2 to 5 year old children targeted for Smallpox Vaccine trial_DHHS

2 to 5 year old children targeted for Smallpox Vaccine trial_DHHS

Sat, 2 Nov 2002

An announcement in the Federal Register, Oct 31, 2002, by the Office of Public Health and Science and Food and Drug Administration calls for public review and comment about proposals to the Secretary of Health and Human Services by Harbor-UCLA and Cincinnati Children’s Hospital for approval of a clinical trial testing the smallpox vaccine–Dryvax– on 2 to 5 year old children. http://www.fda.gov/OHRMS/DOCKETS/98fr/103102c.htm

Federal regulations prohibit conducting research on children that poses greater than minimal risk without a potential direct benefit to them or their condition. The regulations require that any such research proposal must be submitted to the Secretary who is required to convene a panel of experts and provide opportunity for public review and comment.(45 CFR 46.407)

The proposed vaccine trial would put healthy children at high risk of disfigurement and irreversible harm without commensurate evidence of imminent danger if not vaccinated.

Pursuant to HHS regualtions at 45 CFR46.407, The Alliance for Human Research Protection has requested the documents– including the protocol parental permission documents, and the reports of each of the experts. When we and our expert advisers have had an opportunity to review the material along with other relevant information we will submit our comments.

Concerns about the hazzards posed by the smallpox vaccine– most especially for children and those whose immune system has been compromised by various medications /or medical conditions, have led many knowledgeable experts to oppose the proposed innoculations.

For example, The Wall Street Journal reported that the CDC acknowledged in a briefing that “As many as 50 million Americans, including babies, pregnant women, people with the common skin rash eczema, as well as those with weakened immune systems, may be vulnerable to the vaccine’s risks.” [See: Ugly Side Effects of Smallpox Vaccine Color Terror Plans, by Marilyn Chase and Greg Hill, WSJ, Oct 21, 2002, front page]

To appreciate the potential severity of the children’s reaction to the vaccine, one should consider a series of slides that had been presented by one of the government’s top smallpox experts at a meeting in San Diego. According to the Wall Street Journal, these slides of children covered with disfiguring pockmarks had elicited gaspes from an audience of microbiologists. [See: http://phil.cdc.gov/Phil/results.asp?page1

Indeed, Paul Offit, chief of the infectious diseases section of Children’s Hospital of Philadelphia, who is also a member of the CDC advisory committee, said of the smallpox vaccine: “I would never give that vaccine to my children because right now there is no disease out there.”

See several AHRP Infomails providing links to additional sources of information: http://www.ahrp.org/infomail/0902/28.php

http://www.newsday.com/news/health/ny-hssmal252939369sep25.story http://www.usatoday.com/news/health/2002-10-07-smallpox-vaccines_x.htm

http://www.researchprotection.org/about/Nass.html

http://www.redflagsweekly.com/nasspubhlth.html

http://www.anthraxvaccine.org/response.htm

http://www.ahrp.org/infomail/1002/09a.php

http://www.nytimes.com/2002/10/08/health/policy/08DOCS.html?pagewanted=print&position=top

http://www.redflagsweekly.com/nass/2002_oct10.html

Vera Sharav