What I find amazingly stupid is that part of the push for the chickenpox vaccine was the experience in Japan where the vaccine has been in use for over 20 years, however, the shot is optional there so the majority DON'T get it...so the stats are based on a society with lots of natural circulating virus and infections that are STILL causing the natural booster effect. Which means, they have NO IDEA how effective (or ineffective) this vaccine may be when the boosting effect is minimized. That is even stated in the insert for the vaccine...unbelievable!!!!!!!
The answer won't be to pull this ridiculous vaccine, it will be to vaccinate with more doses, and a booster dose has already been approved in April of this year, and then they will push this vax on the adults as well...ack.
BL 103552/5079 Approval lettr for 2nd dose of varicella vax
Product Approval Information - Licensing Action
Proper name: Varicella Virus Vaccine Live
Manufacturer: Merck & Co, Inc, West Point, PA, License #0002
Indication for Use: Optional second dose for children 12 months to 12 years of age
Approval Date: 4/5/2005
Type of submission: Biologics License Application Supplementhttp://www.fda.gov/cber/products/varmer040505.htmhttp://www.fda.gov/cber/label/varmer040505LB.pdf
Product Approval Information
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
April 5, 2005
Submission Tracking Number (STN): BL 103552/5079
David Gutsch, M.D.
Merck & Co., Inc.
P.O. Box 4, BLB-22
West Point, PA 19486
Dear Dr. Gutsch:
The Supplement to your Biologics License Application for Varicella Virus Vaccine Live (VARIVAX), to include an optional second dose for children 12 months to 12 years of age, has been approved. This information will be included in your License Application file.
All applications for new active ingredients, new dosage forms, new indications, new routes of administration, and new dosing regimens are required to contain an assessment of the safety and effectiveness of the product in pediatric patients unless this requirement is waived or deferred. We note that you have fulfilled the pediatric study requirement for this application.
--- signature ---
Philip R. Krause, M.D.
Division of Viral Products
Office of Vaccines Research and Review
Center for Biologics Evaluation and Researchhttp://www.fda.gov/cber/approvltr/varmer040505L.htm