Thursday, October 1, 2009

Serious Adverse Events

I have waited long enough to tell you the scary headline and the resolution at the same time. We have been talking about vaccines a bit lately as they have been in the news. In a few recent posts I introduced and explained the second HPV vaccine that has been proven effective and safe in clinical studies, Cervarix.

It was due to be reviewed by our FDA this past Tuesday, however that has been delayed. In the meantime, Cervarix has been in use in the UK for at least a year when the National Health Services began offering it to teen age girls. It is reported that 1.4 million doses have been administered. (in contrast, in the USA over 20 million doses of Gardasil have been released)

Earlier this week a young girl died within hours of receiving her first Cervarix dose. The vaccines were stopped momentarily but within days we learned that the girl had a malignant tumor on her heart and lungs that caused her death. The programs have resumed.

Cervarix appears to be as embedded in Europe as Gardasil is in the USA. Interestingly, a very recent posting on the FDA website notes over 15000 adverse event reports for Gardasil. Very few are considered serious, but 48 deaths occurred sometime after a person received the shot.

I wonder why we hear so much more about Chantix adverse events than Gardasil?

1 comment:

Jess said...

Wow - 15000 adverse events to Gardasil? Deaths? Instead of a vaccine, I don't suppose we could just teach teenagers (girls AND boys) about safe sex and making educated choices??? I wonder when they'll make a vaccine against fiscal irresponsibility...