 2015 to 2018. NIS, conducted by the CDC, consisted of a telephone survey of the reasons for adult caregivers to reject HPV Vaccine, and included reports of 39,364 unvaccinated adolescents.
The VAERS database was searched for adverse events related to the HPV vaccines Gardasil (approved in 2006) and Gardasil 9. Regulatory Definitions defines serious and non-serious (95.6% of total reports) adverse events.
The teenagers of the NIS participants averaged 15 years old (range 13-17), over 60% were white, and more than half were male. Almost 80% of the participants lived above the poverty line and over 60% were privately insured.
States where parental refusal to vaccinate due to safety concerns has increased the most included South Dakota (7.8% in 2015 versus 26.6% in 2018), California (both 3.5% versus 20.5% ), Mississippi (8.1% versus 24.4%), and Hawaii (5.8% versus 20.9%).
Safety concerns aside, the other main reasons for HPV vaccine reluctance reported by 75% of caregivers were “not necessary”, “not recommended”, lack of sexually active adolescents, and lack of knowledge about them. All of these reasons showed decreasing tendencies during the study period.
The analysis had several limitations, the researchers acknowledged, including the fact that the results are not applicable to other age groups. VAERS, a spontaneous reporting system, is often lacking subsequent relevant accompanying data and is therefore distorted, they added.
Last updated on September 17, 2021
Funding came from the National Cancer Institute of the NIH and the National Institute on Minority Health and Health Disparities.
Sonawane has not provided any reports or information. A co-author reported on industry relationships with Merck.
Osazuwa-Peters has not reported any disclosures.