Speaker1: What is RSV?
Speaker2: RSV is a virus which causes a lung disease, called Bronchiolitis.
Speaker1: And what group is more likely to be exposed to it, to get into trouble?
Speaker2: Well, all children get exposed to RSV virus, and in fact, all children get infected with RSV virus, but about 25% of children who do get infected, get a much more serious disease called Bronchiolitis, where they have wheezing, difficulty breathing, and a real risk for acquiring hospitalization.
Children who have the highest risk of having a severe form of RSV infection are children who have been premature or children who have some other underlying lung problem, even before they are infected by the virus.
Speaker1: It's only particular time a year, where it's more apt to be RSV around?
Speaker2: Well, RSV season starts, for the most part, through the months of October, November, continues straight, straight through the winter months, and tends to get less common as we get into the spring months of April and May.
Speaker1: If someone who is in South America, would it be this same rule or different rules down there?
Speaker2: It seems like in South America, the months are reverse. So where we are in our peak season, is when they are not, and vice-versa.
Speaker1: Europe would follow what we go through?
Speaker2: Europe follows our pattern, Australia follows South America's pattern, and so it seems to be a Northern Hemisphere, Southern Hemisphere phenomena.
Speaker1: Is it there an occasional case found in the summer?
Speaker2: You can always see a sporadic case when we do surveillance in this area, we will pick up cases here and there through other times of the year, but the six months, all through winter and early spring, is the most common time.
Speaker1: Is a passive vaccine available for RSV?
Speaker2: There is a new form of treatment available, called Synagis. This is a type of injection, not truly a vaccine, but a modifying antibody which is given to children on a once a month basis.
By giving this vaccine, this injection on a once a month basis to children, it would provide them with extra protection, so that if they do get infected by the virus, it would not be the most severe form of the infection.
Speaker1: There is also some indications that could be a new improved version of this vaccine coming up?
Speaker2: Well, there is a newer more potent form of this injection which is still in development and clinical trials. I am expecting that those clinical trials should be completed over the next year or two, and at that point, the data gets submitted to the FDA for review.
Speaker1: It's a very expensive drug to give. So the drug companies have put some restrictions what they will cover for. What groups would they usually cover this vaccine or patent drug for?
Speaker2: This vaccine is quite expensive, and estimates are anywhere from $500 to $1000 per dose, and the doses are given once a month. Because of it's expense, the drug companies, I should say the insurance companies, not the drug company, that the insurance companies restrict the use of this vaccine to those that are in the highest risk population. In fact, restricting that use at this time, is also so supported by the American Academy of Pediatrics.
That high risk group includes children who are born premature. Children born at less than 32 weeks, certainly are at the highest risk, and children born between 32 and 36 weeks of gestation are also considered at risk if they have another risk factor, such as other children in school bringing the vaccine home to them, exposure to environmental pollutants, or some other respiratory abnormality.
Speaker1: What about a full term baby born with a Cystic Fibrosis, would that be a require quite a condition?
Speaker2: The studies looking at Cystic Fibrosis children are still on going, and the jury is out. My personal opinion is, I would like to see those children covered just because they do have lung disease, although, their lung disease usually isn't a problem in the new born period.
The other group of children that clearly are at high risk are children with congenital heart disease. Any child born with a congenital heart disease is at much high risk for having a very severe form of RSV infection, and those children are clearly indicated to get this injection as a preventive of that form of disease.
Speaker1: Do the all of them get coverage through insurance, or there is concerns that they may not get covered?
Speaker2: Well, for the most part, the insurance companies do cover all those other children. Some insurance companies are more collaborative in providing that coverage than others, but we are able to provide that coverage through our program and the cooperation of the company.
Speaker1: Oh, you mentioned a program. You actually have a program where you help the pediatricians that we saw, by trying to get the vaccine, and have people come to home, and not getting the kid exposed in the office. Is that true?
Speaker2: Yes, we do. We do have an extensive program for providing Synagis to children in a variety of settings. We have two Out Patients sites, where we provide Synagis, and we even provide the ability to work with the insurance companies, so that if there is any difficulties, we are able to get through a lot of the red tape, and get the injection covered.
In addition to that, once children are given their first dose on our site, we are able to set up home care where visiting nurses are able to actually come into the home, and provide the injection in the home, rather than the child having to come to our clinical site, where they may be exposed to other children who are sick. That type of coverage isn't allowed by every insurance company, but some insurance companies do allow it, and we work with a great deal of zeal to try to provide that coverage for our children.
Speaker1: Since Synagis has been around, and the number of deaths have gone down, hospitalizations are going down, is that true?
Speaker2: It's absolutely true. There is no question that Synagis is a very effective vaccine. We've seen the number of hospitalizations, intensive caring and admissions, children being placed on respirator, and death rates dropped in this high risk population who are given Synagis as a preventive medication.
Speaker1: If a premature gets admitted with RSV, it can be life threatening, he could be in the hospitals for several weeks, and the cost of that would be in the terms of hundreds thousand dollars or more. Is that true?
Speaker2: Oh! Absolutely. The cost of caring for sick child like that can go up, and up, and up, and is more than all set by the cost of the medication.
Speaker1: Thank you.
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