Given the overdose of media coverage of the swine flu virus, there are a couple of points not being discussed:
1.) We keep hearing that clinical trials are underway -- but where? And by who? And how many people are getting tested?
There are five private companies manufacturing the virus, and each is doing their own tests. According to a Reuters article, the five companies are Sanofi Pasteur, the vaccines division of Sanofi-Aventis SA, Glaxo, Novartis AG and Baxter International Inc. The five companies are said to be getting $2 billion from the federal government for 250 million doses of the vaccine. To get the deets on who's being tested, it helps to check out the companies' websites.
Here's Sanofi Pasteur's press release about its test in the U.S. on 849 adults, and here's a release about tests it did in Europe on 300 children and 450 adults.
Novartis tested 784 adults in Costa Rica, did pilot trials on 100 people in the UK, and is in the midst of testing 6,000 people around the world.
Baxter has tested 400 adults and 400 children.
Glaxo says they'll post results on www.clinicaltrials.gov -- where there are actually, at press time, 80+ swine flu-related tests underway -- but few reported results.
The National Institutes of Health is also conducting testing.
We asked Dr. John Livengood, Director of Epidemiology at the Broward County Health Department, about the testing, and he said "The NIH trials are specifically [testing whether people need] one versus two doses, and whether those can be given sequentially versus simultaneously.
The answers are pretty much back
and it looks like younger people should get two doses, while those ten and over can get one dose. The analysis isn't quite finished, but it looks simultaneous doses is fine."
Dr. Livengood said the vaccine is nothing to be worried about, despite the media hype:
"It's just a strain change like we'd do with the flu vaccine anyways. A strain substitution. Each year in January, we pick the strains that we expect to appear the coming flu season. Almost every year it changes." He characterized it as routine and said that he doesn't expect there will be any adverse long-term effects. "We give a hundred million does of flu vaccine each year in the U.S. Flu is a very well-monitored vaccine."
2.) Pregnant Women: Beware which type of flu vaccine you get.
The vaccine is being made in both a shot form and a mist that can be inhaled. Pregnant women should not use the inhaled version because it is made with the live version of the virus, Dr. Livengood said. Instead, they should get the shot. The risk with that, however, is that some shots contain thimerosol, a preservative that contains mercury. Even though some experts believe thimerosol poses no problem, some activists (like Jenny McCarthy) believe it has contributed to autism in their children.
Dr. Livengood broke it down: "The multi-dose vials contain thimerosol. Multi-dose vials require a preservative -- the single-dose vials or prefilled syringes don't." Livengood saids that "the ACIP (Advisory Committee on Immunization Practices) says there is no evidence of harm from thimerosol" but that health workers will be advised to make sure pregnant women get the single-dose, just in case.
3) Is it true that you won't be able to sue the government if the vaccine ends up hurting, rather than helping?
The folks over at the National Vaccine Information Center -- who are skeptical about a number of vaccines -- point out that, per a 2005 law called the PREP Act (Public Readiness Emergency Preparedness Act), drug makers are protected from liability when they release vaccines in response to a public health emergency.
Dr. Livengood points out that there are some exceptions, and anyone who believes they were injured by a vaccine could file a claim through the "Covered Injury Compensation Program" here.
Problem is, that no funds had been appropriated for the program. When we called to ask if that's changed recently since the rise of the swine flu, the kid who answered the phone -- bless his heart, he's new -- said, "to be honest, we're not supposed to know too much about it." He said he just sends out information. "I can't take out my wallet and help everyone." A call to the press office of the National Vaccine Injury Compensation Program (VCIP) resulted in someone saying they'd call us back. Something tells us the courts might end up having a lot of fun with this one!
