The World Health Organization last week granted Covaxin an emergency use listing, or EUL, which means 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. 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 grant of the EUL was "a very significant step towards ensuring global access to India's widely administered, safe and efficacious (vaccine). As an organisation we have focused on maintaining stringent quality and safety standards that meet rigorous assessment and scientific standards established by WHO... EUL authorisation for Covaxin will enable us to contribute to accelerating the equitable access of Covid-19 vaccines..." Dr Krishna Ella, Bharat Biotech Chairman and Managing Director, said.
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 WHO had said it "understands many people are waiting for Covaxin to be included in the Covid-19 Emergency Use Listing" but had also stressed "we cannot cut corners before recommending a product for emergency use... we must evaluate thoroughly to make it is safe and effective".
The WHO also underlined its trust of the Indian vaccine industry, and in its defense, referred to the 30 days it took for an EUL for Serum Institute's Covishield (the AstraZeneca-Oxford University shot). "... this is not about moving quicker with one or another vaccine. We really trust the Indian industry."
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.
