Bharat Biotech will be approaching the WHO for pre-qualification of Covaxin. The Covid-19 vaccine candidate has already been approved by the Indian drug regulator for emergency use even as Phase III trials are under way. It’s being administered along with Serum Institute’s Covishield as part of the nationwide vaccination campaign that started on Saturday.
Bharat Biotech has now set its eyes on tapping the overseas markets for the vaccine. “We are in the process of approaching the WHO for pre-qualification (of Covaxin) next week,” a comapny spokesperson told BusinessLine on Sunday.
The WHO pre-qualification is necessary for UN agencies and Gavi, the Vaccine Alliance, to purchase the vaccine in partnership with developing countries.
According to WHO, its pre-qualification of vaccines is a comprehensive assessment that takes place through a standardised procedure aimed at determining whether the product meets requirements for safety and efficacy in immunisation programmes.
The full pre-qualification assessment process includes review of production process and quality control procedures, laboratory testing, and WHO site audit to manufacturing facilities with the responsible National Regulatory Authority.
The Hyderabad-based vaccine maker signed an agreement last week with Precisa Medicamentos for supply of Covaxin in Brazil. In addition, about 15 countries are showing interest in Covaxin, according to the company.
Bharat Biotech is already a global supplier of vaccines with WHO pre-qualification. It’s pre-qualified vaccines include Biopolio, Rotavac and Typbar TCV.
The WHO is also awaiting data from Serum Institute of India (SII) on the AstraZeneca-Oxford University Covid-19 vaccine, so it can be evaluated and recommended for international use. – The Hindu BusinessLine