Interview with Vicky Debold, Ph.D on the Swine Flu Vaccine

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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".

 
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.