Opinion: Token Pharmacovigilance

A US government website for collecting reports of side effects associated with vaccines is broken. Why has no one noticed?

Written byPeter Doshi
| 4 min read

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ISTOCK, GOROVITSEverything in science involves uncertainty. And for drugs and vaccines, “pharmacovigilance” helps researchers and patients navigate this uncertainty by gathering and processing information on the side effects of medical products in the post-marketing period. Clinical trials conducted prior to approval are often small (median 760 people) and quick (median 14 weeks), making it a challenge to pick up serious but rare or latent side effects of medicines. (And even if researchers capture rare adverse events, determining causality is difficult.)

Active post-marketing surveillance therefore is our safety net, and in the United States, the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) run a pharmacovigilance program for vaccines known as the Vaccine Adverse Event Reporting System (VAERS).

But if you use Chrome, Firefox, or Internet Explorer to browse the Web, chances are you will get an error page when trying to connect to the VAERS website: www.vaers.hhs.gov. “Your connection is not secure,” my browser tells me. “The owner of www.vaers.hhs.gov has configured their website improperly. To protect your information from being stolen, Firefox has not connected to this website.”

If this were a temporary problem, it would not be worth writing about. But I first alerted officials about the problem ...

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