A friend saw recent media reports of lawsuits brought against a vaccine manufacturer, claiming a serious injury from the Zostavax vaccine, which is promoted by Merck to prevent shingles in people over 50 years of age.
"Can you explain why someone is able to sue Merck over Zostavax? Is the NVICP only for childhood vaccines?"
She cited this report of one of the first filed Zostavax claims:
Here is my answer:
The National Childhood Vaccine Injury Act (NCVIA) created the Vaccine Injury Compensation Program (VICP), which provides a legal mechanism for determining whether vaccine injuries for covered vaccines should be compensated. The key phrase is "covered vaccines." To be a "covered vaccine" for which compensation is available under the VICP a vaccine must be added to the vaccine Table, either by legislation or through administrative rule making by the Secretary of Health and Human Services. This applies to all vaccines, whether for adults or children. While the NCVIA includes the term "Childhood" in its title, this is misleading as adult vaccines may be covered under the Vaccine Act. In fact, in recent years most cases that have been compensated have been filed by adults, primarily due to the increased number of doses of the influenza vaccine that have been administered, mostly to adults.
Zostavax, which is a shingles/herpes zoster vaccine manufactured by Merck, is approved for adults over 50 years of age. It is NOT a covered vaccine under the NCVIA and, therefore, cannot be subject to a claim for compensation for vaccine injury under the VICP. The vaccine could be covered under NCVIA, but at present is not. I do not believe there has been an effort by the Secretary of HHS to bring NCVIA/VICP coverage to Zostavax, but this could happen.
The herpes zoster vaccine that is covered under NCVIA/VICP is the varicella vaccine, known by its trade name, Varivax, also manufactured by Merck. Varivax is included in the ACIP/CDC recommended childhood vaccine schedule. (Usually, but not always, when ACIP recommends a vaccine, steps are taken to add the vaccine to the NCVIA/VICP Table of covered vaccines.)
Both Varivax and Zostavax are diploid human cell line manufactured vaccines, manufactured using the MRC-5 (Medical Research Council cell strain 5) cell line. The Varivax has been shown to contain human DNA contamination. Zostavax also likely contains human DNA contamination. An experienced pharaceutical researcher who has examined Zostaax has advised me that Zostavax for adults contains five times more human DNA contamination than the Varivax vaccine for children.
It has been theorized that the DNA contamination in both Varivax and Zostavax can cause injury by either DNA insertion into the human genome, or my provoking an autoimmune reaction, although this theory has met resistance in scientific and legal venues.
I am cocounsel for the petitioners in a proceeding in the VICP in which the petitioners claim that the diploid human cell line contamination in childhood vaccines, including Varivax and MMR, can cause autism.
The Law Office of Robert J. Krakow is accepting representation in Zostavax claims outside the VICP, in addition to VICP claims for other vaccines. Zostavax claims brought in the VICP have been dismissed as not covered by NCVIA.
I am available to answer any of your vaccine injury related questions.
Robert J. Krakow
Law Office of Robert J. Krakow, P.C.
The Woolworth Building
233 Broadway, Suite 2320
New York, N.Y. 10279
(888) 449-8529 (fax)