H1N1 vaccine: Myths, misinformation vs. reality, science

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 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 quickly, 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 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 Department of Health and Human Services, the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA) and elsewhere explain that the swine-flu vaccine isn't a completely new brew cooked up in a panic.

They argue that it's 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 risks from contracting the flu, which can be deadly, far outweigh any risk of side effects from the vaccine.

How the vaccine is made:

When the H1N1 virus first appeared in April in Mexico and California, federal health officials identified it and sent it to pharmaceutical companies so they could formulate vaccine versions for field testing before mass production.

It's a months-long process, but mass production began in August and doctors and clinics received the first 2 million doses two weeks ago. CDC officials Friday acknowledged slower-than-expected production but predicted "widespread availability" by early November.

King County has received approximately 70,000 vaccine doses — fewer than what public-health officials expected. The vaccines are available in some provider offices and at public-health clinics. Snohomish County has about 11,000 doses, to be distributed in mass vaccination clinics starting Oct. 31.

Despite the limited availability, the 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.

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."

Although pharmaceutical researchers are trying to find newer, speedier ways to make flu vaccines, 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, the vaccine activates the body's immune system to produce antibodies that kill the flu virus if the recipient is exposed.

The alternative, nasal-spray vaccine is made using a live virus. It, too, is grown in eggs, but at lower and lower temperatures, weakening or "attenuating" it so it can survive only in the nose, not at greater body heats in the lungs.

"The nasal vaccine infects the mucosal cells [in the nose], which are closely monitored by our immune system," said Patrick Wilson, a University of Chicago immunologist. Once that system detects the vaccine, he said, permanent immunity to the targeted flu virus is produced.

The first testing of both vaccines was performed on 3,000 volunteers at Baylor University, Cincinnati Children's Hospital, Emory University, Seattle Group Health Cooperative, St. Louis University, University of Iowa, University of Maryland and Vanderbilt University.

The vaccine also is being tested on volunteers by the five companies licensed to make up to 250 million doses of the vaccine by spring for the U.S. market — CSL Limited, Novartis Vaccines, Sanofi-Pasteur, GlaxoSmithKline and MedImmune.

"It is tested to see if it produces the level of antibody production in the blood that reaches the FDA standard," said William Schaffner, an infectious-disease specialist at Vanderbilt. "It is also tested for safety in the volunteers, something I know a little bit about since I was one of the volunteers for this vaccine."

On its Web site last week, the FDA posted contents of the vaccines produced by the five companies, including copies of the long, multipage ingredient lists included with the doses at clinics. Schaffner said that, like many everyday foods and medicines, the vaccines contain several vital chemical substances that could be toxic in large volume but are included in such tiny amounts that they are harmless.

The ingredient that anti-vaccine activists question most is thimerosal, a preservative added in trace amounts to keep vaccine in two-shot doses from deteriorating if stored while awaiting application.

Thimerosal contains ethyl mercury, and critics allege it can cause autism and other neurological disorders. But researchers say there is so little thimerosal in the vaccine that it poses no harm. Nevertheless, a thimerosal-free, single-shot dose can be ordered, and no thimerosal is in the nasal spray.

"I continue to be amazed that people bring this issue up," said Paul Offit, a pediatrician and noted University of Pennsylvania vaccine researcher. "There have been six exhaustive studies [of a possible link between thimerosal and autism]. ... They each came back with a definitive answer: no. Three other studies were done to see if thimerosal caused any signs of mercury poisoning. All three answered: no."

Others have concerns about "adjuvants" — compounds sometimes added to vaccines to stimulate immune response. It is added in several European nations, but not in the U.S. Anne Schuchat, the CDC's director of immunization and respiratory diseases, said there's no need to add them unless the virus mutates into a far deadlier form.

"Since April this flu has caused tens of thousands of hospitalizations and more than a thousand deaths," Offit said. "This is only October and influenza is a winter disease, so no telling what we are about to see.

"We should thank the Lord that we have this vaccine at this stage."

Seattle Times staff reporter Marnette Federis contributed to this report.