FDA advisers: Rotavirus vaccine OK

[Olney Blue]

WASHINGTON (AP) -- A vaccine against a virus that hospitalizes thousands of children in the U.S. with diarrhea and kills millions in developing countries moved a step closer to the U.S. market on Wednesday.

If the government gives the go-ahead, Merck & Co.'s vaccine would become the nation's second attempt at preventing rotavirus. A competitor's vaccine was pulled from the market six years ago because of a rare but life-threatening side effect.

Federal health advisers unanimously voted Wednesday that Merck's candidate, RotaTeq, seems safe and effective. They also urged careful monitoring to watch for that side effect, a twisted bowel condition, and other possible problems.

http://www.cnn.com/2005/HEALTH/parenting/12/14/rotavirus.vaccine.ap/index.html

[LeighAnn]

1. Blast from the Past

Burton Critical of Vaccine Approval Process

FDA and CDC Conflicts in Approval of Controversial Rotavirus Vaccine

The Committee found that three out of the five full-time FDA advisory committee members who voted for the vaccine had financial ties to Wyeth Lederle or two companies developing rival rotavirus vaccines -- Merck and SmithKline Beecham. Four out of eight CDC advisory committee members who supported the vaccine had conflicts with the same companies. The staff report concludes that the committees demonstrated a "lack of vigilance" in their review of the rotavirus vaccine known as "Rotashield", with the CDC’s committee rushing to approve guidelines for the vaccine even before the FDA had licensed it.

http://www.house.gov/burton/pr823a.htm

I wonder if anything has changed since those days (2000)

[still_one]

2. lets not cut our nose to spite our face

the christian right, i.e. family research council is also against approval of a cancer of the cervix vaccine because it "might" promote promiscuity

If there are issues with conflict of interest then those should be corrected, but to automatically reject life-saving vaccines is a much larger mistake

risk verses reward