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3l.3 What is the current status of the rotavirus vaccine?




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This article is from the Childhood Vaccinations FAQ, by Lynn Gazis-Sax lynng@alsirat.com with numerous contributions by others.

3l.3 What is the current status of the rotavirus vaccine?

On October 15, 1999, Wyeth Lederle Vaccines announced that it has
withdrawn its RotaShield vaccine from the market and has requested the
immediate return of all doses of the vaccine. The company's press
release can be accessed at the web address
below. http://www.ahp.com/releases/wa_101599.htm

A brief history of the release and withdrawal of this vaccine follows.

After years of research (animal studies beginning in 1983, and human
trials in 1987) into an effective rotavirus vaccine (with a couple of
candidates being rejected), a live, oral, tetravalent rotavirus
vaccine was approved by the FDA on August, 1998. This vaccine is
composes of one rhesus monkey virus, and three genetically engineered
combinations of rhesus monkey and human rotavirus. In the December,
1998 issue of Pediatrics, the AAP Committee on Infections Diseases
recommended that the vaccine be added to the standard vaccination
schedule, with shots being given at 2, 4, and 6 months, with the
understanding that it might take time to incorporate the new vaccine
into the schedule.

On July 18, 1999, US health officials recommended postponement of
rotavirus vaccine. Shipments have temporarily been suspended. The
company which makes the vaccine is working with the CDC to investigate
reports of bowel obstruction among infants who received the
vaccine. An additional reason for postponement was the fact that the
rotavirus season, in the US, occurs during the winter, allowing
several months for investigation of these adverse reactions, before a
decision needed to be made about whether the vaccine should be used
prior to this year's rotavirus season. Results of a case-control study
were expected to be available by October, 1999. Additional studies
could continue into next year. Further information from the CDC about
rotavirus vaccine and intussusception can be found at
http://www.cdc.gov/nip/Q&A/genqa/Rotavirus.htm and at
http://www.cdc.gov/nip/news/rotavirus.htm.

 

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