CHICAGO — Untested? No.
Rushed into production? Not really.
Full of substances that do harm? Hardly, and especially not compared to the dangers of the H1N1 flu virus.
That is the retort of researchers, scientists, federal health authorities and others familiar with how swine flu vaccine is being made, as they listen — at times with disbelief — to the debate about it unfolding around kitchen tables and over the Internet.
They hear the arguments — about what's in the vaccine, whether it was made too fast, whether there are side effects — all the while frustrated that decades of experience in making effective flu vaccines hasn't resulted in more public confidence that they got this one right, too.
"We've been baking this bread for 60 years, and we're pretty good at it, buddy," said Kenneth Alexander, an infectious disease expert at the University of Chicago.
For all who will listen, Alexander and other experts at research facilities, the U.S. Department of Health and Human Services, the U.S. Centers for Disease Control and Prevention, the U.S. Food and Drug Administration and elsewhere explain that the swine flu vaccine isn't a completely new brew cooked up in a panic.
They argue that it's actually the result of a 60-year-old, tried-and-true process of flu vaccine making that was tested on thousands of people before being scheduled for distribution — including on some researchers who volunteered themselves.
"A lot of misinformation is being brought up and spread around," said Jesse Goodman, the FDA's acting deputy commissioner for public health. "We think it is important to have the actual facts laid out and let people make their own decisions."
The vaccine "is the absolute best protection and a perfectly safe one," Goodman said, adding that the risks from contracting the flu, which can be deadly, far outweigh any risk of side effects from the vaccine.
Here is how the vaccine is made: When the H1N1 virus first appeared last April in Mexico and California, federal health officials identified it and sent it to pharmaceutical companies it contracts so they each could formulate their vaccine versions for field testing before mass production.
It is a months-long process, but mass production geared up in August and the first 2 million doses were delivered to doctors and clinics two weeks ago. On Friday, CDC officials acknowledged slower production than they'd hoped but predicted "widespread availability" by the beginning of November.
That turnaround from discovery to delivery was fast enough that many Americans who told pollsters they don't plan to vaccinate their children said they worried that the vaccine was rushed into production before being tested adequately for potential side effects.
Nonsense, Alexander said.
"This H1N1 vaccine is made just like all the flu vaccines we have been making for 60 years, which have an extraordinary record for safety," he said. "The only difference between this one and the seasonal flu shots is the virus it is made from, so we have no reason to believe this one will be any less safe."
Though pharmaceutical researchers around the globe are trying to find newer and speedier ways to make flu vaccines, in the U.S. the only FDA-approved method is the original, 1940s way: injecting the virus into chicken eggs to be grown into larger quantities.
For the arm-shot vaccine, the virus eventually is harvested from the eggs, killed and chopped into segments. When injected into the recipient, it activates the body's immune system to produce antibodies that kill the actual flu virus if the recipient is exposed.