Conference Coverage

Bivalent HPV vaccine brings no significant increase in 38 potential adverse outcomes



Another two cases occurred more than 365 days postvaccination, for a whopping 3100% increased risk, compared with unvaccinated children; however, this too was a nonstatistically significant finding, with extraordinarily broad confidence intervals of 1.59-652.4. And there is no plausible mechanism to account for a true association between HPV vaccination and a complication, such as this, occurring more than 1 year later. It appeared to be a matter of chance, she added.

However, session cochair Ron Dagan, MD, commented that vaccine skeptics won’t find the Guillain-Barré findings reassuring.

“With HPV vaccination, there are a lot of issues related to mass perception. You say it’s not statistically significant, but some people will say, ‘Forget about the statistics – look at the confidence intervals, the risk could be more than 600 times increased.’ How do you answer this? It’s not easy, especially when we’re talking about a vaccine which has a strong adjuvant,” said Dr. Dagan, director of the pediatric infectious disease unit at Soroka University Medical Center and professor of pediatrics and infectious diseases at the Ben-Gurion University of the Negev, both in Beer-Sheva, Israel.

“I completely agree, how to communicate results to the public is one of the most challenging things. They don’t understand about statistics,” Dr. Skufca replied.

The ball is now in the court of the Finnish health ministry, she added. These study results are brand new. Ministry officials are now going over the details and developing a strategy to communicate the results to the media, the public, and affected families.

The study was funded by the Finnish National Institute for Health and Welfare. Dr. Skufca reported receiving research grants from GlaxoSmithKline and Pfizer.


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