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By Linda G. Rastelli
Oct 20, 2009
Contributing reporter Linda Rastelli caught up with Vicki Debold, member of the US government’s Vaccine Safety Working Group of the National Vaccine Advisory Committee (NVAC), at the 4th annual NVIC (National Vaccine Information Center) conference in Virgina.
In addition to reviewing clinical trials for VRBPAC as a full committee member,Vicki Debold is an ad hoc member of the government’s Vaccine Safety Working Group of the National Vaccine Advisory Committee (NVAC). She’s also a registered nurse, health policy analyst and the mother of a 12-year-old son living with autism.
Please read the accompanying Mothering article "Experts Weigh in on the Swine Flu Vaccine [1]".
Rastelli: How has the definition of “pandemic” changed recently?
Debold: The World Health Organization (WHO) took out a clause associated with a pandemic causing high levels of morbidity and mortality. That made it possible to declare a high level pandemic although it’s not causing alot of deaths, as in the old definition. The public health epidemic was declared on April 26th because the U.S. government needed to declare an emergency to allow access to certain resources that they don’t otherwise have. In the past a pandemic was a real disaster. It’s a scary term.
Rastelli: Should parents be worried about H1N1?
Debold: Only to the extent that people would be scared about the seasonal flu. In a sense the seasonal flu is a pandemic. Last year seasonal flu killed and hospitalized way more people than H1N1 has. People should be no more scared than they already are with regular seasonal influenza.
Rastelli: Why are our government and the WHO sounding an alarm if it’s not that dangerous?
Debold: Because it could mutate - it’s got strains in it that are new. It spread very rapidly and was highly transmissible. It’s behaving in a way we’re not used to seeing. We’re seeing disproportionate deaths in pregnant women and young adults. That’s atypical. Usually the flu kills older people. It’s not particularly virulent in that it’s not causing a lot of deaths or hospitalizations, but if it “reassorts” or mutates with H5N1 avian flu or other strains, it could become a tremendous killer. The CDC has stated, though, that the H1N1 virus is stable and is not mutating. And some people say that if it’s mild now, wouldn’t it be better to get it now so that you’d have the antibodies if it comes back in a more virulent form?
Rastelli: You’re not opposed to vaccines.
Debold: I’m not opposed to developing the vaccine at all. It’s the obligation of our government to be prepared. They also have a responsibility to make sure that it’s used responsibly and give people choices. People need full access to information regarding risks and benefits to make their decisions. And all vaccine decisions should be voluntary.
Rastelli: Even if it’s a deadly disease?
Debold: If it’s a deadly disease aren’t most people going to take it? It should be their choice. New York state health care workers are being told they’ll lose their jobs by Nov 30th if they don’t get the swine flu vaccine. This doesn’t seem right.
Rastelli: What’s the status of the swine flu vaccine?
Debold: Four manufacturers’ vaccines have been approved for the H1N1 swine flu. The only one that’s still pending is GlaxoSmithKline’s. Three are inactivated injectable vaccines and one is a live attenuated virus nasal spray vaccine. These are being approved under a special circumstance. Each year the FDA evaluates what strains of seasonal flu actually circulated in the southern hemisphere and if they don’t match last year’s vaccine they recommend that the strains be changed to better match the strains that might be circulating. So each year the seasonal flu vaccine undergoes what’s called a “strain change.” The swine flu vaccine is being approved under a strain change. It’s not a new vaccine per se.
Rastelli: Is it being tested adequately?
Debold: As with all vaccines I’ve reviewed on the FDA committee, the H1N1 vaccine is primarily being studied in healthy kids. Excluded from clinical trials are any kid with eczema and food allergies, any kid who was sick, any kid with autoimmune or neurological problems.
Rastelli: But is it ethical to test vaccines on sick kids?
Debold: I’m being told the FDA does not permit this. You cannot intentionally study sick kids because it’s unethical.<!--pagebreak-->
Rastelli: Isn’t it a contradiction to say we can’t study them but it’s ethical to give them the vaccine later?
Debold: You’re absolutely right there’s a contradiction. How is it unethical to enroll them in clinical trials but then vaccinate them in uncontrolled situations? I think this gap in the science needs to be shouted to the rooftops. We’re just flying by the seat of our pants here. If it’s true that kids with diabetes or asthma are more at risk for adverse reactions from both vaccines and natural infections like H1N1, shouldn’t they be vaccinated and studied under controlled circumstances? Parents have a right to know that we just don’t know that much about efficacy and safety with sick children.
Rastelli: What about Guillain-Barre Syndrome (GBS) – wasn’t it a problem in the past with swine flu vaccines?
Debold: For some reason the 1976 swine flu vaccine was associated with more cases than would customarily be seen in the population. GBS causes paralysis . . . and can occur with the seasonal flu and from the seasonal flu vaccine, so what caused it? Nobody knows.
Rastelli: What was learned from that?
Debold: As far as I know there are no take home messages from the 1976 vaccine being applied to this vaccine. I don’t think they know why that vaccine was associated with neurological problems. Guillain-Barre showed up in 1 in 100,000 vaccinated people, but we’ve only got a few 1,000 in all the trials. There’s never been a trial that big. The public really needs to take the time to read and make a careful decision, particularly if you’re talking about a child with immune issues like eczema, asthma, diabetes, arthritis or neurological issues such as epilepsy. If there’s any history of GBS, numbness and tingling after vaccination, I’d think twice. Other risk factors are family histories of immune and neurological illness.
Rastelli: What about squalene, which is sometimes added to make a vaccine more effective?
Debold: It’s not going to have an adjuvant [squalene] at this point, although we’re not completely out of the woods on that. What your readers need to know is that all of the injectable vaccine that’s been approved so far will have a thimerosol-containing and thimerosol-free version [a mercury-based preservative]. The thimerosol is the same amount that’s in the seasonal flu vaccine: 25 micrograms per dose. So people who don’t want mercury have to ask for a thimerosal-free vaccine. When they asked the FDA committee about using squalene, I raised a load of objections. There’s animal data related to squalene’s effects but it wasn’t provided to the committee. Your readers should know about a book called “Vaccine A” by Gary Matsumoto, an investigative journalist who’s written about squalene in the anthrax vaccines.
Please read the accompanying Mothering article "Experts Weigh in on the Swine Flu Vaccine [1]".
You can visit the NVIC website [2] for more information on NVIC conferences and the NVIC mission.
View the Mothering Special Report on the Swine Flu [3].
Linda G. Rastelli is an award-winning journalist and editor who specializes in health, education and business. She and Stephen M. Shore are the co-authors of Understanding Autism For Dummies.