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Gardasil 9 safe, effective when taken with other routine vaccines
Simultaneous administration of Gardasil 9-valent HPV vaccine with Menactra and Adacel vaccines was safe and well-tolerated in boys and girls, according to a recent study.
“Concomitant administration of [Gardasil 9-valent HPV vaccine, Merck (9vHPV)] and [Menactra meningococcal vaccine, Sanofi Pasteur (MenACWY‐D)] and [Adacel, Sanofi Pasteur (Tdap)] was generally well-tolerated and the immune responses to components of either vaccine were noninferior compared with nonconcomitant administration,” Andrea Schilling, MD, of the Clinica Alemana-Universidad del Desarrollo, Chile, and colleagues wrote. “Concomitant administration would minimize the number of visits required to deliver each vaccine individually and therefore facilitate adherence to recommended vaccination regimens.”
The researchers compiled a cohort of 1,241 boys and girls aged 11 to 15 years. The cohort was split into a nonconcomitant group that received 9vHPV (n = 621), and a concomitant group that received Tdap and MenACWY‐D in conjunction with 9vHPV (n = 620). In the concomitant group, HPV vaccines were administered in three doses at day 1, month 2 and month 6, with Tdap and MenACWY‐D given on day 1. The nonconcomitant group received Tdap and MenACWY‐D during a separate visit at month 1.
The researchers wrote that when 9vHPV was administered concomitantly, immune responses are equally as strong as when it is administered nonconcomitantly. Likewise, study results found that when Tdap and MenACWY‐D were administered concomitantly, antibody responses were essentially the same as when the vaccines were administered separately.
The only reported adverse reaction associated with concomitant administration of 9vHPV was injection site swelling, which ranged from mild to moderate. The researchers did not record any severe adverse events associated with concomitant administration of 9vHPV.
“Providing vaccinations to adolescents is challenging because they make infrequent health care visits,” Schilling and colleagues wrote. “It is estimated that coadministration of HPV vaccine with other vaccines such as diphtheria, tetanus, pertussis, meningococcal conjugate, and influenza vaccines could increase coverage for the first dose of HPV vaccine to more than 90 percent.”– by David Costill
Disclosure: Schilling reports receiving research support for this clinical study and other HPV vaccine-related studies from Merck and honoraria outside the submitted work from Merck-Chile, Grunenthal-Chile and Grunenthal-L.A. Please see the full study for a list of all other authors’ relevant financial disclosures.
Perspective
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The recently approved 9vHPV vaccine provides protection against additional oncogenic strains of the virus. In this study Schilling et al evaluated the safety and immunogenecity of administering this vaccine to children aged 11 to 15 years concomitantly with the 2 other vaccines recommended at this age (MCV4 and Tdap) compared to giving the Tdap and MCV4 separately at one month after the initial dose of 9vHPV vaccine. They demonstrated that the concomitant administration of all 3 vaccines did not interfere with immune responses to each of the components. There was an increase in arm swelling in the group receiving all 3 injections at one time; however, most of the reactions were classified as mild to moderate and there were few discontinuations of future 9vHPV doses based on these reactions suggesting that they were of minor clinical significance.
Given the difficulties in completing the adolescent vaccine series, especially HPV vaccine, this observation supporting concomitant dosing of all 3 vaccines as safe and immunogenic may help by decreasing the number of visits necessary. However, more importantly there needs to be equal advocacy from the health care provider for HPV vaccine as for MCV4 and Tdap and the approach to routine administration should be the same for all 3 vaccines. Mandates for Tdap vaccine and school recommendations for MCV4 have contributed to the increased uptake of these immunizations, while HPV vaccination rates still lag at the 50-60% level. I believe the absence of such support and the social contexts associated with a vaccine for a sexually transmitted infection (HPV) have led to differing degrees of acceptance for HPV vaccination among both families and providers. Minimizing the number of visits to complete the vaccine series can be very helpful for adolescents, but the major issue remains the need for ongoing education and support for the routine administration of HPV vaccine at the recommended ages (prior to onset of sexual activity) in order to have the desired impact on preventing HPV infection and their associated malignancies.
Perspective
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There is a notable downward trend in health care utilization from childhood through early adulthood. As the majority of vaccines are administered as part of health maintenance, this decrease in adolescent well visits has contributed to subpar adolescent immunization rates. Therefore, concomitant administration of vaccines, when appropriate, is key to reducing missed vaccination opportunities.
Schilling and colleagues have documented that giving 9vHPV with MCV4 and Tdap at the same visit was well-tolerated and did not interfere with immune responses. This study supports the CDC prediction that if the HPV vaccine were concurrently administered with another vaccine, like Tdap or MCV4, during the same clinical visit, the vaccination rate for at least one dose of HPV would exceed 90%. Pediatric providers should be reassured that the administration of all three of these vaccines at the same visit is an effective approach in trying to immunize as many adolescents as possible.
