Can the Rotavirus vaccine cause injury and/or death?

Can the Rotavirus vaccine cause injury and/or death?

Can the Rotavirus vaccine cause injury and/or death?

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.

Vaccines are pharmaceutical products and, like all pharmaceutical products, carry a biological risk of injury or death that may be greater for some than for others. The risk of injury or death from vaccination depends on the vaccine(s) administered and the individual's medical condition at the time of vaccination, history of vaccine reactions, and personal or family medical history.

There is a gap in medical knowledge in terms of predicting who will have an adverse reaction to vaccination, including reactions to rotavirus vaccine, and who will not.(1)

According to the US Centers for Disease Control and Prevention (CDC), mild vomiting and diarrhea, and irritability may occur after administration of the rotavirus vaccine. Use of rotavirus vaccines is also associated with an increased risk of intussusception, a severe intestinal blockage that requires medical attention and may require surgery. The CDC estimates that this increased risk of intussusception occurs within the first week after receiving the first or second dose of the vaccine, at a rate of one in 20.000 to one in 100.000 infants receiving the vaccine.(2)

The CDC also acknowledges the presence of porcine circovirus DNA in rotavirus vaccines, but reports that there are no known safety concerns related to these contaminants and that the viruses do not infect people.(3)

Adverse events reported by Merck in the RotaTeq vaccine package insert include:(4)

  • Commonly reported adverse events: Vomiting, diarrhea and irritability, fever, otitis media, nasopharyngitis and bronchospasm.
  • Reported Serious Adverse Events: Intussusception, bronchiolitis, pneumonia, fever, gastroenteritis, urinary tract infection, hematochezia (fresh blood in stool), seizures, Kawasaki disease, anaphylactic reaction, urticaria, angioedema, and death.

Adverse events reported by GlaxoSmithKline in the ROTARIX live rotavirus vaccine package insert include:(5)

  • Commonly Reported Adverse Events: Diarrhea, agitation/irritability, cough/runny nose, fever, loss of appetite and vomiting.
  • Reported serious adverse events: Intussusception, Kawasaki disease, hematochezia, gastroenteritis with vaccine viral shedding in infants with severe combined immunodeficiency (SCID), idiopathic thrombocytopenic purpura, seizures, pneumonia, and death.

The most commonly reported serious adverse reaction associated with rotavirus vaccines is intussusception. Intussusception occurs when part of the intestine pulls inward and can block the passage of food through the intestines. If there is a rush of blood to the affected part of the intestine, the death of that segment of intestine can occur. Also, if a hole occurs in the intestines, it can lead to infection, dehydration, shock, and can be life-threatening.(6-7) Both RotaTeq and ROTARIX, the two rotavirus vaccines available in Italy, can cause intussusception. 

In addition to intussusception, rotavirus vaccines have been associated with Kawasaki disease, a childhood condition that causes inflammation of the body's blood vessel walls. Notably, in RotaTeq's Phase 3 clinical trials, rates of Kawasaki disease within 42 days of vaccine administration were higher among children who received the vaccine than among those who did not. Published cases and reports of Kawasaki disease following vaccination with RotaTeq were also reported to the US Vaccine Adverse Events Reporting System (VAERS) postmarketing. Some studies, however, have found no increased risk of Kawasaki disease after the administration of the rotavirus vaccine.(8-9)

On March 22, 2010, the US Food and Drug Administration (FDA) announced that it has become aware that an independent US academic research team has found DNA from porcine circovirus 1 (PCV1) in the ROTARIX vaccine. The FDA has recommended that healthcare professionals temporarily suspend use of the ROTARIX vaccine in the United States, pending learning more about PCV1; however it was stated that this finding did not pose a safety concern and that PCV1 was not known to cause disease in humans or other animals.(10) On May 14, 2010, the US FDA announced that it had reviewed the scientific evidence and determined that the vaccine was safe and that use of the product should continue.(11) PCV1 remains a contaminant of the ROTARIX vaccine.(12)

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 was known to be a lethal porcine virus causing immunosuppression and severe wasting disease in pig pups, with lung, kidney, reproductive and brain problems and ultimately, 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 .(13) To date, PCV1 and PCV2 continue to contaminate RotaTeq vaccines.(14)

This article is summarized and translated by National Vaccine Information Center.


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