The government expects the World Health Organization (WHO) to provide approval for emergency use to Covaxin in the next 2-3 months, the Health Ministry has told Parliament.
In a written response to the Rajya Sabha on July 20, Minister of State for Health and Family Welfare Bharati Pravin Pawar said Covaxin manufacturer Bharat Biotech International Limited submitted the data required for approval to the WHO on July 9.
"Based on time taken for approval of other COVID-19 vaccines, it is estimated that the WHO-EUL process takes approximately 2 to 3 months from the date of submission," Pawar said, responding to a question by Shiv Sena MP Priyanka Chaturvedi.
According to the WHO, its Emergency Use Listing Procedure (EUL) is a risk-based procedure for assessing and listing unlicensed vaccines, therapeutics and in vitro diagnostics with the ultimate aim of expediting the availability of these products to people affected by a public health emergency.
The WHO's approval of Covaxin will be significant as it will likely lead to more international acceptance of the vaccine. It will also boost prospects of international travel for the many Indians who have taken Covaxin, as it is currently excluded from the list of globally accepted vaccines.
The approval will also allow Covaxin to join the WHO’s COVAX vaccine alliance which is ensuring supply for other countries. So far, only six vaccines have EUL from the apex global health body – AstraZeneca-Oxford, Moderna, Johnson & Johnson, Pfizer-BioNTech, Sinopharm and Sinovac.
India's other major vaccine, Covishield manufactured by Serum Institute of India has received WHO prequalification.
Earlier this year, the government had streamlined regulatory norms for approval of import and usage of offshore manufactured vaccines in India. It had allowed all foreign vaccines that have already been granted Emergency Use Authorisation (EUA) in other countries.
This allowed all vaccines currently approved by the United States Food and Drug Administration (USFDA), the European Medicines Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) to be sold in India soon.
On July 20, the government told Parliament that vaccine manufactured by Moderna has already been approved for import and usage in India by the national regulator i.e. Drug Controller General of India. "NEGVAC is in regular dialogue with offshore vaccine manufacturers for facilitating import of COVID-19 vaccines some of which have already received WHO Prequalification," it said.