Rotavirus vaccine: tortured data analyses raise false safety alarm

Sub: Science and tech

Sec: Health

Context:

A recent study has revealed that Rotovac, an indigenous rotavirus vaccine by Bharat Biotech can lead to bowel complications.

More on news:

According to the study, the vaccine which is a part of the government’s immunization programme, has been associated with an increased risk of intussusception in infants.
0.5 billion doses of Rotovac have been used globally to date.

Bharat Biotech Reaction:

Bharat Biotech dismissed the study and stated that the vaccine’s safety had been rigorously evaluated.

Virologist Dr Gagandeep Kang study:

The main objective was to monitor Bharat Biotech’s rotavirus vaccine (Rotavac) for any increased risk of intussusception after any dose of the vaccine.
Three doses of the vaccine are administered at 6, 10, and 14 weeks of age.
The vaccine was introduced into the universal immunization programme in a few States in 2016 and across India in 2019.

About Rotavirus:

Rotaviruses are the most common cause of diarrhoeal disease among infants and young children. Nearly every child in the world is infected with a rotavirus at least once by the age of five.
Immunity develops with each infection, so subsequent infections are less severe.
Adults are rarely affected.

About Rotavirus Vaccine:

The rotavirus vaccine is a vaccine used to protect against rotavirus infections, which are the leading cause of severe diarrhea among young children.
The vaccines prevent 15–34% of severe diarrhea in the developing world and 37–96% of the risk of death among young children due to severe diarrhea.
Rotavirus vaccine is administered by putting drops in the child’s mouth.
Babies should get 2 or 3 doses of rotavirus vaccine, depending on the brand of vaccine used.
The first dose must be administered before 15 weeks of age.
The last dose must be administered by 8 months of age.

What is Intussusception?

Intussusception is a serious condition where one part of the intestine slides into the next, potentially leading to bowel gangrene or even death without immediate treatment.
Intussusception is a medical emergency involving obstruction of the intestine. It can be fatal if not treated.
It occurs most often in children.
Symptoms include sudden, loud crying that comes and goes every 15 to 20 minutes, vomiting, and stool mixed with blood and mucus.