What are Rotavirus vaccines?
IMPORTANT NOTE: Corvelva invites you to get in-depth information by reading all the sections and links, as well as the manufacturer's product leaflets and technical data sheets, and to speak with one or more trusted professionals before deciding to vaccinate yourself or your child. This information is for informational purposes only and is not intended as medical advice.
There are two anti-Rotavirus vaccines authorized by the Italian Medicines Agency (AIFA) and they differ in the methods of production and in the number of doses prescribed for administration. Both are administered orally and contain genetically engineered live attenuated human rotavirus strains or reassorted human-bovine (cow) rotavirus hybrid strains.
Rotateq - Sanofi Pasteur MSD (click to open)
RotaTeq is an oral, live virus vaccine indicated for active immunization of neonates for the prevention of gastroenteritis caused by rotavirus G1, G2, G3, G4 and P1 infection.
Dosage declared by the manufacturer
The full course of vaccination consists of three doses from 6 to 12 weeks of age.
Italian National Vaccination Prevention Plan (PNPV).
Two or three doses, depending on the vaccine, from the 3rd to the 7th month.
Adverse events declared by the manufacturer
- Upper respiratory tract infection
- nasopharyngitis
- otitis media
- anaphylactic reaction
- bronchospasm
- Diarrhea
- vomiting
- hematochezia
- upper abdominal pain
- intestinal intussusception
- rash
- urticaria,
- angioedema
- pyrexia
- irritability
- apnea in very premature infants (≤ 28 weeks of gestation),
- upper abdominal pain
- gastroenteritis with vaccine virus shedding in children with SCID.
During the experience Post-marketing has been observed the strain transmission vaccine virus to unvaccinated contacts. RotaTeq should be administered with ccare for individuals which are in ststraight contact with immunosuppressed individuals (eg., individuals with malignant disease or otherwise immunocompromised, or individuals who are subjected a immunosuppressive therapy). Also, those who take care of subjects recently vaccinated, must observebe careful hygiene measures, especially when are handledand biological secretions.
Cases of vaccinia associated gastroenteritis in infants with severe combined immunodeficiency (SCID) have been reported during post-marketing surveillance.
Excipients declared by the manufacturer
- Rotavirus type* G1
- Rotavirus type* G2
- Rotavirus type* G3
- Rotavirus type* G4
- Human-bovine rotavirus reassortant type* P1A (live), produced on Vero cells.
- Sucrose
- sodium citrate
- Sodium dihydrogen phosphate monohydrate
- Sodium hydroxide
- Polysorbate 80
- Culture medium (containing inorganic salts, amino acids and vitamins)
- Purified water
Curiosity
On May 7, 2010, the FDA announced that the RotaTeq vaccine was contaminated with DNA from two porcine circoviruses: PCV1 and PCV2. Although PCV1 has not been associated with clinical disease in pigs, PCV2 is a lethal virus that causes immunosuppression and severe wasting disease in dairy pigs that damages the lungs, kidneys, reproductive system and brain, and ultimately analysis, causes death. On March 22, 2010, the FDA recommended temporary suspension of use of the ROTARIX vaccine after PCV1 DNA was identified in ROTARIX, but did not request suspension of use of the RotaTeq vaccine after PCV2 was found in RotaTeq. To date, PCV1 and PCV2 continue to contaminate RotaTeq vaccines.
Rotarix-GlaxoSmithKline (click to open)
Rotarix is a live virus vaccine, for oral use, indicated for the active immunization of newborns for the prevention of gastroenteritis caused by infection with rotavirus strain RIX4414.
Dosage declared by the manufacturer
The full course of vaccination consists of two doses from 6 to 24 weeks of age.
Italian National Vaccination Prevention Plan (PNPV).
Two or three doses, depending on the vaccine, from the 3rd to the 7th month.
Reported adverse events
- Diarrhea
- Abdominal pain, flatulence
- Intestinal intussusception
- Hematochezia
- Gastroenteritis with vaccine virus shedding in children with Severe Combined Immunodeficiency (SCID) disease
- Dermatitis
- Urticaria
- Irritability
- Apnea in very premature infants (≤ 28 weeks of gestation)
Data from observational safety studies performed in several countries indicate that rotavirus vaccines carry an increased risk of intussusception, mostly within 7 days of vaccination.
Cases of transmission of excreted vaccine virus to seronegative contacts have been observed.
Declared qualitative composition
- Human rotavirus strain RIX4414 produced on lines True cell phones
- Sorbitol (E420)
- Sucrose
- glucose
- phenylalanine
- Destrono
- Dulbecco's modified culture medium (DMEM) (containing phenylalanine, sodium, glucose, and other substances)
- Solvent
- Calcium carbonate
- Xantana gum
- Sterile water
Curiosity
On March 22, 2010, the FDA announced that an independent US academic research group had found porcine circovirus 1 (PCV1) DNA in the ROTARIX vaccine. The FDA has recommended that healthcare professionals temporarily suspend use of the ROTARIX vaccine in the United States pending further information on PCV1; however, he said this finding did not pose a safety concern and stated that PCV1 was not known to cause disease in humans or other animals. On May 14, 2010, the FDA announced that it had reviewed the scientific evidence and determined that the vaccine was safe and that use of the product should continue. PCV1 remains a contaminant of the ROTARIX vaccine.
