The World Health Organization (WHO) has issued an emergency use listing (EUL) for COVAXIN® (developed by Bharat Biotech), adding to a growing portfolio of vaccines validated by WHO for the prevention of COVID-19 caused by SARS-CoV-2.
WHO’s EUL procedure assesses the quality, safety and efficacy of COVID-19 vaccines and is a prerequisite for COVAX vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.
“This emergency use listing expands the availability of vaccines, the most effective medical tools we have to end the pandemic,” said Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products. “But we must keep up the pressure to meet the needs of all populations, giving priority to the at-risk groups who are still waiting for their first dose, before we can start declaring victory.”
COVAXIN® was assessed under the WHO EUL procedure based on the review of data on quality, safety, efficacy, a risk management plan and programmatic suitability. The Technical Advisory Group (TAG), convened by WHO and made up of regulatory experts from around the world, has determined that the vaccine meets WHO standards for protection against COVID-19, that the benefit of the vaccine far outweighs risks and the vaccine can be used globally.
The vaccine is formulated from an inactivated SARS-CoV-2 antigen and is presented in single dose vials and multidose vials of 5, 10 and 20 doses.
COVAXIN® was also reviewed on 5 October by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), which formulates vaccine specific policies and recommendations for vaccines’ use in populations (i.e. recommended age groups, intervals between doses, specific groups such as pregnant and lactating women).
The SAGE recommended use of the vaccine in two doses, with a dose interval of four weeks, in all age groups 18 and above. COVAXIN® was found to have 78% efficacy 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.
Available data from clinical trials on vaccination of pregnant women are insufficient to assess vaccine safety or efficacy in pregnancy; however, initial studies were reassuring. The vaccine has been given to over 120,000 pregnant women in India, with no short-term adverse effects noted. Further studies in pregnant women are planned.