Rotavac

Rotavac is a live attenuated oral rotavirus vaccine developed to prevent rotavirus gastroenteritis, a leading cause of severe diarrhoea among infants and young children worldwide. Produced in India, Rotavac represents a significant achievement in indigenous vaccine research, development, and manufacturing. It offers an effective, affordable, and accessible solution to one of the most persistent causes of childhood morbidity and mortality, particularly in developing countries.

Background and Need for the Vaccine

Rotavirus is a highly contagious virus that infects the intestines and is transmitted primarily through the faeco-oral route. It is a major cause of acute watery diarrhoea in children under five years of age. Before the introduction of vaccines, rotavirus infections accounted for approximately half a million deaths annually worldwide, with the majority occurring in low- and middle-income countries.
In India alone, rotavirus was responsible for nearly one-third of all diarrhoeal deaths among children. Given the socioeconomic burden of hospitalisations, dehydration, and loss of productivity, the development of a low-cost vaccine became a public health priority.
Rotavac emerged from a collaborative initiative involving Indian and international research institutions, aiming to create a vaccine suitable for the Indian environment, genetic diversity, and affordability requirements.

Development and Research Collaboration

Rotavac was developed through a partnership led by Bharat Biotech International Limited, in collaboration with the Department of Biotechnology (DBT), Government of India, and international organisations including the National Institutes of Health (NIH), USA, and the Rotavirus Vaccine Program (PATH).
The vaccine’s origin traces back to the discovery of a naturally attenuated rotavirus strain, 116E, isolated from an asymptomatic newborn at the All India Institute of Medical Sciences (AIIMS), New Delhi, in the 1980s. This strain showed natural protection against severe rotavirus diarrhoea, making it a promising candidate for vaccine development.
Extensive preclinical studies and clinical trials followed over two decades, culminating in successful phase III trials involving approximately 7,000 infants across multiple Indian sites. The trials demonstrated high efficacy, safety, and immunogenicity of the vaccine against severe rotavirus gastroenteritis.

Composition and Mechanism of Action

Rotavac is a monovalent live attenuated vaccine containing the G9P[11] human-bovine reassortant rotavirus strain (116E). As an oral vaccine, it mimics natural infection by stimulating mucosal and systemic immune responses in the gastrointestinal tract.
When administered, the attenuated virus replicates in the intestine, prompting the immune system to produce antibodies against rotavirus. These antibodies provide protection against subsequent infections, particularly severe diarrhoeal episodes.
The vaccine does not cause disease because the viral strain has been weakened to remove its pathogenic potential while retaining immunogenicity.

Dosage and Administration

Rotavac is administered orally in three doses, recommended at:

• 6 weeks of age,
• 10 weeks of age, and
• 14 weeks of age.

Each dose consists of 0.5 ml of liquid suspension, given at the same time as other routine immunisations under the Universal Immunisation Programme (UIP) of India. The oral route simplifies delivery and increases compliance, especially in rural and resource-limited settings.
The vaccine must be stored at 2–8°C, maintaining the cold chain for optimal efficacy. Bharat Biotech later developed Rotavac 5D, a more thermostable formulation that remains stable even outside strict refrigeration for a limited period, improving logistical feasibility.

Efficacy and Safety Profile

Clinical trials of Rotavac demonstrated an efficacy of approximately 56–60% against severe rotavirus gastroenteritis during the first two years of life—a significant reduction in disease burden given the high prevalence of rotavirus in India.
The vaccine has been shown to reduce:

• Hospitalisations due to severe diarrhoea.
• Duration and severity of illness.
• Mortality associated with dehydration.

Post-marketing surveillance and large-scale safety evaluations confirmed that Rotavac has an excellent safety profile, with no evidence of increased risk of intussusception (a rare bowel obstruction), which had been a concern with some earlier rotavirus vaccines.

Regulatory Approval and Introduction in India

Rotavac received licensure from the Drugs Controller General of India (DCGI) in 2014, following rigorous evaluation. In 2016, the Government of India introduced Rotavac into the Universal Immunisation Programme (UIP), initially in select states and later expanded to the entire country.
India thus became one of the few countries to develop and produce its own rotavirus vaccine and include it in a national immunisation schedule. This achievement marked a milestone in India’s self-reliance in vaccine technology and public health innovation.

Global Recognition and Distribution

Rotavac was prequalified by the World Health Organization (WHO) in 2018, making it eligible for global procurement through agencies such as UNICEF and Gavi, the Vaccine Alliance. This recognition positioned Rotavac as an affordable vaccine option for other developing nations seeking to combat rotavirus-related diseases.
Following WHO prequalification, several countries in Asia and Africa adopted or approved Rotavac for use in their immunisation programmes, demonstrating its global applicability.

Cost and Accessibility

One of Rotavac’s most significant advantages is its affordability. Bharat Biotech priced the vaccine at approximately ₹60 per dose (around 1 US dollar) for public health programmes, making it substantially cheaper than earlier international alternatives.
This cost-effectiveness allows broader coverage under national immunisation schemes and ensures equitable access for low-income populations. The vaccine’s local production also reduces dependency on imported vaccines and strengthens national vaccine security.

Scientific and Public Health Impact

Rotavac has had a transformative effect on child health in India and other low-resource settings by reducing:

• Rotavirus-associated hospital admissions.
• Healthcare expenditure on diarrhoeal disease.
• Mortality among infants and young children.

It has also strengthened India’s position as a global vaccine innovator, contributing to research capacity and fostering international partnerships in vaccine development.
Furthermore, Rotavac’s success supports the Sustainable Development Goals (SDGs), particularly those related to child survival and reducing preventable deaths under Goal 3: Good Health and Well-Being.

Challenges and Future Directions

While Rotavac has achieved considerable success, challenges remain in ensuring:

• Cold chain maintenance in remote areas.
• Awareness and uptake among caregivers and healthcare workers.
• Continuous monitoring of vaccine effectiveness against emerging rotavirus strains.

Ongoing research focuses on enhancing strain coverage, thermostability, and duration of protection. The development of Rotavac 5D, which can be stored at higher temperatures for short periods, represents an important step towards overcoming logistical barriers.
Future versions may incorporate multivalent formulations targeting broader genotypes to ensure sustained efficacy across different regions.