Monday, January 16, 2012

Vincent Racaniello on poliovirus vaccine litigation

Vincent Racaniello on poliovirus vaccine litigation – a must read in its entirety:

Second, a single monkey with a 3-3 neurovirulence score appears to have played an important role in this case, but that ignores the fact that there are almost always wide variations that result in “outliers” whenever biological assays are involved.  We have studied poliovirus infection of mice in my laboratory, for example, and outliers are common – the one mouse in twenty that becomes ill or dies, while the others remain well. Other investigators have shown that poliovirus recovered from the spinal cord of an outlier monkey – one with a 3-3 neurovirulence score – does not produce these results when re-injected in a different group of monkeys. The monkey with a 3-3 score observed in the government’s test of one monopool of type 3 poliovirus vaccine is clearly an outlier. The other 14 monkeys in the intraspinal test had very low scores, and Lederle’s neurovirulence test did not produce a monkey with a 3-3 score. I conclude that the neurovirulence test on this type 3 monopool clearly did not exceed that of the reference virus – there is no scientifically valid justification for arguing otherwise.

If you don’t believe in outliers, there is another way to look at this issue: does a monkey with a 3-3 score in the neurovirulence test mean that the lot of vaccine is more likely to cause paralysis in humans? We cannot carry out such an experiment prospectively, but we can do the next best thing – compare the results of the monkey neurovirulence test with the rate of vaccine-associated poliomyelitis. In the entire history of the monkey neurovirulence test – from 1962-1999 – some monopools of vaccine periodically had one or two monkeys with a 3-3 neurovirulence score, and others did not. Nevertheless, the rate of vaccine-associated paralytic disease remained remarkably constant over this time: 5-10 cases per year. There were no spikes in the years when the “3-3″ vaccines were in distribution. The conclusion is clear: no lot of vaccine is associated with an increase in the number of paralytic cases in any year.

Why do the Sabin vaccine strains cause paralytic disease in some recipients and contacts? Albert Sabin derived these vaccine strains by serially passing neurovirulent isolates in different cell types, empirically identifying viral mutants with a reduced capacity to cause disease. There are few mutations responsible for the reduced neurovirulence of the Sabin strains – 5 for type 1, and 2 each for the type 1 and type 2 strains. These mutations rapidly revert during multiplication of the vaccine viruses in the human gut, and that occurs in every recipient of the vaccine. Within several days, the recipient sheds viruses that no longer bear the mutations that Sabin so painstakingly selected. These excreted revertants, when tested in monkeys, are more neurovirulent than the vaccine that was fed to the recipient.

Oral polio vaccine has an inherent risk that public health authorities deemed to be acceptable, given the extraordinary benefits of the vaccine. However, in a sense, the ~400 individuals who contracted vaccine-associated polio from 1962-1999 paid a price for the greater good of the population. For this reason alone they deserved compensation, which is what they now receive under the National Childhood Vaccine Injury Act. Compensation for these individuals is given without the need to castigate life-saving vaccines likes OPV.

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