Nepal gives emergency use approval to Bharat Biotech’s Covaxin

PTI, Mar 20, 2021, 1:34 PM IST

Kathmandu: Nepal’s national drug regulatory authority on Saturday granted emergency use approval to Bharat Biotech’s Covaxin, becoming the third country to approve India’s indigenously developed COVID-19 vaccine.

A meeting of the drug advisory committee of the Department of Drug Administration decided to issue a conditional emergency use authorization to India’s homegrown government-backed vaccine Covaxin, the third COVID-19 vaccine authorised in the country, The Kathmandu Post reported.

COVAXIN, which demonstrated an interim vaccine efficacy of 81 per cent in Phase 3 clinical trials in India, was approved for emergency use in India in January and Zimbabwe cleared it early this month.

Bharat Biotech had applied for emergency use authorization for its vaccine in Nepal on January 13. Of the three applications filed on January 13, the department had first granted emergency use authorization to Oxford-AstraZeneca on January 15.

The AstraZeneca vaccine, manufactured by the Serum Institute of India under the name of Covishiled, was then accordingly brought to the country.

Nepal granted emergency use authorization to BBIBP-CorV vaccine, developed by China’s Sinopharm on February 17.

Emergency use authorization (EUA) is granted for some drugs and vaccines by authorities during a declared emergency when officials can make a judgment that the drug is worth releasing, even without all the evidence that would fully establish its effectiveness and safety.

Such a decision is taken when there’s enough evidence to suggest that patients have benefitted from the drug/vaccine.

Nepal has used one million doses of AstraZeneca vaccines provided by India in January under grant assistance in sync with its ‘Neighbourhood First’ policy.

It is now also awaiting another consignment of 2 million AstraZeneca vaccines from the Serum Institute of India (SII).

The latest approval comes as authorities in Nepal said they were suspending their vaccination campaign because of a lack of supply. Nepal has reported 275,750 cases and 3,016 deaths so far, according to government data.