Posted by: mkirschmd | May 23, 2010

FDA Now Says Rotavirus Vaccines Safe

Travelers expect that travel vaccinations are safe and pure.   No one would willingly accept – or prescribe – a travel vaccine that is contaminated.  Yet, the Food and Drug Administration (FDA) has just reassured the public and the medical community that both ‘contaminated’ vaccines for rotavirus are safe.  Sound scary? 

FDA Initially Halted Rotarix

Currently there are two vaccines against rotavirus, Rotarix and Rotateq.   This past March, the FDA discovered that Rotarix vaccine contained fragments of a pig virus.  The agency advised against using this vaccine and recommended Rotateq instead, which was assumed to be pure.  Weeks later, Rotateq was also found to contain pig virus.  It is a mystery how this contamination occurred.

 FDA Clears Both Vaccines

The FDA has now declared that both vaccines are safe, and should be administered to prevent rotavirus infection.  The FDA advised that there is no evidence that pig virus within the vaccine can harm humans.  Rotavirus vaccines have prevented millions of cases of gastroenterititis, a disease with diarrhea that can cause severe dehydration.  The disease is particularly deadly to children in the developing world.  Experts predict that rotavirus vaccines can save millions of lives over the next decade.

Just this year, scientists reported hard evidence that these vaccines are highly effective.  Should international travelers receive this vaccines?  Discuss this with your travel doctor.

International travelers may need a variety of travel vaccines before departure.  Should travelers be concerned about the quality of these vaccinations?  Travelers should relax.  Vaccines are subjected to the highest standards of quality control.  While every vaccine or medication has some risk, these risks are much less than the risk of not receiving a recommended vaccine.  Nothing is 100% pure.  Even Ivory Soap, for those of us old enough to recall their commercials, is only 99.44% pure. 

Perhaps, we should avoid the term ‘contaminated’ which can spook travelers.  Let’s use the phrase ‘inert ingredients’ instead.  Let’s keep this issue in perspective. I would swallow some inert pig virus any day of the week if it might spare me from the thrill and excitement of acute gastroenteritis.  How bad is this disease?  I’m a gastroenterologist; I should know.


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