India Develops Rotavirus Vaccine for Developing Countries

Rotavirus vaccine Rotavac received WHO prequalification approval

indian mom and infant

The World Health Organization (WHO) has awarded prequalification status to the developing world’s first rotavirus vaccine, ROTAVAC®.

WHO Prequalification is necessary for UN agencies and Gavi, the Vaccine Alliance to purchase the vaccine in partnership with developing countries and will help accelerate the availability of ROTAVAC.

India already introduced ROTAVAC into its national immunization program during 2016 and has delivered approximately 35 million doses.

“The true impact of vaccines can be seen, when vaccinations are carried out in affected populations," said Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech.

Rotavirus is a contagious virus that can cause gastroenteritis (inflammation of the stomach and intestines). Symptoms include severe watery diarrhea, often with vomiting, fever, and abdominal pain. Infants and young children are most likely to get rotavirus disease.

They can become severely dehydrated and need to be hospitalized and can even die, says the Centers for Disease Control and Prevention.

Bharat Biotech has successfully miniaturized the dose volume of ROTAVAC to 0.5 ml/dose and is presented in a ready-to-use format, requiring no further reconstitution, similar to oral polio vaccines.

The product profile of ROTAVAC® has been optimally designed for the cold chain footprint, has been reduced to ~3 cm3 / dose, resulting in significant savings in cold chain storage and distribution costs.

The 0.5 ml dose volume also reduces the number of spit-ups by infants when the vaccine is administered.

The ROTAVAC® partnership has resulted in more than 15 international publications, including the pivotal phase III publication in Lancet in 2014.

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Steele, deputy director on the Enteric Diarrheal Diseases team at the Bill & Melinda Gates Foundation said, “The advent of a locally manufactured, WHO Prequalified rotavirus vaccine offers promise to protect children in India, Africa, the Americas and the rest of Asia from this debilitating disease.”

Two oral rotavirus vaccines are currently licensed for use in infants in the United States:

  • RotaTeq (RV5) is given in 3 doses at ages 2 months, 4 months, and 6 months
  • Rotarix (RV1) is given in 2 doses at ages 2 months and 4 months

The first dose of either vaccine is most effective if it is given before a child is 15 weeks of age. Also, children should receive all doses of rotavirus vaccine before they turn 8 months old.

The rotavirus vaccine cost varies depending on your insurance and which state you live.

The CDC Vaccine Price List provides the private sector vaccine prices for general information.

Vaccine discounts can be found here.

Vaccines, like any medicine, can have side effects, says the CDC. You are encouraged to report negative side effects of vaccines to the FDA or CDC.

Contacts: Bharat Biotech, Sheela Panicker, [email protected]