Sunday, August 23, 2009

Swine Flu Campaign Waits on Vaccine; Only Third of Supply Is Expected for First Round of Vast Effort

The Washington Post's Rob Stein updates us on the current thinking about availability of swine flu vaccine and its voluntary nature. He does not cover liability issues nor how care will be delivered for illnesses that attend vaccination. Excerpts:

"There's little doubt we're going to vaccinate people," said Anthony S. Fauci of the National Institute of Allergy and Infectious Diseases, who is leading the government's testing of the vaccine. "Who and when and exactly how -- we have to figure out."

The campaign is haunted by memories of the government's ill-fated 1976 effort to vaccinate against swine flu. The epidemic fizzled, but the vaccine was given to 40 million people and blamed for causing a rare paralyzing disorder known as Guillain-Barré Syndrome.

Another wild card will be whether the vaccine will be delivered with an "adjuvant" to boost its effectiveness or stretch limited supplies into more doses. Adjuvants have been used in Europe, but the Food and Drug Administration has not authorized their use in the United States.

Officials stress that they are proceeding cautiously. A final decision to move forward will not be made until they get the results of clinical trials -- testing to determine safety and dosing -- and assess the virus's threat. But officials are confident the vaccine will pass muster and expect a campaign will be launched as soon as manufacturers deliver the first vials.

Authorities are adamant that vaccination will be voluntary, and they say there is no reason to think the vaccine will be any less safe than the usual flu vaccine. An adjuvant will be used only if necessary and proven safe, they say.

[However, an article in US News today pointed out that testing of novel adjuvants for H1N1 swine flu vaccines has not yet begun.--Nass] "This trial is set to launch in mid- to late September, Fauci said."

[So tests of swine vaccines using novel adjuvants won't start until mid to late September, but vaccine is expected to be available for use in mid-October. If I understand this correctly, the adjuvants will have been tested for less than 4 weeks when they start being used. Yet autoimmune side effects take months to appear, in general. GBS took 4-8 weeks. Why aren't they already in US clinical trials?!--Nass]

Earlier this week, federal officials announced that there will only be an estimated 45 million doses of vaccine on hand by Oct. 15, rather than the originally anticipated 120 million doses. After mid-October, 20 million more doses of the vaccine will be shipped each week.

To address concerns of pregnant women and parents with young children, some vaccine is being produced without a mercury additive. And because the short-term studies can identify only common, immediate side effects, the CDC will step up monitoring for rarer, serious complications such as Guillain-Barré.

"We're putting into place systems that are as good as we can have to identify problems quickly if they do occur," CDC Director Thomas R. Frieden said.

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