I predicted a few months ago that the H1N1 vaccine was going to come too late for many Americans to be protected from the virus. Indeed, the Centers for Disease Control and Prevention estimates that 1 in 6 Americans has already been infected and that the epidemic is actually on the wane. But now finally there's enough vaccine to go around. Available doses are expected to top 100 million in our country by today. At least 24 states and some other counties and towns have enough to open distribution to everyone.
The question is: Will we actually make an effort to get the immunization after our government shelled out billions to buy it? I probably won't since I already had the classic symptoms (fever, chills, dry cough, headache) back in October. Yet the government tells me I should, because I can't tell with 100 percent certainty whether I had H1N1, given that doctors didn't test for it during the fall outbreak.
The CDC's big worry is that H1N1 will return with a vengeance in January after college kids come home for the holidays, infecting the rest of their family. They'd like to see those families vaccinated before their germinators return. And this is a legitimate point. After all, there have a number of documented H1N1 infections that have shown to be resistant to Tamiflu—possibly a sign that the virus is mutating into a drug-resistant bug.
"We have a wonderful window of opportunity to prevent or lessen a third wave," said Health and Human Services Secretary Kathleen Sebelius at a news conference. The 1957 Asian flu pandemic hit the country with a second wallop after the first fall outbreak, possibly triggered by holiday travel.
I'm guessing, though, that HHS is going to have a particularly hard time pushing immunization after a report comes out today from the agency's inspector general. According to the New York Times, which received a leaked copy yesterday, the report finds that most of the experts who served on vaccine safety advisory panels in 2007 to evaluate vaccines for flu and cervical cancer had potential conflicts of interest that were never resolved. Some who weighed in on safety issues had been legally barred from doing so since they had taken money from vaccine manufacturers.
Whether this holds true for the H1N1 vaccine developed in 2009 isn't known, but once this becomes big news, some people may rightly question whether flu vaccine safety risks have been downplayed in an effort to get everyone immunized quickly.
The report presents some shocking findings:
- The CDC failed nearly every time to ensure that safety advisers adequately filled out forms confirming that they weren't being paid by companies with an interest in their decision.
- 64 percent of CDC advisers had potential conflicts that weren't identified or were left unresolved.
- 13 percent of advisors failed to have an appropriate conflicts form filled out, which should have barred them from participating in safety meetings, and 3 percent voted on matters that ethics officers had already barred them from considering.
I'd also like to know what this means for Gardasil, a vaccine whose safety has been a concern for some parents and physicians. The CDC has periodically issued safety reports on the vaccine insisting that it has few side effects beyond rare reported instances of blood clots and fainting, but now those evaluations will most likely be scrutinized. [More details on a previous Gardasil safety report.]
The inspector general said the CDC should do a far better job of screening advisers, according to the New York Times, and the CDC's new director, Thomas R. Frieden, concurred. Last year, I wrote a feature on the need to improve the government's system of vaccine safety. Read "Vaccines Get New Scrutiny" to find out what experts say needs to be done to better monitor safety risks.