India’s Rotavirus Vaccine Increases Risk of Serious Bowel Condition in Infants — Are U.S. Vaccines Any Safer?

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by John-Michael Dumais, Childrens Health Defense:

A rotavirus vaccine used in India increases infants’ risk of intussusception, a serious bowel condition that if left untreated could cause death, according to a new peer-reviewed study by Dr. Jacob Puliyel and Children’s Health Defense’s Brian Hooker, Ph.D. U.S. rotavirus vaccines may pose similar risks.

Rotavac, the rotavirus vaccine used in India, increases the risk of intussusception in infants, according to a peer-reviewed study published Tuesday in the International Journal of Risk & Safety in Medicine.

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Intussusception is a serious condition that occurs when the intestine slides or telescopes into itself, obstructing the bowel and potentially leading to gangrene or death if left untreated.

The study, co-authored by Dr. Jacob Puliyel of the Indian Institute of Health Management Research and Children’s Health Defense Chief Scientific Officer Brian Hooker, Ph.D., calls into question the safety of the vaccine and the statistical methods used in previous analyses of the product.

Puliyel told The Defender that although the rotavirus vaccines used in the U.S. — Merck’s RotaTeq and GSK’s Rotarix — are safer than the Rotavac brand used in India, a review of information sheets for the U.S. vaccines indicates concerns are still warranted.

Intussusception can be life-threatening

Puliyel and Hooker emphasized the need for parents and caregivers to be aware of the potential risk of intussusception associated with the Rotavac vaccine and to recognize the symptoms of this serious condition.

The sliding or telescoping of the intestine can block food or fluid from passing through and also can cut off the blood supply to the affected portion.

The most common symptoms in infants and young children include abdominal pain, vomiting, blood and mucus in stool, abdominal mass, and lethargy and irritability.

In a press release Wednesday, Hooker noted that “the first symptom of intussusception is typically the passage of blood and mucus in the stools,” sometimes referred to as “currant jelly” stool, which “parents can easily mistake … for infectious dysentery,” a more common condition.

As the condition worsens, infants may become increasingly lethargic, irritable and difficult to console. If left untreated, intussusception can lead to bowel necrosis, perforation and potentially life-threatening complications such as sepsis.

Intussusception often requires a fairly minor surgical intervention to prevent death, making it crucial for parents to be informed and vigilant.

This is especially important when the vaccine is administered in remote rural areas to the infants of poor, illiterate parents as part of a national immunization program such as India’s.

Study highlights Rotavac vaccine risks

Bharat Biotech’s Rotavac vaccine used in India is an oral monovalent, live, attenuated 116E strain formulation prepared in Vero (monkey kidney) cells. The three-dose administration takes place at 6, 10 and 14 weeks of age.

In 2013, Bharat Biotech and a consortium of organizations including the Bill & Melinda Gates Foundation completed the Rotavac clinical trial, which included a two-year follow-up. The vaccine was licensed in India in 2014.

The study by Puliyel and Hooker found a 1.6-fold increase in the risk of intussusception in vaccinated infants. An earlier analysis, published in 2020 in the New England Journal of Medicine (NEJM) did not find the increase. The NEJM study used the self-controlled case series (SCCS) method.

According to the new study, the increased risk rose to nearly 2.5 times within 21 days after the third dose. The study also revealed that the mean age of developing intussusception was lower in vaccinated babies — 205 days versus 223 days in the unvaccinated.

The SCCS method, used in the NEJM study, compares the incidence of an adverse event during a high-risk period following vaccination (the 21 days immediately after) to the incidence of intussusception in the same infant (28-365 days old) during a control period.

By comparing the number of intussusception cases during the high-risk period to the number of cases during the control period, researchers can see if there’s an increased risk of intussusception shortly after vaccination.

The NEJM study determined that the risk of intussusception in the high-risk window, defined as 21 days after any dose of the vaccine, was comparable to the background risk.

Puliyel and Hooker used several alternate statistical approaches, including one called self-controlled risk interval (SCRI), to reevaluate the data from the 2020 NEJM study.

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