Questionable new Vaccine Risk
On Friday February 15, it was announced that the investigational rotavirus vaccine (Rotarix), manufactured by GlaxoSmithKline Plc's, is associated with increased pneumonia-related deaths and other adverse reactions.
Rotavirus is a winter gastrointestinal virus that afflicts many young children, but even a very bad case of diarrhea is less worrisome than the increased risks they are seeing in these studies.
This announcement comes ahead of a Food and Drug Administration advisory meeting scheduled for Wednesday to consider approval of the oral vaccine.
The analysis looked at 11 studies and they showed a statistically significant increase in deaths related to pneumonia with the vaccine compared with placebo.
That largest study enrolled about 63,000 children and it also found an increase in convulsions in children given the vaccine.
Another study found an increased rate of bronchitis compared with placebo.
The FDA advisory panel will weigh the staff review of these studies and the data but the panel makes its own recommendation which is then followed by an official FDA announcement.
We'll have to wait and see what their decision will be.
Rotavirus is a winter gastrointestinal virus that afflicts many young children, but even a very bad case of diarrhea is less worrisome than the increased risks they are seeing in these studies.
This announcement comes ahead of a Food and Drug Administration advisory meeting scheduled for Wednesday to consider approval of the oral vaccine.
The analysis looked at 11 studies and they showed a statistically significant increase in deaths related to pneumonia with the vaccine compared with placebo.
That largest study enrolled about 63,000 children and it also found an increase in convulsions in children given the vaccine.
Another study found an increased rate of bronchitis compared with placebo.
The FDA advisory panel will weigh the staff review of these studies and the data but the panel makes its own recommendation which is then followed by an official FDA announcement.
We'll have to wait and see what their decision will be.
posted by Anonymous at 6:00 AM
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