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Hepatitis B

SECOND TESTIMONY OF MICHAEL BELKIN

BEFORE THE ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES

CENTERS FOR DISEASE CONTROL AND PREVENTION

February 18, 1999 -- Atlanta Georgia

Michael Belkin, NVIC

The National Vaccine Information Center calls on the CDC to immediately make public all of the pre-licensure and post-licensure scientific data this Committee used to justify the safety of instituting a policy of universal vaccination of all newborn infants under two months of age with hepatitis B vaccine. We call on you to release to the public the scientific data, both basic science research into the biological mechanism of hepatitis B vaccine injury and death, and the case-controlled, long-term studies conducted on infants - including the location of the studies, the number and ages of infants enrolled and the time periods for follow-up for vaccine adverse events, including death, that you used to prove that this vaccine is safe to give to all
newborns.

We also call for the CDC and FDA to release to the public all scientific studies (if any) that were done to justify increasing the newborn dose of Merck Recombivax Hepatitis B vaccine from 2.5 mcg to 5 mcg in August 1998 -- after which my daughter died with the double dose. Finally, We request a detailed explanation of the statistical technique Dr. Chen from the CDC used to adjust the data in his Hepatitis B vaccine and Demyelination charts Results 1 and Results 2 in yesterday’s presentation and handout, which reduced the rate from 10 times that of other vaccines to below -- including references from statistical textbooks showing that the method he used is a legitimate technique in the field of statistics.

We expect to have the scientific data we requested no later than 30 days from today, a request we are also making under the Freedom of Information Act.

Thank you very much.

 

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