New Delhi: The World Health Organization (WHO) on Wednesday granted emergency use listing (EUL) to Bharat Biotech's Covid-19 vaccine Covaxin, the UN health body announced.
This means that the 'made-in-India' vaccine will finally be recognised by other countries and Indians who received the shot need not self-quarantine or face restrictions when travelling abroad merely on account of having no recognised vaccination.
Covaxin has been cleared for use in all age groups (18+) over two doses spaced four weeks apart. However, no recommendation has been made for use on children, and available data for use on pregnant women is insufficient to assess safety or efficacy, WHO said.
"The Technical Advisory Group (an independent panel that provides the WHO with vaccine recommendations) has determined Covaxin meets standards for protection against COVID-19... the benefit of the vaccine far outweighs risks (and) the vaccine can be used," the global health body said.
"Covaxin was also reviewed by WHO's Strategic Advisory Group of Experts on Immunization (SAGE), and recommended use of this vaccine (is) in two doses, with an interval of four weeks, in all age groups 18+," the WHO tweeted.
"Available data on vaccination of pregnant women with Covaxin are insufficient to assess vaccine safety or efficacy in pregnancy; studies in pregnant women are planned, including a pregnancy sub-study and a pregnancy registry," it said.
The WHO confirmed Covaxin had been found to be "78 per cent effective against COVID-19 of any severity, 14 or more days after the second dose, and is extremely suitable for low- and middle-income countries due to easy storage requirements".
Bharat Biotech said the grant of the EUL was "a very significant step towards ensuring global access to India's widely administered, safe and efficacious (vaccine)".
The EUL comes after a lengthy and rigorous review period - Bharat Biotech provided the first batch of data in July - that involves assurances about the vaccine's safety, efficacy and stability, as well as checks of production facilities.
The delay left millions in limbo; in particular, it was a huge problem for Indian students studying abroad in countries like Canada, the US, the UK, and Australia.
The approval is also likely to clear the way for India to commit vaccine supplies to COVAX - the global vaccine-sharing effort co-led by the WHO which aims to provide vaccines to poorer countries.