Who is responsible for monitoring vaccine's safety?

Unlike nearly every other company in America, pharmaceutical companies have almost no liability for injuries caused by their vaccine products.
By granting immunity from actual or potential liability from injuries caused by vaccines, Congress eliminated the market forces that are generally relied upon to assure the safety of all other products. As the 1986 Act expressly provides: “No person may bring a civil action … against a vaccine administrator or manufacturer in a State or Federal court for damages arising from a vaccine-related injury or death.” Every pediatric vaccine recommended by the CDC creates for its manufacturer a liability-free captive market of 78 million children with guaranteed payment. So, who is there making sure vaccines are SAFE since manufacturers have no financial incentive do to so.




As 1 In 2016, the IOM formally changed its name to the National Academies of Sciences, Engineering, and Medicine. explained by the Institute of Medicine (IOM)1 , by 1986, the “litigation costs associated with claims of damage from vaccines had forced several companies to end their vaccine research and development programs as well as to stop producing already licensed vaccines.”2

Instead of letting market forces compel vaccine makers to create safer vaccines, Congress granted pharmaceutical companies financial immunity from injuries caused by vaccines recommended by the CDC. 3 Congress did so by passing the National Childhood Vaccine Injury Act (the 1986 Act). 4

By granting immunity from actual or potential liability from injuries caused by vaccines, Congress eliminated the market forces that are generally relied upon to assure the safety of all other products.

As the 1986 Act expressly provides: “No person may bring a civil action … against a vaccine administrator or manufacturer in a State or Federal court for damages arising from a vaccine-related injury or death.”5

The 1986 Act even shields vaccine makers from liability where it is clear and unmistakable that the vaccine in question could have been designed safer. 6 As recently explained in a U.S. Supreme Court opinion: [N]o one—neither the FDA nor any other federal agency, nor state and federal juries—ensures that vaccine manufacturers adequately take account of scientific and technological advancements. This concern is especially acute with respect to vaccines that have already released and marketed to the public. Manufacturers ... will often have little or no incentive to improve the designs of vaccines that are already generating significant profit margins.7

Recognizing that the 1986 Act eliminated the incentive for vaccine makers to assure the safety of their vaccine products, the 1986 Act explicitly places this responsibility in the hands of the United States Department of Health & Human Services (HHS).8  




As provided in the 1986 Act, HHS is responsible for “research ... to prevent adverse reactions to vaccines,” “develop[ing] the techniques needed to produce safe ... vaccines,” “safety ... testing of vaccines,” “monitoring ... adverse effects of vaccines,” and “shall make or assure improvements in ... the licensing, manufacturing, processing, testing, labeling, warning, use instructions, distribution, storage, administration, field surveillance, adverse reaction reporting, ... and research on vaccines in order to reduce the risks of adverse reactions to vaccines.”9

Since passage of the 1986 Act, the number of required pediatric vaccines has grown rapidly. In 1983, the CDC’s childhood vaccine schedule included 11 injections of 4 vaccines.10



As of 2017, the CDC’s childhood vaccine schedule includes 56 injections of 30 different vaccines. It is only when the CDC adds a vaccine to its recommended vaccine schedule that the manufacturer is granted immunity from liability for vaccine injuries.

And due to a federal funding scheme, CDC recommended vaccines are then made compulsory to American children under state laws and subsidized by the Federal government for children unable to afford the vaccine.13

The end result is that under the 1986 Act, every pediatric vaccine recommended by the CDC creates for its manufacturer a liability-free captive market of 78 million children with guaranteed payment. This incentive structure is unequal in the marketplace and eliminates the normal market forces driving product safety. Hence the 1986 Act’s transferred essentially all responsibility for vaccine safety from the pharmaceutical companies to HHS.



Read this important letter putting Health and Human Services on notice for failing to conduct proper science to demonstrate vaccine safety. "ICAN lays out the provisions of the (1986 Act) that legally require HHS to conduct science that reduces the risk of all vaccine injury. Failure to do so could result in legal action against HHS on behalf of the American public."
http://www.icandecide.com/white-papers/ICAN-HHS-Notice.pdf



2 https://www.nap.edu/read/2138/chapter/2#2
3 42 U.S.C. § 300aa-1 et seq.
4 Ibid.
5 42 U.S.C. § 300aa-11
6 Bruesewitz v. Wyeth LLC, 562 U.S. 223 (2011)
7 Ibid.
8 42 U.S.C. § 300aa-2; 42 U.S.C. § 300aa-27
9 Ibid.
10 https://www.cdc.gov/vaccines/schedules/images/schedule 1983s.jpg
11 https://www.cdc.gov/vaccines/schedules/hcp/imz/child-adol escent.html (note that the influenza vaccine is different every year)
12 The rapid growth of CDC’s vaccine schedule is excepted to accelerate since there were 271 new vaccines under development in 2013 and far more currently under development. http://www.phrma.org/press-release/medicines-in-developme nt-vaccines (listing 2,300 trials in search for “vaccines” between 2013 and 2017)
13 See Section IV below.
14 https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/ 103795s5503lbl.pdf
15 https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/ 020702s056lbl.pdf
16 https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/ 103000s5302lbl.pdf

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