The World Health Organization on Wednesday 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 is the only vaccine which has shown best results against COVID-19 particularly delta variant in pioneer studies but it had to wait for a long time because of political turmoil that move around western countries. US, European and even Chinese vaccines were given approval as soon they submitted data but Bharat Biotech was enquired several times on small points even when it submitted data in June 2021. Now more than 100 crore doses have been given in India in total with no adverse event reporting.
It is also noted that COVAXIN is the only vaccine which did not show any severe side effects unlike Pfizer and Astrazeneca which were widely criticized but given EUA. Now, when people have started questioning WHO approval process it is bound to give approval to Covaxin.
Today, 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.
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”.
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.