How Big is the Risk of H1N1 ("Swine") Flu? Part 3:
Why is the vaccine in short supply?
25 Oct 2009 in Regulatory Science, Regulatory Policy
We'e blogged here and here on H1N1 ("swine") flu. Saturday's Wall Street Journal includes a Page One story about the shortfall in supply, noting that the vaccine is cultured in eggs and the yield has been much lower than predicted.
After the jump to page A4 and near the end of the story, another explanation is provided: The federal government chose an inefficient vaccine delivery method in deference to the anti-vaccine movement.
Betsy McKay and Jennifer Corbett Dooren describe in some detail why production of H1N1 vaccine has been hampered by yield issues. Beginning in paragraph 21 (of 27), they say that the federal government decided to accommodate the scientifically-unsupported fears of the anti-vaccination movement:
The head of Novartis's vaccine business, Andrin Oswald, said the low yield was the main reason for production delays. But he also said the U.S. request for a greater amount of its vaccine order in single-dose syringes was slowing the process.
The U.S. government wanted more single-dose syringes because they contain only very small amounts of thimerosal, a mercury-containing substance that causes concern among some people, he said. Multidose vials contain more thimerosal.
Even this passing reference appears to be incorrect. According to the Centers for Disease Control, the single-dose syringes contain no thimerosol:
Will the 2009 H1N1 influenza vaccine contain thimerosal?
The 2009 H1N1 influenza vaccines that FDA is licensing (approving) will be manufactured in several formulations. Some will come in multi-dose vials and will contain thimerosal as a preservative. Multi-dose vials of seasonal influenza vaccine also contain thimerosal to prevent potential contamination after the vial is opened.
Some 2009 H1N1 influenza vaccines will be available in single-dose units, which will not require the use of thimerosal as a preservative. In addition, the live-attenuated version of the vaccine, which is administered intranasally (through the nose), is produced in single-units and will not contain thimerosal. For more information on thimerosal.
The anti-vaccine movement believes that thimerosol causes autism and other maladies. The link above takes readers to a web page on which the CDC tries very hard to assure vaccine opponents that thimerosol is safe by appealing to scientific authority:
Three leading federal agencies (CDC, FDA, and NIH) have reviewed the published research on thimerosal and found it to be a safe product to use in vaccines. Three independent organizations [The National Academy of Sciences’ Institute of Medicine, Advisory Committee on Immunization Practices (ACIP), and the American Academy of Pediatrics (AAP)] reviewed the published research and also found thimerosal to be a safe product to use in vaccines. The scientific community supports the use of thimerosal in influenza vaccines.
The government's decision to provide a thimerosol-free version could have been motivated by a desire to persuade opponents to accept vaccination. More likely, the government feared that vaccine opponents might cause a public controversy that undermined the vaccination program. Given the resistance of the anti-vaccination movement to these scientific claims, and its proven ability to generate and amplify uncertainty and worry, the government's decision is hard to challenge given that its sole objective is to maximize the rate of inoculation.
Nonetheless, this decision inevitably created a public health tradeoff. Actual risk to those who do not fear thimerosol was increased in hopes of reducing the perception of risk to those who do.
