India / Bharat Biotech's rotavirus vaccine awarded WHO prequalification

New Delhi: Bharat Biotech International Limited announced on Monday that Rotavac 5D, a variant of its Rotavac vaccine, has received “Prequalification” from the World Health Organization (WHO). Rotavac is used to prevent rotavirus, which causes severe diarrhea and vomiting, and is mostly found in babies and children.

“Today’s announcement is an important step to further strengthen and fulfil Bharat Biotech’s vision to address neglected diseases, and prevent infections that continue to affect millions in the developing world,” a statement from Suchitra Ella, the Hyderabad-based pharmaceutical firm’s Joint Managing Director, said.

WHO’s website describes “prequalification” as a “systematic process to determine a manufacturer’s capacity to produce a product of consistent quality in accordance with international standards and specifications laid out by WHO/United Nations Population Fund (UNFPA).” The purpose, it says, is to ensure procurement and distribution of good quality products.

Once “prequalified,” vaccines can be procured by organisations such as the United Nations Childrens’ Emergency Fund (UNICEF) and Pan-American Health Organization (PAHO).

Rotavac 5D, which was rolled out in December 2019, has a “unique” vaccine formulation that can be administered without a “buffer,” Bharat Biotech’s statement noted. With a low dosage volume of 0.5 ml, the shot is easier to be stored, and further facilitates easy cold chain management and low biomedical waste disposal after vaccination, the statement noted further.

Bharat Biotech developed Rotavac, a first-generation vaccine, in a partnership with the Government of India’s Department of Biotechnology. 16 other international partners were also involved in the project. In March 2016, India became the first country in Asia to launch an anti-rotavirus vaccine, doing so under the Universal Immunisation Program (UIP).