Tuesday, July 21, 2009

Calls to vaccinate for swine flu without clinical data/LA Times

The LA Times' Rosie Mestel wrote about the timeline for swine flu vaccine production July 20:
Five companies are at work producing the H1N1 vaccine right now. Testing is starting this month--and by month's end, an advisory committee will meet to decide who in the U.S. is likely to be first in line for a shot.

But it takes a while get the results of these tests. "If we wait, we can't do vaccination until November," says Dr. John Treanor, chief of infectious diseases at the University of Rochester, N.Y., in the WebMD article. "If the pandemic flu follows the seasonal-flu pattern with the bulk of activity in January through March, fine. But if we see this second wave coming in September, we might be faced with the decision to do vaccinations without clinical data."
However, Dr. Treanor may not be the best person to advise on vaccine safety. He was one of five researchers who shared responsibility for a 1,565 subject anthrax vaccine clinical trial with CDC from 2002-2007, and his Rochester group vaccinated approximately 260 civilians. One in seven of those enrolled experienced a severe adverse event during the trial, but it was not halted. CDC and the investigators have still not released any detailed safety data from the trial, while military anthrax vaccinations continue.

Treanor may not feel the availability of clinical data are critical when deciding on a mass vaccination program; but I don't think the public shares this view. Especially when we have the lesson of the 1976 swine flu vaccine program to teach us about the need to establish vaccine safety before vaccinating millions of Americans.

The Australians are not so bold as Dr. Treanor:
"I think it's important for the public to know that they're going to get a safe and effective vaccine," Andrew Pesce, president of the Australian Medical Association, told Sky News television. "No one will give anybody brownie points for putting out a vaccine that didn't work or caused harm."

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