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Nine-valent human papillomavirus vaccine shows favourable safety profile

26 Dec 2019

Safety data of the 9-valent human papillomavirus vaccine (9vHPV) from the Vaccine Adverse Event Reporting System (VAERS) during the first 3 years of its licensure in the United States have shown neither new or unexpected safety signals, nor unusual reporting patterns for clinically important adverse events (AEs), as reported in a study. Furthermore, the safety profile of the vaccine is similar to that of its quadrivalent predecessor.

VAERS documented 7,244 AEs following receipt of 9vHPV. Of the AEs, 31.2 percent occurred among females and 21.6 percent among males; sex was not reported in 42.7 percent.

Majority (97.4 percent) of the AEs were nonserious, the most common being dizziness, syncope, headache and injection site reactions. These AEs occurred with similar frequency in men and women. There were two verified cases of deaths post-9vHPV treatment, although autopsy reports or death certificates suggested no evidence of a causal relationship with vaccination.

Roughly 28 million 9vHPV doses were administered during the study period, giving crude AE reporting rates of 259 reports per million doses distributed for all reports and 7 per million doses distributed for serious reports.

Empirical Bayesian data mining findings showed a significant association between 9vHPV and syncope and several types of vaccine administration errors (eg, administered at wrong age).

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Most Read Articles
Pearl Toh, 31 Dec 2019
Adding the neuraminidase inhibitor oseltamivir to usual care speeds up recovery from influenza-like illness by a day compared with usual care alone, with even greater benefits seen in older, sicker patients with comorbidities, according to the ALIC4E study.
23 Dec 2019
At a Menarini-sponsored symposium held during the Asian Pacific Society Congress, renowned cardiologist Prof John Camm provided the latest evidence for chronic stable angina with or without concomitant diseases, with a special focus on the antianginal agent ranolazine and combination therapies. The event was chaired and moderated by Dr Dante Morales from the University of the Philippines College of Medicine.
Pearl Toh, 5 days ago
Obeticholic acid significantly improves fibrosis and disease activity in patients with nonalcoholic steatohepatitis (NASH), a chronic liver disease currently with no approved therapy, according to an interim analysis of the landmark REGENERATE* study.
6 days ago
Testosterone treatment may slightly improve sexual functioning and quality of life in men without underlying organic causes of hypogonadism, but it offers little to no benefit for other common symptoms of ageing, according to a study. In addition, long-term efficacy and safety of this therapy remain unknown.