Indigenous Rotovac Vaccine Raises Safety Concerns


Highlights:

  • Rotovac is linked to a 1.6-fold increase in intussusception risk

  • Bharat Biotech refutes study findings, citing thorough safety evaluations

  • Emphasis on parental awareness and ongoing vigilance in vaccine programs

Bharat Biotech’s Rotovac, an indigenous rotavirus vaccine included in the Indian government’s immunisation program, has recently come under scrutiny. A study reported by the Economic Times from the International Journal of Risk and Safety in Medicine has linked the vaccine to an increased risk of intussusception in infants (1✔ ✔Trusted Source
Rotavirus vaccine in India faces controversy

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).

Rotovac and Its Potential Risks

Intussusception is a severe medical condition where a part of the intestine folds into an adjacent section. This can lead to severe complications, including bowel gangrene and potentially death if not treated immediately. It is crucial to understand this risk, especially in the context of widespread vaccination programs.

The study, co-authored by Jacob Puliyel, MD of the International Institute of Health Management Research, India, and Brian Hooker of Children’s Health Defense, found a 1.6-fold increased risk of intussusception among infants vaccinated with Rotovac. This heightened risk was not detected in initial analyses, raising concerns about the vaccine’s safety profile. Puliyel emphasized the importance of parents being aware of this risk since the symptoms of intussusception can resemble those of dysentery.

Bharat Biotech’s Safety Assurance

Bharat Biotech reaffirmed the safety of Rotovac, highlighting that it is manufactured from human rotavirus strains, not animal origins. They criticized the recent study’s methodology, claiming it deviated from established statistical plans, thereby questioning its validity. The company remains confident in the vaccine’s safety and efficacy.

While Bharat Biotech stands by its product, the study underscores the need for ongoing vigilance and transparency in vaccination programs. It is essential for healthcare providers and parents to stay informed about potential risks associated with vaccines to make well-informed decisions for their children’s health.

The debate over Rotovac’s safety highlights the complexities and challenges in vaccine safety monitoring. As research continues, it is vital to balance the benefits of widespread immunisation against potential risks, ensuring the well-being of all infants.

Awareness is the first step toward ensuring our children’s health and safety.

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Reference:

  1. Rotavirus vaccine in India faces controversy – (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3761026/)

Source-Medindia





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