Finally, Covaxin gets WHO nod
New Delhi : A long wait for the approval on emergency use of Covaxin came to an end after WHO gave approval to the coronavirus vaccine. With this other countries will now recognize the vaccine and Indian travellers who have taken Covaxin shots will not require a quarantine on their arrival to a country.
Covaxin has been cleared for use in all age groups (18+) over two doses spaced four weeks apart.
"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.