10 March 2011
Japan’s Ministry of Health, Labor, and Welfare has pulled two ‘flu’ vaccines from the market in the wake of the deaths of several children. The two vaccines, Pfizer’s Prevenar and Sanofi-Aventis’ Act-HIB, are widely used in the USA to prevent influenzae type b. The vaccines are used to prevent influenza type b infections, which can be fatal if meningitis or pneumonia develop. A Japanese drug panel has since determined no causal connection between the vaccines and the death of the six infants who received the vaccines. Also, no defects in the vaccine batches were discovered. The vaccines remain banned in Japan pending further investigation. The Japanese drug panel, the Safety Countermeasure Committee and Vaccines Adverse Event Committee, has requested further information as to the safety of administering multiple vaccines simultaneously.
The vaccines in question generate billions of dollars of revenue every year for the manufacturers. While the vaccines provide protection, a concern remains as to the risk-benefit analysis of the vaccines. Once concern is that several of the children who died received a combination of other vaccines simultaneously including those for diptheria, pertussis, and tetanus. Multiple vaccines pose a potential drug interaction issue. This concern may lead to changes in vaccine schedules to minimize potential adverse effects. By definition, vaccines introduce toxins into the body in an effort to prevent future illness. At question is whether or not the introduction of the vaccine can be safely handled by the immune system of children who are very young, have received multiple vaccines, or who are immunocompromised. The Japanese investigation determined that there were no manufacturer defects in the vaccines at issue.
US Supreme Court
This is a hot issue in light of a current pending vaccine case in the US Supreme Court, Bruesewitz v. Wyeth. In this case, the US Justice Department is siding with Pfizer pharmaceuticals to limit the liability of pharmaceutical manufacturers in cases of illnesses caused by vaccination. At issue is whether or not a pharmaceutical company is liable if they are aware of a better designed vaccine (one with fewer side effects) yet continue to use the less safe vaccination.
The federal Vaccine Court system provides compensation for vaccine injured persons from the money generated by a tax on vaccine manufacturers. In Bruesewitz v. Wyeth, the parents of Hannah Bruesewtiz were denied compensation in the Vaccine Court system and now seek the right to receive compensation through State court. Six month old Hannah received a DPT (diphtheria, pertussis, tetanus) vaccination and immediately suffered a series of 125 seizures over a period of 16 days. Now 18 years of age, Hannah cannot speak or care for herself as a result of her injuries. The vaccine used on Hannah has since been discontinued in favor of safer alternatives. Before the Supreme Court, attorneys for the Bruesewitz family argue that safer alternatives were available at the time Hannah received her vaccine and that the manufacturer had the responsibility of providing the safer alternative and at the very least had the responsibility of providing labeling noting that a safer alternative was available.
Justice Ginsburg showed deep concern in this case, “there were an unusual number of adverse reactions to the particular lot that this child's third vaccine came from, and that those adverse reactions were not disclosed to the doctors. And the doctors -- the child's doctor said if I had known about the unusual number of adverse reactions, I never would have used this vaccine.” Justice Breyer noted that the1986 National Childhood Vaccine Injury Act legally protects drug companies from lawsuits due to unavoidable harm (such as side effects from vaccinations) but that the drug company lawyers in this case are now suggesting that they are also protected from avoidable harm lawsuits. Avoidable harm includes withholding information from the government and the public concerning safer vaccines and also not informing doctors and nurses of high incidences of reactions to particular batches of vaccines. The attorney for the drug company replied that if manufacturers were to be sued for avoidable harm they would be “driven from the market” and she reiterated her position that pharmaceutical manufacturers should only be held liable for manufacturing defects and warning claim issues. The drug company lawyer argued that pharmaceutical companies are not responsible for informing nurses, doctors, the pubilc, and the government if safer vaccines are available.