Rotavirus vaccine

The following is a transcript of the interview that Ann Devlin did with Donald P. Middleton, MD, Department of Family Medicine

"A childhood vaccine for diarrhea is being pulled. At least 23 children who received the Rotavirus vaccine have developed a type of bowel obstruction known as intussusception." A beautiful baby is shown in her mother's arms being given oral doses of RotaShield as Ann Devlin voices over. "If not detected early enough, the obstruction may require surgery. The Centers for Disease Control and Prevention (CDC) and the American Academy of "Pediatrics (AAP) are recommending suspension and postponement of rotavirus vaccinations until November, 1999."

"If your child has already received the rotavirus vaccination, doctors recommend that you watch for symptoms of bowel obstruction." An employee at the vaccine manufacturing plant is shown gloved, capped and gown with mask in a sterile field, placing plastic bottles with dropper bulb syringe tops, into a box to be shipped out to the various areas for inoculation.

"If your child has not received the full regimen of the vaccine shots then discontinue them at this time. If your child has received only one or two of the three shots you are advised to NOT, I repeat NOT to complete the vaccination regimen."

"Globally, rotaviruse is one of the leading causes of childhood death. Here in the United States there are approximately 50,000 children hospitalized each year."

ANN: "This is going to be deeply disturbing for parents who are either in the series of in vaccinations or perhaps have already been vaccinated. What is the problem? And, how did the vaccination get to the marketplace with this risk of creating bowel obstructions in infants?"

DM: "Those are very good questions. I think that it disturbs us, as well as, the parents, and I think that is why the vaccine has been put on the back shelf until later this year until some change can be made to make it more safe."

"When Vaccines are brought into the population and generally recommended that they be used, they're studied in a large number of people. But, unfortunately, in this case, sometimes you need to treat zillions of people before you see that there is, indeed, perhaps an associated problem. This bowel obstruction, that we are dealing with now is called intussusception. And what happens, actually, is you have this tube of bowel" (he smiles and demonstrates with his hands) "and something in the tube of bowel causes the peristaltic wave of movement through the intestine to be trapped or stopped right at that point, and the bowel, instead of moving nicely along sort of flops over top of the bowel behind it and makes a blockade. Unfortunately, the stuff inside does not get enough blood and it can break down and cause the patient to loose that part of the intestines, if not treated appropriately." (He kind of shifts himself in his chair at this point.)

ANN: "In your earlier conversation you remarked that this problem actually surfaced in the trials of this vaccine, but in not significant enough cases that stopped the vaccine from coming into the marketplace."

DM: "That is correct. The..the vaccine itself is a live virus vaccine. And we knew from the "wild virus"...from the "wild rotavirus" that intussuception was a possible side effect of this infection. So when this vaccine was developed, children were watched carefully for this problem, INTUSSUSCEPTION. Unfortunately, it took not the hundreds of thousands of dose that were given in the trials, but the millions of doses that we have given over the past year to see that, perhaps this association is abit more then we can tolerate."

"You have to understand, that in the background, there are cases of intussusception occurring every year, anyway. I think that it is roughly 45 to 50 cases of children per 100,000 per year" (Nodding his head as he says this and pursing his lips and closing his eyes to think of the numbers.) "naturally occurring. And with the.."

DM: "Naturally occurring. And with the rotavirus vaccine we are seeing, in the first week, rates as high as 300 cases per 100,000 after the vaccine, But over time it actually drops down to closer to 120 or 100 cases per 100,000... Child years." (He smiles and nods his head once at that statement.) My 9 yr old informs me that "Child years" are rates calculated to the age of 18yr.

"So its..it..., it looks as if this vaccine is associated but...but..no one has come out and said that this vaccince is causing this problem. But what they have come out and said is, 'We are seeing too many cases of intussusception. Since we have seen this number of cases of intussusception, and, it appears to be, at lease, on a time basis related to this vaccine, we should stop giving it and investigate further.'

"These agh...this problem was actually looked for because when the trial was going on it was seen a few times. So everyone was aware of this potentical problem occurring, and a system was set up to moniter the vaccine as it was utilized in the public to make sure that the problem didn't, indeed, surface. And, that is exactly what has happened. So many cases were report to the Vaccine Adverse Events Reporting System and so when the cases got to this level people said, 'Let's put a halt. And wait and see what happens.'"

DM: "Yes, Ann. You ask me earlier how do doctors find out about these kinds of things? And it's almost a 'word of mouth' thing unless there is a person assigned in a practice to sort of 'keep-up'. The CDCs does send out e-mails and they do have a website that we can look at. Dr Richard Zimmerman, who is in my department at Pitt, actually is the representative for the American Academy for Family Physicians to the advicery council on immunization practices at the CDC. So I get alittle bit faster information then most doctors do...but. But, as of last week there were mailings to people throughout various journals, such as JAMA that will have a section saying that this shouldn't be done and other journals that will tell doctors in practice not to give it.... But in the meantime, every parent needs to say, 'I don't want this vaccine. We need to wait till Novenber of '99 to see if it is going to be pulled permenantly or altered some way so that it can be utilized again.'"

ANN: "And this is shocking to me because I would think that doctors would get an immediate alert and that it would not be up to the patient or the mother or the father of that baby to say, 'Let's make sure that this baby doesn't get this vaccine'."

DM: "Yes. Well that's true. Um...we knew about this last Thursday. I would suspect that by this time, most doctors know about it already. But parents, should also, be abit cautious....They.... Every parent needs to sign a permission form to get vaccines to begin with....because, vaccines all, unfortunately, have some side effects that are not pleasant. And.., um,... those side effects may sometimes be serious, as intussusception is quite serious."

DM: "Now.... the longest case was 59 days after the shot. But remember that there is a background number of these cases going on to begin with. So whether that "59 day old" would have been in the background while he was developing another problem..."

She and Dr. Middleton were chiming in at the same time and he was parroting back the first line she was actually saying--- to her. It was almost like she was helping him to get throught this most uncomfortable interview.

DM: "naturally occurring.... exactly....versus--by the vaccine (nodding quickly). Most of the cases, as you have mentioned, have been occurring the first week or 2 weeks.'

I tried to use their exact words throughout this text. It was very difficult. If you wish to have their text, you can call WQED TV13 at 412-683-1300 and ask them if they have transcripts of the Health Talk show with Ann Devlin.