Published January 12, 2017
In 2013, pharmaceutical firm Sanofi Pasteur issued no recalls after finding glass shards in vials of ActHIB, its conjugate vaccine...
— William Wilberforce
It came as no surprise to me that during the meeting of the Advisory Commission on Childhood Vaccines (ACCV) on December 4, 2015 the U.S. Department of Justice (DOJ) and Division of Injury Compensation Programs (DICP) reported that the number of vaccine injury claims for this fiscal year will exceed previous years.
I have monitored this committee for the past six years and have seen the number of claims rise every year. Sadly, they are likely to represent only a fraction of the vaccine injured, due to the lack of public awareness1 of the existence of the federal Vaccine Injury Compensation Program (VICP) created under the National Childhood Vaccine Injury Act of 1986, which has a record of dismissing two-thirds of claims received.2
The estimated 1,000 claims that the VICP anticipates being filed in 2016 are projected to cost $224 million. Although the VICP was originally created by Congress to shield drug companies producing government licensed, recommended and mandated vaccines for children, today it is not children but adults injured by influenza vaccine who are receiving most of the compensation.
The majority of compensated flu shot injury claims are for nerve inflammation diagnosed as Guillain-Barré syndrome (GBS), an autoimmune disorder that attacks the nervous system and can result in life-long paralysis.3 Also on the rise are government conceded claims for shoulder injuries (SIRVA) caused by vaccine providers failing to properly administer vaccinations. GBS and SIRVA are in the process of being added to the federal Vaccine Injury Table4 to expedite the administrative vaccine injury claims process for those two injuries.
Under the 1986 law, the only adult vaccine injury claims that can be compensated by the VICP are for injuries caused by vaccines recommended by the CDC for “universal use” by children.5 Most, but not all, of the CDC recommended vaccines for adults are also recommended for children.6 The shingles (herpes zoster) vaccine and 23-valent pneumococcal vaccine (PNEUMOVAX 23) recommended for adults are not eligible for compensation under the VICP7 and federal health officials and the ACCV has wrestled in recent years with how to protect vaccine manufacturers and compensate adult vaccine injuries not covered by the VICP.
Vaccine manufacturers are also expanding their reach and developing vaccines solely for use by pregnant women. Currently, there are two vaccines under development for exclusive use by pregnant women for Respiratory Syncytial Virus (RSV) and group B streptococcal disease.
As a result, the ACCV recommended in 2013 that the U.S. Secretary of the Department of Health and Human Services (DHHS) pursue statutory changes to the 1986 law to extend vaccine injury compensation for injuries caused by vaccines being developed for exclusive use by pregnant women,8 as well as for live born infants injured by a these vaccines in utero (before birth).9 However, during a December 2015 ACCV meeting, the ACCV’s working group recommended not pursuing statutory changes to the 1986 law that would extend coverage to vaccines given to adults but not recommended for children.
In effect, unlike the legal requirement under the 1986 law that shields vaccine manufacturers from civil liability for government recommended vaccines for children that are also used by adults, vaccine injuries sustained by adults from vaccines used exclusively by adults (like shingles and PNEUMOVAX 23 vaccines) can pursue civil lawsuits against vaccine manufacturers and negligent physicians in order to obtain vaccine injury compensation.
While ACCV’s recommendations carry no legal authority, it does not appear likely that the DHHS Secretary will pursue legal changes necessary to cover adults. The vaccine manufacturer representative on the working group stated that vaccine manufactures did not support extending VICP coverage to adult-only vaccines, due to a potential risk of “certain groups” weakening the 1986 law’s liability protections if legal changes to the law were pursued.
Noe: This article is an excerpt from a federal vaccine advisory committee update published in the NVIC Newsletter and on NVIC.org on Feb. 22, 2016 by NVIC’s Executive Director, Theresa Wrangham, which can be read here.References:
1 Altarum Institute Determining the Feasibility of Evaluating the National Vaccine Injury Compensation Program. June 15, 2009.
2 VICP Data & Statistics Report—Petitions Filed, Compensated and Dismissed, by Alleged Vaccine, Since the Beginning of VICP, 10/01/1988 through 02/03/2016.
3 National Institutes of Health. NINDS Guillain-Barré Syndrome Information Page.
4 Federal Register Notice. National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table. 07/29/2015.
5 National Childhood Vaccine Injury Act of 1986 (42 U.S.C. §§ 300aa-1 to 300aa-34).
6 Centers for Disease Control and Prevention (CDC). Recommended Adult Immunization Schedule—United States 2002-2003. Morbidity and Mortality Weekly Report Oct. 11, 2002.
7 CDC. Recommended Adult Immunization Schedule for Adults Aged 19 Years or Older, by Vaccine and Age Group. 2016.
8 Advisory Commission on Childhood Vaccines. MIWG Response to Secretary on Compensability of In Utero Injuries from Vaccines Not Currently Covered. Dec. 3, 2013.
9 Advisory Commission on Childhood Vaccines. MIWG Response to Secretary on Compensability of In Utero Injuries from Covered Vaccines. Dec. 3, 2015.