National Childhood Vaccine Injury Act: Revision of the Vaccine Injury Table

PEDIATRICS ◽  
1996 ◽  
Vol 98 (6) ◽  
pp. 1179-1181
Author(s):  
Geoffrey Evans

The National Childhood Vaccine Injury Act of 1986 (the Act) established the National Vaccine Injury Compensation Program (VICP) as a federal "no-fault" compensation system for individuals who may have been injured by specific covered vaccines. Entering its ninth year of operation, the VICP has ensured childhood vaccine supplies by dramatically reducing vaccine companies' and providers' liability that threatened the production of vaccines during the 1980s. The VICP has received 5057 petitions filed for possible injury from vaccines covered under the VICP, including 4240 filed for vaccines administered before October 1988, and 817 for vaccines administered between October 1988 and August 1996. Over 3700 claims have been adjudicated, 985 of which have been found to be compensable, and the remainder have been dismissed. The Vaccine Injury Table (the Table) lists specific injuries or conditions and timeframes after vaccination that may be compensated under the VICP. The Table establishes legal presumptions about causation, which are used by the US Court of Federal Claims (the Court) to adjudicate petitions. The VICP covers seven "childhood" vaccines: diphtheria, pertussis, tetanus, measles, mumps, rubella, and polio. Effective March 10, 1995, the Table was revised to better reflect current scientific knowledge about vaccine injuries (Table 1). As part of the Act, Congress mandated a review of the scientific literature and other information on specific adverse consequences of pertussis and rubella vaccines. The Institute of Medicine (IOM) performed and published a report of this review in 1991, and a review of a follow-up study of the National Childhood Encephalopathy Study in 1994.

2020 ◽  
Vol 22 (10) ◽  
pp. 1805-1815 ◽  
Author(s):  
Jessica K Pepper ◽  
Anh Nguyen Zarndt ◽  
Matthew E Eggers ◽  
James M Nonnemaker ◽  
David B Portnoy

Abstract Introduction Pursuant to the Tobacco Control Act (TCA), the US Food and Drug Administration (FDA) is developing new cigarette health warnings to convey the negative health consequences of cigarette smoking. Aims and Methods This study assessed which of 15 revised warning statements (10 on topics similar to TCA statements and 5 on other topics) promoted greater understanding of cigarette smoking risks relative to TCA statements. In February 2018, adolescent and adult smokers and adolescents susceptible to smoking (n = 2505) completed an online experiment. Control condition participants viewed TCA statements; treatment condition participants viewed combinations of TCA and revised statements. Analyses compared revised statements to TCA statements on the same health topic or to randomly selected TCA statements if there were no statements on the same topic. Results Relative to TCA statements, 12 of 15 revised statements were more likely to be considered new information, and 12 resulted in more self-reported learning. Three revised statements made participants think more about health risks than TCA statements; the reverse was true for one revised statement. Participants rated most TCA and revised statements as moderately believable and informative. Seven revised statements were found to be less believable and factual, and one revised statement more believable and factual. Treatment condition participants correctly selected more smoking-related health conditions than control condition participants (13.79 versus 12.42 of 25). Conclusions Findings suggest that revised statements can promote greater understanding of cigarette smoking risks. Results informed FDA’s selection of warning text that was paired with images for testing in a follow-up study. Implications The US FDA may adjust the text of the cigarette warning statements provided in the TCA if the revised statements promote greater public understanding of the negative health consequences of cigarette smoking. Most of the revised warning statements tested were more likely to be considered new information and resulted in more self-reported learning compared with paired TCA statements, providing support for using revised statements as part of cigarette health warnings. These results informed the development of pictorial cigarette warnings by FDA that were tested in a follow-up study and included in a proposed rule.


1990 ◽  
Vol 33 (2-4) ◽  
pp. 116-120 ◽  
Author(s):  
J.L. Mills ◽  
J. Fradkin ◽  
L. Schonberger ◽  
W. Gunn ◽  
R.A. Thomson ◽  
...  

2017 ◽  
Vol 4 (6) ◽  
pp. 469-476 ◽  
Author(s):  
Deborah S Hasin ◽  
Melanie Wall ◽  
Katie Witkiewitz ◽  
Henry R Kranzler ◽  
Daniel Falk ◽  
...  

2021 ◽  
Vol 5 (6) ◽  
pp. e178
Author(s):  
Yenan Xu ◽  
Jarvis T. Chen ◽  
Isabel Holland ◽  
Jeff D. Yanosky ◽  
Duanping Liao ◽  
...  

Author(s):  
S.W. Nho ◽  
M. Kim ◽  
O. Kweon ◽  
S.‐J. Kim ◽  
M.S. Moon ◽  
...  

2012 ◽  
Vol 48 (2) ◽  
pp. 195-203 ◽  
Author(s):  
Gus Zhang ◽  
Carol S. North ◽  
Pushpa Narayanan ◽  
You-Seung Kim ◽  
Samuel Thielman ◽  
...  

eLife ◽  
2020 ◽  
Vol 9 ◽  
Author(s):  
Nicole C Woitowich ◽  
Annaliese Beery ◽  
Teresa Woodruff

In 2016, to address the historical overrepresentation of male subjects in biomedical research, the US National Institutes of Health implemented a policy requiring investigators to consider sex as a biological variable. In order to assess the impact of this policy, we conducted a bibliometric analysis across nine biological disciplines for papers published in 34 journals in 2019, and compared our results with those of a similar study carried out by Beery and Zucker in 2009. There was a significant increase in the proportion of studies that included both sexes across all nine disciplines, but in eight of the disciplines there was no change in the proportion studies that included data analyzed by sex. The majority of studies failed to provide rationale for single-sex studies or the lack of sex-based analyses, and those that did relied on misconceptions surrounding the hormonal variability of females. Together, these data demonstrate that while sex-inclusive research practices are more commonplace, there are still gaps in analyses and reporting of data by sex in many biological disciplines.


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