(STUDY) Safety concerns about rotavirus vaccine for babies in India

The following is from Children’s Heath Defense.

A study published Tuesday in the peer-reviewed journal The International Journal of Risk and Safety in Medicine found that Rotavac, the rotavirus vaccine used in India, increases the risk of intussusception in infants.

Intussusception is a condition where the intestine telescopes into itself and can lead to gangrene of the bowel or death if not treated immediately.

The paper was co-authored by Jacob Puliyel, MD of the International Institute of Health Management Research, India and Children’s Health Defense Chief Scientific Officer Brian Hooker, Ph.D.

A 2020 New England Journal of Medicine analysis found there was no risk of intussusception from Rotavac, a live attenuated rotavirus vaccine manufactured by Hyderabad-based Bharat Biotech. A statistical method called self-controlled case series (SCCS) determined that the risk of intussusception in the high-risk window (21 days after any dose of the vaccine) was comparable to the background risk.

Using the same raw surveillance data, Puliyel and Hooker used an alternate method called self-controlled risk interval (SCRI) to ascertain if the 2020 conclusion could be substantiated. They found that there was a 1.6-fold increase in the risk of intussusception in the vaccinated, which was missed in the earlier SCCS analysis. Additionally, the mean age of developing intussusception was lower in the vaccinated babies, putting them at risk of serious harm, including death.

The authors also performed a novel analysis of time-to-intussusception from the last vaccination. The number of babies developing intussusceptions was highest within a month after vaccination, with risks tapering off over time. They found 93 cases of intussusception in the first 30 days compared to 63 in the next 30 days. “This was statistically very significant and suggested vaccine risk very much like the SCRI analysis,” according to the paper.

“The first symptom of intussusception is typically the passage of blood and mucus in the stools,” said Dr. Hooker. “Parents can easily mistake this for infectious dysentery, which is more common. Intussusception often requires surgery to prevent death, so parents need to be informed and vigilant.”

The SCCS method is useful when the overall age of onset of intussusception is not altered by vaccination. The authors found that the rotavirus vaccine lowers the age of intussusception, rendering the standard SCCS analysis ineffective in detecting the risk of this serious adverse effect. “The original SCCS analysis had missed the risk and all previous SCCS studies may need to be re-evaluated,” the authors conclude.

The paper underscores the need for awareness of this risk from the Rotavac vaccine and the symptoms of intussusception among parents and caregivers.

“This is especially crucial when the vaccine is administered in remote rural areas to the infants of poor, illiterate parents as part of the national immunization programme,” said Dr. Puliyel. “Every parent must know the symptoms of intussusception so that the children impacted can receive emergency medical intervention.”

Dr. Puliyel emphasized that post-marketing surveillance can indicate if there is an increased risk, but without data from unvaccinated controls, the magnitude of the risk is difficult to estimate. He hopes that data from the original randomized control trial (RCT) in each of the three study centers in India will now be published.