Children's Health Defense Says Vaccine Adverse Event Reporting System Disregarded Regulations on Counting Serious Cases for Years, Resulting in a Grossly Inaccurate Safety Assessment

WASHINGTON, May 27, 2021 /PRNewswire/ -- A peer reviewed journal, Science, Public Health Policy, and The Law, published an article on vaccine adverse event reporting for human papilloma virus (HPV) vaccines earlier this month. The article calls into question the integrity of the U.S. Vaccine Adverse Event Reporting System (VAERS).

From 1998-2020, the Centers for Disease Control and Prevention (CDC) failed to acknowledge "persistent or significant disability/incapacity" as a serious adverse event (SAE) in VAERS, even though the Code of Federal Regulations requires that it be categorized as "serious." In a 2009 study on Merck's HPV vaccine Gardasil, the U.S. Food and Drug Administration (FDA) and CDC determined the rate of SAEs to be 6.2%, which they concluded did not signal a safety problem.

The FDA and CDC officials excluded "a persistent or significant disability/incapacity" as "serious" despite federal regulations to the contrary. They appear to have left out thousands of disability and incapacity reports from teenagers and young adults after Gardasil vaccination. An independent assessment of SAEs based on the correct regulatory definition suggests that VAERS was off by almost 400%. The article explores the implications of this grossly inadequate reporting.

Empirical evidence suggests that the VAERS mis-categorization of "serious" events hid major safety problems with Gardasil and possibly with other vaccines.

"The failure of the VAERS system is profound," said Robert F. Kennedy, Jr., Chair of Children's Health Defense. "This article pinpoints the FDA and CDC's dereliction of duty regarding Gardasil vaccines; its implications are enormous." Lead authors Lucija Tomljenovic and Emily Tarsell agree new surveillance methods are critically needed and long overdue.

The article is available here.

Contact
Rita Shreffler
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SOURCE Children's Health Defense

Related Links

http://www.childrenshealthdefense.org