kayaknya masih ada simpang siur kontradiksi masalah vaksin ini,
copas yaaahhh :
History of the VaccineTop
The rotavirus vaccines currently available in the US are both attenuated (weakened) live virus vaccines: Rotateq is a pentavalent human-bovine reassortant rotavirus vaccine licensed in 2006 and RotaRix is a monovalent attenuated human rotavirus licensed in 2008. Both vaccines are given by mouth.
A previously released rotavirus vaccine, RotaShield, was withdrawn from the market in 1999. RotaShield, was a tetravalent, reassortant rhesus-human rotavirus vaccine licensed by the Food and Drug Administration (FDA) in August 1998.
However, in July 1999, after approximately 1 million children had been immunized with that vaccine, the CDC suspended its recommendation because they detected an increase in the number of children who developed a serious bowel disease called “intussusception.” Investigators calculated that the risk of intussusception attributable to the vaccine was about 1 per 10,000 infants vaccinated which was about three times higher than for unvaccinated children. That vaccine was voluntarily withdrawn from the market by the manufacturer in October 1999. Those who received the RotaShield vaccine in 1998 and 1999 do not have a continuing risk of developing intussusception.
Both Rotateq and RotaRix were tested in many thousands of children before licensure. No association with intussusception was found for either vaccine. Because the two licensed vaccines are different, the vaccine series should be completed using the same brand of vaccine, although if the previous dose type is unknown, the next vaccine dose should not be delayed.
On March 22, 2010 the FDA recommended that the use of the Rotarix vaccine be suspended in the United States because of some DNA from a porcine (pig) virus detected in the vaccine. Subsequently, some DNA from this and another porcine virus were also detected in Rotateq. On May 14, 2010 the FDA updated their recommendations for the use of rotavirus vaccines based on a review of the literature and the input from experts. The FDA has determined that it is “appropriate for clinicians and health care professionals to resume the use of Rotarix and to continue the use of Rotateq” because both vaccines have excellent safety records and the benefits of the vaccines are substantial.
>> rekomendasi FDA ini yg dirubah menjadi 'suspended'
Who Should and Should Not Receive the VaccineTop
Who should receive the rotavirus vaccine?
Who should not receive the rotavirus vaccine?
- All full term infants should begin the series between the ages of 6-14 weeks of age. Breast fed infants can receive rotavirus vaccine.
- There is limited information on the immunization of infants born at less than 37 weeks gestation but consideration should be given for immunization of these children because they may be at increased risk for hospitalization from gastroenteritis in the first year of life.
- The vaccine series should not be initiated after 15 weeks of age.
- These vaccines should not be administered after 7 months of age because of insufficient data on vaccine safety in children who are 8 months of age and older.
- A child who has had a life-threatening allergic reaction to a previous dose or a component of the vaccine should not get another dose.
- A child who has had life-threatening allergic reaction to latex rubber should not receive the RotaRix vaccine which is packaged in a latex applicator.
- There is no safety information for administration of rotavirus vaccine to infants who are immunocompromised. However, both children and adults who are immunocompromised because of congenital immunodeficiency or following transplantation can experience severe and potentially fatal rotavirus gastroenteritis.
- Infants who have received blood products should have the vaccine postponed for 6 weeks unless that delay might make the child ineligible for vaccination because of age.
- Both children and adults who are immunocompromised because of congenital immunodeficiency or following transplantation can experience severe and potentially fatal rotavirus gastroenteritis. Prolonged infection with vaccine rotavirus virus has also been reported in immunocompromised children.
- There is no safety information related to the administration of vaccine to infants with pre-existing gastrointestinal disease but vaccine might be considered for these infants if they are not receiving immunosuppressive drugs.
- People who are moderately or severely ill should consult with their physician before receiving any vaccine.
so? faktor safety nya yg masih dirasa kurang, sehingga FDA mengeluarkan rekomendasi 'suspend'..
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