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FDA Approves New Rotavirus Vaccine—But Do You Want It?

©iStockphoto.com/naumoid

by Mary Jessica Hammes
April 07, 2008

My friend Allison had a rough week not long ago, to put it mildly.

First, she and her 19-month old son, Asher, flew across country (to attend a funeral, no less). Traveling alone with a toddler would be trying enough, but then, the morning of their return home, Asher started vomiting.

A lot.

He vomited in the hotel. He vomited on the airplane. He vomited during the hour-plus drive from the airport back home.

And then the real fun started—diarrhea, skyrocketing temperature, dehydration, and two days in the hospital.

Poor Asher (and poor Asher’s parents). He had rotavirus, a disease that causes 2.7 million cases of gastroenteritis in the U.S. each year.

Perhaps other children can now escape a similar hospital stay. On April 3, the U.S. Food and Drug Administration approved a second oral vaccine—Rotarix, made by GlaxoSmithKline—that prevents rotavirus.

“I think that knowing what I know, and having been through it, I probably would not do the vaccine,” says Allison. “I mean, it was an intense experience, and I hated seeing Asher feel so badly, but not all kids who get it [rotavirus] get so sick that they have to go the hospital. And even though we did, the hospital was just exactly what he needed and got him through it just fine. I guess it’s the devil you know versus the devil you don’t know.”

What the devil is she talking about? It turns out that this new vaccine might give some parents pause.

What’s the fuss?
In electron micrographs, rotaviruses look innocuous—more like a handful of just-picked, fuzzy dandelion clocks than a nasty virus that lands about 55,000–70,000 U.S. children in the hospital each year. And it’s life-threatening, causing 20-60 deaths a year. The FDA says that without the vaccination, nearly every child in the U.S. will be infected at least once by the age of 5.

Cheery thought. Well, let’s all get vaccinated, right?

Hold on. Did you notice that this is the second oral vaccine to be approved?

Wait, there was a first vaccine?

Yes, indeed. There’s even a rival vaccine (Merck & Co Inc’s Rotateq, which was approved two years ago), which, truthfully, I have never even heard of over the course of our son’s somewhat delayed vaccination schedule. The discernible difference to parents is that Rotateq is given in three doses, while Rotarix is given in two.

The big stink about any rotavirus vaccine stems from one called RotaShield (made by Wyeth) that was removed from the U.S. market in 1999 (less than a year after it went on the market), because it was linked to increased risk of intussusception, which is intestinal folding. That can be life-threatening, and sometimes requires surgery to unfold the intestine.

The thing is, there were warning signs all along. During clinical trials, there were reports of intussusception 30 times the normal rate. The FDA approved it anyway in August 1998, and in early 1999, the Centers for Disease Control and Prevention (CDC) added it to its list of recommended vaccines. Yet, by June 1999, epidemiologists began reporting unusual numbers of intussusception cases. In July, both the CDC and the American Academy of Pediatrics recommended that the vaccine be suspended. The Association of American Physicians and Surgeons wrote several statements critical of the vaccine, and in a letter to Congress asked why the vaccine had been approved at all.

And now, there have been similar concerns about Rotarix before it was approved, too. To the casual observer, it might seem worrying—that history is repeating itself.

According to a Reuters report published February 15 (just months before Rotarix was approved), the FDA then reported links between this vaccine and increased pneumonia-related deaths, convulsions, and rates of bronchitis.

On the FDA website, you can download the product approval information for the vaccine, and it’s decidedly more reassuring.

“The risk of intussusception with Rotarix was evaluated in a safety study (including 63,225 infants) conducted in Latin America and Finland,” reads the document. “No increased risk of intussusception was observed in this clinical trial following administration of Rotarix when compared with placebo.”

However, intussusception (along with blood and lymphatic system disorders) is listed as one of the side effects in post-marketing experience, reported outside the U.S. But, reads the product approval information, “because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a casual relationship to vaccination with Rotarix.”

In an official statement, the FDA says studies showed no increased risk of intussusception (though common side effects reported during trials included fussiness, irritability, cough, runny nose, fever, loss of appetite, and vomiting).

Says the statement: “Although the FDA has concluded that the available data do not establish that these events are related to the vaccine, the agency has requested the manufacturer to conduct post-marketing safety studies involving more than 40,000 infants to provide additional safety information.”

What should parents do?
If you have concerns, and are not opposed to the possibility of your child getting rotavirus in the meantime, you can always take the “wait and see” approach.

“As much as I would hate to end up in the hospital, I think I would hate intestinal blockages caused by a vaccine even more,” says Christmas, mom to Rinney, 4, and Neil, 2. “I know this was reported with the previous rotavirus vaccine they developed, not the new one, but that’s enough to scare me into waiting at least five years or so to see what the potential kinks might be with the new one… and by that time, my kids would have already been exposed to this virus several times, anyway.”

Jenny, an emergency physician, holds a similar view, and chose to pass on the rotavirus vaccine for her 1-year-old son.

“Medically, I tend to hold off prescribing new medications, because I feel more comfortable waiting to see if new side effects arise,” she says. “I felt that as rotavirus is rarely fatal, and I know how to recognize and treat it, that it wasn’t worth the risk of intussusception or other side effects for my son Riley.”

Angie was one mom who did have concerns, but after researching the issue and asking a lot of questions at her pediatrician’s office, she opted for the vaccine for her 1-year-old daughter—and, she says, she couldn’t be happier.

“Ella has not had any reactions to any of the vaccines she has gotten, including Rotavirus,” she says. “I haven’t even noticed a low grade fever, so I have been very happy with the vaccines, the schedule and so far the outcome. I am particularly happy with the Rotavirus vaccine because after she had the 24 hour stomach bug, I absolutely do not want her to get Rotavirus!”

Vaccines are a hotly debated issue; as previously reported by baby gooroo. Some parents are choosing to delay or outright reject routine vaccinations. When it comes to a new one, weigh your options—Can you afford a hospital stay if it comes to that? Are you willing to deal with severe side effects?—and trust your instincts.

Susan

I’m just glad I wasn’t on the plane with a 19 month old. Putting her baby on the plane probably caused the vomiting.

It’s really irresponsible parenting to put a baby on an aircraft. It’s bad for the baby (as we see in this story) and it’s bad for the other passengers (does anyone really want to be in a small enclosed space with a screaming, vomiting baby for 4-18 hours?).

Pleeeeease, find a nanny to keep your baby when you travel. Your baby will thank you and so will everyone at the airport and on the plane. And try not to travel during your child’s first 3-4 years. Again, your baby will thank you. And if you have to fly a lot, maybe now is not the time for you to have a baby.
http://www.maryjessicahammes.com Mary Jessica Hammes

Hi, Susan,

Thanks for reading the story. Regardless of how Asher contacted the virus (which could have been anywhere), I’d like to address your comment. Perhaps you didn’t realize that this particular family was going to a funeral. Sometimes, it is impossible to leave your baby behind while traveling (or to hire a nanny – unless you have access to unlimited funds).

Your suggestion that parents put off traveling for three or four years seems unrealistic. I am wondering if you are a parent yourself, and what experience you have had related to travel? Perhaps other parents with travel experiences different from yours, will be kind enough to share their thoughts. It has been my experience that many people travel with ease, including those with infants and young children.

MJH
Bob Wiskind

As a Pediatrician I am asked daily about vaccine safety. The earliest Rotavirus vaccine (Rotashield) was pulled from the market prematurely, in my opinion. Yes, there did appear to be a slighty increased risk of intestinal blockage (intussusception) in children who received that version of the vaccine, but that condition is easily treated and none of those children suffered any harm. It is well documented that Rotavirus illness affects millions of children in the U.S. yearly, thousand are hospitalized with the complications, primarily dehydration, and some do unfortunately die. Rotavirus is a bigger problem in less developed countries where medical care and clean water is less readily available, resulting in 400,000 or more deaths worldwide each year.

The second Rotavirus vaccine (Rotateq) was tested very extensively before licensing to prove that it did not increase the chance of an infant getting intussusception. Two years of monitoring after the vaccine was released, and millions of doses later, there is no evidence showing an increased risk. The newest vaccine (Rotarix) has also been extensively tested prior to being put on the market.

I encourage parents to weigh the risk of any vaccine against the risk of the disease the vaccine will prevent. In my opinion, for the Rotavirus vaccines the known risk of dehydration, despite parents best efforts, outweigh any theoretical risks of the vaccine itself.
http://www.deadlinesanddiapers.blogspot.com pauline lupercio

Welcome to Baby Gooroo and great column!
I am the mom of a 10 month-old little girl who so far, has had every vaccine recommended by our pediatrician with no ill-effects. Luckily, she just sleeps after her shots, for hours on end.
But it’s tough to make the call on what to do regarding vaccines. Should you or shouldn’t you? Tradtional or delayed schedule? Opt in or opt out? The choices are endless and something that every parent has to wrestle with.
As for this particular vaccine, I would have to check my baby’s vaccination records (isn’t that terrible?) but i am sure she already had it. After reading your column, I am sure she had the Rotateq, as it was three doses. But when it comes to the new two-dose version, I’d seriously consider skipping it.
And from now on, I’m calling ahead to check on what vaccines to expect, so I can research and make an informed decision.
Cheryle

I’m going to have to agree with Susan on this one. Carrying a sick infant on an aircraft is not a good idea for a myriad of reasons. I understand a first-time mother may make this mistake, but after having 5 children I know it is a really bad idea. Babies and airplanes just don’t mix.
Penny

Carrying a sick infant on an aircraft seemed unavoidable in this situation. Asher and his mom were returning, by plane, from a funeral. He was well on the trip there; he got sick right before they returned home. Surely all of us moms know that unexpected illnesses can happen anytime, anywhere, and we just have to do our best to deal with them.

Anyway, to me, the whole point of this article was whether or not a rotovius vaccine is a good idea for your child – not whether or not traveling with a sick child is a good idea. I appreciated being able to learn about available vaccines and their potential side effects. Many thanks to Ms. Hammes for giving me some great starting points to discuss with our childrens’ pediatrician.
sarah

My daughter received the first two doses. The first time there was a virus going around in my home with lots of diarrhea and fevers and misery, and she had much more then usual poopy diapers that day. Although the insert says not to give it to a child who is ill with diarrhea, the Dr convinced me to let him do it. She was sick for two months, with various symptoms.

She got better and they gave her the next dose, along with half of her vaccinations as I decided not to do all the vaccines at once. She had the rotovirus and DTaP and influenza vaccine. Again, she was very ill for two months, with various symptoms. I don’t know if it was the rotovirus vaccine or one of the other vaccines or maybe ALL of them, but she was terribly sick, complete with the ‘high pitch cry.’ What concerns me is they keep piling on more vaccines and some of them are not likely to be contracted (like giving the hepatitis vaccine to newborns before they leave the hospital just in case the mother was a drug user or had STD related hepatitis EVEN THOUGH mom’s already been tested) or may get but probably won’t die from (like chickenpox and rotovirus.)

I chose not to give her the other half of her 6 month vaccines and she has been much healthier. She hasn’t been sick at all since then. I saw 4 drs who all said it was normal for a breastfed baby who does not go to day care and has no siblings in school be sick all the time. How is that normal? No more vaccines for this baby- at least not until she’s older.

By the way, she is twelve months old and speaking in phrases such as” I did it, I love you and I like that.” Her sisters at that age were vaccinated with the regular schedule and regressed into autism within a month of the one year vaccines. So, we shall see how she does.

springolife@trostfamily.org
Debra Martinez

I just got home from a 5 day stay in the hospital and six days of severe rotavirus in my 2.5 year old son, who did not get the vaccine. I came home to my 1.5 year old who received two out of the three doses of the new vaccine (not sure why he missed the third) who had a VERY mild case of watery poop and one vomiting episode, a fever all in a twenty four period and feels fine now. My 2.5 year old vommited over 30 times in 12 hours and had severe diarrhea six times in the same time period, a fever of over 103.00 and lots of stomach pain…. he lost approx 3 lbs in that time…..I am NOT big on vaccines, I have a 9 year old with Autism….but in this case..two kids, same house, same life, no differences, same caregiver……..I thought I was going to loose my 2.5 year old this past week….I am glad I gave my youngest the vaccine (which wasn’t being offered yet by my pediatrician when my 2.5 year old was a baby, that’s why he did not get it..no ones fault) because I truly believe it may have saved my youngest from a week of hell and now all the follow up.
http://www.facebook.com/cutiebutt Nickki Robinson

My kids have both had rotavirus. It was a terrible experience, but I do not regret my choice to keep them un-vaccinated.