December 4, 2005

Offit's Vaccine Up For Approval by FDA

From John Gilmore at ACHAMP:

A vaccine for rotavirus (Rotateq) developed by Merck, the Children's Hospital of Philadelphia and Paul Offit, America's most quoted promoter and apologist for the vaccine industry, will be considered for licensure on December 14 and by the Vaccines and Related Biological Products Advisory Committee of the Center for Biologics Evaluation and Research of the FDA.

Offit and his partners Merck and the Children's Hospital of Philadelphia, first received a patent for a rotavirus vaccine in 1994. Offit later voted to add rotavirus vaccine (a variety from Wyeth not Merck) to the recommended schedule of vaccines when he was a member of the FDA's Advisory Committee of Immunization Practices. Despite his ownership of a rotavirus vaccine patent Offit saw no need to recuse himself from several votes on adding rotavirus to the schedule, which is one of the last steps to inclusion in the mandatory schedules, and a guaranteed market worth billions to a vaccine maker, and comes with complete immunity from lawsuits.

This vaccine was rushed into distribution has quickly shown to cause massive intestinal damage and death in a small but vulnerable subset of children. It was just as quickly removed form the market.

According to the FDA website three of the members of the Committee's members have applied for and received waivers dor potential conflicts of interest

Participation of the public is permitted in this meeting:

Date and Time:
The meeting will be held on December 14, 2005, 9:00 am to 4:30 pm; and on December 15, 2005, 9:00 am to 4:30 pm

Holiday Inn Select, 8120 Wisconsin Avenue, Bethesda, MD, 20814, 301-652-2000 .

Contact Persons:
Christine Walsh, R.N. or Denise Royster, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512391. Please call the Information Line for up-to-date information on this meeting.

On December 14, 2005, the Committee will hear presentations and make recommendations on the safety and efficacy of a Rotavirus Vaccine manufactured by Merck. On December 15, 2005, the Committee will hear presentations and make recommendations on the safety and efficacy of ZOSTAVAX (Zoster Vaccine Live [Oka/Merck] ) manufactured by Merck.

Oral Presentations:
Between approximately 1:15 and 1:45 pm, on December 14, 2005; and 1:30 and 2:00 pm on December 15, 2005, oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before December 7, 2005.

Paul Offit at The Children's Hospital of Philadelphia developed a vaccine based on a bovine strain of rotavirus (WC-3). Merck is currently running Phase III trials of a modified version of his quadravalent reassortant vaccine.

Aiming to avoid the adverse affects that RotaShield® was associated with, the vaccine is based on a bovine strain of rotavirus. The bovine strain was chosen because it replicates less prolifically in the human gastrointestinal tract than the simian strain used for the tetravalent rhesus reassortant vaccine. [1] Each of the five reassortants consists of the genetic backbone of the bovine virus with an inserted gene coding for a different human rotavirus surface protein. The inserted genes were selected to represent a broad range of serotypes in order to elicit protection against a wide variety of strains.

Genes coding for four VP7 proteins and one VP4 protein are included in the reassortants. Human serotypes G1, G2, G3 and G4 are represented by the four VP7 proteins, and serotype P1a is represented by the VP4 protein. [2]

Initial trials of a similar live quadrivalent human-bovine reassortant vaccine demonstrated promising protection against rotavirus infection. [3] Differing from the Merck vaccine only by the exclusion of serotype G4, this vaccine's results likely mirror the protection that RotaTeq® will afford.

The quadrivalent vaccine, which was delivered to vaccinees in three oral doses at 2, 4, and 6 months of age (identical to the Merck vaccine delivery schedule), showed 74.6% efficacy against any rotavirus infection and 100% efficacy against severe rotavirus infection. No increase in diarrhea, vomiting, fever or irritability was reported as compared to the recipients of the placebo.

The immunogenicity of the quadrivalent vaccine was reflected in an increased ratio of rotavirus specific IgA to total IgA as measured in the vaccinee's stool. [3]

Licensure of RotaTeq® by the FDA is predicted for 2005 if Phase III trials are successful.

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