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Vaccine for Newborns

Dear Dr. Lanny: I’ve just had my second child and my pediatrician is recommending a new oral vaccine only for newborns that is supposed to prevent diarrhea, to be given when my daughter is 2 months old. I’m a little concerned about adding yet another vaccine to all that she is already getting. A friend also told me that there could be some scary side effects to this new vaccine. Do you think it’s safe?

A: Your question actually raises two issues: Is there a point at which there are too many immunizations? And is this specific vaccine, brand name RotaTeq, safe for your newborn?

As with all immunization issues, there are people who remain convinced that there are unanswered questions, or that problems are being swept under the rug in the name of profit. Is there anything in the past to give one pause? You bet. Having said that, I firmly believe that the scientists who develop new vaccines and those who monitor safety and effectiveness are honorable people dedicating their careers to finding ways to diminish the incidence and consequences of disease.

Despite people’s anxiety that there could be a limit to the amount of antigens (the molecules in vaccines and natural illness that cause immunity to develop) that a child can safely handle, there is no evidence to support that concern. Humans are subject to myriad antigens in the natural world, far exceeding anything that medicine recommends. In fact, over the years vaccines have become increasingly pure, thereby actually decreasing the amount of antigens a child is exposed to through immunizations.

The new vaccine your pediatrician is recommending has been created to prevent diarrhea caused by the virus rotavirus. Rotavirus is widespread around the globe and virtually all children—nearly 100 percent, everywhere—will have been infected by age 5.

Worldwide, rotavirus is estimated to be responsible for some 500,000 deaths per year. In the United States, where hospitals, intravenous fluids and oral solutions such as Pedialyte are readily available, deaths are estimated at 20 to 60 per year. Even in the United States, however, rotavirus results in approximately 250,000 emergency room visits and 50,000 to 70,000 hospital admissions annually, not to mention the number of visits to the doctor’s office.

An oral vaccine to prevent rotavirus first came on the market in 1998. Under the brand name RotaShield, this oral vaccine was tested on more than 10,000 children in nine different countries. Results showed the vaccine to be effective and safe.

Soon after its introduction, however, an association was noted with a type of intestinal obstruction called intussusception. Within a short period of time, this association was confirmed and RotaShield was withdrawn from the market. At that point in time some 3.5 million doses of vaccine had been distributed, although it is not clear how many were actually given. It is important to understand that intussusception also occurs naturally in young children and is not solely the result of the RotaShield vaccine.

Moving to the present, we now have RotaTeq. Although similar to RotaShield, it is not made by the same company, and as a result of the previous problems, RotaTeq has been tested in more than 70,000 children. Again, it seems effective and safe.

Could intussusception or some other rare side effect be waiting to appear? Hard to say, but every day that goes by without a problem makes that scenario less likely. Your friend probably read a news article that stated that 28 cases of intussusception had occurred in children who had been given RotaTeq. While this is correct, what it neglects to state is that 18 to 43 cases of naturally occurring intussusception would be expected in this period.

I don’t want to make this confusing, so let me just say that the news reports, as they often do, look to the extreme and the dark side. At this point significant side effects do not seem to exist. Given the prior experience in 1998 to 1999 with RotaShield, everyone is on the lookout for problems, and mechanisms are in place to find them if they exist.

In summary, as you might expect, I believe that immunizations are a triumph of public health. I further believe that at this point in time there is no sign of significant side effects associated with RotaTeq, and that you can feel safe that this is a wise choice for your infant daughter.                          

Dr. Alan Freshman, father of two grown boys, practices at Syracuse Pediatrics. Consult your own physician before making decisions about your family’s health care. Send e-mail to him at editorial@familytimes.biz.

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